Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Air Force Department
Federal Energy Regulatory Commission
Agency for Toxic Substances and Disease Registry
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
U.S. Citizenship and Immigration Services
Fish and Wildlife Service
Indian Affairs Bureau
Federal Aviation Administration
Federal Highway Administration
Federal Transit Administration
National Highway Traffic Safety Administration
Foreign Assets Control Office
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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Office of Personnel Management.
Direct final rule; confirmation of effective date.
The Office of Personnel Management (OPM) is confirming the effective date of its direct final rule amending 5 CFR part 591, subpart A, to increase the governmentwide maximum annual uniform allowance rate to $1,500 and make related technical and clarifying changes. OPM received no significant adverse comments during the comment period and therefore confirms the rule will become effective as scheduled.
The effective date of July 13, 2026, for the direct final rule published on April 14, 2026, (91 FR 19057) is confirmed.
Please refer to the direct final rule published at 91 FR 19057 (April 14, 2026) for address information.
Ed Ames, Office of Personnel Management, Workforce Policy and Innovation, (202) 606-2858,
On April 14, 2026, OPM published in the
A significant adverse comment is a comment where the commenter explains why the rule would be inappropriate, challenges its underlying premise or approach, or shows why it would be ineffective or unacceptable without a change. A comment is adverse and significant if:
1. The comment opposes the rule and provides a reason sufficient to require a substantive response in a notice-and-comment process. For example, a substantive response is required when: (a) The comment causes OPM to reevaluate (or reconsider) its position or conduct additional analysis; (b) The comment raises an issue serious enough to warrant a substantive response to clarify or complete the record; or (c) The comment raises a relevant issue that was not previously addressed or considered by OPM.
2. The comment proposes a change or an addition to the rule, and it is apparent that the rule would be ineffective or unacceptable without incorporation of the change or addition; or
3. The comment causes OPM to make a substantive change to the rule.
As discussed in more detail in Section II, “Public Comment Analysis,” OPM evaluated the comments received against the criteria described above and determined that none of the comments rose to the level of a significant adverse comment.
OPM received 12 timely comments related to the direct final rule. Commenters included individual Federal employees and private citizens and two labor organizations representing Federal employees in uniformed roles. Commenters overwhelmingly supported the increase in the governmentwide maximum annual uniform allowance, explaining that costs of uniform items such as specialized firefighting and public safety uniforms, jackets, pants, shirts, and boots have risen substantially since the last adjustment in 2007 and now often exceed the $800 maximum allowance. Commenters stated that employees frequently must purchase multiple complete uniform sets to meet agency requirements, which can lead to significant out-of-pocket expenses and affect morale and retention.
Several commenters also supported OPM's clarification of the distinction between uniforms and personal protective equipment and the strengthened guidance on appropriate and inappropriate uses of uniform allowance funds, noting that these changes will improve transparency, accountability, and consistent implementation across agencies. One commenter suggested that OPM and agencies consider a mechanism to adjust uniform allowance amounts periodically based on changes in costs or inflation, and a labor organization and an individual commenter urged consideration of higher initial uniform allowance amounts for newly hired employees, particularly newly hired Federal civilian firefighters who must purchase several complete uniform sets at the outset of employment. One labor organization noted that its members in uniformed roles have observed that the agency has at times had difficulty sourcing American-made uniform components within previous allowance amounts.
OPM has considered these comments and agrees that uniform costs have increased significantly since the last governmentwide adjustment and that the increase in the governmentwide maximum annual uniform allowance rate to $1,500 is warranted.
The suggestion that OPM make periodic adjustments based on inflation to the maximum uniform allowance rate would require OPM to propose regulations and is not within the scope of this rulemaking. OPM notes that 5 CFR 591.104 allows an agency head to establish higher initial maximum uniform allowance rates for uniform costs greater than the new $1,500 maximum allowance rate to address its agency-specific needs. OPM believes the increase in the governmentwide maximum annual uniform allowance rate to $1,500 should provide agencies with greater flexibility when establishing agency-level uniform procurement arrangements. Accordingly, no change to the regulatory text is required.
After evaluating all of the comments received against the criteria for significant adverse comments described in Section I of this notice, OPM has determined that none of the comments
Accordingly, OPM is issuing this notice to confirm that the amendments to 5 CFR part 591, subpart A, published at 91 FR 19057 (April 14, 2026), will become effective on July 13, 2026.
Government employees, Travel and transportation expenses, Wages.
The Director of OPM, Scott Kupor, reviewed and approved this document and has authorized the undersigned to electronically sign and submit this document to the Office of the Federal Register for publication.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or removes Standard Instrument Approach Procedures (SIAPS) and associated Takeoff Minimums and Obstacle Departure procedures (ODPs) for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective June 26, 2026. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of June 26, 2026.
Availability of matters incorporated by reference in the amendment is as follows:
1. U.S. Department of Transportation, Docket Ops-M30. 1200 New Jersey Avenue SE, West Bldg., Ground Floor, Washington, DC 20590-0001.
2. The FAA Air Traffic Organization Service Area in which the affected airport is located;
3. The office of Aeronautical Information Services, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or,
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, visit
All SIAPs and Takeoff Minimums and ODPs are available online free of charge. Visit the National Flight Data Center at
Rune Duke, Manager, Standards Section, Flight Procedures and Airspace Group, Aviation Safety, Federal Aviation Administration. Mailing Address: FAA Mike Monroney Aeronautical Center, Flight Procedures and Airspace Group, 6500 South MacArthur Blvd., STB Annex, Bldg 26, Room 217, Oklahoma City, OK 73099. Telephone (405) 954-1139.
This rule amends 14 CFR part 97 by establishing, amending, suspending, or removes SIAPS, Takeoff Minimums and/or ODPS. The complete regulatory description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA Forms are 8260-3, 8260-4, 8260-5, 8260-15A, 8260-15B, when required by an entry on 8260-15A, and 8260-15C.
The large number of SIAPs, Takeoff Minimums and ODPs, their complex nature, and the need for a special format make publication in the
The material incorporated by reference is publicly available as listed in the
The material incorporated by reference describes SIAPS, Takeoff Minimums and/or ODPs as identified in the amendatory language for part 97 of this final rule.
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as amended in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flights safety relating directly to published aeronautical charts.
The circumstances that created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPs and Takeoff Minimums and ODPs, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPs contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedure under 5 U.S.C. 553(b) are impracticable and contrary to the public interest and, where applicable, under 5 U.S.C. 553(d), good cause exists for making some SIAPs effective in less than 30 days.
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 Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, 14 CFR part 97 is amended by establishing, amending, suspending, or removing Standard Instrument Approach Procedures and/or Takeoff Minimums and Obstacle Departure Procedures effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(f), 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the prognostic test for development or progression of preeclampsia 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 prognostic test for development or progression of preeclampsia. 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 June 26, 2026. The classification was applicable on May 18, 2023.
Joseph Kotarek, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3528, Silver Spring, MD 20993-0002, 301-796-2718,
Upon request, FDA (the Agency or we) has classified the prognostic test for development or progression of preeclampsia 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 Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
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 May 2, 2022, FDA received BRAHMS GmbH's request for De Novo classification of the B·R·A·H·M·S sFlt-1/PlGF KRYPTOR Test 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 May 18, 2023, 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 862.1602.
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 prognostic tests for development or progression of preeclampsia. 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 (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.
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 862 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Design verification and validation must include:
(i) Detailed documentation of a study that demonstrates the clinical performance of the device for its intended use, evaluated across multiple intended use sites and broad demographics representative of intended use patients in the United States; or through an alternative approach determined to be appropriate by FDA;
(ii) Detailed documentation of studies that demonstrate the analytical performance of the device for its intended use, including for each analyte and device output. These studies must include precision, reproducibility, metrological accuracy, and analytical specificity studies, or alternative approaches determined to be appropriate by FDA; and
(iii) As part of the risk management activities, documentation of an appropriate licensed practitioner training program on the proper use of the device and proper interpretation of results that must be offered to licensed practitioners, or an alternative approach determined to be appropriate by FDA.
(2) The labeling required under § 809.10(b) of this chapter must include:
(i) Detailed descriptions of the device studies demonstrating the performance of the device, including results; and
(ii) Limiting statements including the following:
(A) The test result is intended as an aid in the management of the patient, and not to be used to replace clinical judgement.
(B) The test result is not to be used to aid in the diagnosis of preeclampsia or conditions resulting from progression of preeclampsia.
(C) The test result is not to be used to aid in decisions of hospital discharge.
(D) The test result is not to be used to aid in decisions of pregnancy delivery.
(E) The test is not intended to inform the healthcare provider about whether or not changes in immediate treatment, including medication or hospitalization, are needed.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the SARS-CoV-2 serology test 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 SARS-CoV-2 serology test. 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 June 26, 2026. The classification was applicable on May 5, 2023.
Maria Esteve-Gasent, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3213, Silver Spring, MD 20993-0002, 301-837-7365,
Upon request, FDA (the Agency or we) has classified the SARS-CoV-2 serology test 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 Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
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 September 20, 2021, FDA received Ortho-Clinical Diagnostics, Inc.'s request for De Novo classification of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack and Calibrator. On September 21, 2021, FDA received Ortho-Clinical Diagnostics, Inc.'s request for De Novo classification of the VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack and Calibrator. FDA reviewed both requests in order to classify the devices 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
Therefore, on May 5, 2023, FDA issued an order to the requester classifying the devices into class II. In this final order, FDA is codifying the classification of the devices by adding 21 CFR 866.3983.
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.
At the time of classification, SARS-CoV-2 serology tests are for prescription use only. Therefore, these devices are subject to the prescription labeling requirements for in vitro diagnostic (IVD) products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)).
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 SARS-CoV-2 serology tests. 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 (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification
Biologics, Laboratories, 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 866 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes the device detects, the specimen types tested, the results provided to the end user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use, as appropriate.
(2) If sample collection devices are used, any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies, including the following, as applicable: Assay cutoff or limit of detection expressed in international standard units, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover and cross contamination, matrix equivalency, hook effect, specimen stability, precision, reproducibility, and clinical studies, including the time period in which the clinical performance was established and the variant(s) prevalent in the United States at the time of performance validation;
(iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) When applicable, performance results of the analytical study testing of a standardized reference material that FDA has determined is appropriate;
(v) Limiting statements that indicate:
(A) A negative test result does not preclude the possibility of infection;
(B) A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the specimen is below the detection limits of the assay, or the antibodies that are detected are not present during the stage of disease in which a sample is collected;
(C) There is a risk of erroneous results (
(D) The performance characteristics for that analyte were established when [insert predominant strain, subtype, or variant] was prevalent and that due to the propensity of the virus to mutate, new strains emerge over time which may affect the performance of this device and have serious public health implications;
(E) The test results should be interpreted in conjunction with other clinical and laboratory data available to the healthcare provider (as applicable);
(F) Positive and negative predictive values are highly dependent on prevalence;
(G) Accurate results are dependent on adequate specimen collection, transport, storage, and processing (as applicable). Failure to observe proper procedures in any one of these steps can lead to incorrect results;
(H) The test is not intended for donor screening; and
(I) The test is not intended to diagnose acute SARS-CoV-2 infection. An assay that directly detects the virus should be used to evaluate individuals for acute COVID-19, particularly those who have been in contact with the virus.
(vi) For devices intended for the quantitative detection of SARS-CoV-2 antibodies, labeling must include a prominent statement that includes the following: the test calibrators' traceability to a standardized reference material that FDA has determined is appropriate and the limit of blank, limit of detection, and limit of quantitation, with the defined analytical measuring interval.
(4) Design verification and validation must include:
(i) Detailed documentation of performance from a multisite clinical study with an appropriate number of clinical samples (
(ii) For any SARS-CoV-2 antibody test intended for use in near-patient settings, detailed documentation that demonstrates the effectiveness of risk control measures and device robustness, including flex studies, and performance with weakly-reactive samples when used by the intended operators;
(iii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as failure modes effects analysis and hazard analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains (
(iv) Documentation of the specific amino acid sequence of the SARS-CoV-2 target protein(s) that the device utilizes to detect specific antibodies to SARS-CoV-2;
(v) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including protein sequence target(s) for each analyte, design of target detection reagents, internal and external controls, and computational path from collected raw data to reported result (
(vi) For devices with associated software or instrumentation, documentation must include a detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users and patients as part of cybersecurity review;
(vii) For devices intended for the detection of SARS-CoV-2 antibodies for which a standardized reference material (that FDA has determined is appropriate) is available, the performance results of an analytical study testing this standardized reference material. Detailed documentation of that study and its results must be provided, including the study protocol, study report, testing results, and all statistical analyses;
(viii) Detailed documentation of analytical studies conducted as appropriate to the technology, specimen types tested, and intended use of the device, including precision, endogenous interferences, cross reactivity, carryover, matrix equivalency, class specificity, hook effect, and sample and reagent stability. Samples selected for use in analytical studies or used to prepare contrived samples for use in analytical studies must be from subjects with clinically relevant circulating antibodies to SARS-CoV-2 in the United States. Cross-reactivity studies must include samples from SARS-CoV-2 antibody negative subjects with antibodies to viruses, high prevalence disease agents, and normal or pathogenic flora. Endogenous interference studies must include SARS-CoV-2 antibody negative and low positive samples with endogenous interference substances, including antibodies present in autoimmune diseases that are reasonably likely to be encountered in clinical specimens under actual use conditions. In addition, for devices intended for the quantitative detection of SARS-CoV-2 antibodies, the information provided must also include the metrological calibration traceability hierarchy to a standardized reference material that FDA has determined is appropriate. As appropriate to the technology and specimen types tested, the information provided to support quantitative tests must also include studies to support the analytical measuring interval, including a limit of blank study, a limit of detection study, an upper and lower limits of quantitation study, a precision study, and a linearity study using clinical samples, and, using a standardized reference material that FDA has determined is appropriate, an accuracy study;
(ix) Detailed documentation of data and protocols, including acceptance criteria, from a real-time reagent stability study must include testing of samples with adequately challenging analyte concentrations and must include shelf-life stability and shipping stability, and, as applicable, in-use and open-kit stability and freeze-thaw stability. The shelf-life stability assessment must include a minimum of three lots;
(x) Detailed documentation of a multisite reproducibility study with testing conducted at a minimum of three sites;
(xi) Final release criteria to be used for manufactured test lots with appropriate evidence that lots released at the extremes of the specifications will meet the claimed analytical and clinical performance characteristics as well as the stability claims; and
(xii) Lot-to-lot precision studies, as appropriate.
(5) For any SARS-CoV-2 antibody test intended for use in near-patient settings, labeling must also include a brief reference sheet (quick reference instructions) for the intended user(s) that includes, at a minimum, the name and intended use of the test, easy to follow step-by-step instructions of all control and sample testing procedures for the claimed sample types, including graphic illustrations targeted towards lay users (as applicable), the result(s) interpretation guidance, warnings and limitation statements, toxicology information and safety considerations for any hazardous materials, information for troubleshooting (
(6) If one of the actions listed in section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to one or more of the analytes claimed in the intended use, or if the Secretary of Health and Human Services determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to one or more of the analytes claimed in the intended use:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized samples are available for test evaluation, the manufacturer must have testing performed on the device with those samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate; and
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized samples are available for test evaluation and continuing until 3 years from that date, the results of the emergency analytical reactivity testing, including the detailed information for the samples tested as described in the certificate of authentication, must be
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the breast implant suction retrieval system 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 breast implant suction retrieval system. 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 June 26, 2026. The classification was applicable on April 20, 2023.
Cal Rabang, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4633, Silver Spring, MD 20993-0002, 301-796-6412,
Upon request, FDA (the Agency or we) has classified the breast implant suction retrieval system 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 Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
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 November 21, 2022, FDA received Empower Medical Devices' request for De Novo classification of the Bateman Bottle. 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 April 20, 2023, 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 878.4675.
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. FDA supports the principles of the “3Rs,” to replace, reduce, and/or refine animal use in testing when feasible. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider whether such an alternative method could be assessed for equivalency to an animal test method.
At the time of classification, breast implant suction retrieval systems are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
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 breast implant suction retrieval systems. 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 (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.
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) Animal performance testing must demonstrate that the device performs as intended and will not result in tissue injury. Testing must:
(i) Demonstrate the ability to remove implants of the sizes and types specified in device labeling; and
(ii) Assess tissue integrity and injury at multiple time intervals to assess tissue healing response after device use.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including the following:
(i) Characterization of the range of device operation, including minimum and maximum vacuum suction parameters;
(ii) Durability and integrity testing; and
(iii) Characterization of control and variation of suction application.
(3) Performance testing must demonstrate the sterility of the device.
(4) Performance testing must support the shelf life of the device by demonstrating continued sterility,
(5) The tissue-contacting components of the device must be demonstrated to be biocompatible.
(6) Usability testing must demonstrate that intended users can correctly use the device, based solely on reading the directions for use.
(7) Labeling must include the following:
(i) Summary of device specifications, including vacuum suction pressure ranges and bottle capacity; and
(ii) Sizes and types of implants that can be removed with the device.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the foam or gel chemical sterilant/high level disinfectant 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 foam or gel chemical sterilant/high level disinfectant. 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 June 26, 2026. The classification was applicable on June 2, 2023.
Yongqing Chen, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4620, Silver Spring, MD 20993-0002, 240-402-9433,
Upon request, FDA (the Agency or we) has classified the foam or gel chemical sterilant/high level disinfectant 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 Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
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 July 13, 2022, FDA received Tristel Solutions Limited's request for De Novo classification of the Tristel Duo ULT device. 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
Therefore, on June 2, 2023, 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 880.6886.
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 foam or gel chemical sterilant/high level disinfectants. 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 (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.
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 880 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. The following performance characteristics must be evaluated under challenging conditions:
(i) Storage stability testing must demonstrate the real time stability and dynamics of the device formulation within the expiration date (shelf life) of the unopened product and within a use period of the opened container from the date of opening under the proposed storage conditions;
(ii) Transport stability testing must demonstrate device resilience to transport conditions (such as temperature, pressure, and humidity), environmental factors (such as freeze and thaw), and mechanical impacts (such as the effect of drops on package integrity);
(iii) Potency testing must demonstrate the sporicidal, mycobactericidal,
(iv) Simulated use testing must use the mycobacterium species most resistant to the germicide as the test organism on inoculated instruments to demonstrate a kill of at least 10
(v) In-use testing must test clinically-relevant microorganism on clinically used instruments, in accordance with the labeled contact conditions for high level disinfection, to confirm the results of simulated use testing;
(vi) Testing must demonstrate compatibility with labeled devices and materials; and
(vii) Chemical indicator validation must demonstrate a characteristic chemical reaction to the concentration of active ingredients of the germicide.
(2) The device must be demonstrated to be biocompatible.
(3) Human factors testing must demonstrate that the device can be used correctly, based solely on the device labeling.
(4) Labeling must include:
(i) Directions for use, including:
(A) Instructions for preparation and use of the germicide; cleaning steps in preparation for high level disinfection; high level disinfections of cleaned devices; rinsing, neutralizing, and removing residues, when needed; and reuse of the solution, if applicable; and
(B) Chemical indicator for monitoring the minimum effective concentration or minimum recommended concentration of the product's active ingredient(s);
(ii) Instructions for personal protective equipment to be used with the device;
(iii) Instructions for disposal of the germicide and any neutralizers, including an instruction to check local and state regulations;
(iv) Storage conditions and expiration date information for stock solution, opened containers, activated solution, and use-dilution;
(v) A statement that the end user should be trained in the reprocessing (decontamination and sterilization or disinfection) of medical devices and in the handling of toxic substances, such as liquid chemical germicides;
(vi) The germicide classification scheme;
(vii) General information on selection and use of germicides for medical device reprocessing;
(viii) Material and device compatibility and incompatibility information;
(ix) The microbial mode of action of germicidal activity;
(x) Precleaning agent/method compatibility and incompatibility; and
(xi) The toxicology profile of the final product formulation and information on adverse reactions following exposure to the product.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the infant supine sleep system 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 infant supine sleep system. 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 June 26, 2026. The classification was applicable on March 30, 2023.
Kathleen Everett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2522, Silver Spring, MD 20993-0002, 301-796-6292,
Upon request, FDA (the Agency or we) has classified the infant supine sleep system 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 Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
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
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 September 20, 2021, FDA received Happiest Baby, Inc.'s request for De Novo classification of the SNOO Smart Sleeper. 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 March 30, 2023, 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 880.5690.
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 infant supine sleep systems. 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 (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the
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 880 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360
(a)
(b)
(1) Premarket clinical information and, as determined by FDA, postmarket surveillance data acquired under anticipated conditions of use must be collected to fulfill the following:
(i) Demonstrate that the device holds the infant on the back;
(ii) Provide data on adverse events (including deaths and injuries) and malfunctions to demonstrate the device can be safely used in the intended use population; and
(iii) Provide data to demonstrate that use of the device does not increase the rate of SIDS/SUID in the intended use population.
(2) Human factors testing must demonstrate that the user can safely and correctly use the device.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
(i) Testing to ensure the mechanical and structural stability of the device and demonstrate that the device does not present a tipping hazard due to mechanical failures; and
(ii) Material compatibility testing to demonstrate that the cleaning instructions provided by the manufacturer do not cause crazing, cracking, or deterioration of the device.
(5) Labeling must include:
(i) Unless clinical performance data demonstrates that it can be removed or modified, a prominent warning that the device has not been demonstrated to reduce the risk of SIDS/SUID. Such warning must appear prominently on all labeling;
(ii) A summary of available clinical information with the device, including a discussion of adverse events;
(iii) A warning that the device is only indicated for use with infants who cannot consistently roll over;
(iv) Instructions to ensure proper fit;
(v) Instructions for cleaning the device; and
(vi) Information regarding safe sleep practices to ensure the safe use of the device, including:
(A) Recommendations for safe sleep environments; and
(B) The level of supervision necessary to monitor a sleeping infant.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the external lower extremity nerve stimulator for Restless Legs Syndrome 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 external lower extremity nerve stimulator for Restless Legs Syndrome. 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 June 26, 2026. The classification was applicable on April 17, 2023.
Chun Xu, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4256, Silver Spring, MD 20993-0002, 301-796-2068,
Upon request, FDA (the Agency or we) has classified the external lower extremity nerve stimulator for Restless Legs Syndrome 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
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 Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
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 September 21, 2022, FDA received Noctrix Health, Inc.'s request for De Novo classification of the NTX100 Tonic Motor Activation (NTX100 ToMAc) 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 April 17, 2023, 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 882.5887.
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.
At the time of classification, external lower extremity nerve stimulators for Restless Legs Syndrome are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
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 external lower extremity nerve stimulators for Restless Legs Syndrome. 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 (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.
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 882 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. This testing must include:
(i) Characterization of the electrical stimulation parameters, including the following: waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);
(ii) Characterization of the therapy output across sudden and rapid changes in load impedance; and
(iii) Characterization of electrode performance, including electrical performance, adhesive integrity, shelf life, reusability, and variation of impedance over the use of therapy.
(2) The tissue-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electrical, thermal, and mechanical safety along with electromagnetic compatibility of the device in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Physician and patient labeling must include the following:
(i) Recommended treatment regimens, including frequency and duration of use, and identification of application site(s);
(ii) Typical sensations experienced during treatment;
(iii) Methods for identifying the appropriate stimulation intensity that is needed to reduce symptoms of Restless Legs Syndrome and is tolerable to patients;
(iv) A shelf life for the electrode and reuse information;
(v) Summaries of the electrical stimulation parameters and device technical parameters (including any wireless specifications); and
(vi) Instructions on how to maintain the device, including all user-interface components.
Food and Drug Administration, HHS.
Final amendment; final order.
The Food and Drug Administration (FDA) is classifying the computerized behavioral therapy device for the treatment of fibromyalgia symptoms 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 computerized behavioral therapy device for the treatment of fibromyalgia symptoms. 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 June 26, 2026. The classification was applicable on May 9, 2023.
Amber Ballard, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4226, Silver Spring, MD 20993-0002, 204-402-9983,
Upon request, FDA (the Agency or we) has classified the computerized behavioral therapy device for the
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 Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.
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 November 21, 2022, FDA received Swing Therapeutics, Inc.'s request for De Novo classification of the Stanza device. 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 May 9, 2023, 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 882.5804.
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
At the time of classification, computerized behavioral therapy devices for the treatment of fibromyalgia symptoms are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.
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 computerized behavioral therapy devices for the treatment of fibromyalgia symptoms. 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 (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.
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 882 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
(a)
(b)
(1) Clinical data must demonstrate that the device performs as intended under the anticipated conditions of use and include the following:
(i) Evaluation of improvement in the symptoms of fibromyalgia; and
(ii) Evaluation of relevant adverse events.
(2) Software verification, validation, and hazard analysis must demonstrate that the device performs as intended.
(3) Physician and patient labeling must include the following:
(i) Recommended treatment regimes, including frequency and duration of use; and
(ii) A summary of the clinical data for the device, including a discussion of adverse events.
Coast Guard, DHS.
Notification of enforcement of regulation.
The Coast Guard will enforce safety zones for annually reoccurring fireworks events taking place on July 4, 2026 in the Los Angeles—Long Beach Captain of the Port Zone. This action is necessary and intended to provide for the safety of life and property on the navigable waterways during these events. During the enforcement periods, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any official patrol vessel.
The regulations in 33 CFR 165.1125 will be enforced on July 4, 2026 for the safety zones identified in the
If you have questions about this notification of enforcement, call or email Lieutenant Commander Kevin Kinsella, U.S. Coast Guard Sector Los Angeles—Long Beach at telephone (310) 467-2099 or email
The Coast Guard will enforce the safety zones in 33 CFR 165.1125 for the below listed events under Table 1 of § 165.1125, for the 2026 Fourth of July Fireworks Displays.
During the enforcement periods, as reflected in Table 1 of § 165.1125, if you are the operator of a vessel in the regulated area you must comply with directions from the Patrol Commander or any official patrol vessel.
In addition to this notification of enforcement in the
If the Captain of the Port Los Angeles—Long Beach determines that the safety zone need not be enforced for the full duration stated in this notice, the Captain of the Port may use a Broadcast Notice to Mariners to reflect the change.
Coast Guard, Department of Homeland Security.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters on the Ohio River from MM 602.0-605.0. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with an over water fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Ohio Valley, or their designated representative.
This rule is effective from 10:00 p.m. to 10:30 p.m. on June 27, 2026.
To view available documents go to
If you have questions about this rule, contact MST2 Shane Cuthrell, Sector Ohio Valley Waterways Management Division, U.S. Coast Guard; telephone 502-779-5348, or email
The Coast Guard received notification that on June 27, 2026, fireworks will be launched from a barge on the Ohio River in the Louisville, KY waterfront area. The Captain of the Port (COTP), Ohio Valley has determined that potential hazards associated with fireworks are a safety concern for anyone within a mile of the fireworks display.
Because of these potential hazards, the Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The Coast Guard was notified of this event on June 12, 2026, but we must establish this safety zone by June 27, 2026, to protect personnel, vessels, and the marine environment. Therefore, we do not have enough time to solicit and respond to comments.
For the same reason, the Coast Guard finds that under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the
This rule establishes a safety zone from 10:00 p.m. to 10:30 p.m. on June 27, 2026. The safety zone will cover all navigable waters from mile markers 602.0-605.0 on the Ohio River. Vessels and persons will not be allowed to enter the zone during this time, unless authorized by the Captain of the Port.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.
The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the
Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the
We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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.
As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
This rule is a safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket.
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; DHS Delegation No. 00170.1, Revision No. 01.4.
(a)
(b)
(c)
(2) To seek permission to enter, contact the COTP or the COTP's representative on VHF-FM channel 16 or by telephone at (502) 779-5348. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Coast Guard, Department of Homeland Security.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters in the Los Angeles Main Channel, Los Angeles Harbor, CA. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards associated with an over water fireworks display for the 2026 Cars & Stripes Forever event. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Los Angeles—Long Beach, or their designated representative.
This rule is effective on June 26, 2026.
To view available documents go to
If you have questions about this rule, contact LCDR Kevin Kinsella, Sector Los Angeles—Long Beach Waterways Management Division, U.S. Coast Guard; telephone 310-521-3860, or email
The Coast Guard received notification that fireworks will be launched from a barge in the Los Angeles Main Channel during the Cars & Stripes Forever event on June 26, 2026. The Captain of the Port (COTP) Los Angeles—Long Beach has determined that potential hazards associated with fireworks are a safety concern for anyone within a 500-foot radius of the fireworks barge. Therefore, the COTP is issuing this rule under the authority in 46 U.S.C. 70034, which is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.
Because of these potential hazards, the Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable and contrary to the public interest.
For the same reasons, the Coast Guard finds that under 5 U.S.C. 553(d)(3), good cause exists for making this rule
This rule establishes a safety zone on June 26, 2026 from 9 p.m. through 9:30 p.m. The safety zone will cover all navigable waters in the Los Angeles Main Channel within a 500-foot radius of the fireworks barge for the 2026 Cars & Stripes Forever Fireworks event. Vessels and persons will not be allowed to enter the zone during this time, unless authorized by the Captain of the Port.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.
The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the
Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect 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.
As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.
We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
This rule is a safety zone. It is categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket.
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; DHS Delegation No. 00170.1, Revision No. 01.4.
(a)
(b)
(c)
(2) To seek permission to enter, contact the COTP or the COTP's representative on VHF-FM channel 16 or by telephone at (310) 521-3801. Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or the COTP's designated representative.
(d)
Coast Guard, DHS.
Notification of enforcement of regulation.
The Coast Guard will enforce various safety zones for maritime events in the Captain of the Port Northern Great Lakes zone. Enforcement of these safety zones is necessary to protect the
The regulations in 33 CFR 165.918 will be enforced for the safety zones identified in the
If you have questions about this notification of enforcement, contact LT Rebecca Simpson, Sector Northern Great Lakes Waterways Management Division, U.S. Coast Guard; telephone 906-635-3223, email
The Coast Guard will enforce the following annual safety zones in the Captain of the Port Northern Great Lakes zone listed in the table to 33 CFR 165.918:
(a) Event No. (5): National Cherry Festival Airshow Safety Zone (Traverse City, MI) from 1 p.m. through 4 p.m. each day from July 3, 2026 through July 5, 2026.
(b) Event No. (6): National Cherry Festival Finale Fireworks (Traverse City, MI) from 10 p.m. through 10:30 p.m. on July 11, 2026.
(c) Event No. (7): Canada Day Celebration Fireworks (Sault Sainte Marie, MI) from 10 p.m. to 11 p.m. on July 1, 2026.
(d) Event No. (8): Marquette Fourth of July Celebration Fireworks (Marquette, MI) from 10 p.m. through 10:30 p.m. on July 3, 2026. In the event of inclement weather, this event will be held on July 4, 2026, with the safety zone enforced from 10 p.m. through 10:30 p.m. on July 4, 2026.
(e) Event No. (10): Sault Sainte Marie Fourth of July Celebration Fireworks (Sault Sainte Marie, MI) from 10 p.m. to 10:30 p.m. on July 4, 2026. In the event of inclement weather, this event will be held on July 5, 2026, with the safety zone enforced from 10 p.m. through 10:30 p.m. on July 5, 2026.
(f) Event No. (12): Harbor Springs Fourth of July Celebration Fireworks (Harbor Springs, MI) from 10 p.m. through 11:30 p.m. on July 4, 2026.
(g) Event No. (13): Bay Harbor Yacht Club Fourth of July Celebration Fireworks (Petoskey, MI) from 10 p.m. to 10:45 p.m. on July 3, 2026.
(h) Event No. (14): Petoskey Fourth of July Celebration Fireworks (Petoskey, MI) from 10 p.m. through 11 p.m. on July 4, 2026.
(i) Event No. (16): Alpena Fourth of July Celebration Fireworks (Alpena, MI) from 10 p.m. through 11 p.m. on July 3, 2026.
(j) Event No. (18): Charlevoix Venetian Festival Friday Night Fireworks (Charlevoix, MI) from 10:15 p.m. through 10:40 p.m. on July 24, 2026.
(k) Event No. (19): Charlevoix Venetian Festival Saturday Night Fireworks (Charlevoix, MI) from 10:30 p.m. through 10:45 p.m. on July 25, 2026.
In addition to this notice of enforcement in the
Coast Guard, Department of Homeland Security.
Notification of enforcement of regulation.
The Coast Guard will enforce a safety zone for the Joliet Independence Day Celebration Fireworks on a portion of the Des Plaines River in Joliet, IL. This action is necessary to protect personnel, vessels, and the marine environment from potential hazards created by the fireworks display. During the enforcement period listed below, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated representative.
The regulation in 33 CFR 165.929 will be enforced from 9:15 p.m. through 10:00 p.m. on July 3, 2026, for the safety zone described in Event 8 of Table 1 to § 165.929.
If you have questions about this notification of enforcement, call or email LT Kyle Goetz, Waterways Management Division, Marine Safety Unit Chicago, U.S. Coast Guard; telephone 630-986-2155, email
The Coast Guard will enforce the regulations in 33 CFR 165.929 for the safety zone described in Event 8 of Table 1 to § 165.929. This safety zone consists of all waters of the Des Plaines River at Mile Marker 288 within the arc of a circle with a 500-foot radius of the approximate launch site at 41°31.522′ N, 088°05.244′ W. This safety zone will be enforced from 9:15 p.m. through 10:00 p.m. on July 3, 2026.
Pursuant to 33 CFR 165.929, all vessels must obtain permission from the Captain of the Port Lake Michigan (COTP) or a designated representative to enter, move within, or exit this safety zone during the enforcement times listed in this notification of enforcement. The designation of the COTP's representative need not be in writing. Requests must be made in advance and approved by the COTP or a designated representative before transits will be authorized. Approvals will be granted on a case-by-case basis. Vessels and persons granted permission to enter the safety and security zone shall obey all lawful orders or directions of the COTP or the designated representative.
In addition to this notification of enforcement in the
Coast Guard, Department of Homeland Security.
Notification of enforcement of regulation.
The Coast Guard will enforce a safety zone for the Town of Dune Acres Independence Day Fireworks event on a portion of Lake Michigan in Dune Acres, Indiana. This action is necessary to protect personnel, vessels, and the marine environment from potential hazards created by the fireworks display. During the enforcement period listed below, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated representative.
The regulation in 33 CFR 165.929 will be enforced from 8:45 p.m. through 9:30 p.m. on July 3, 2026, for the safety zone listed as Event 2 of Table 2 to § 165.929.
If you have questions about this notice of enforcement, call or email LT Kyle Goetz, Waterways Management Division, Marine Safety Unit Chicago, U.S. Coast Guard; telephone 630-986-2155, email
The Coast Guard will enforce the regulations in 33 CFR 165.929 for the safety zone listed as Event 2 of Table 2 to § 165.929, for the Town of Dune Acres Independence Day Fireworks. This safety zone includes of all waters of Lake Michigan, from surface to bottom, within a 300-foot radius of the approximate launch position at 41°39.303′ N, 087°05.239′ W. These coordinates are based on the World Geodetic System (WGS 84)/North American Datum 83 (NAD 83). This safety zone will be enforced from 8:45 p.m. through 9:30 p.m. on July 3, 2026.
Pursuant to 33 CFR 165.929, all vessels must obtain permission from the Captain of the Port (COTP) Lake Michigan or his or her designated on-scene representative to enter, move within, or exit this safety zone during the enforcement times listed in this notice of enforcement. The designation of the COTP Lake Michigan's on-scene representative need not be in writing. Requests must be made in advance and approved by the COTP or his or her designated on-scene representative before transits are authorized. Approvals will be granted on a case-by-case basis. Vessels and persons granted permission to enter the safety and security zone shall obey all lawful orders or directions of the COTP Lake Michigan or designated on-scene representative.
In addition to this notification of enforcement in the
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving source-specific State Implementation Plan (SIP) revisions submitted by Ohio. These revisions address major source volatile organic compound (VOC) and nitrogen oxide (NO
This final rule is effective on June 26, 2026.
The EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2025-0237. All documents in the docket are listed on the
Katie Caskey, Air and Radiation Division (AR18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone number: (312) 353-3490, email address:
Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA.
On April 10, 2026, the EPA proposed to approve source-specific SIP revisions that address major source VOC and NO
CAA section 172(c)(1) requires the implementation of RACT measures as expeditiously as practicable and shall provide for attainment of the NAAQS.
CAA section 182(b)(2) requires implementation of RACT for Moderate ozone nonattainment areas, and references CAA section 172(c)(1). The EPA has long defined RACT as the lowest emission limitation a source can meet through application of control technology that is reasonably available, considering technological and economic feasibility.
Consistent with this definition, major source RACT is evaluated at the source level by determining whether additional control technologies are technologically feasible and economically reasonable for that source. Ohio evaluated various available control options for each source, including feasibility, emission reduction efficiency, and cost, and determined whether more stringent controls met this standard. Each of these analyses were considered by the EPA and were part of the docket for this rulemaking.
Emission reduction potential is inherently reflected in the evaluation of control technologies, including consideration of control efficiency; however, the CAA does not require a separate or independent analysis of the significance of emission reductions in determining RACT. Instead, RACT determinations focus on whether controls are technologically feasible and economically reasonable for that source.
The EPA reviewed Ohio's analysis and confirmed that Ohio evaluated available control options and did not rely solely on existing controls without analysis. Therefore, the EPA finds that Ohio's RACT determinations are consistent with CAA requirements.
The EPA does not establish or apply a cost-effectiveness metric for RACT. The commenter asserts that the EPA chose to apply such a metric. The States may establish and apply their own cost-effectiveness metrics, but the EPA does not adopt these metrics. Instead, the EPA uses cost-effectiveness as one tool to determine whether a control technology is economically reasonable for a specific source. What constitutes reasonable cost-effectiveness varies depending on the characteristics of the source and the control technology.
The EPA reviewed Ohio's source-specific analyses for each non-CTG major source. In each analysis, Ohio evaluated available control technologies, including emission reduction efficiency and associated costs, and determined whether those technologies were economically reasonable for each source. Where Ohio determined that certain technologically feasible controls were not economically reasonable, the EPA reviewed those determinations and found that the record supports those conclusions.
The commenter compares cost-effectiveness values in this action to values from other EPA analyses, including the EPA's “Regulatory Impact Analysis of the Final revisions to the National Ambient Air Quality Standards for Ground-Level Ozone” (September 2015), the Federal Implementation Plan Addressing Regional Ozone Transport for the 2015 Ozone National Ambient Air Quality Standard (88 FR 36654, June 5, 2023), and the EPA's study “The Benefits and Costs of the Clean Air Act from 1990 to 2020: Final Report—Rev. A” (April 2011). Those analyses were developed for different statutory purposes and broader regulatory contexts and do not establish applicable cost benchmarks for source-specific RACT determinations.
The commenter identified each facility specifically and asserted that more stringent controls should have been required. The EPA reviewed the source-specific analyses for these facilities and finds that Ohio evaluated technically feasible control options and associated costs and determined which controls are economically reasonable for each source.
Therefore, the EPA finds that the economic analyses in Ohio's RACT demonstrations satisfy RACT requirements under the CAA.
The EPA is not relying on deviation reporting alone to satisfy CAA requirements. Ohio's framework relies on periodic reporting under OAC rule 3745-15-03 along with source-specific permit conditions that are approved into the Ohio SIP. These requirements allow compliance to be determined on an ongoing basis. The emission limitations and associated monitoring, recordkeeping, and reporting requirements in Ohio's SIP and permits are federally enforceable, and information submitted to the State under OAC rule 3745-15-03 is available to the public through applicable public records processes, including the Freedom of Information Act. The EPA reviewed Ohio's SIP and permitting framework and finds that it provides enforceable mechanisms to ensure compliance.
Thus, the EPA finds that Ohio's reporting and permitting requirements are sufficient to meet the CAA and regulatory enforceability requirements.
The EPA is approving the following as meeting RACT in the Cleveland Moderate nonattainment area for the 2015 ozone standard:
• NO
• Reheat Furnaces (P046-P048): Requirement to submit updated NO
• Batch annealing Furnaces (P049 and P050): Continued operation of existing LNBs and compliance with existing NO
• HDGL Annealing Furnace (Unit P071): Continued use of the existing LNBs and compliance with the 0.23 lb/MMBtu NO
• Blast Furnaces (P903 and P904): Continued use of low-NO
• Basic Oxygen Furnaces and Ladle Preheaters (P905/P906 and P925/P926): BOFs—install, maintain, and operate the source in accordance with the manufacturer's specifications and with good operating practices for the control of NO
• VOC RACT—the following provisions, as detailed in permit numbers P0138035, P0138036, and P0138136, issued 11/13/2025, effective 11/13/2025:
• Combustion Units (B001-B007, B046-B050, P903-P906): Operate the source in accordance with the manufacturer's specifications and with good operating practices for the control of VOC emissions.
• Tandem Mill (P107): Continued operation of chevron-style oil demister in accordance with good engineering practices; Compliance with existing VOC BAT limit of 138.91 tons per rolling 12-month period; Compliance with the following VOC content limits for rolling oils—Rolling Oil: ≤4.6 lb VOC/gal, Rust Preventive Oil: ≤3.3 lb VOC/gal, Anti-Galling Material: ≤1.2 lb VOC/gal, and Pre-Lube Oil: ≤0.8 lb VOC/gal.
In accordance with 5 U.S.C. 553(d), EPA finds there is good cause for these actions to become effective immediately upon publication. This is because a delayed effective date is unnecessary due to the nature of this SIP revision, which merely makes Federally enforceable requirements that are already applicable to the sources at the State level. The immediate effective date for this action is authorized under section 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. Today's rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, today's rule makes federally enforceable regulatory requirements that are already applicable to these sources at the State level. For this reason, EPA finds good cause under 5 U.S.C. 553(d)(3) for these actions to become effective on the date of publication of these actions.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Ohio Permits described in section II of this preamble and set forth in the amendments to 40 CFR part 52 below. The EPA has made, and will continue to make, these documents generally available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not an Executive Order 14192 (90 FR 9065, February 6, 2025) regulatory action because this action is not significant under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal
This rule is exempt from the Congressional Review Act because it is a rule of particular applicability.
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 25, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Volatile organic compounds.
For the reasons stated in the preamble, title 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The additions read as follows:
(d) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving source-specific State Implementation Plan (SIP) revisions submitted by Ohio. These revisions address major source volatile organic compound (VOC) and nitrogen oxide (NO
This final rule is effective on June 26, 2026.
The EPA has established a docket for this action under Docket ID No. EPA-R05-OAR-2025-0032. All documents in the docket are listed on the
Katie Caskey, Air and Radiation Division (AR18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, telephone number: (312) 353-3490, email address:
Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA.
On February 27, 2026 (91 FR 9771), the EPA proposed to approve source-specific SIP revisions that address major source VOC and NO
The commenter also recommends periodic reevaluation of RACT to reflect advances in control technology. The EPA acknowledges the commenter's interest in ensuring that emission control requirements reflect evolving technologies. However, the CAA establishes that RACT requirements are triggered by a nonattainment area's classification and apply when an area is classified as Moderate or higher under CAA section 182. RACT is assessed when areas are initially classified as Moderate and reassessed if an area is reclassified to a higher classification level and is thus subject to a more stringent RACT requirement. The CAA does not require periodic reevaluation of RACT on a fixed schedule. While states may adopt additional provisions, such as reevaluation requirements, these are not required under the CAA. Therefore, the EPA cannot require periodic RACT reevaluation outside the statutory framework of the CAA.
CAA section 172(c)(1) requires the implementation of RACT measures as expeditiously as practicable and shall provide for attainment of the national primary ambient air quality standards. Reductions in emissions from existing sources is part of that stated purpose, but the language does not specify or require an evaluation of the emissions impacts.
CAA section 182(b)(2) requires implementation of RACT for Moderate ozone nonattainment areas, and references CAA section 172(c)(1). The EPA has long defined RACT as the lowest emission limitation a source can meet through application of control technology that is reasonably available, considering technological and economic feasibility.
Consistent with this definition, major source RACT is evaluated at the source level by determining whether additional control technologies are technologically feasible and economically reasonable for that source. Ohio evaluated various available control options for each source, including feasibility, emission reduction efficiency, and cost, and determined whether more stringent controls met this standard. Each of these analyses were considered by the EPA and were part of the docket for this rulemaking.
Emission reduction potential is inherently reflected in the evaluation of control technologies, including consideration of control efficiency; however, the CAA does not require a separate or independent analysis of the significance of emission reductions in determining RACT. Instead, RACT determinations focus on whether controls are technologically feasible and economically reasonable for that source.
The EPA reviewed Ohio's analysis and confirmed that Ohio evaluated available control options and did not rely solely on existing controls without analysis. Therefore, the EPA finds that Ohio's RACT determinations are consistent with CAA requirements.
The EPA does not establish or apply a cost-effectiveness metric for RACT. The commenter asserts that the EPA chose to apply such a metric. The States may establish and apply their own cost-effectiveness metrics, but the EPA does not adopt these metrics. Instead, the EPA uses cost-effectiveness as one tool to determine whether a control technology is economically reasonable for a specific source. What constitutes reasonable cost-effectiveness varies depending on the characteristics of the source and the control technology. The EPA reviewed Ohio's source-specific analyses for each non-CTG major source. In each analysis, Ohio evaluated available control technologies, including emission reduction efficiency and associated costs, and determined whether those technologies were economically reasonable for each source. Where Ohio determined that certain technologically feasible controls were not economically reasonable, the EPA reviewed those determinations and founds that the record supports those conclusions.
The commenter compares cost-effectiveness values in this action to values from other EPA analyses, including the EPA's “Regulatory Impact Analysis of the Final revisions to the National Ambient Air Quality Standards for Ground-Level Ozone” (September 2015), the Federal Implementation Plan Addressing Regional Ozone Transport for the 2015 Ozone National Ambient Air Quality Standard (88 FR 36654, June 5, 2023), and the EPA's study “The Benefits and Costs of the Clean Air Act from 1990 to 2020: Final Report—Rev. A” (April 2011). Those analyses were developed for different statutory purposes and broader regulatory contexts and do not establish applicable cost benchmarks for source-specific RACT determinations.
The commenter also identified specific facilities, including Charter Steel, U.S. Steel Tubular Lorain, and Ross Incineration, and asserted that more stringent controls should have been required. The EPA reviewed the source-specific analyses for these facilities and finds that Ohio evaluated technically feasible control options and associated costs and determined which controls are economically reasonable for each source.
Therefore, the EPA finds that the economic analyses in Ohio's RACT demonstrations satisfy RACT requirements under the CAA.
The EPA is not relying on deviation reporting alone to satisfy CAA requirements. Ohio's framework relies on periodic reporting under OAC rule 3745-15-03 along with source-specific permit conditions that are approved into the Ohio SIP. These requirements allow compliance to be determined on an ongoing basis. The emission limitations and associated monitoring, recordkeeping, and reporting requirements in Ohio's SIP and permits are federally enforceable, and information submitted to the State under OAC rule 3745-15-03 is available to the public through applicable public records processes, including the Freedom of Information Act. The EPA reviewed Ohio's SIP and permitting framework and finds that it provides enforceable mechanisms to ensure compliance.
Finally, the SIP strengthening measures addressed in this action apply to sources in the Cincinnati maintenance area under the 2015 ozone standard. As a maintenance area, this area is not required to implement RACT. The EPA's evaluation therefore focuses on whether the submitted provisions strengthen the SIP and remain consistent with CAA requirements.
Thus, the EPA finds that Ohio's reporting and permitting requirements are sufficient to meet the CAA and regulatory enforceability requirements.
The EPA is approving the following as meeting RACT in the Cleveland moderate nonattainment area under the 2015 ozone standard:
• Akron Paint and Varnish: Facility-wide VOC limit of 99.9 tons per year and work practice standards, including the use of existing mixer covers, as detailed in permit number P0136483, issued 12/11/2024, effective 12/11/2024.
• Carmeuse Lime: 4.6 pounds per ton NO
• Charter Steel: Operation of LNBs in compliance with emission limits in OAC 3745-110-03(Q).
• Owens Corning: Production limits, a vapor pressure limit for asphalt storage, and continued use of RTOs and incinerators, as detailed in permit number P0137247, issued 01/06/2025, effective 01/06/2025.
• PPG Industries Ohio, Inc.: Existing source-specific RACT in OAC 3745-21-09(MM).
• Ross Incineration: Good operating and combustion practices to control NO
• U.S. Steel Tubular Lorain: Operation of existing LNBs in compliance with emission limits in OAC 3745-110-03(P).
○ P003: 0.068 lb/MMBtu.
○ P035: 0.12 lb/MMBtu.
○ P037: 0.15 lb/MMBtu.
○ P039:0.08 lb/MMBtu.
○ P040:0.15 lb/MMBtu.
The EPA is approving the following actions as SIP strengthening for the Cincinnati maintenance area under the 2015 ozone standard:
• GE Evendale: Good operating practices for combustion units and operation under engineering test plans that minimize fuel use for turbine testing and ancillary operations. These measures are detailed in permit number P0136500, issued 01/30/2025, effective 01/30/2025 and permit number P0136501, issued 01/30/2025, effective 01/30/2025. Presumptive limits under OAC 3745-21-19 for robotic coaters.
• Tyson Foods: Installation of a combined mist eliminator and thermal oxidizer system achieving 98% VOC control efficiency from all cook lines, as reflected in permit number P0137384, issued 06/11/2025, effective 06/11/2025.
Finally, the EPA is approving the removal of the site-specific VOC RACT rule for Formica in OAC 3745-21-09(PP), as these units are now regulated under the equivalent CTG-based rule in OAC 3745-21-09(F).
In accordance with 5 U.S.C. 553(d), EPA finds there is good cause for these actions to become effective immediately upon publication. This is because a delayed effective date is unnecessary due to the nature of this SIP revision, which merely makes Federally enforceable, requirements that are already applicable to the sources at the state level. The immediate effective date for this action is authorized under section 553(d)(3), which allows an effective date less than 30 days after publication “as otherwise provided by the agency for good cause found and published with the rule.” The purpose of the 30-day waiting period prescribed in section 553(d) is to give affected parties a reasonable time to adjust their behavior and prepare before the final rule takes effect. This rule, however, does not create any new regulatory requirements such that affected parties would need time to prepare before the rule takes effect. Rather, this rule makes federally enforceable regulatory requirements that are already applicable to these sources at the state level. For this reason, EPA finds good cause under 5 U.S.C. 553(d)(3) for these actions to become effective on the date of publication of these actions.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the Ohio Regulations and Permits described in sections I and II of this preamble and set
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This rule is exempt from the Congressional Review Act because it is a rule of particular applicability.
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 25, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Volatile organic compounds.
For the reasons stated in the preamble, title 40 CFR part 52 is amended as follows:
42 U.S.C. 7401
The additions and revision read as follows:
(c) * * *
(d) * * *
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a state implementation plan (SIP) revision submitted by the Department of Energy and Environment (DOEE) on behalf of the District of Columbia (DC). The revision pertains to creating a synthetic minor permit program and resolving the regulatory differences between DC's current regulations and those regulations approved previously in Chapters 1 and 2 of the Air Quality Regulations codified in title 20 of the District of Columbia Municipal Regulations (DCMR). The intended effect of this action is to enable DC to create federally enforceable synthetic minor permit conditions for sources of criteria pollutants. The EPA is approving these revisions to the DC SIP in accordance with the requirements of the Clean Air Act (CAA).
This final rule is effective on July 27, 2026.
The EPA has established a docket for this action under Docket ID Number EPA-R03-OAR-2025-0734. All documents in the docket are listed on the
Yongtian He, Permits Branch (3AD10), Air & Radiation Division, U.S. Environmental Protection Agency, Region III, 1600 John F Kennedy Boulevard, Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-2339. Mr. He can also be reached via electronic mail at
On November 20, 2025 (90 FR 52305), the EPA published a notice of proposed rulemaking (NPRM) for the District of Columbia. In the NPRM, the EPA proposed the approval of a revision to the DC SIP to create a synthetic minor permit program and to address regulatory differences between DC's current regulations and those approved previously in Chapters 1 and 2 of the Air Quality Regulations. The formal SIP revision was submitted by DOEE on August 11, 2023.
A SIP-approved minor source permitting program can include provisions for issuing permits that establish federally enforceable emissions limits to restrict the Potential to Emit (PTE) of certain pollutants below major stationary source and major modification applicability thresholds. “Synthetic minor” permits establish these federally enforceable emission limits for sources obtaining construction permits and also establish these emission limits in the corresponding operating permits.
This DC SIP revision is intended to create a synthetic minor permit program through provisions in title 20 of the District of Columbia Municipal Regulations (20 DCMR), specifically 20 DCMR Chapter 2 sections 200.6 and 200.7 as amended, in conjunction with other provisions that already existed in 20 DCMR Chapters 1 and 2, that were previously approved into the DC SIP. These provisions enable a new source or modification of an existing source to limit its PTE below major source thresholds in order to qualify as a minor source or minor modification and to avoid applicability of major new source review (NSR) requirements, including the requirements of the prevention of significant deterioration (PSD) program in attainment areas and of the nonattainment NSR (NNSR) program in nonattainment areas. These provisions also allow new sources or modifications of existing sources to avoid Title V major source status by limiting their PTE. The SIP approved synthetic minor program will provide sources a mechanism to avoid Title V and new source review major source applicability and make those synthetic minor permit conditions both enforceable by DC and at the Federal level.
The District of Columbia submitted a SIP revision to create a synthetic minor permitting program. Section 200
In a June 28, 1989 Final Rule, the EPA established five criteria for an approvable state operating permit program.
Additional rationale for the EPA's now final action is explained in the NPRM and will not be restated here.
The EPA received three sets of comments on its November 20, 2025 proposed action to approve revisions to the DC SIP. These comments, provided by Earthjustice, Citizens Rulemaking Alliance, and an anonymous concerned citizen, raised concerns with regard to the EPA's November 20, 2025 proposed action. A full set of these comments is provided in the docket for this final action. A summary of the comments and the EPA's responses are provided below.
The commenter incorrectly characterizes the requirements in the DC's public participation provisions. In addition to section 210.4, section 210.3 has further requirements for public participation. Specifically, 20 DCMR 210.3 states that DOEE shall publish a notice regarding the draft permit or denial in the DC Register and shall make the information required by section 210.2 available for public inspection at the DOEE's office and by one or more of the methods described in section 210.4.
One of the main goals of the CAA is to assure the achievement and maintenance of the NAAQS in every state of the US. The state and local air districts establish laws, regulations, and specific air permitting programs to regulate the air pollution emissions from industrial sources so that the area under its jurisdiction can achieve and maintain the NAAQS. Whether an area's air quality meets the NAAQS or not is the ultimate criterion for evaluating the cumulative impacts of all air emissions sources in the area (including synthetic minor sources, which are the focus of this rulemaking). This action is neither arbitrary nor capricious since the SIP revision's underlying rationale and purpose will help DC achieve and maintain the NAAQS and enable DC to implement its CAA programs more efficiently. Furthermore, there is a rational connection between the facts and the agency action proposed in the NPRM, as well as the procedural requirements followed for public notice and comment by the EPA, that sufficiently demonstrate that the EPA did not act arbitrarily and capriciously in proposing to approve the DC synthetic minor permit program; therefore, this action did not violate the APA.
The EPA disagrees with the comment that this NPRM deviates from prior agency positions recognizing risks posed by synthetic minor permitting. The EPA does agree that the identification of deficiencies in States' implementation of their minor source permitting programs by the EPA's Office of Inspector General helps strengthen some aspects of States' synthetic minor programs such as monitoring, recordkeeping, and enforcement by highlighting these deficiencies so that States can address them.
The EPA is approving the changes to the DOEE's permit program in 20 DCMR Chapter 2 to create a synthetic minor permit program as a revision to the District of Columbia SIP, pursuant to the CAA and the approval criteria specified in the June 28, 1989
In this document, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the DC air quality regulations in Chapter 2 of 20 DCMR, as described in section II of this preamble. The EPA has made, and will continue to make, these materials generally available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as follows:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Final rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is notifying the public that we have received CAA section 111(d)/129 negative declarations from Oklahoma for existing incinerators subject to the Other Solid Waste Incineration units (OSWI), Hospital/Medical/Infectious Waste Incinerator units (HMIWI), and Commercial and Industrial Solid Waste Incineration Units (CISWI) Emission Guidelines (EG). These negative declarations certify that existing incinerators subject to the OSWI, HMIWI, and CISWI EG and the requirements of sections 111(d) and 129 of the CAA do not exist within specified jurisdictions in Oklahoma. The EPA is accepting these negative declarations and amending agency regulations in accordance with the requirements of the CAA.
This rule is effective on July 27, 2026.
The EPA has established a docket for this action under Docket ID No. EPA-R06-OAR-2020-0610. All documents in the docket are listed on the
Matthew Gesualdo, EPA Region 6 Office, State Planning and Implementation Branch, 214-665-6530,
Throughout this document “we,” “us,” and “our” means the EPA.
The background for this action is discussed in detail in our July 10, 2025, proposal (90 FR 30616). In that document, we proposed to accept the OSWI, HMIWI, and CISWI negative declarations submitted by the Oklahoma Department of Environmental Quality (ODEQ), withdraw EPA's proposed approval of the Oklahoma CISWI state plan revision, and amend the Code of Federal Regulations (CFR) in accordance with the requirements of sections 111(d) and 129 of the CAA.
EPA received three comments during the 30-day public comment period which closed on August 11, 2025. Summaries of the three comments and EPA's responses to them are provided below.
The commenter additionally provided their interpretation and context regarding the Federal rules under the NSPS and EG, the process for negative declarations and Oklahoma's handling and categorization of facilities under the NSPS and EG, including which facilities would be subject to exemptions or negative declarations under these rules. The commenter also provided some background on the Reworld facility as well as the public notice process and status for the facility's proposed permit revision.
The LMWC rules provide that incinerators that have a combustion capacity greater than 250 tons per day and burn greater than 30 percent MSW by feedstream meet the LMWC NSPS/EG applicability requirements, unless the facility falls under an exemption (see 40 CFR 60.32b and 60.50b).
In addition, EPA notes that on March 10, 2026, EPA finalized revised NSPS (40 CFR part 60, subpart VVVV) and EG (40 CFR part 60, subpart WWWW) for LMWC effective May 11, 2026 (91 FR 11802). The LMWC final rule revises emission limits to be more stringent for cadmium, lead, particulate matter, dioxins/furans, hydrogen chloride, and sulfur dioxide for all NSPS/EG sources, and for nitrogen oxides and carbon monoxide for certain EG sources and all NSPS sources; and, among other revisions, reestablishes applicability dates for new and existing sources. EPA estimates a reduction of 3,269 tons per year of regulated pollutants from existing sources. State plans implementing the revised LMWC EG requirements at 40 CFR part 60, subpart WWWW, are due March 10, 2027.
Therefore, under the new LMWC EG, Reworld will be subject to more stringent emission limits and requirements than under the previous LMWC EG. Table 2 of the final rule establishing the revised LMWC EG (91 FR 11802, May 11, 2026) details how emission limits have become more stringent across all of the aforementioned pollutants. While the HMIWI EG are broadly more stringent than the LMWC EG, the revised LMWC contains a lower emissions limit for PM
Overall, EPA agrees with ODEQ's assessment that the Reworld facility meets the applicability requirements for the LMWC EG and therefore is not subject to the HMIWI EG. EPA has not found or been provided any evidence that suggests that Oklahoma has such facilities (incinerators subject to the HMIWI EG) within their jurisdiction. The negative declaration submitted by ODEQ for facilities that fall under the HMIWI EG in Oklahoma is still considered acceptable by EPA and addresses the corresponding provisions of Clean Air Act sections 111(d) and 129 and 40 CFR 60.23(b) and 62.06.
Following the U.S. Supreme Court decision in
The EPA has approved Oklahoma's SAFETEA request to administer all of the States's EPA-approved environmental regulatory programs in the requested areas of Indian country. As requested by Oklahoma, EPA's approval under SAFETEA does not include Indian country lands, including rights-of-way running through the same, that: (1) qualify as Indian allotments, the Indian titles to which have not been extinguished, under 18 U.S.C. 1151(c); (2) are held in trust by the United States on behalf of an individual Indian or Tribe; or (3) are owned in fee by a Tribe, if the Tribe (a) acquired that fee title to such land, or an area that included such land, in accordance with a treaty with the United States to which such Tribe was a party, and (b) never allotted the land to a member or citizen of the Tribe (collectively “excluded Indian country lands”).
The EPA's approval under SAFETEA expressly provided that to the extent the EPA's prior approvals of Oklahoma's environmental programs excluded Indian country, any such exclusions are superseded for the geographic areas of Indian country covered by the EPA's approval of Oklahoma's SAFETEA request. The approval also provided that future revisions or amendments to Oklahoma's approved environmental regulatory programs would extend to the covered areas of Indian country (without any further need for additional requests under SAFETEA).
As explained above, the EPA is accepting the CAA sections 111(d)/129 negative declarations submitted by the State of Oklahoma for sources subject to the OSWI EG, HMIWI EG, and CISWI EG. These negative declarations apply statewide in Oklahoma, including certain areas of Indian country in the State of Oklahoma other than the excluded Indian country lands as described above.
In this final action, the EPA is amending 40 CFR part 62, subpart LL, to reflect receipt of negative declaration letters submitted by ODEQ on August 10, 2020, April 1, 2020, and September 13, 2024, for facilities subject to the OSWI, HMIWI, and CISWI EGs, respectively. These letters certify that there are no existing incinerators subject to 40 CFR part 60, subparts FFFF (as amended on November 24, 2006), Ce, and DDDD, within Oklahoma's jurisdiction, in accordance with 40 CFR 60.23(b), 40 CFR 60.2982, 40 CFR 62.06, and sections 111(d) and 129 of the CAA.
Under the CAA, the Administrator is required to approve a CAA section 111(d)/129 submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7411(d); 42 U.S.C. 7429; 40 CFR part 60, subparts B, FFFF, Ce, and DDDD; and 40 CFR part 62, subpart A. With regard to negative declarations for designated facilities received by the EPA from states, the EPA's role is to notify the public of the receipt of such negative declarations and revise 40 CFR part 62 accordingly. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not an Executive Order 14192 (90 FR 9065, February 6, 2025) regulatory action because this action is not significant under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
This final action that amends 40 CFR part 62 to reflect receipt of these OSWI, HMIWI, and CISWI negative declarations will apply to certain areas of Indian country throughout Oklahoma as discussed in the preamble, and therefore has tribal implications as specified in E.O. 13175 (65 FR 67249, November 9, 2000). However, this action will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. This action will not impose substantial direct compliance costs on federally recognized tribal governments because no actions will be required of tribal governments. This action will also not preempt tribal law as no Oklahoma tribe implements a regulatory program under the CAA, and thus does not have applicable or related tribal laws. Consistent with the EPA Policy on Consultation with Indian Tribes (December 7, 2023), the EPA offered consultation to tribal governments that may be affected by this action and provided information about this action.
This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 25, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements, Waste treatment and disposal.
42 U.S.C. 7401
For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 62 as follows:
42 U.S.C. 7401
Letter from the Oklahoma Department of Environmental Quality dated April 1, 2020, certifying that there are no incinerators subject to the Hospital, Medical, and Infectious Waste Incineration units (HMIWI) Emission Guidelines, at 40 CFR part 60, subpart Ce, within its jurisdiction in the State of Oklahoma.
Letter from the Oklahoma Department of Environmental Quality dated September 13, 2024, certifying that there are no incinerators subject to the Commercial and Industrial Solid Waste Incineration units (CISWI) Emission Guidelines, at 40 CFR part 60, subpart DDDD, within its jurisdiction in the State of Oklahoma.
Letter from the Oklahoma Department of Environmental Quality dated August 10, 2020, certifying that there are no incinerators that commenced construction on or before December 9, 2004, subject to the Other Solid Waste Incineration units (OSWI) Emission Guidelines, at 40 CFR part 60, subpart FFFF, as promulgated on December 16, 2005, and amended on November 24, 2006, within its jurisdiction in the State of Oklahoma.
Environmental Protection Agency (EPA).
Final rule.
Pursuant to the Federal Clean Air Act (CAA or the Act), the Environmental Protection Agency (EPA) is notifying the public that we have received a CAA section 111(d)/129 negative declaration from Louisiana for existing incinerators subject to the Other Solid Waste Incineration units (OSWI) Emission Guidelines (EG). This negative declaration certifies that existing incinerators subject to the OSWI EG and the requirements of sections 111(d) and 129 of the CAA do not exist within specified jurisdictions in Louisiana. The EPA is accepting the negative declaration and amending the agency regulations in accordance with the requirements of the CAA.
This rule is effective on July 27, 2026.
The EPA has established a docket for this action under Docket No. EPA-R06-OAR-2026-0233. All documents in the docket are listed on the
Kevin Kim, EPA Region 6 Office, Air and Radiation Division—State Planning and Implementation Branch, telephone number: (214) 665-8554, email address:
Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.
The background for this action is discussed in detail in our March 23, 2026, proposal (91 FR 13802). In that document, we proposed to accept the OSWI negative declaration submitted by the Louisiana Department of Environmental Quality (LDEQ) and to amend the Code of Federal Regulations (CFR) in accordance with the requirements of sections 111(d) and 129 of the CAA. We held a 30-day comment period for our March 23, 2026, proposal, which closed on April 22, 2026. We received one supportive comment regarding the proposal. We acknowledge and appreciate the commenter's general support for the proposed action. We are finalizing the action as proposed without changes.
In this final action, the EPA is amending 40 CFR part 62, subpart T, to reflect receipt of the negative declaration letter from LDEQ for existing OSWI facilities submitted on November 4, 2025. The letter certifies that there are no existing incinerators subject to 40 CFR part 60, subpart FFFF, as revised on June 30, 2025 (90 FR 27910), within Louisiana's jurisdiction in accordance with 40 CFR 60.2982, 40 CFR 60.23(b), 40 CFR 62.06, and sections 111(d) and 129 of the CAA.
Under the CAA, the Administrator is required to approve a CAA section 111(d)/129 submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7411(d); 42 U.S.C. 7429; 40 CFR part 60, subparts B and FFFF; and 40 CFR part 62, subpart A. Thus, in reviewing CAA section 111(d)/129 State plan submissions, EPA's role is to approve State choices, provided that they meet the criteria of the Act and implementing regulations. Accordingly, this action merely finalizes the acceptance of a CAA section 111(d)/129 negative declaration from a State and does not impose additional requirements. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not an Executive Order 14192 (90 FR 9065, February 6, 2025) regulatory action because this action is not significant under Executive Order 12866;
• Does not impose an information collection burden under the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in Unfunded Mandated Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.
In addition, the CAA 111(d)/129 action is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the final rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by August 25, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see CAA section 307(b)(2)).
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements, Waste treatment and disposal.
For the reasons stated in the preamble, the Environmental Protection Agency amends 40 CFR part 62 as follows:
42 U.S.C. 7401
Letter from the Louisiana Department of Environmental Quality dated November 3, 2025, and submitted to EPA on November 4, 2026, certifying that there are no incinerators subject to the Other Solid Waste Incineration units (OSWI) Emission Guidelines, at 40 CFR part 60, subpart FFFF, within its jurisdiction in the State of Louisiana.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes an exemption from the requirement of a tolerance for residues of cinnamaldehyde (CAS Reg. No. 104-55-2) when used as an inert ingredient (preservative/stabilizer) on growing crops and raw agricultural commodities pre- and post-harvest, limited to no more than 100 parts per million (ppm) in the end-use pesticide formulation. Wagner Regulatory Associates, Inc., on behalf of Minagro, submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of cinnamaldehyde, when used in accordance with the terms of this exemption.
This regulation is effective June 26, 2026. Objections and requests for hearings must be received on or before August 25, 2026 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of this document).
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2025-0816, is available online at
Charles Smith, Registration Division (7505T), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (202) 566-1030; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them.
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this proposed action to a particular entity, consult the person listed under
EPA is issuing this rulemaking under section 408 of the FFDCA, 21 U.S.C. 346a. FFDCA section 408(c)(2)(A)(i) allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” FFDCA section 408(c)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Pursuant to FFDCA section 408(c)(2)(B), in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in FFDCA section 408(b)(2)(C), which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a
Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify the docket ID number EPA-HQ-OPP-2025-0816 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before August 25, 2026.
EPA's Administrative Law Judges Division (ALJD), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings.
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket at
In the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no harm to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for cinnamaldehyde, including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with cinnamaldehyde follows.
EPA has evaluated the available toxicity data and considered their validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by cinnamaldehyde as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in this unit.
The toxicological database of cinnamaldehyde is supported by data regarding
Cinnamaldehyde exhibits low levels of acute toxicity via the oral, dermal, and inhalation routes of exposure. It is a moderate dermal and eye irritant, and a strong dermal sensitizer. Decreased body weight in female rats was observed at 4100 ppm (200 mg/kg/day) in a 2-year chronic/carcinogenicity study. No increased offspring susceptibility was observed in the available studies as offspring effects (reduced fetal body weights) were only observed in the presence of parental toxicity (increased incidence of clinical signs of toxicity, reduced pregnancy rate, and pathological changes in the stomach) at 500 mg/kg/day. The established chronic reference dose (1.0 mg/kg/day) will be protective of offspring effects. No evidence of neurotoxicity or immunotoxicity was observed in the available studies. Concern for carcinogenicity is low, based on the absence of treatment-related neoplastic lesions or tumors in chronic/carcinogenicity studies in rats and mice, and negative results in mutagenicity studies.
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the NOAEL and the LOAEL. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level, generally referred to as a population-adjusted dose (PAD) or a reference dose, and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
An acute dietary endpoint was not selected because no effect attributable to a single dose was identified in the database. The 2-year chronic/carcinogenicity study in rats was selected for the chronic dietary exposure scenario as well as short- and intermediate-term incidental oral, dermal and inhalation exposure scenarios. The NOAEL of 2100 ppm (100 mg/kg/day) and LOAEL of 4100 ppm (200 mg/kg/day), based on decreased body weight in female rats, were selected for risk assessment. The study is appropriate for the duration of exposure and is protective of all chronic effects, including for the general population and the most sensitive lifestage (children). The standard inter- and intra-species uncertainty factors of 10x are applied (total uncertainty factor = 100x). The default factor of 100% is applied for the dermal and inhalation absorption rates.
1.
Dietary exposure (food and drinking water) may occur from the existing and proposed pesticidal uses of cinnamaldehyde (
In conducting the dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software using the Food Commodity Intake Database, Version 4.02, which uses food consumption information from the U.S. Department of Agriculture's 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America. As to residue levels in food, no residue data were submitted for cinnamaldehyde. In the absence of specific residue data, EPA has developed an approach which uses surrogate information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete description of the general approach taken to assess inert ingredient risks in the absence of residue data is contained in the December 21, 2021, memorandum “Update to D361707: Dietary Exposure and Risk Assessments for the Inerts,” which can be found at
In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a given commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the concentration of inert ingredient in the scenarios leading to these highest levels of tolerances would be no higher than the concentration of the active ingredient.
The Agency believes the assumptions used to estimate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate exposure. When used as an active ingredient, the concentrations of cinnamaldehyde in agricultural products are generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingredient; rather, there is generally a combination of different inert ingredients used which additionally reduces the concentration of any single inert ingredient in the pesticide product in relation to that of the active ingredient. In the case of cinnamaldehyde, EPA made a specific adjustment to the dietary exposure assessment to account for the limit on the amount of cinnamaldehyde that can be used in pesticide formulations (100 ppm), rather than assuming that cinnamaldehyde will be present at equal quantities with the active ingredient.
For the purpose of the screening level dietary risk assessment, a conservative drinking water concentration value of 100 parts per billion based on screening level modeling was used to assess the contribution to drinking water for the chronic dietary risk assessments for cinnamaldehyde.
2.
Cinnamaldehyde can be used as an inert ingredient in pesticide products that are registered for specific uses that
3.
EPA has not found cinnamaldehyde to share a common mechanism of toxicity with any other substances, and cinnamaldehyde does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that cinnamaldehyde does not have a common mechanism of toxicity with other substances. Information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals is available at
Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) safety factor. In applying this provision, EPA either retains the default value of 10X or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.
Based on the evaluation of available toxicity studies, there is low concern for pre- and postnatal susceptibility from exposure to cinnamaldehyde. The FQPA safety factor has been reduced to 1X because: (1) the toxicity database is adequate to characterize potential pre- and postnatal risk; (2) the established POD of 2100 ppm (100 mg/kg/day) will be protective of reduced fetal body weight seen at 4100 ppm (500 mg/kg/day) in the developmental toxicity study in rats; (3) no evidence of neurotoxicity was observed in the database; and (4) the assumptions for the exposure assessment are conservative and unlikely to underestimate risk.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
1.
2.
3.
Cinnamaldehyde can be used as an inert ingredient in pesticide products that are registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to cinnamaldehyde.
Using the exposure assumptions described in this unit for short- and intermediate-term exposures, EPA has concluded the combined short- and intermediate-term food, water, and residential exposures result in an aggregate MOE of 12658 for adults. Adult residential exposure combines high-end dermal and inhalation residential handler exposure from aerosol spray/trigger pump application with high-end post-application dermal exposure from contact with treated lawns. The combined short- and intermediate-term aggregated food, water, and residential pesticide exposures result in an aggregate MOE of 3154 for children. Children's residential exposure is based on total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). Because EPA's level of concern for cinnamaldehyde is an MOE of 100 or below, these MOEs are not of concern.
4.
An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of cinnamaldehyde in or on any food commodities. EPA is establishing a limitation on the amount of cinnamaldehyde that may be used in pesticide formulations. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. 136
Therefore, an exemption from the requirement of a tolerance is established for residues of cinnamaldehyde (CAS Reg. No. 104-55-2) when used as an inert ingredient (preservative/stabilizer) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest under 40 CFR 180.910, limited to no more than 100 ppm in the end-use pesticide formulation.
Additional information about these statutes and Executive Orders can be found at
This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), because it establishes or modifies a pesticide tolerance or a tolerance exemption under FFDCA section 408 in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866.
Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because actions that establish a tolerance or a tolerance exemption under FFDCA section 408 are exempted from review under Executive Order 12866.
This action does not impose an information collection burden under the PRA 44 U.S.C. 3501
This action is not subject to the RFA, 5 U.S.C. 601
This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any State, local or Tribal governments or the private sector.
This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will 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 action does not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on Tribal governments, on the relationship between the Federal Government and the Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and Indian Tribes.
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866 (See Unit VI.A.), and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.
However, EPA's 2026
This action is not subject to Executive Order 13211 (66 FR 28355) (May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.
This action does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.
This action is subject to the CRA, 5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, EPA is amending 40 CFR chapter I as follows:
21 U.S.C. 321(q), 346a and 371.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is granting, with conditions, U.S. Ecology Nevada Inc.'s (USE) petition for a site-specific treatability variance (SSTV) from the Resource Conservation and Recovery Act (RCRA) Land Disposal Restrictions (LDR) treatment standards. USE's petition is for a variance from the existing treatment and disposal standard for elemental mercury waste generated from retorting high mercury waste as prescribed by the LDR technology-based standard of RMERC. The petition demonstrated that the LDR standard for placing elemental mercury waste generated from RMERC back into commerce for reuse is inappropriate and the alternative treatment variance proposed by USE is sufficient to minimize threats to human health and the environment posed by land disposal of the waste. Under the approved SSTV, the existing LDR treatment standard of RMERC will continue to apply to high mercury hazardous wastes, but the elemental mercury generated from this process will be treated and land disposed subject to specified conditions at both Bethlehem Apparatus's facility in Bethlehem, Pennsylvania, and USE's Beatty, Nevada, subtitle C treatment, storage, and disposal (TSD) facility where the treated mercury wastes will be disposed in a designated RCRA subtitle C compliant monofill.
This final rule is effective July 27, 2026.
Bethany Russell, Waste Characterization Branch, Waste Identification, Notice, and Generators Division, Office of Resource Conservation and Recovery (5304P), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 566-0823; email address:
This action applies only to elemental mercury treated at Bethlehem Apparatus's Pennsylvania facility located at 935 Bethlehem Drive, Bethlehem, PA, and land disposed at USE's facility located at Highway 95, 11 Miles South of Beatty, Beatty, Nevada. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the
The EPA is finalizing a SSTV for U.S. Ecology's treatment and disposal of elemental mercury waste generated from retorting high mercury waste in accordance with the LDR technology-based standard of RMERC. In this action, the EPA hereby approves, with conditions, a variance for USE from the requirement that elemental mercury reclaimed from RMERC of D009, U151, or Bevill-exempt high mercury wastes generated in the U.S. gold mining industry
For the reasons described in the February 6, 2026, preamble to the proposed approval (91 FR 5400) and in the Agency's response to comments received on the proposal, the EPA is finalizing the variance without alteration.
Under 40 CFR 268.44, EPA may grant site-specific treatability variances in cases when facilities generate hazardous wastes that cannot be treated to the specified levels or when it is technically inappropriate for such wastes to undergo the prescribed treatment. See 51 FR 40605-40606, November 7, 1986, and 62 FR 64504, December 5, 1997. The requirements for an LDR treatment variance are found at 40 CFR 268.44 and LDR variance petitioners must follow the procedures in 40 CFR 260.20. Of note, 40 CFR 268.44(k) cross-references compliance with 40 CFR 268.7, which includes testing, tracking and recordkeeping requirements for generators, reverse distributors, treaters and disposal facilities.
In this case, EPA finds that the existing requirement is inappropriate,
On June 30, 2021, USE submitted a petition to the EPA for a Determination
Many commenters on the proposed variance expressed concern that mercury is a persistent, bioaccumulative neurotoxin and raised the possibility of leaching into groundwater, surrounding soils, nearby wells or surface water. Some commenters questioned the long-term integrity of monofill containment systems. While EPA agrees that mercury poses serious risks to human health and the environment, these risks are the basis for stringent controls under RCRA and are fully considered in EPA's evaluation of this petition. As detailed in the proposed variance, the approved treatment—conversion of elemental mercury generated from RMERC to mercuric sulfide and stabilization in LLDPE monolithic solids—significantly reduces mercury mobility and the treatment meets or exceeds the performance standards applicable under the LDR program.
Several commenters supported the variance but recommended long-term groundwater monitoring, limits on stored volumes, periodic inspections, and further measures to address contingency scenarios. EPA notes that the variance does not remove or alter any existing regulatory obligations under RCRA subtitle C. The facility must adhere to all applicable monitoring, inspection, and contingency requirements under its hazardous waste permit. Additionally, the Nevada Department of Environmental Protection, as the authorized entity that oversees permitting at U.S. Ecology's Nevada facility, may choose to require additional controls or disposal volume limits based on its review of U.S. Ecology's permit application for the subtitle C monofill where the treated elemental mercury will be disposed.
Some comments opposed departing from traditional RMERC recycling requirements, while others noted that the elemental mercury market has collapsed and supported permanent disposal through stabilization. EPA's review of the mercury market as discussed in the proposed rule shows that the mandated recycling standard is no longer technically appropriate due to the lack of viable market demand. The variance authority exists precisely for circumstances such as this, in which the underlying treatment standard is inappropriate even if technically possible.
Some commenters questioned whether granting the variance could set a precedent for weakening hazardous waste controls or raised concerns about long-term facility responsibility. EPA points out that this variance applies only to the specific waste streams and facility described in the petition. Approval does not alter national standards and does not create an automatic pathway for future variances. Long-term oversight obligations remain in effect under existing RCRA requirements. Further, the record demonstrates that the treatment approach significantly limits the potential mobility of the elemental mercury and that disposal in a designated monofill will ensure that any leaching is discovered before it can contaminate ground or surface water in the surrounding areas. The EPA also believes the approved treatment approach is preferable to the status quo, which is indefinite long-term storage in its elemental mercury form since the market for mercury is currently insufficient.
Several commenters supported the proposed variance, noting that the treatment method reduces long-term environmental risks. One commenter provided only a correction to a facility location description and did not take a position.
The petition includes the conclusions of a study of a process for treating and stabilizing elemental mercury reclaimed from high mercury wastes that will minimize the risk of mercury release from the treated waste and allow for land disposal. USE has an existing agreement with Bethlehem Apparatus to perform the treatment process. The Bethlehem Apparatus process post-RMERC includes: (1) conversion of distilled and retorted high-purity elemental mercury into a stable form of mercuric sulfide (HgS) powder by reaction without significant excess sulfur through a patented proprietary process (U.S. Patent Nos. 7,691,361 and 8,501,107); (2) blending the HgS powder with melted linear low-density polyethylene (LLDPE) under a proprietary process with defined parameters under vacuum; and (3) extruding the LLDPE-HgS blend as a monolith (hereafter referred to in this document as “HgS waste”) directly into Department of Transportation (DOT)-rated nonreactive container (such as high density polyethylene (HDPE) closed-head drums). USE must only accept containers of HgS waste that meet all applicable DOT requirements under 49 CFR.
For final disposal, USE must construct a designated HgS waste RCRA monofill at its Beatty, Nevada facility, in compliance with its RCRA permit. Controlling variable environmental conditions that may influence mercury leaching from HgS waste is a critical part of this variance. USE's proposed monofill must only accept HgS waste treated by the process described in this rule and USE's September 22, 2025, petition, subject to the conditions summarized in section IV of this preamble, Conditions for Treatment and Disposal of HgS Wastes. The proposed monofill disposal site must be located within a RCRA subtitle C permitted facility in an arid environment in Beatty, Nevada. This location limits the potential impacts of rainwater to the disposal site by lowering the potential for leachate generation. Disposal in a segregated monofill reduces potential infiltration of storm water or leachate from other portions of the facility and the introduction of other contaminants or minerals from rainwater that may increase mercury leachability. For these reasons, the EPA has determined that the proposed monofill location will minimize the potential for mercury migration or leaching from the treated waste.
The Nevada Department of Environmental Protection (NDEP) regulates hazardous waste pursuant to Nevada Administrative Code (NAC) and the Nevada Revised Statutes (NRS), as a State authorized to implement a hazardous waste program under the RCRA. As such, prior to construction of the monofill and acceptance/disposal of any HgS waste at the Beatty, Nevada, facility, USE must obtain all necessary permits and permit modifications from NDEP.
The proposed monofill must meet, at a minimum, all hazardous waste
In addition to the alternative treatment protocol described in section III.A. of this preamble and of this variance approval and further detailed in USE's September 22, 2025, petition, USE must comply with the following conditions.
1. Prior to construction of the monofill and acceptance/disposal of any HgS waste at the Beatty, Nevada, facility, USE must obtain all necessary Federal, State and local permits.
2. For HgS waste, USE must meet the concentration based LDR standard of 0.025 mg/L using TCLP, Method 1311; however, USE must also conduct periodic confirmation testing on two (2) batches at least quarterly for the first two (2) years and annually on two (2) batches thereafter of the HgS waste using the most recently approved revision of LEAF Method 1315 with modifications appropriate for mercury (See EPA “Summary Document” in the docket for details) to confirm continued compliance with the concentration-based LDR standard of 0.025 mg/L. Additional confirmation testing may be established by NDEP as part of the permitting process.
3. USE must confirm that excess mercury is not present in the HgS powder prior to blending with LLDPE, for at least one (1) of every twenty (20) batches of HgS powder destined to be blended with LLDPE and disposed at the Beatty, Nevada, facility.
4. HgS waste must be disposed within a permitted subtitle C monofill at the USE Beatty, Nevada, TSD facility.
5. Disposal of HgS waste at the Beatty, Nevada, monofill must comply with USE's RCRA permit conditions for the treated HgS waste.
6. The HgS waste management facilities at USE, including any waste storage or disposal areas, must be designed and constructed such that the containment system, leachate management system, stormwater collection and control system, and future cover and closure systems are independent of other environmental control systems for the facility. The stormwater control systems for the HgS waste management facilities must not allow stormwater run-off to or run-on from other waste management units and must be designed to contain at least the water volume resulting from a 24-hour, 100-year event. This condition must be met during the life of the facility for operation, closure, and post-closure periods.
7. Leachate from other waste management units of the USE facility must not be used for dust suppression at the monofill. Leachate from the monofill itself may only be used for dust suppression at the monofill if the leachate collected from the monofill is analyzed and does not contain any hazardous constituents.
8. Unless a Future Amendment to this variance is approved as described in section V of this preamble, Future Amendments to this Variance, below, USE must only accept HgS waste treated via existing agreement between USE and Bethlehem Apparatus as is described in this variance.
Prior to the acceptance of HgS powder or HgS waste at the Beatty, Nevada, facility from any facility other than Bethlehem Apparatus's Bethlehem, Pennsylvania, location, USE must submit a request for a modification of this variance through a revised petition submitted pursuant to 40 CFR 268.44 for approval by the EPA. To ensure such a process change does not alter the performance of the treatment process for HgS waste, the following steps are required for the Agency to determine that the process and treatment residuals are equivalent to those analyzed for this variance.
A.
1. Ensure any alternate vendor has secured all necessary permits for such treatment processes from local, State and Federal regulators.
2. Demonstrate and receive approval from EPA that the conversion process is the same as or equivalent to the Bethlehem Apparatus process. The demonstration must detail equivalency for the following process controls: type of equipment used, conversion temperature, color of the HgS powder, type and quantity of sulfur added for reaction completion without significant excess sulfur, external environmental conditions at the time of conversion (humidity and temperature), control of mercury losses through volatilization and residual concentrations of other mercury species. If any process controls differ from the Bethlehem Apparatus process, USE must submit such revisions to EPA for approval and request a technical meeting to discuss such revisions with the Agency prior to receiving HgS powder from the alternate vendor.
3. Provide third-party analysis from at least five (5) samples of HgS waste from different batches to the EPA. The analysis must demonstrate that leaching does not exceed 0.025mg/L using TCLP and EPA Method 1315 with modifications appropriate for mercury (refer to the mercury leaching report at document ID: EPA-HQ-OLEM-2025-2038-0026 for data transformation from Method 1315 to aqueous concentration using the liquid-to-solid ratio and liquid-to-solid equilibration time for TCLP).
B.
1. Secure all necessary permits for such treatment processes from local, State and Federal regulators.
2. Demonstrate and receive approval from EPA that the blending and extrusion process is the same as or equivalent to the Bethlehem Apparatus process. The demonstration must detail equivalency for the following process controls: type of equipment used, temperature of the blending and extrusion process, residence time of HgS in the mixing chamber, mixing speed, external environmental conditions at the time of blending (humidity and temperature) and control of mercury losses thorough volatilization. If any process controls differ from the Bethlehem Apparatus process, USE must submit such revisions to the EPA for approval and request a technical meeting to discuss such revisions with the Agency prior to commencement of the treatment process.
3. Provide third-party analysis of at least three (3) samples of the treated LLDPE-HgS monolithic waste using TCLP and EPA Method 1315 from different batches of HgS powder with modifications appropriate for mercury (refer to the mercury leaching report at document ID: EPA-HQ-OLEM-2025-2038-0026 for data transformation from Method 1315 to aqueous concentration using the liquid-to-solid ratio and
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action is an Executive Order 14192 deregulatory action. This rule is expected to provide burden reduction by replacing an unachievable LDR standard that led to the requirement for indefinite storage of high concentration mercury wastes by DOE. The site-specific LDR standard will allow for the treatment and disposal of high concentration mercury wastes.
This rule is exempt from the CRA because it is a rule of particular applicability.
Environmental protection, Hazardous waste, and Variances.
For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is amended as follows:
42 U.S.C. 6905, 6912(a), 6921, and 6924.
The addition reads as follows:
(o) * * *
Fish and Wildlife Service, Interior.
Direct final rule; request for comments.
This direct final rule changes the administrative process for authorizing seasonal migratory game bird hunting in the United States. Migratory game bird hunting regulations are currently promulgated annually to provide opportunities for recreation and sustenance; aid Federal, State, and Tribal governments in the management of migratory game birds; and allow harvests at levels compatible with migratory game bird population status and habitat conditions.The U.S. Fish and Wildlife Service (Service or we) is adopting a more efficient administrative process for authorizing seasonal migratory game bird hunting. The Service will issue a memorandum for migratory game bird hunting once every 3 years. The Service will continue to make annual decisions on harvest levels and will update the memorandum sooner than 3 years if changes are prescribed by our decision frameworks. The process eliminates the need for subsequent annual Federal regulation promulgation and rulemaking and is expected to increase efficiency; better meet State, Tribal, and Federal rulemaking constraints; and reduce the complexity and costs. Our goal is to better serve State partners and the hunting public while continuing to meet the legal and conservation purposes of the Migratory Bird Treaty Act.Tribes are already authorized under a similar process.
This final rule is effective on August 25, 2026, without further action, unless significant adverse comments are received by July 27, 2026. If significant adverse comments are received, we will publish a notification in the
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Comments submitted through any method not authorized in this document, or sent to an address not listed here, will not be considered. We will not accept comments via email, fax, or hand delivery. We are not required to consider comments that are submitted after the comment period ends or that are submitted via a method outside of these instructions. Comments containing profanity, vulgarity, threats, or other inappropriate content will not be considered.
We will post all comments at
Jerome Ford, U.S. Fish and Wildlife Service, Department of the Interior, (703) 358-2606. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point of contact in the United States. Please see Docket No. FWS-HQ-MB-2026-1421 on
The Service is issuing this rule as a direct final rule. Although the Administrative Procedure Act (APA; 5 U.S.C. 551-559) generally requires agencies to engage in notice and comment rulemaking, the APA provides an exception when the agency “for good cause finds” that notice and comment are “impracticable, unnecessary, or contrary to the public interest” (5 U.S.C. 553(b)(B)). The Service has determined that notice and comment are unnecessary because this rule is noncontroversial; of a minor, technical nature; involves little agency discretion; and is unlikely to receive any significant adverse comments. Significant adverse comments are those that oppose the revision of this direct final rule and raise, alone or in combination, (1) reasons why the revision of the rule is inappropriate, including challenges to the revision's underlying premise; or (2) serious unintended consequences of the revision. A comment recommending an addition to the rule will not be considered significant and adverse unless the comment explains how this direct final rule would be ineffective without the addition.
The Service is publishing this rule concurrently with a proposed rule because we view this as a noncontroversial action and anticipate no adverse comment since this is a change only in internal administrative process to increase efficiency in authorizing seasonal migratory game bird hunting. If we receive significant adverse comments by July 27, 2026, we may withdraw all or part of this direct final rule or issue a revised final rule. For further information about commenting on this rule, see the
Migratory game birds are species designated in the conventions between the United States and several foreign nations for the protection and management of migratory birds. The conventions restrict migratory game bird hunting to the fall-winter period (1 September-10 March) and not more than 3.5 months (interpreted as 107 days) for any species. Under the Migratory Bird Treaty Act (MBTA; 16 U.S.C. 703-712), the Secretary of the Interior is authorized and directed to determine when and to what extent “hunting, taking, capture, killing, possession, sale, purchase, shipment, transportation, carriage, or export of any such bird, or any part, nest, or egg” of migratory game birds can take place compatible with the terms of the conventions, and to adopt regulations for this purpose (16 U.S.C. 704(a)). The Secretary is authorized and directed to give “due regard to the zones of temperature and to the distribution, abundance, economic value, breeding habits, and times and lines of migratory flight of such birds” (16 U.S.C. 704(a)). This responsibility has been delegated to the Service as the lead Federal agency for managing and conserving migratory birds in the United States.
The Service established regulations governing migratory game bird hunting at title 50 part 20 of the Code of Federal Regulations (50 CFR 20). Currently, the Service publishes additional annual regulations (50 CFR 20 subpart K) to authorize migratory game bird hunting for the season. These regulations set the parameters for open seasons including season dates, season lengths, shooting hours, daily bag and possession limits, areas where hunting may occur, and other restrictions based on biological data. The annual regulations ensure that harvest occurs at levels compatible with migratory game bird population demographics, including production and survival, which vary in space and time with habitat conditions. These conditions may differ over North America, and within the United States. (For purposes of our regulations, and in this final rule, the term “States” includes the territories of Puerto Rico and the U.S. Virgin Islands, consistent with 50 CFR 10.12).
Migratory game birds use four primary migratory routes in North America. Because of the unique biological characteristics and the relative number of hunters in these routes, the Service adopted the flyway structure for administering migratory bird resources within the United States, referred to as the flyways (Atlantic, Mississippi, Central, and Pacific). The current annual migratory bird hunting regulations at 50 CFR part 20 subpart K establish regulations for each administrative flyway including all or portions of States in the 48 conterminous United States. We may have separate regulations in Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands.
Each administrative flyway has a Flyway Council, a formal organization established through the Association of Fish and Wildlife Agencies. Flyway Councils are administrative bodies that
To support the annual regulation process, Service biologists gather, analyze, and interpret biological survey data and provide this information to all those involved in the process through a series of published status reports and presentations to Flyway Councils and other interested parties. The Service considers abundance of migratory game birds and other biological factors; and therefore, undertake several surveys throughout the year in conjunction with Service Regional Offices, the Canadian Wildlife Service, and State and Provincial wildlife management agencies. To determine the appropriate annual regulations authorizing hunting for certain game bird species and populations, we consider factors such as population size and trend, geographical distribution, reproductive capacity, condition of breeding and wintering habitat, number of hunters, and anticipated harvest.
The Service Migratory Bird Regulations Committee (SRC) and Flyway Councils recommend to the Service appropriate parameters for State and Tribal migratory game bird hunting regulations. The SRC conducts meetings, generally in the spring and fall, to review and discuss information on the status of migratory game birds and recommendations from the four Flyway Councils and the Service. The SRC then develops recommendations for parameters for annual State and Tribal migratory game bird hunting regulations. In accordance with current regulations at 50 CFR 20.153, these meetings are open to public observation, and observers may submit written comments to the Service on the matters to be discussed. The SRC then submits recommendations to the Service for review. If approved, they are published in one of the several annual rulemaking documents for public comment.
The current administrative process for authorizing seasonal migratory game bird hunting requires annual promulgation of State-specific Federal regulations to open the hunting season. These annual regulations expire at the end of the hunting season. The process involves publishing a series of at least four proposed and final rulemaking documents in the
(1) A proposed rule (preliminary) that provides the process, regulatory schedule, and initial proposals for seasons, limits, and other regulations for annual migratory game bird hunting.
(2) A proposed rule that proposes the parameters within which States may select hunting seasons. The parameters specify season dates, season lengths, shooting hours, daily bag and possession limits, areas where hunting may occur, and other restrictions.
(3) A final rule that establishes the final parameters within which States and Tribes may select hunting seasons, including season dates, season length, shooting hours, daily bag and possessions limits, areas where hunting may occur, and other restrictions. This final rule incorporates public comments received on the proposed frameworks rule and recommendations from the Flyway Councils.
(4) A final rule that sets forth the annual regulations in subpart K of 50 CFR part 20 to authorize the migratory game bird hunting seasons in each State. This final rule is developed based on a process where each State submits their selection of annual hunting seasons within our parameters.
The process of establishing annual migratory game bird hunting regulations is both complex and time intensive. It begins with extensive data collection from May through December of the preceding calendar year, followed by several months of coordination with state agencies through the Flyway Councils. These efforts culminate in regulatory decisions made by the SRC. Each phase of this process is tightly sequenced, limiting flexibility in the timing of regulatory actions. Additionally, the targeted opening date of September 1 for hunting seasons imposes a hard deadline under which regulations must be finalized through the federal rulemaking process before any seasons can legally begin. This provides only a few months to complete a 4-publication rulemaking process every year. The Service has narrowly met publication deadlines in the last 8 years (2018-2025 hunting seasons; average publication of final rule 7 days prior to the start of the hunting season), placing undue strain on States, the public, and the Service. We provided a detailed overview of the current process and administrative schedule in our August 6, 2015, proposed rule for the 2016-17 migratory game bird hunting season (80 FR 47388).
To alleviate the time constraint issues, the Service is issuing this direct final rule to change the process for authorizing seasonal migratory game bird hunting. This rule will codify in Federal regulations a streamlined annual process for authorizing migratory game bird hunting. This will replace the need for annual Federal regulation promulgation and reduce the need for future rulemaking in the
(1) The process for determining the parameters (“authorization conditions”) within which States and Tribes may establish their annual regulations;
(2) The process for communicating the authorization conditions to States and Tribes through a Migratory Game Bird Hunting (MGBH) memorandum and notice of availability in the
(3) Authorization for States and Tribes to establish migratory game bird hunting regulations in accordance with the authorization conditions set forth in the MGBH memorandum and regulations at 50 CFR part 20.
Federal regulation of migratory game bird hunting has been in place since 1918 under the MBTA, which directs the Secretary of the Interior to authorize hunting based on periodic assessments of bird population status and habitat conditions. The original regulatory process was straightforward due to limited biological information and relatively low hunter participation. As scientific understanding, data availability, and hunter participation increased, the regulatory process expanded in complexity to ensure resultant regulations were based on sound biological principles for conservation and hunting opportunities.
Over time, the annual rulemaking process has become increasingly burdensome for States, the public, and the Service due to compressed publication timelines, administrative inefficiencies, and the growing volume of technical material required to support annual updates. These challenges have constrained transparency and limit the ability of States, Tribes, and the public to plan effectively.
The new process maintains all statutory obligations under the MBTA
By codifying these provisions in regulations, annual rulemaking will no longer be required to authorize seasonal migratory game bird hunting. Future rulemaking will be infrequent and undertaken only if changes to the underlying process are warranted. The process is similar to that established for Tribes (50 CFR 20.110) where Tribes are authorized to establish hunting regulations within our basic regulations and annual parameters. The process also aligns with the regulations at 50 CFR 92 authorizing Alaska subsistence hunting, where the regulations do not expire and thus do not have to be established annually before seasonal hunting may occur.
We are not making any changes to the biological approach or the process used to determine the appropriate parameters from which States and Tribes may establish their migratory game bird hunting regulations. The Service will continue biological monitoring and assessment consistent with the programmatic document, “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (EIS 20130139).
This rulemaking changes the administrative process for authorizing seasonal migratory game bird hunting. We are making these changes to increase efficiency; better meet Federal, State, and Tribal rulemaking constraints; and reduce the complexity and costs associated with promulgating annual migratory game bird hunting regulations. Our goal is to better serve State and Tribal partners and the hunting public while continuing to meet the legal and conservation purposes of the MBTA.
The nationwide economic effects generated by migratory game bird hunting are substantial, as detailed in the most recent annual rulemaking, estimated at about $2.7 billion in associated economic activity. Small, incremental adjustments made to Federal migratory bird hunting authorization conditions (limits) are not expected to materially alter those underlying economic inputs nor impose additional Federal costs. As a result, preparing a full Regulatory Impact Analysis for every annual MGBH memorandum would provide limited additional value for Federal decision-making. Annual adjustments to season lengths or bag limits have historically produced minimal and highly variable economic effects, and available evidence shows hunter participation remains stable despite such changes. As all previous annual rulemakings under the current administrative process have been “economically significant” actions under section 3(f)(1) of E.O. 12866, we intend to continue preparing a full Regulatory Impact Analysis, following the directives in E.O. 12866 for economically significant actions and the guidelines in Circular A-4, for the primary MGBH memorandum issued every 3 years under the new process to ensure continued sustainable harvest levels while also minimizing negative economic impacts.
Table 1 provides a comparison between the existing and new processes for each major component in the process of authorizing seasonal migratory game bird hunting. The following sections describe the changes in greater detail.
This rulemaking changes 50 CFR 20 subparts H, K, and N. In subpart H, we revise §§ 20.71 and 20.72 to provide that a violation of our regulations or of any State or Tribal law or regulation for migratory game bird hunting constitutes a violation of Federal law. However, we retain existing language in subpart H that prohibits take of migratory game birds except as provided in Federal, State, and Tribal hunting regulations.
In subpart K, we remove the regulations at §§ 20.100-20.107 (annual
We eliminate subpart N by moving the existing regulations regarding the Service Migratory Bird Regulations Committee and Flyway Councils to subpart K, which describes the administrative process for authorizing States and Tribes to establish their regulations for migratory game bird hunting.
We are also making minor, nonsubstantive terminology changes to subpart B at § 20.11, subpart C at § 20.21 and § 20.23, and subpart K at § 20.110 to align with the new process. At § 20.11, we are making additional nonsubstantive edits to correct two typographical errors. We further update subpart C at § 20.21 to recognize the split of cackling goose (
The Service will publish the Migratory Game Bird Hunting (MGBH) memorandum and notice in the
The MGBH memorandum will authorize seasonal hunting for certain designated migratory game bird groups or species of in the conterminous United States, Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands. Migratory game birds are defined in regulations at 50 CFR part 20, subpart B, at § 20.11 as those species included in the terms of the Conventions for the protection of migratory birds and belonging to five families of birds and for which open seasons are authorized in 50 CFR part 20. Open hunting seasons may include certain designated members of the avian families Anatidae (ducks, geese, and swans); Columbidae (doves and pigeons); Gruidae (cranes); Rallidae (rails, coots, and gallinules); and Scolopacidae (shorebirds including woodcock and snipe). The Service maintains a list at 50 CFR 10.13 of all species considered migratory birds and protected by the MBTA, and we review and update this list regularly (see 88 FR 49310, July 31, 2023, for the most recent update). There are currently 185 migratory game bird species that may be subject to open hunting seasons based on the game bird families identified in § 20.11 and associated species at § 10.13. The regulations for the 2024-25 hunting seasons established open hunting seasons in at least some part of the United States for 93 of these species. We will not authorize hunting through the MGBH memorandum for any migratory game bird species group (
To determine the authorization conditions, we will apply the most current information on game bird demographics and habitat conditions to the decision frameworks previously adopted through rulemaking or notice published in the
We will make available the MGBH memorandum at the address indicated in
The notice of availability of the MGBH memorandum in the
States and Tribes will establish regulations for migratory game bird hunting seasons through their own development processes that are within the Federal authorization conditions set forth in the MGBH memorandum and in accordance with Federal regulations. State and Tribal regulations for migratory game bird hunting will be federally authorized provided they are within the Federal authorization conditions provided in the MGBH memorandum and notice in the
The Service will no longer continue the current practice of publishing State annual hunting regulations as Federal regulations. We recognize that this may be a transition for some states. Therefore, the Service may continue to publish State annual hunting regulations for up to 3 years for those few States that do not currently have their own processes for issuing annual migratory game bird hunting regulations. These State annual regulations will be published as a Federal policy memorandum, separate from the MGBH memorandum, available at the address indicated in
The Service will continue to have public Flyway and SRC meetings, public review of notifications in the
• April-May: As necessary, SRC meeting for proposed changes to the decision frameworks or hunting regulations, which we expect to be infrequent.
• April-June: Spring game bird population surveys.
• August: Completion of game bird population status reports and hunter activity and harvest report.
• September: Biological data are applied to federally established decision frameworks. Preliminary outcomes from the decision frameworks are prepared as the draft authorization conditions for migratory game bird hunting.
• September: Flyway Council meetings.
• October: As necessary, SRC meeting for proposed deviations and changes to the decision frameworks or hunting regulations, which we expect to be infrequent.
• December-January: Winter game bird population surveys.
• January: The draft annual authorization conditions for migratory game bird hunting are updated to account for new data.
• On or before February 28 (every 3 years): The authorization conditions for annual migratory game bird hunting are set forth and communicated via the MGBH memorandum and notice of availability is published in the
• March: Flyway Council meetings.
• April: If warranted, the MGBH memorandum may be revised for administrative corrections.
• May: Each State's proposed annual regulations for migratory game bird hunting is due to the Service by May 31.
• July: Federal policy memorandum with State annual hunting regulations posted on the Service website annually for up to 3 years after the final rule, upon request by the States.
• February-August: States and Tribes develop their regulations for annual migratory game bird hunting.
• 1 September-10 March: Annual migratory game bird hunting occurs.
Like the current administrative process, we will determine authorization conditions using decision frameworks based on the U.S. Code and the Code of Federal Regulations or adopted in the
The authorization conditions for 24 species or species groups are currently established based on 16 decision frameworks, and some have been in use for 30 years. For example, adaptive harvest management (AHM) decision frameworks for duck harvest management, a specific kind of decision framework including a formal mechanism for reducing uncertainty over time, were first implemented in 1995. The decision frameworks for determination of authorization conditions for hunting migratory game birds are listed in Table 2 below. We will maintain a list of current decision frameworks used to determine authorization conditions and post these on the Service's website
Currently, determination of some authorization conditions depends on Flyway Council recommendations based on formal Council harvest strategies (
As with the current administrative process, this new process applies biological data (
We note that the Service and Flyway Councils have not recommended deviation from the prescriptions of the general duck season decision frameworks since they were first implemented in 1995. Thus, for nearly 30 years, we have applied current biological data to established decision frameworks and accepted the outcomes as the authorization conditions for the general duck seasons. However, a notable example of a more restrictive deviation from a species-specific decision framework occurred for the northern pintail season in 2002 (67 FR 59110, September 19, 2002) and 2003 (68 FR 55784, September 26, 2003), when unforeseen circumstances (record low numbers, combined with the poor production forecast) indicated that a departure from the pintail decision framework was justified and consistent with the Council recommendations we received in those years. The Councils and Service revised the decision framework for northern pintails in 2004 to incorporate the new information (69 FR 52970, August 30, 2004). Also, the Atlantic Flyway Council and Service recommended more restrictive authorization conditions for the Atlantic Flyway population of Canada geese for the 2022-23 hunting season in deviation from the Council's harvest strategy (87
The two cases of restrictive deviations from decision frameworks in at least the last 30 years indicate that such departures are unlikely. Restrictive deviations are unlikely because unforeseen circumstances rarely occur given the long-term nature of monitoring programs, some since 1955, and our decision frameworks are developed based on observed long-term demographic data. If the Councils and SRC recommend any liberalization beyond the authorization conditions prescribed by the decision framework, those changes will be reviewed by the Service, and, if supported, we will initiate a rulemaking to revise the decision framework.
In some cases, for reasons outside our control, we may need to temporarily and minimally deviate from our decision frameworks to address missing data. For example, due to the coronavirus pandemic and associated travel restrictions and human health concerns in the United States and Canada, certain migratory bird monitoring surveys were cancelled in 2020 and 2021. As such, the Waterfowl Breeding Population and Habitat Survey, which provides status information for many species of waterfowl, including those used in our AHM decision frameworks, were cancelled during those years. When unforeseen data gaps occur, as in 2020 and 2021, the Service may need to use time series forecasting tools and population and habitat models to make inference to current population status as needed in established decision frameworks. Such deviations would be limited to those necessary to determine appropriate authorization conditions in existing decision frameworks. Any deviation would be described in the MGBH memorandum, with any longer-term adjustments to decision frameworks addressed through future rulemaking. Temporary deviations from decision frameworks to address data gaps fall within the scope of existing regulatory authority and maintain intent of established decision frameworks. These temporary adjustments apply the best available data and scientific methods within the established framework and are critical to making informed decisions about appropriate authorization conditions for the current season when this would otherwise not be possible in the case of missing data. The compulsory, minimal, and urgent nature of these temporary deviations are appropriately communicated through the MGBH memorandum rather than through a separate rulemaking.
Any technical updates or adjustments to the federally established decision frameworks will be published in a notice in the
These technical updates are discussed at public meetings including the Flyway Council and SRC meetings and are open to public comment. After receiving support from the Flyway Councils and SRC, technical updates or changes to decision frameworks will be published in a
We periodically publish reports that provide detailed information on the status and harvest of certain migratory game bird species. These reports contain descriptions of species population segments referenced in status assessments. These reports are available at the address indicated in
We will use the most recently published reports in the development of annual authorization conditions for migratory game bird hunting. These reports currently include the following:
• Adaptive Harvest Management;
• American Woodcock Population Status;
• Band-tailed Pigeon Population Status;
• Migratory Bird Hunting Activity and Harvest;
• Mourning Dove Population Status;
• Status and Harvests of Sandhill Cranes, Mid-continent, Rocky Mountain, Lower Colorado River Valley and Eastern Populations; and
• Waterfowl Population Status.
Additional information, status reports, and special assessments may be provided by the Service and each of the four Flyway Councils.
Our long-term objectives continue to include providing opportunities to harvest portions of certain migratory game bird populations and to limit harvests to levels compatible with each population's ability to maintain healthy, viable numbers. The Service's goals and objectives for migratory game bird harvest management are specified in a 2013 supplemental environmental impact statement (notice of availability published at 78 FR 32686, May 31, 2013) and the proposed rule that published at 52 FR 7900, March 13, 1987. Migratory game bird hunting seasons provide opportunities for recreation and sustenance, and aid Federal, State, and Tribal governments in the management of migratory game birds.
We periodically receive recommendations on the authorization conditions and other policies and regulations for migratory game bird hunting from the four Flyway Councils at the SRC meetings, generally held in spring and fall. We may also receive public comments from the SRC meetings and notices published in the
We will continue to use our AHM decision frameworks to determine appropriate regulatory alternatives for annual duck hunting as described in earlier rulemaking for annual migratory game bird hunting regulations (89 FR 68500, August 26, 2024). AHM is a tool that permits sound resource decisions in the face of uncertain regulatory impacts and provides a mechanism for reducing that uncertainty over time. We use an AHM decision framework to evaluate four regulatory alternatives, each with a different expected harvest level, and choose the optimal alternative for duck hunting authorization conditions based on the status and demographics of mallards for the Mississippi, Central, and Pacific Flyways, and based on the status and demographics of four duck species (green-winged teal, common goldeneye, ring-necked duck, and wood duck) in the Atlantic Flyway. We have species-specific AHM decision frameworks that guide appropriate authorization conditions for species of special concern, including black ducks, scaup, northern pintails, and mallards in the Atlantic Flyway (eastern mallards), within the general duck hunting regulations. These protocols have species-specific regulatory alternatives but share some aspects of the regulatory alternatives for the general duck seasons.
We currently use independent optimizations to determine the appropriate regulatory alternative based on the status of mallards in the Mississippi, Central, and Pacific Flyways and status of the four duck species mentioned above in the Atlantic Flyway. This means that we develop authorization conditions for mid-continent mallards, western mallards, and eastern ducks independently based on the breeding ducks that contribute primarily to each Flyway. These species-populations are a surrogate for the status of ducks in general in each flyway. We provided an overview of the AHM decision frameworks for general duck hunting authorization conditions in each Flyway in an August 26, 2024, rule (89 FR 68500).
The regulatory alternatives considered in the general duck season AHM decision frameworks associated with each flyway were described in a January 21, 2025, proposed rule (90 FR 7056). Regulatory alternatives include opening and closing dates, season lengths, daily bag limits, and shooting hours. Current regulatory alternatives for each of the four flyways include restrictive (relatively short seasons and low daily bag limits), moderate (intermediate season lengths and daily bag limits), liberal (longer seasons, higher daily bag limits), and closed seasons. The authorization conditions within each of these alternatives may vary by flyway. The differences in season lengths and daily bag limits among flyways reflect the historic differences in waterfowl abundance and hunter numbers in these regions. Each regulatory alternative has an associated target harvest rate for one or more species as a representative of all duck species.
AHM decision frameworks are used with the most current population status, habitat, and harvest survey data to govern the selection of one of the regulatory alternatives (
The basic structure of the current regulatory alternatives for AHM was adopted in 1997 (beginning with the 1997-98 general duck hunting season; 62 FR 31298, June 6, 1997). Changes to these alternatives have been infrequent and are detailed in the January 21, 2025, proposed rule (90 FR 7056). The alternatives were last revised beginning with the 2021-22 hunting season based on recommendations of the Flyway Councils (85 FR 51854, August 21, 2020).
We anticipate that, under the AHM approach, the regulatory alternatives will remain the same over time, because the optimization process assumes that the expected harvest rates resulting from the various alternatives remain constant over long-term (about 100 years) forecasting. That process accounts for the uncertainty resulting from the difference between projected harvest rates and actual harvest rates in any given year. Recognizing that constituents may favor periodic adjustments to the regulatory alternatives, we will adopt a regular process to review and incorporate possible modifications.
Although in the past the Service adopted the regulatory alternatives annually, that process does not account for the need to maintain predictable harvest projections for the optimization step in the current AHM process. We expect annual changes to the regulatory alternatives to have a negative impact on our ability to predict the harvest associated with each regulatory alternative. This approach would result in greater uncertainty in forecasting the impacts of the regulatory alternatives for a given set of environmental and biological conditions.
We will adopt in regulations the same regulatory alternatives for the general duck seasons that have been in effect since the 2021-22 season. (See 90 FR 17300 at 17302 (under B. Regulatory Alternatives), April 24, 2025, for the most recent rulemaking document that adopted the alternatives used prior to this final rule and 90 FR 7056 at 7061 (under B. Regulatory Alternatives), January 21, 2025, for a description of the alternatives and their history.) We also will codify in regulations restrictions on the frequency of changes to these regulatory alternatives because of the need to maintain predictable harvest projections for the optimization step in the AHM decision frameworks. We intend to have the first open review and possible modification of these regulatory alternatives no sooner than 2026. The last modification occurred in 2021. Establishing duck regulatory alternatives for 5-year periods was the preferred alternative in the “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds” (see full reference in Required Determinations,
The intent for open review and possible modification of these regulatory alternatives should begin
We note that we are codifying the alternatives for general duck hunting in regulations. However, regulatory alternatives from other decision frameworks are specified only in the preambles to rulemaking documents, not in the Code of Federal Regulations. We are codifying the duck hunting alternatives because the alternatives for general duck hunting apply in some aspects to multiple decision frameworks including those for duck species of special concern (
Zones and split seasons are designed to distribute hunting opportunities and harvests according to temporal, geographic, and demographic variability in waterfowl and other migratory game bird populations. For ducks, States have been allowed the option of splitting their allotted hunting days into two or three temporal segments to take advantage of species-specific peaks of abundance or to satisfy hunters in different areas who want to hunt during the peak of waterfowl abundance in their area. However, the split-season option does not fully satisfy many States that wish to provide a more equitable distribution of harvest opportunities. Therefore, we also have allowed the establishment of independent seasons in up to four geographic zones within States for the purpose of providing more equitable distribution of harvest opportunity for hunters throughout the State.
In 1978, we prepared an environmental assessment (EA) on the use of zones to set duck hunting regulations. A primary tenet of the 1978 EA was that zoning would be used to provide equitable distribution of duck hunting opportunities within a State or region. The intent was not to increase total annual waterfowl harvest in the zoned areas; target harvest levels were to be adjusted downward if they exceeded traditional levels because of zoning.
In 1990, we conducted a review of the use of zones and split seasons. We determined that the ability to detect the impacts of zones and splits on waterfowl demographics and harvest was poor because of the absence of adequate study designs and experimental controls, limitations in monitoring capacities, imprecise parameter estimates, and low power to detect changes in parameter estimates. Substantial concern remained about the unknown consequences of zones and split seasons on duck populations and harvest redistribution among States and flyways, potential reduced effectiveness of regulations (season length and bag limit) to reduce duck harvest if needed, and the administrative burden associated with changing regulations annually. Consequently, we established guidelines to provide a framework for controlling the proliferation of zones and split seasons. The guidelines identified a limited number of zone and split-season configurations that could be used for duck hunting and restricted the frequency of changes in State selection among these configurations to the first year of each 5-year interval (
In 2011, we prepared a new EA analyzing proposed changes to the guidelines for zones and split seasons. Revised guidelines were finalized in the preamble to a 2011 proposed rule (76 FR 53536, August 26, 2011). In 2020, at the request of the four Flyway Councils, we modified the existing guidelines for duck zones and split seasons to allow an additional configuration including two zones with up to three season segments per zone for use beginning with the 2021 duck hunting season (85 FR 51854, August 21, 2020). States that select this new configuration must conduct an evaluation of impacts to hunter dynamics (
Previously, we established guidelines for duck zones and split seasons for each 5-year period via rulemaking (proposed and final rules) regardless of changes to the guidelines. We now will codify the existing guidelines for duck zones and split seasons (85 FR 51854, August 21, 2020), with minor clarifications, in our regulations. By codifying existing guidelines in regulations, we will need to undertake rulemaking only if we decide to modify the guidelines. To modify the guidelines for duck zones and split seasons, we will initiate a new rulemaking and issue proposed and final rules. Any changes to the guidelines will apply beginning the first year of the subsequent 5-year interval to maintain consistency in configurations within the intervals. At least 1 year prior to the possible adoption of any modifications, either the Service or Flyway Councils will announce at an SRC meeting their intent to review and possibly modify the guidelines.
When we first implemented guidelines for duck zones and split seasons in 1991, several States had completed experiments with zone and split-season arrangements different from our original options. We offered those States a one-time opportunity to continue those arrangements, with the stipulation that only minor changes could be made to zone boundaries. If any of those States now wish to change their zone and split arrangement:
(1) The new arrangement must conform to one of the currently allowable configurations; and
(2) The State may not revert to the special case arrangement that it previously had in place.
The following guidelines for zones and split seasons apply only for the regular duck season:
(1) A zone is a geographic area or portion of a State, with a contiguous boundary, for which independent dates may be selected for the regular duck season.
(2) States wishing to change their duck zone and split-season configurations may do so the first year of the 5-year period that it would apply (
(3) Once a zone and split-season configuration is selected, it must remain in place for 5 consecutive years.
(4) Only minor (less than one county in size) zone boundary changes are allowed for any special case arrangement, and such changes are allowed only the first year of the 5-year period during which it would apply.
(5) Minor (less than one county in size) zone boundary changes may be allowed for any State to resolve law enforcement or other boundary clarification issues resulting from implication of a new configuration. Changes would be evaluated on a case-by-case basis and must be approved by the respective Flyway Council and the SRC.
(6) Consideration of changes for management-unit boundaries is not subject to the guidelines and provisions governing the use of zones and split seasons for ducks.
Any State may continue their zone and split-season configuration used in the previous 5-year period. If changes are made, the zone and split-season configuration must conform to one of the following five options:
(1) One zone (same as no zones) with up to three season segments;
(2) Two zones with up to two season segments in each zone;
(3) Two zones with up to three season segments in each zone;
(4) Three zones with up to two season segments in each zone; or
(5) Four zones with a continuous season (
Because the two zones and three season segments configuration is new, States that select this configuration must conduct a one-time evaluation of impacts to hunter dynamics (
For the States that have a recognized management unit (Columbia Basin Management Unit in the Pacific Flyway, High Plains Management Unit in the Central Flyway) and include a non-management unit portion, an independent two-segment duck season with no zones can be selected for the management unit. The remainder of the State in the non-management unit portion can be zoned and have split seasons according to existing guidelines. In the Central Flyway, additional duck season days afforded to the management unit must occur on or after the Saturday nearest December 10.
States wishing to change their duck hunting zone and split-season configuration selection from within our established guidelines must provide their selected configuration and zone descriptions to the Service's Migratory Bird Program by the end of August in the year prior to the first year of the 5-year period that the selection would apply. However, we encourage States to submit their selections and zone boundaries as soon as possible. The Service's Migratory Bird Program will approve State selections once they are determined to be consistent with the above guidelines and zones and split-season configurations and boundary descriptions are complete. Any discrepancies between the State selections and the zone and split-season guidelines and configurations will be addressed by the SRC at their fall meeting, generally held in October. States may continue their zone and split-season configuration used in the previous 5-year period, and we will assume this is the case unless we receive configuration selections and zone descriptions from the State by the deadline for requesting configuration changes. We will publish State-selected duck zone and split-season configurations and zone descriptions in the MGBH memorandum.
In 2004, we recognized the need to work with the States to review our current policy regarding zoning for dove hunting (69 FR 52970, August 30, 2004). We asked the Flyway Councils and Mourning Dove Management Unit Technical Committees to review the current policies regarding the use of zones and split seasons for dove hunting, with a view toward establishing guidelines for the use of these harvest-management tools, as has been done for ducks. Items considered included the number of zone and split-season configurations among which each State may choose, the frequency with which each State may change their configuration selection, and the need for a restricted framework opening date in southern zones. In 2006, we adopted a set of guidelines for dove zones and split seasons applicable in the Eastern and Central Mourning Dove Management Units (EMU and CMU) based on recommendations of the Atlantic, Mississippi, and Central Flyway Councils for use beginning with the 2007 hunting season and conforming to those 5-year periods used for ducks, for example, 2021-25 hunting seasons (71 FR 51406, August 29, 2006). These guidelines were not extended to the Western Management Unit (WMU) at the time because they were not endorsed by the Pacific Flyway Council and no dove zones occurred in the WMU. Furthermore, the framework season length in the WMU was 30 consecutive days, except in Arizona and California where the season length was 60 days and could be split into two segments.
The season length in the WMU was expanded to 60 days beginning with the 2014 hunting season (78 FR 52658 at 52662, August 23, 2013, and 79 FR 51402 at 51405, August 28, 2014). The Pacific Flyway Council requested the same flexibility for zones and split seasons that we have afforded the EMU and CMU, with the exception that the WMU would be allowed only two season segments in one or both zones rather than three. Thus, in 2020, we extended the guidelines for dove zones and split seasons to the WMU, with the exception that seasons may be split into no more than two segments (85 FR 51854, August 21, 2020).
Similar to the situation for ducks, described above, we previously established guidelines for dove zones and split seasons for each 5-year period via rulemaking (proposed and final rules) regardless of changes to the guidelines. We now adopt the existing guidelines for dove zones and split seasons (85 FR 51854, August 21, 2020), with minor clarifications, in our regulations. By codifying existing guidelines in regulations, we will need to undertake rulemaking only if we decide to modify the guidelines. To modify the guidelines for dove zones and split seasons, we will initiate a new rulemaking and issue proposed and final rules. Any changes to the guidelines will apply beginning the first year of the 5-year interval to maintain consistency in configurations within the intervals. At least 1 year prior to the possible adoption of any modifications, either the Service or Flyway Councils
When we first implemented the guidelines for dove zones and split seasons in 2006, some States had completed experiments with zone and split-season arrangements different from our original options. We offered those States a one-time opportunity to continue those arrangements (special case), with the stipulation that only minor changes could be made to zone boundaries. If any of those States now wish to change their zone and split arrangement:
(1) The new arrangement must conform to one of the currently allowable configurations; and
(2) The State may not revert to the special case arrangement that it previously had in place.
The following guidelines for zones and split seasons apply only for the regular dove season:
(1) A zone is a geographic area or portion of a State, with a contiguous boundary, for which independent seasons may be selected for the regular dove season.
(2) States wishing to change their dove zone and split-season configurations may do so the first year of the 5-year period that it would apply (
(3) Once a zone and split-season configuration is selected, it must remain in place for 5 consecutive years.
(4) Only minor (less than one county in size) zone boundary changes would be allowed for any special case arrangement, and such changes are allowed only beginning the first year of the 5-year period during which it would apply.
(5) Minor (less than one county in size) zone boundary changes may be allowed for any State to resolve law enforcement or other boundary clarification issues resulting from implication of a new configuration. Changes will be evaluated on a case-by-case basis and must be approved by the respective Flyway Council and the SRC.
Any State may continue their dove zone and split-season configuration selected in the previous 5-year period. If changes are made, the zone and split-season configuration must conform to one of the following two options:
(1) One zone (same as no zones) with up to three season segments; or
(2) Two zones with up to three season segments in each zone, except in the WMU where the season in one or both zones may be split into two segments.
The process for States to select their dove hunting zone and split-season configuration is the same as that for selecting the duck hunting zone and split-season configuration. States wishing to change their dove zone and split-season configuration selection from within our established guidelines must provide their selected configuration and zone descriptions to the Service's Migratory Bird Program by the end of August in the year prior to the first year of the 5-year period that the selection would apply. However, we encourage States to submit their selections and zone boundaries as soon as possible. The Service's Migratory Bird Program will approve State selections once they are determined to be consistent with the above guidelines and zones and split-season configurations and boundary descriptions are complete. Any discrepancies between the State selections and the zone and split-season guidelines and configurations will be addressed by the SRC at their fall meeting, generally held in October. States may continue their zone and split-season configuration used in the previous 5-year period, and we will assume this is the case unless we receive configuration selections and zone descriptions from the State by the deadline for requesting configuration changes. We will publish State-selected dove zone and split-season configurations and zone descriptions in the MGBH memorandum.
Special seasons may be used for species considered to be underutilized, to address nuisance problems with overabundant species, or to provide special hunting opportunities. Special seasons differ from regular seasons in that they entail additional hunting opportunity outside the established regular seasons but within the 107-day limit mandated by the MBTA. Special seasons are used only for species whose migration and distribution provide opportunities outside the period in which regular seasons are held and when harvest can be achieved without appreciable impacts to nontarget species. An important tenet of special seasons is that harvest pressure can be effectively directed primarily at target species or population segments that can be temporally and geographically isolated to avoid nontarget take. Currently, special seasons include: (1) Early teal seasons in the Atlantic, Mississippi, and Central Flyways; (2) bonus blue-winged teal bag limits in certain States in the Mississippi and Central Flyways; (3) early teal and wood duck seasons in Florida, Kentucky, and Tennessee; (4) waterfowl hunting days for youth and veterans-active military personnel; and (5) early seasons on overabundant resident Canada and cackling geese.
The Service has required that States implementing special seasons conduct experiments to assess the biological impacts of those seasons on both target and nontarget species. However, the Service eliminated experimental evaluation requirements for special seasons on overabundant resident Canada and cackling geese, except: (1) in areas where previous evaluations indicate an unacceptable level of take of migrant Canada and cackling geese; and (2) in areas where evaluations have not been conducted and one could reasonably expect an unacceptable level of take of migrant Canada and cackling geese (
Experimental seasons are used to evaluate expansion of regular seasons to new areas; the use of zones and splits in duck, dove, and, in some cases, goose seasons; special seasons; and alternative regulations for regular or special seasons. The Service may require implementing States to conduct research for at least 3 years to assess the environmental effects of experimental seasons, including on target and nontarget species. The Service may also require a memorandum of understanding with any State that implements experimental seasons. Experimental seasons may be authorized for up to 5 years, after which a new request must be submitted. A season may be offered on an
Crows are in the family Corvidae and were not initially identified as a migratory bird in the four bilateral conventions for the protection of migratory birds. The family was added to the list of migratory birds with the convention amendment with Mexico in 1972. However, crows were not identified as a game bird; Corvidae are not one of the five families that comprise migratory game birds. At the time Federal protection was extended to Corvidae, some States had existing hunting seasons for crows. Therefore, Federal regulations were established to allow crow hunting; see 50 CFR part 20, subpart L, at § 20.133, hunting regulations for crows. Federal regulations allow States to establish dates and durations of hunting seasons, bag and possession limits, and methods of taking crows, subject to limitations defined in § 20.133. The hunting season on crows can have a maximum of 124 days within a calendar year because of specific provisions included in the convention with Mexico and must be outside the peak crow nesting period. Some States allow crow hunting 4 days a week, extending the open season nearly 8 months. Most States have no daily bag limit on crows. Crows may also be taken under a depredation order as defined in § 21.150, the depredation order for blackbirds, cowbirds, crows, grackles, and magpies.
Migratory bird hunting regulations at 50 CFR part 20 apply to game birds and crows. Thus, we make the distinction in our regulations between migratory bird hunting (crows included) and migratory game bird hunting (crows excluded). Thus, crow hunting regulations (§ 20.133) are not affected by this rulemaking regarding the administrative process for authorizing migratory game bird hunting. However, this rulemaking action revises § 20.133 to authorize Tribes to establish crow hunting regulations along with the States to be consistent with our Tribal migratory game bird hunting regulations at § 20.110 (see 88 FR 60375, September 1, 2023).
We generally establish the authorization conditions for migratory game bird hunting for the conterminous U.S. States by flyway or management unit/region. We will include the authorization conditions for Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands in separate sections near the end of the MGBH memorandum. The States included in the flyways and management units/regions are described below:
The programmatic document, “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (EIS 20130139),” filed with the Environmental Protection Agency (EPA) on May 24, 2013, addresses criteria of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
This direct final rule is administrative in nature and is categorically excluded. It revises the process for transmitting authorization conditions for seasonal migratory game bird hunting to States and Tribes. Importantly, it does not alter the substantive annual biological monitoring and assessment process that determines those conditions.
The categorical exclusion determination is based on primarily 43 CFR 46.210(i) (in addition to 43 CFR 46.205 and 46.215), which provides that policies, directives, regulations, and guidelines of administrative, financial, legal, technical, or procedural nature qualify for categorical exclusion. The environmental effects of this action are too broad or speculative to lend themselves to meaningful analysis and are addressed in an environmental action statement, which is part of the record for this direct final rule and available for public inspection as provided in
Section 7 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
E.O. 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) reviews all significant rules as defined by that E.O. This rulemaking action will serve only to change the administrative process for authorizing States and Tribes to establish their regulations for migratory game bird hunting. OIRA has determined that this rule is significant under section 3(f) of E.O. 12866.
E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. E.O. 13653 directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. By eliminating annual rulemaking, the Service will save about $80,000 per year in printing costs, reduce staff workload by at least 50 percent, and reduce 200 hours of managerial workload reviewing and surnaming documents.
We have developed this direct final rule in a manner consistent with these requirements. This final rule is an E.O. 14192 deregulatory action.
Under the Regulatory Flexibility Act (5 U.S.C. 601
We have examined this final rule's potential effects on small entities as required by the Regulatory Flexibility Act and determined that this action will not have an economic impact on any small entities. This final rule is administrative in nature, and the affected entities are State and Tribal governments. The rulemaking action changes only our internal administrative process for authorizing States and Tribes to establish seasonal migratory game bird hunting regulations. The annual process is largely a cooperative effort between the Service and the States. The change in our administrative process eliminates the need for annual rulemaking and is expected to increase efficiency; better meet State, Tribal, and Federal rulemaking constraints; and reduce the complexity and costs associated with promulgating annual migratory game bird hunting regulations.
This is not a major rule under SBREFA (5 U.S.C. 804(2)). This direct final rule will not have an annual effect on the economy of $100 million or more; will not cause a major increase in costs or prices for consumers, individual industries, or Federal, State, or local government agencies, or geographic regions; and will not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
Pursuant to subtitle E of the Small Business Regulatory Enforcement Fairness Act (also known as the Congressional Review Act or CRA, 5 U.S.C. 801
This direct final rule does not contain any new collection of information that requires approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
• 1018-0019, “North American Woodcock Singing Ground Survey” (expires 02/28/2027).
• 1018-0023, “Migratory Bird Surveys, 50 CFR 20.20” (expires 09/30/2028). Includes Migratory Bird Harvest Information Program, Migratory Bird Hunter Surveys, Sandhill Crane Survey, and Parts Collection Survey.
• 1018-0171, “Establishment of Annual Migratory Bird Hunting Seasons, 50 CFR part 20” (expires 10/30/2027).
You may view the information collection request(s) at
We have determined and certify, in compliance with the requirements of the Unfunded Mandates Reform Act, 2 U.S.C. 1502
The Department, in promulgating this direct final rule, has determined that this rulemaking action will not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of E.O. 12988.
In accordance with E.O. 12630, this direct final rule, authorized by the MBTA, does not have significant takings implications and does not affect any constitutionally protected property rights. This direct final rule will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. In fact, this final rulemaking action would allow hunters to exercise otherwise unavailable privileges and, therefore, will reduce restrictions on the use of private and public property.
E.O. 13211 requires agencies to prepare statements of energy effects when undertaking certain actions. This rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy and has not been designated by OIRA as a significant energy action. Therefore, no statement of energy effects is required.
In accordance with E.O. 13175 (“Consultation and Coordination with Native American Indian Tribal Governments”) and the Department of the Interior's manual at 512 DM 2, we considered possible effects of this direct final rule on federally recognized Indian Tribes with respect to impacts to Tribes' treaty rights to hunt waterfowl. We have determined that there are de minimis effects on Indian Tribes for that aspect of their treaty rights. Through this process to establish and announce authorization conditions for migratory game bird hunting, we regularly coordinate with Tribes that are affected. Tribes could attend spring and fall Flyway Council meetings, participate in SRC meetings, and provide comments on
This direct final rule is administrative in nature and does not directly affect any specific Tribal lands, treaty rights, or Tribal trust resources. In addition, this direct final rule will not interfere with the ability of Tribes to manage themselves or their funds or to regulate migratory bird activities on Tribal lands. Therefore, we preliminarily conclude that this rulemaking action does not have “Tribal implications” under section 1(a) of E.O. 13175. Thus, formal government-to-government consultation is not required by E.O. 13175 and related policies of the Department of the Interior. We will continue to collaborate with Tribes on concerns related to migratory game bird hunting regulations.
We routinely provide
Due to the migratory nature of certain species of birds, the Federal Government has been given responsibility over these species by the MBTA. We prescribe authorization conditions from which States and Tribes may establish their annual regulations for migratory game bird hunting seasons. This final rule changes only the Federal internal administrative process for establishing the authorization conditions and preserves the ability of the States and Tribes to establish hunting seasons that meet their individual needs. We maintain our regulations at 50 CFR 20.110 (Regulations for certain Federal Indian reservations and ceded lands) recognizing Tribal sovereignty to exercise reserved hunting rights and, for some Tribes, recognition of their authority to regulate hunting by both Tribal and nontribal members on their reservation. Consistent with our longstanding policy, we continue to recognize that, in certain cases, conflicts may arise between specific States and Tribes on aspects of Tribal treaty rights. The Service actively supports the parties reaching a mutually agreeable solution to such conflicts.
Any State or Tribe may be more restrictive in its regulations than the Federal authorization conditions and regulations at any time. The authorization conditions are developed in a cooperative process with the States and the Flyway Councils. This process allows States to participate in the development of the authorization conditions from which they will establish their own hunting regulations. This final rule will 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. Therefore, in accordance with E.O. 13132, these regulations do not have federalism implications and do not warrant the preparation of a federalism summary impact statement.
Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, for the reasons described in the preamble, the U.S. Fish and Wildlife Service is amending title 50, chapter I, subchapter B, part 20, of the
16 U.S.C. 703
These revisions read as follows:
In addition to definitions contained in part 10 of this chapter, as used in this part, the following terms will be construed, respectively, to mean and to include:
(a)
(b) * * *
(2) A hunting season only for Canada and cackling geese during the period of September 1 to September 30, provided:
(i) The season occurs within the Atlantic, Central, and Mississippi Flyways (see § 20.107 for definitions of the flyways);
(ii) All other waterfowl and crane hunting seasons, excluding falconry, are closed; and
(iii) The State notifies the Service's Migratory Bird Program by May 31 each year of its intention to authorize the additional hunting method in its regulations for the seasonal hunting of migratory game birds.
(g) * * *
(2) A hunting season only for Canada and cackling geese during the period of September 1 to September 30, provided:
(i) The season occurs within the Atlantic, Central, and Mississippi Flyways (see § 20.107 for definitions of the flyways);
(ii) All other waterfowl and crane hunting seasons, excluding falconry, are closed; and
(iii) The State notifies the Service's Migratory Bird Program by May 31 each year of its intention to authorize the additional hunting method in its regulations for the seasonal hunting of migratory game birds.
No person may take migratory game birds except during the hours open to shooting, which includes hawking (taking by falconry), as prescribed in subpart K of this part and 50 CFR 21.180 and 21.183 of this chapter.
No person shall at any time, by any means or in any manner, take, possess, transport, or export any migratory bird, or any part, nest, or egg of any such bird, in violation of any act of Congress or any regulation, including the regulations in this part and the authorization conditions (see § 20.107 for a definition) for migratory bird hunting and in accordance with § 20.125(a), issued pursuant thereto.
No person shall at any time, by any means or in any manner, take, possess, transport, or export any migratory bird, or any part, nest, or egg of any such bird, in violation of any applicable law or regulation of any State or Tribe. A violation of State or Tribal law or regulation, including State regulations in a Federal policy memorandum posted on a Service website, for migratory bird hunting constitutes a violation of Federal law.
(a) The taking, possession, transportation, and other uses of migratory birds is prohibited unless it is specifically provided for in regulations developed in accordance with the Migratory Bird Treaty Act. Consequently, migratory game bird hunting is prohibited except as authorized in regulations in this part and in accordance with the authorization conditions (see § 20.107 for a definition) for State and Tribal migratory bird hunting regulations.
(b) Authorization conditions will be based on data including, but not limited to, migratory game bird population status and trends, habitat conditions, and anticipated harvest. The authorization conditions will be periodically adjusted to account for bird abundance and other biological factors.
(c) In the Atlantic Flyway States of Connecticut, Maine, Maryland, Massachusetts, New Jersey, North Carolina, and Pennsylvania, if Sunday hunting of migratory game birds is prohibited statewide by State law or regulation, all Sundays are closed to the take of all migratory game birds.
For the purpose of this subpart, the following terms will be construed, respectively, to mean and to include:
(1) The selected regulatory alternatives may change periodically based on the status of populations and environmental conditions and will include the regulatory parameters most directly related to maintaining harvests at levels compatible with a game bird population's ability to be self-sustaining.
(2) Authorization conditions specify the bracket dates, season lengths,
(1) Atlantic Flyway is Connecticut, Delaware, Florida, Georgia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, South Carolina, Vermont, Virginia, and West Virginia.
(2) Mississippi Flyway is Alabama, Arkansas, Illinois, Indiana, Iowa, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Ohio, Tennessee, and Wisconsin.
(3) Central Flyway is Colorado (east of the Continental Divide), Kansas, Montana (Counties of Blaine, Carbon, Fergus, Judith Basin, Stillwater, Sweetgrass, Wheatland, and all counties east thereof), Nebraska, New Mexico (east of the Continental Divide except the Jicarilla Apache Indian Reservation), North Dakota, Oklahoma, South Dakota, Texas, and Wyoming (east of the Continental Divide).
(4) Pacific Flyway is Arizona, California, Idaho, Nevada, Oregon, Utah, Washington, and those portions of Colorado, Montana, New Mexico, and Wyoming not included in the Central Flyway.
(1) The Council recommends actions necessary for science-based and sustainable harvest management of migratory birds to the Service.
(2) The Flyway Councils are advised by the Flyway technical committees, which evaluate population and habitat information and make recommendations to the Councils on matters of migratory bird conservation.
Beginning September 1, 1991, the contiguous 48 United States, and the States of Alaska and Hawaii, the Territories of Puerto Rico and the Virgin Islands, and the territorial waters of the United States, are designated for the purpose of § 20.21(j) as nontoxic shot zones for hunting waterfowl, coots, and certain other species. “Certain other species” refers to those species, other than waterfowl or coots, that are affected by reason of being included in aggregate bags and concurrent seasons.
(a) In accordance with 50 CFR 21.82, falconry is a permitted means of taking migratory game birds in any State except for Hawaii. General hunting regulations, including seasons and shooting hours, apply to falconry.
(b) States and Tribes may establish an extended season for taking migratory game birds in accordance with the following:
(1) Bracket dates: September 1-March 10.
(2) Season lengths: For all hunting methods combined, the combined length of the extended season, regular season, and any special or experimental seasons must not exceed 107 days for any species or group of species in a geographical area. Each extended season may be split into three segments.
(3) Daily bag limits: Falconry daily bag limits for all permitted migratory game birds must not exceed 3 birds in the aggregate during extended falconry seasons, any special or experimental seasons, and regular hunting seasons in each State or Tribe, including those that do not establish an extended falconry season. Regular season bag limits do not apply to falconry. The falconry bag limit is not in addition to shooting limits.
(4) Hawking hours: One-half hour before sunrise until sunset except as otherwise restricted by State or Tribal regulations.
(a)
(b)
(c)
(1) Tribes may establish on-reservation hunting regulations, for both Tribal and nontribal members, with hunting seasons that may differ from those in the State(s) in which the reservations are located.
(i)
(ii)
(A) For a short-term experimental hunting season, a Tribe and the Service may formally agree on allowed methods of take, notwithstanding the regulations in § 20.21, for on-reservation and ceded lands hunting by Tribal members. The Service will make public any such formal agreement.
(B) A Tribe that would like to make an additional hunting method operational would need to provide data to the Service for consideration. If the Service agrees with the Tribe's proposal, the Service will conduct rulemaking to amend the regulations in this part to allow Tribal members to use the additional hunting method.
(2) Tribes may establish off-reservation hunting regulations by Tribal members on ceded lands, with hunting seasons that may differ from the authorization conditions for season dates, season length, and daily bag and possession limits.
(d)
The alternative combinations of zones and season segments that a State may use for duck and dove hunting in a 5-year period are described in paragraphs (a) and (b) of this section. The SRC may approve a deviation from the 5-year period length for all four flyways.
(a) Duck hunting zone and split-season configurations include:
(1) One zone (same as no zones) with up to three season segments;
(2) Two zones with up to two season segments in each zone;
(3) Two zones with up to three season segments in each zone;
(4) Three zones with up to two season segments in each zone; or
(5) Four zones with a continuous season (
(b) Dove hunting zone and split-season configurations include:
(1) One zone (same as no zones) with up to three season segments; or
(2) Two zones with up to three season segments in each zone, except in the Western Management Unit where the season in one or both zones may be split into two segments.
For the general duck season authorization conditions, each Flyway has four possible regulatory alternatives (closed, restrictive, moderate, and liberal), each with a different expected harvest level. The open season alternatives are specified as:
(a) For Atlantic Flyway:
(b) For Mississippi Flyway:
(c) For Central Flyway:
(d) For Pacific Flyway, except Alaska:
(e) For Alaska:
(f) Shooting and hawking hours are from one-half hour before sunrise to sunset daily.
(g) In the Central Flyway High Plains Mallard Management Unit, the season length may be extended 12 additional days in the restrictive alternative and 23 additional days in the moderate and liberal alternatives; additional days must be on or after the Saturday nearest December 10.
(h) In the Pacific Flyway Columbia Basin Mallard Management Unit, the season length may be extended 7 additional days in the restrictive and moderate alternatives.
(i) Additional species-specific restrictions may be established in the authorization conditions.
(j) Duck season regulatory alternatives are fixed for a period of not less than 5 years.
(a) The authorization conditions will be determined using available biological and habitat information and decision frameworks. A list of current decision frameworks is posted on the Service's website with the Migratory Game Bird Hunting Memorandum. The Service will apply available biological and habitat information to the relevant decision framework for that species and will announce the outcomes as the authorization conditions within which States and Tribes may establish their migratory game bird hunting regulations in accordance with the regulations in this part and other applicable Federal regulations.
(b) Consistent with the Migratory Bird Treaty Act, the authorization conditions for any migratory game bird season must:
(1) Not start prior to September 1;
(2) Not end after March 10, except the season for ducks, mergansers, and coots may not end later than January 31 (16 U.S.C. 704(c)(1)(B)); and
(3) Not exceed 107 days.
(c) The Service and Flyway Councils may establish decision frameworks for the determination of authorization conditions that are more restrictive than the provisions in the Migratory Bird Treaty Act.
(a) The Service will communicate the authorization conditions in the Migratory Game Bird Hunting Memorandum. The memorandum and any supporting documentation will be made publicly available in the
(b) The Service may update the Migratory Game Bird Hunting Memorandum and notice of availability annually if changes are prescribed by decision frameworks. Updates would occur no later than February 28 of each
(c) The notice of availability will open a public comment period of not less than 30 days. The Service may revise the Migratory Game Bird Hunting Memorandum based on public comment and, if so, the revised memorandum will be made publicly available in the
(a) Special seasons authorize additional hunting opportunity outside the regular season but within the 107-day limit mandated by the MBTA. Special seasons are authorized to promote harvest of underutilized species, address overabundance of nuisance species, or provide special hunting opportunities. Experimental seasons are authorized to evaluate expansion of regular and special seasons to new areas, evaluate use of zones and splits, or evaluate alternative seasons.
(b) Special or experimental season requests may be made by the Flyway Council(s) or requested by a State. Requests must be submitted by September 1 prior to the requested hunting season. If the Service approves a special or experimental season, it will be authorized in the Migratory Game Bird Hunting Memorandum.
(c) To approve special and experimental seasons, the Service must find:
(1) The Flyway Council(s) where the hunting will take place endorse the special or experimental season;
(2) Species migration and distribution provide sufficient hunting opportunity outside the regular season;
(3) There is no or negligible impact to nontarget species; and
(4) Authorizations are consistent with existing environmental compliance determinations.
(d) Approved experimental seasons may be valid for up to 5 years, after which a new request must be submitted. The Service may require implementing States to collect data for at least 3 years to assess the environmental effects of special or experimental seasons, including effects on target and nontarget species.
(a) States may authorize migratory game bird hunting provided the State establishes hunting regulations in accordance with Federal authorization conditions and regulations. State hunting regulations must be at least as restrictive as the Federal authorization conditions and regulations. Hunting that occurs outside the State regulations or Federal authorization conditions and regulations constitutes a violation of Federal law pursuant to § 20.71.
(b) No later than May 31 of each calendar year, States must submit their proposed migratory game bird hunting regulations implementing the Federal authorization conditions to the Service's Migratory Bird Program for review.
(c) Areas and zones for which open seasons are specified in a State's hunting regulations must be described, delineated, and designated as such in each State's hunting regulations, and these areas must also be included in the Migratory Game Bird Hunting Memorandum.
(d) Unless otherwise specified, States may establish hunting seasons by zones as defined in § 20.107. Zones for certain duck seasons (and associated youth and veterans-active military waterfowl hunting days, gallinule seasons, and snipe seasons) and dove seasons must comply with Federal zone and split-season configurations. Changes among configurations may occur in the first year of the 5-year period that it would apply and according to the following guidelines:
(1) States seeking to change their duck or dove hunting zone and split-season configuration selection must provide their selection and zone descriptions to the Service by August 31 of the year prior to the 5-year interval during which they would apply.
(2) States with approved special case arrangements to change their zone and split-season configuration must conform to the current configurations and may not revert to the special case arrangements that they previously had in place.
(3) Only minor (less than one county in size) zone boundary changes will be allowed for any special case arrangement, and such changes are allowed only in the first year of the 5-year period during which it would apply.
(4) Minor (less than one county in size) zone boundary changes may be allowed for any State to resolve law enforcement or other boundary clarification issues resulting from implication of a new configuration. Changes will be evaluated on a case-by-case basis and must be approved by the respective Flyway Council and the Service Migratory Bird Regulations Committee.
(5) Consideration of changes for management-unit boundaries is not subject to the guidelines and provisions governing the use of zones and split seasons for ducks and doves.
(e) States may issue hunting permits for migratory game bird hunting at levels predicted to result in the amount of take authorized by the authorization conditions. Federally authorized, State-issued hunting permits are valid only for the individual whose name and address appears on the hunting permit and must specify a take authorization.
(f) States may select 2 days per duck-hunting zone, designated as “Youth Waterfowl Hunting Days,” and 2 days per duck-hunting zone, designated as “Veterans and Active Military Personnel Waterfowl Hunting Days,” in addition to their regular duck seasons.
(1) The days may be held concurrently or may be nonconsecutive. Days may be held up to 14 days before or after any regular duck-season bracket dates in the authorization conditions or within any split of a regular duck season, or within any other open season on migratory game birds. Youth Waterfowl Hunting Days must be held outside any regular duck season on weekends, holidays, or other non-school days when youth hunters would have the maximum opportunity to participate.
(2) Youth hunters must be younger than 18 years of age. States may specify a more restrictive age definition. An adult 18 years of age or older must accompany the youth hunter into the field. This adult may not duck hunt but may participate in other seasons that are open on the special youth day. Permitted species may be taken only by participants possessing applicable hunting permits.
(3) Veterans (as defined in 38 U.S.C. 101) and members of the U.S. Armed Forces on active duty, including members of the National Guard and Reserves on active duty (other than for training), may participate. Permitted species may be taken only by participants possessing applicable hunting permits.
(a) Any individual hunting must comply with the regulations in this part, Federal authorization conditions, and any applicable State or Tribal hunting regulations. Violation of any applicable Federal, State, Tribal, or local law or regulation is a violation of Federal law pursuant to § 20.71 and § 20.72.
(b) Any individual hunting under a federally authorized, State-issued hunting permit must adhere to the provisions of the hunting permit,
(a)
(b)
(c)
Notice of each meeting of a Flyway Council to be attended by any official of the Department of the Interior will be announced online on the Service's Migratory Bird Program website at least 2 weeks before the meeting or as soon as practicable after the Department of the Interior learns of the meeting. The notice will state the time, place, and general subject(s) of the meeting.
(a) Crows may be taken, possessed, transported, exported, or imported, only in accordance with such laws or regulations as may be prescribed by a State or Tribe pursuant to this section.
(b) Except in the State of Hawaii, where take of crows is prohibited, States and Tribes may by statute or regulation prescribe a hunting season for crows. Such State and Tribal statutes or regulations may set forth the method of taking, the bag and possession limits, the dates and duration of the hunting season, and such other regulations as may be deemed appropriate, subject to the following limitations for each State or Tribe:
(1) Crows must not be hunted from aircraft;
(2) The hunting season or seasons on crows must not exceed a total of 124 days during a calendar year;
(3) Hunting must not be permitted during the peak crow nesting period within a State; and
(4) Crows may be taken only by firearms, bow and arrow, and falconry.
Nuclear Regulatory Commission.
Request for information.
The U.S. Nuclear Regulatory Commission (NRC) invites public input to inform its implementation of Executive Order (E.O.) 14270, “Zero-Based Regulatory Budgeting to Unleash American Energy.” The E.O. directs the NRC to offer the public opportunity to comment on the costs and benefits of certain regulations that the NRC has identified to be sunset.
Comments must be submitted electronically using
Submit your comments, identified by Docket ID NRC-2026-2278, at
Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are public records; they are publicly displayed exactly as received, and will not be deleted, modified, or redacted. Comments may be submitted anonymously.
Follow the search instructions on
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Cindy Bladey, Office of Nuclear Materials Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington DC, 20555-0001; telephone: 301-415-3280, email:
Please refer to Docket ID NRC-2026-2278 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.
Executive Order (E.O.) 14270, “Zero-Based Regulatory Budgeting to Unleash American Energy” (90 FR 15643; April 9, 2025), directed the NRC to issue a rule inserting a conditional sunset date into each of its regulations that were in effect as of the date of the E.O. and were issued in whole or in part pursuant to the following statutes, as amended: the Atomic Energy Act of 1954, the Energy Reorganization Act of 1974, and the Nuclear Waste Policy Act of 1982. The E.O. stated that sunsetting provisions must include a conditional sunset date that is one year after the effective date of the rule and that the agency could extend the cessation deadline to a date not more than 5 years in the future after offering the public an opportunity to comment on the costs and benefits of the regulations to be conditionally sunset prior to each provision's sunset date.
On December 3, 2025, the NRC published “The Sunset Rule” (90 FR 55621), which amended regulations throughout chapter I of title 10 of the
This request is for information-gathering purposes and does not propose new regulations, requirements, or policies.
The NRC is requesting information on the costs and benefits of the regulations shown in Table 1. Please provide, to the extent possible, economic data to demonstrate the cost of complying with the existing regulations, as well as any savings that eliminating the regulation might provide. If there are benefits that are difficult to calculate, include a qualitative discussion in any justification offered for not sunsetting a particular regulation in Table 1.
This document serves solely as a request for information. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (PRA), specifically paragraph (h)(4) of 5 CFR 1320.3, this general solicitation is exempt from the PRA. Facts or opinions submitted in response to general solicitations of comments from the public, published in the
For the Nuclear Regulatory Commission.
Federal Housing Finance Agency.
Notice of proposed rulemaking; correction.
The Federal Housing Finance Agency is correcting the amendatory regulatory text of the proposed rule regarding its Enteprise Duty to Serve Underserved Markets regulation that published in the
June 26, 2026. The comment due date of the proposed rule remains July 24, 2026.
For general questions, please contact
In proposed rule FR Doc. 2026-12750, in the issue of June 24, 2026, 91 FR 37848, on page 37872, in § 1283.7, in the first column, in paragraph (a)(2)(ii), correct “Refinancing mortgages that are not arms-length transactions or borrower driven;” to read “Refinancing mortgages that are not arms-length transactions and borrower driven;”.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking.
FAA proposes to remove obsolete references to pilot certificates and ratings issued more than 50 years ago.
Send comments on or before July 27, 2026.
Send comments identified by docket number FAA-2026-7163 using any of the following methods:
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•
•
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Bradley Zeigler, Flight Standards Service, Federal Aviation Administration, 800 Independence Ave. SW, Washington, DC 20591; telephone (202) 267-1100; email
As part of its implementation of Executive Orders issued by President Trump, including Executive Order 14192, “Unleashing Prosperity through Deregulation,” issued on January 31, 2025, and Executive Order 14219, “Ensuring Lawful Governance and Implementation of the President's `Department of Government Efficiency' Deregulatory Agenda,” issued on February 19, 2025, the U.S. Department of Transportation (DOT) sought comments and information to assist DOT in identifying existing regulations, guidance, paperwork requirements, and other regulatory obligations to be modified or repealed, consistent with law, to ensure that DOT administrative actions do not undermine the national interest and that DOT achieves meaningful burden reduction while continuing to meet statutory obligations and ensuring the safety of the U.S. transportation system. This request for information was published on April 3, 2025, titled
FAA agrees with EAA and proposes to remove and reserve § 61.11
In addition, FAA proposes to remove and reserve § 61.7
In conclusion, FAA proposes to remove and reserve §§ 61.7 and 61.11 because these regulations are obsolete. FAA does not anticipate these changes would affect the privileges of any airman currently holding a valid pilot certificate.
FAA's authority to issue rules on aviation safety is found in title 49 of the United States Code (U.S.C.). Subtitle I, section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of FAA's authority. This proposed rule is promulgated under the authority described in 49 U.S.C. 106(f), which establishes the authority of the Administrator to promulgate, rescind, and revise regulations and rules related to aviation safety.
This proposed rule is promulgated under the authority granted to the Administrator in 49 U.S.C. subtitle VII, part A, subpart III, section 40113 (prescribing general authority of the Administrator of FAA with respect to aviation safety duties and powers to prescribe regulations) and subpart III, chapter 447, sections 44701 (general authority of the Administrator of FAA to promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for cybersecurity and other practices, methods, and procedures the Administrator finds necessary for safety in air commerce and national security), 44702 (general authority of the Administrator of FAA to issue airman certificates), and 44703 (general authority of the Administrator of FAA to prescribe regulations for the issuance of airman certificates when the Administrator finds, after investigation, an individual is qualified for and physically able to perform the duties related to the position authorized by the certificate). This rulemaking proposal is within the scope of that authority.
Executive Order (E.O.) 12866 (“Regulatory Planning and Review”) and E.O. 13563 (“Improving Regulation and Regulatory Review”) require agencies to regulate in the “most cost-effective manner,” to make a “reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.” The Office of Management and Budget has determined this rule is not a significant regulatory action as defined in section (3)(f) of E. O. 12866.
FAA proposes to remove and reserve §§ 61.7 and 61.11 because they are obsolete or redundant. This change would not alter pilot privileges. As described in this proposal, removing these sections would not change current certification practices or require any action from existing certificate holders. This proposal involves non-substantive amendments. FAA does not expect any additional costs to the public or the Federal Government because none of the changes in this proposal would change existing regulatory requirements. FAA anticipates minor administrative cost savings due to efficiencies for both industry and FAA by eliminating outdated language.
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996, 5 U.S.C. 601
FAA certifies that this rule will not have a significant economic impact on a substantial number of small entities. FAA invites public comment on this certification.
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, they be the basis for U.S. standards. Because the proposed changes would remove unnecessary regulatory text, they do not implicate any issues regarding international regulatory cooperation.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or Tribal government or the private sector to incur direct costs without the Federal Government having first provided the funds to pay those costs. FAA determined the proposed rule would not result in the expenditure of $187,000,000 or more ($100,000,000 adjusted for inflation using the most current Implicit Price Deflator for the Gross Domestic Product) by State, local, or Tribal governments, in the aggregate, or the private sector, in any one year.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires FAA to consider the impact of paperwork and other information collection burdens
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. FAA has determined there are no ICAO Standards and Recommended Practices that correspond to these proposed regulations.
FAA has analyzed the environmental impacts of this proposed rule pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
FAA has analyzed this proposed rule under the principles and criteria of E.O. 13132, Federalism. FAA has determined this action would not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have federalism implications.
E.O. 13609, Promoting International Regulatory Cooperation, promotes international regulatory cooperation to meet shared challenges involving health, safety, labor, security, environmental, and other issues and to reduce, eliminate, or prevent unnecessary differences in regulatory requirements. FAA has analyzed this action under the policies and agency responsibilities of E.O. 13609 and has determined this action would have no effect on international regulatory cooperation.
This proposed rule, if finalized as proposed, is expected to be an E.O. 14192 deregulatory action.
FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. FAA also invites comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rule. Before acting on this proposal, FAA will consider all comments it receives on or before the closing date for comments. FAA may change this proposal in light of the comments it receives.
Confidential Business Information (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 is relevant or responsive to this NPRM, it is important you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” 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 the person in the
A copy of this NPRM, all comments received, any final rule, and all background material may be viewed online at
Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Commenters must identify the docket or notice number of this rulemaking.
All documents FAA considered in developing this proposed rule, including economic analyses and technical reports, may be accessed in the electronic docket for this rulemaking.
The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104 121) requires FAA to comply with small entity requests for
Aircraft, Airmen, Aviation safety, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Aviation Administration proposes to amend chapter I of title 14, Code of Federal Regulations as follows:
49 U.S.C. 106(f), 40113, 44701-44703, 44707, 44709-44711, 44729, 44903, 45102-45103, 45301-45302; Sec. 2307, Pub. L. 114-190, 130 Stat. 615 (49 U.S.C. 44703 note); sec. 318, Pub. L. 115-254, 132 Stat. 3186 (49 U.S.C. 44703 note); sec. 820, Pub. L. 118-63, 138 Stat. 1330 (49 U.S.C. 44939 note); secs. 815 and 828, Pub. L. 118-63, 138 Stat. 1328, 1336 (49 U.S.C. 44703 note).
Issued under authority provided by 49 U.S.C. 106(f), 40113, and 44701 through 44703 in Washington, DC.
Department of Veterans Affairs.
Proposed rule.
The Department of Veterans Affairs (VA) proposes to amend its regulations implementing Title VI of the Civil Rights Act of 1964 (Title VI) to eliminate disparate-impact liability. These amendments would align VA's regulations with Title VI's original public meaning, avoid constitutional concerns, reduce compliance costs, serve the public interest, and implement changes directed in Executive Order (E.O.) 14281. This is a deregulatory action in furtherance of E.O. 14219, which requires that Federal regulations reflect the best reading of the underlying statutory authority.
Comments must be received by July 27, 2026.
You may submit comments through
Sterling Akins, Office of Resolution Management, 202-461-4145.
VA proposes
Specifically, this rule proposes to remove the full text of 38 CFR 18.3(b)(2), which prohibits the utilization of criteria or methods of administration which have the effect of subjecting individuals to discrimination because of their race, color, or national origin. This rule would also remove uses of the phrase “or effect” from § 18.3(b)(3). This rule would remove a related example in paragraph (d) of Appendix B of subpart A of part 18 and would rescind the full text of § 18.3(b)(6). This rule further would rescind the full text of § 18.3(d)(2), which addresses employment practices subject to Federal financial assistance. VA would also make unrelated, minor technical changes to part 18.
The rule's proposed revisions conform to E.O. 14281,
On December 10, 2025, the Department of Justice (DOJ) amended its Title VI regulations to eliminate disparate-impact liability.
Title VI, as amended, provides: “No person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.” 42 U.S.C. 2000d. Title VI also directs Federal departments and agencies that extend Federal financial assistance to effectuate the provisions of Title VI by issuing rules, regulations, or orders of general applicability. 42 U.S.C. 2000d-1. Section 2000d specifically prohibits intentional discrimination and makes no reference to unintentional disparate effects or impact.
VA's Title VI implementing regulations are codified at 38 CFR part 18. These regulations, until DOJ's recent final rule, were consistent with those of DOJ as well as other agencies. On December 31, 1964, VA initially promulgated regulations in part 18 to effectuate Title VI. 29 FR 19301. This set of regulations included several references (§§ 18.3(b)(2) and 18.5(d), the latter of which was redesignated as current paragraph (d) of Appendix B to subpart A of part 18) to, or uses of, the “effect of” language in the “discrimination prohibited” provision of the rule.
The Supreme Court has held that Title VI does not prohibit facially neutral policies that result in disparate outcomes when there is no discriminatory intent. Rather, it prohibits only intentional discrimination. In 1978, the Supreme Court held that Congress intended Title VI to prohibit “only those racial classifications that would violate the Equal Protection Clause” if committed by a government actor.
In 2001, the Supreme Court, in
Finally, in 2024, the Supreme Court overruled
On April 23, 2025, the President issued E.O. 14281, which restated the “bedrock principle of the United States . . . that all citizens are treated equally under the law.” 90 FR 17537. The E.O. explained that this principle guarantees equality of opportunity, not equal outcomes, and promises that people are treated as individuals, not components of a particular race or group.
That E.O. also explained that disparate-impact liability endangers this foundational principle, as disparate-impact liability all but requires individuals and businesses to consider race and engage in racial balancing to avoid potentially crippling legal liability.
The E.O. explained that “[i]t is the policy of the United States to eliminate the use of disparate-impact liability in all contexts to the maximum degree possible to avoid violating the Constitution, Federal civil rights laws, and basic American ideals.”
In any event, VA would have independently initiated steps toward making these proposed changes regardless of E.O. 14281. Even in the absence of E.O. 14281, in other words, VA would have initiated steps to eliminate the use of disparate-impact liability under Title VI. VA believes that all citizens should be treated equally under the law. Imposing disparate-impact liability endangers this objective. Disparate-impact liability also raises serious constitutional concerns, is in considerable tension with the original public meaning of Title VI, creates confusion, increases the costs of compliance, and does not serve the public interest.
VA's regulation at 38 CFR 18.3, entitled “Discrimination prohibited,” contains several provisions that go beyond the statutory text and constitutional requirements by
Beyond that general prohibition, § 18.3(b)(3) addresses a Federal-funding recipient's selection of the site or location of facilities and includes two references to “effect” that extend the scope of prohibited conduct to include conduct with unintentional disparate impact. Section 18.3(b)(6) concerns the use of “affirmative action,” and provides that funding recipients may (and sometimes must) use race, color, or national origin to overcome unintentional disparate “effects.” But this provision does not expressly specify that the funding recipient must narrowly tailor such use nor that this use must serve a compelling governmental interest, as is required to satisfy strict scrutiny. Section 18.3(d) addresses prohibited discriminatory employment practices, and paragraph (d)(2) extends beyond intentional discrimination to prohibiting conduct that “tends” to have a discriminatory effect. Finally, paragraph (d) of Appendix B of subpart A of part 18 provides an illustrative example of the use of disparate-impact liability in the selection and approval of projects or sites for the construction of a nursing home.
There are serious statutory and constitutional concerns with the legality of VA's Title VI disparate-impact regulations. VA also has serious policy concerns with its current disparate-impact regulations because they create confusion, undermine public confidence in the nation's civil rights laws and the rule of law, and produce burdensome litigation and compliance costs.
There are serious statutory concerns as to whether Title VI authorizes the disparate-impact provisions of the current regulations. As the Supreme Court has made clear, Title VI prohibits “only intentional discrimination” and “permits” facially neutral policies that result in disparate outcomes when there is no discriminatory intent.
Title VI authorizes agencies to promulgate regulations “to effectuate” the statute's prohibition of intentional discrimination. 42 U.S.C. 2000d-1. The current regulations' extension of prohibited conduct to include conduct with an unintentional disparate impact reaches a vastly broader scope than the statute itself. This scope is too broad to be considered a simple prophylactic measure aimed at preventing intentional discrimination.
There are also serious concerns about whether VA's Title VI regulations pass constitutional muster under the Equal Protection Clause. As the Supreme Court recently held in
In short, disparate-impact liability encourages and, in some cases, requires covered entities to engage in the intentional use of race and racial balancing to eliminate those disparate outcomes by treating certain racial groups differently from others—the exact conduct the Equal Protection Clause forbids.
This encouraged or required use of race, color, or national origin violates the Equal Protection Clause unless it survives review under the “daunting” strict-scrutiny standard.
Similarly, the “affirmative action” provision authorizes and sometimes requires the intentional use of race without requiring that this intentional use be narrowly tailored to serve a recognized compelling interest. Instead, it encourages intentional racial balancing “to overcome the effects of” unintended racial disparities. 38 CFR 18.3(b)(6). Thus, for substantially the same reasons as above, the “affirmative action” provision raises serious constitutional concerns.
As summarized above, there are serious statutory and constitutional concerns with VA's disparate-impact regulations. But even if the regulations were legal, VA finds that eliminating the potential constitutional concerns addressed above would independently justify proposed amendment of the regulations.
VA also has serious policy concerns with the imposition of disparate-impact liability. While VA expresses its policy concerns with disparate-impact liability independent of E.O. 14281, that E.O. sets forth many valid policy concerns with disparate-impact liability. As noted in section 1 of the E.O., “On a practical level, disparate-impact liability has hindered businesses from making hiring and other employment decisions based on merit and skill, their needs, or the needs of their customers because of the specter that such a process might lead to disparate outcomes, and thus disparate-impact lawsuits. This has made it difficult, and in some cases impossible, for employers to use bona fide job-oriented evaluations when recruiting, which prevents job seekers from being paired with jobs to which their skills are most suited—in other words, it deprives them of opportunities for success.” 90 FR at 17537. Moreover, the legal concerns identified above have caused uncertainty and confusion for Federal-funding recipients as to whether and when they need to comply with the disparate-impact regulations and when they can or must consider race, color, and national origin. As explained above,
Additionally, in practice, and as explained above, disparate-impact liability leads covered entities to engage in racial balancing even as Title VI forbids intentional racial discrimination. This tension tends to create confusion and undermine public confidence in the nation's civil rights laws and in the rule of law itself, as the law seems to both forbid and require the same conduct.
These problems are amplified by the arbitrary nature of the racial and ethnic categories typically used to measure disparate effects, which, by virtue of their arbitrariness, typically lack a meaningful connection to a compelling interest.
On December 10, 2025, DOJ issued a final rule amending its Title VI regulations to eliminate disparate-impact liability. 90 FR 57141. DOJ made these amendments to align its regulations with Title VI's original public meaning, avoid constitutional concerns, reduce compliance costs, and serve the public interest.
Currently, 38 CFR 18.3 contains several provisions that prohibit conduct or activities causing an unintentional disparate impact and, in some instances, encourage or even require unlawful discrimination labeled as “affirmative action,” without a statutory or constitutional basis for doing so. For the reasons discussed above, VA is proposing to amend several paragraphs in 38 CFR 18.3 and a related appendix to remove the disparate-impact liability and affirmative-action language.
The table below indicates the exact wording changes. For each section indicated in the left column, the text shown in the middle column is proposed to be removed, and the text shown in the right column is proposed to be added:
Current paragraph (b)(2) states that a recipient, in determining the types of services, financial aid, or other benefits, or facilities which will be provided under any such program, or the class of individuals to whom, or the situations in which, such services, financial aid, other benefits, or facilities will be provided under any such program, or the class of individuals to be afforded an opportunity to participate in any such program, may not, directly or through contractual or other arrangements, utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination because of their race, color, or national origin, or have the effect of defeating or substantially impairing accomplishment of the objectives of the program with respect to individuals of a particular race, color, or national origin.
Because this language's only apparent purpose is to prohibit disparate-impact discrimination, VA proposes to remove paragraph (b)(2) in its entirety. VA would thus amend the regulations to conform to Title VI and to address the legal and policy considerations and determinations described in this
Current paragraph (b)(3) states that in determining the site or location of facilities, a recipient or applicant may not make selections with the purpose or effect of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any program to which this part applies on the grounds of race, color, or national origin; or with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of the Act or this part.
Because this language includes references to “effect,” which extends the scope of the regulations to conduct having an unintentional disparate impact, VA proposes to remove “or effect,” which is used twice in paragraph (b)(3). Thus, this paragraph would be revised to read as follows: In determining the site or location of facilities, a recipient or applicant may not make selections with the purpose of excluding individuals from, denying them the benefits of, or subjecting them to discrimination under any program to which this part applies on the grounds of race, color, or national origin; or with the purpose of defeating or substantially impairing the accomplishment of the objectives of the Act or this part.
Paragraph (b)(6) concerns the use of “affirmative action,” and states that (i) in administering a program regarding which the recipient has previously discriminated against persons on the ground of race, color, or national origin, the recipient must take affirmative action to overcome the effects of prior discrimination; and (ii) even in the absence of such prior discrimination, a recipient in administering a program may take affirmative action to overcome the effects of conditions which resulted in limiting participation by persons of a particular race, color, or national origin.
Paragraph (b)(6)(ii) authorizes affirmative action even in the absence of a finding of prior discrimination in a program “to overcome the effects of conditions which resulted in limiting participation by persons of a particular race, color, or national origin.” This provision points not to intentional discrimination, but rather to the unintentional “effects of conditions.” It consequently encourages intentional racial classifications, racial preferences, and other race-based actions without specifying the compelling governmental interest and narrow tailoring that the Equal Protection Clause demands. This section has long been unlawful under the Equal Protection Clause.
Paragraph (b)(6)(i) requires that a recipient “must take affirmative action to overcome the effects of prior discrimination” if, in “administering a program,” the funding “recipient has previously discriminated against persons on the ground of race, color, or national origin.” This provision goes beyond the Equal Protection Clause, which permits in limited circumstances, but does not mandate, a government actor to take narrowly tailored action to remedy the effects of its identified past discrimination.
Current paragraph (d)(2) states that in regard to Federal financial assistance that does not have providing employment as a primary objective, the provisions of paragraph (d)(1) of this section apply to the employment practices of the recipient if discrimination on the ground of race, color, or national origin in such employment practices tends, on the grounds of race, color, or national origin, to exclude persons from participation in, to deny them the benefits of or to subject them to discrimination under the program receiving Federal financial assistance. In any such case, the provisions of paragraph (d)(1) of this section shall apply to the extent necessary to assure equality of opportunity to and nondiscriminatory treatment of beneficiaries.
Because this paragraph extends its prohibition of discriminatory employment practices to conduct that “tends” to have a discriminatory effect and conflicts with 42 U.S.C. 2000d-3, which states “[n]othing contained in [Title VI] shall be construed to authorize action under [Title VI] by any department or agency with respect to any employment practice of any employer, employment agency, or labor organization except where a primary objective of the Federal financial assistance is to provide employment,” VA proposes removing paragraph (d)(2) in its entirety. VA would move the language from current paragraph (d)(1) to paragraph (d) with one change and would remove paragraphs (d)(1) and (2).
On September 28, 1965, E.O. 11246, Equal Employment Opportunity, was published. It established, in part, that the policy of the U.S. Government was to provide equal opportunity in Federal employment for all qualified persons and to prohibit discrimination in employment because of race, creed, color, or national origin. On January 31, 2025, E.O. 14173 was published, which rescinded E.O. 11246. See 90 FR 8633. Thus, VA proposes to delete the last sentence of current paragraph (d)(1) as it references E.O. 11246.
As proposed, paragraph (d) would read:
Appendix B to part 18, subpart A includes illustrative applications of the nondiscrimination provisions to certain VA grants. Paragraph (d) provides the following example: A recipient may not take action that is calculated to bring about indirectly what this part forbids it to accomplish directly. Thus, a State, in selecting or approving projects or sites for the construction of a nursing home which will receive Federal financial assistance, may not base its selections or approvals on criteria which have the effect of defeating or of substantially impairing accomplishment of the objectives of the Federal assistance program with respect to individuals of a particular race, color, or national origin.
Because this language includes references to “effect,” which may extend the scope of Title VI to
Current 18.3(b)(1)(v) explains that a recipient to which part 18 applies may not, directly or through contractual or other arrangements, on grounds of race, color, or national origin treat an individual differently from others in determining whether is satisfied any admission, enrollment, quota, eligibility, membership, or other requirement or condition which individuals must meet in order to be provided any service, financial aid, or other benefit provided under the program.
For purposes of clarity and ease for the reader, VA proposes to revise this provision to move “is satisfied” to the end of the sentence. Thus, as proposed, paragraph (b)(1)(v) would read as follows: a recipient to which part 18 applies may not, directly or through contractual or other arrangements, on grounds of race, color, or national origin treat an individual differently from others in determining whether any admission, enrollment, quota, eligibility, membership, or other requirement or condition which individuals must meet in order to be provided any service, financial aid, or other benefit provided under the program is satisfied.
This is a non-substantive change. VA would make no other changes to this paragraph.
Section 18.12 addresses the effect on other regulations, forms, and instructions. Paragraph (a)(1) explains, in pertinent part, that nothing in part 18 shall be deemed to supersede E.O.s 10925 (3 CFR, 1959-1963 Comp., p. 448), 11114 (3 CFR, 1959-1963, p. 774), and 11246 (3 CFR, 1965 Supp., p. 167).
As previously discussed, on January 31, 2025, E.O. 14173 was published, which rescinded E.O. 11246. See 90 FR 8633. Thus, VA proposes to remove reference to E.O. 11246 in 38 CFR 18.12(a)(1). As proposed, paragraph (a)(1) would read as follows: Executive Orders 10925 (3 CFR, 1959-1963 Comp., p. 448), 11114 (3 CFR, 1959-1963, p. 774), and regulations issued thereunder.
Appendix A identifies the various statutory provisions to which subpart A applies. VA acknowledges that this list is outdated, as various programs are subject to subpart
A. However, VA will add additional programs in a future rulemaking.
As part of this rulemaking, VA merely proposes to update the currently referenced statutory provisions to reflect the correct provisions. Thus, VA specifically proposes to update the following statutory provisions: Payments to State homes (38 U.S.C. 1741-1745); State home facilities for furnishing domiciliary, nursing home, and hospital care (38 U.S.C. 8131-8138); All-volunteer force educational assistance, Veteran Readiness and Employment, post-Vietnam era veterans' educational assistance, veteran's educational assistance, survivors' and dependents' educational assistance, and administration of educational benefits (38 U.S.C. Chapters 30, 31, 32, 34, 35 and 36, respectively); Sharing of medical facilities, equipment, and information (38 U.S.C. 8151-8159); Space and office facilities for representatives of State employment services (38 U.S.C. 6306(e)); Medical care for survivors and dependents of certain veterans (38 U.S.C. 1781); Aid to States, counties, and tribal organizations for establishment, expansion, and improvement of veterans cemeteries (38 U.S.C. 2408); Assistance in establishing new state medical schools; grants to affiliated medical schools; assistance to health manpower training institutions (38 U.S.C. Chapter 82); and Department of Veterans Affairs health professional scholarship program (38 U.S.C. 7611-7619).
VA's position is that each of the proposed amendments, if finalized, would serve a vital, related, but distinct purpose. VA also confirms that each of the proposed amendments, if finalized, would be intended to operate independently of each other and that the potential invalidity of one amendment should not affect the other amendments. VA would adopt any of the proposed amendments independently of the invalidity of a separate proposed amendment.
VA examined the impact of this proposed rulemaking as required by EOs 12866 (Sept. 30, 1993) and 13563 (Jan. 18, 2011), which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. The Office of Information and Regulatory Affairs has determined that this proposed rulemaking would be a significant regulatory action under section 3(f) of E.O. 12866, but would not be an “economically significant” action under section 3(f)(1). This proposed rule would be a deregulatory action under E.O. 14192.
This proposed regulation has been drafted and reviewed in accordance with E.O. 12866 section 1(b),
Data limitations make the costs and benefits of the proposed rule difficult to quantify. In FY25, eight VA discretionary grant programs supported 621 awards, totaling $1,055,770,349. However, due to the data limitations, VA is unable to provide specifics regarding any active investigations and compliance reviews regarding these funds. Additionally, VA does not comprehensively track its investigations and compliance reviews involving solely allegations of disparate-impact discrimination. For enforcement actions that relate to both intentional discrimination and conduct having an unintentional disparate impact, VA does not track and cannot reliably quantify the costs attributable to the disparate-impact portions of enforcement actions. That the existence of a disparate impact
VA recognizes that a funding recipient may receive Federal funds from other sources. This deregulatory action would not create any new obligations for funding recipients. On the contrary, by eliminating disparate-impact liability from the regulation, it would eliminate a source of regulatory confusion, narrow the conduct prohibited, and thus lessen the costs of compliance and potential liability. Moreover, recipients who receive funds for the same program or activity from more than one Federal entity already enter into separate contractual assurances with each funding entity.
Based on the analysis of the practical qualitative costs and benefits noted above, VA believes that this proposed rule would be consistent with the principles of EOs 12866 and 13563, including the requirements that, to the extent permitted by law, VA adopt a regulation only upon a reasoned determination that its benefits justify its costs and choose a regulatory approach that maximizes net benefits.
E.O. 14192 requires an agency, unless prohibited by law, to identify at least 10 existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation. 90 FR 9065, 9065 (Jan. 31, 2025). In furtherance of this requirement, section 3(c) of the E.O. requires that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.”
Pursuant to section 1-202 of E.O. 12250, DOJ has the responsibility to “review . . . proposed rules . . . of the Executive agencies” implementing nondiscrimination statutes such as Title VI in order to identify those which are inadequate, unclear, or unnecessarily inconsistent. Additionally, section 1-101 of E.O. 12250 delegated the President's responsibility to approve Title VI regulations to the Attorney General.
The Secretary hereby certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities as defined in the Regulatory Flexibility Act (5 U.S.C. 601-612). This certification is based on the fact that this proposed rule's changes would not have a significant economic impact on a substantial number of small entities, in large part because these regulatory changes would not impose any new substantive obligations on Federal-funding recipients. The rule would amend and clarify existing regulations that are required by Title VI. The rule would merely bring VA into compliance with the Equal Protection Clause and harmonize the scope of its regulations to conform with the scope of Title VI, which does not prohibit unintentional disparate impact. All Federal-funding recipients have been bound by the existing standards that would remain in place after this rule since their initial promulgation.
This proposed rule would not result in the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year.
This proposed rule contains no provisions constituting a collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
Aged, Civil Rights, Equal educational opportunity, Equal employment opportunity, Individuals with disabilities, Reporting and recordkeeping requirements, Veterans.
Douglas A. Collins, Secretary of Veterans Affairs, approved this document on June 22, 2026, and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs.
For the reasons stated in the preamble, the Department of Veterans Affairs proposes to amend 38 CFR part 18 as set forth below:
38 U.S.C. 501, 42 U.S.C. 2000d-1, and the laws referred to in Appendix A.
The revisions read as follows:
(b) * * *
(1) * * *
(v) Treat an individual differently from others in determining whether any admission, enrollment, quota, eligibility, membership, or other requirement or condition which individuals must meet in order to be provided any service, financial aid, or other benefit provided under the program is satisfied.
(2) [Reserved]
(3) In determining the site or location of facilities, a recipient or applicant may not make selections with the purpose of excluding individuals from, denying them the benefits of, or subjecting them
(d)
(a) * * *
(1) Executive Orders 10925 (3 CFR, 1959-1963 Comp., p. 448), 11114 (3 CFR,
1959-1963, p. 774), and regulations issued thereunder, or
1. Payments to State homes (38 U.S.C. 1741-1745).
2. State home facilities for furnishing domiciliary, nursing home, and hospital care (38 U.S.C. 8131-8138).
3. Space and office facilities for representatives of recognized national organizations (38 U.S.C. 5902(a)(2)).
4. All-volunteer force educational assistance, Veteran Readiness and Employment, post-Vietnam era veterans' educational assistance, veteran's educational assistance, survivors' and dependents' educational assistance, and administration of educational benefits (38 U.S.C. Chapters 30, 31, 32, 34, 35 and 36, respectively).
5. Sharing of medical facilities, equipment, and information (38 U.S.C. 8151-8159).
6. Approval of educational institutions (38 U.S.C. 104).
7. Space and office facilities for representatives of State employment services (38 U.S.C. 6306(e)).
8. Medical care for survivors and dependents of certain veterans (38 U.S.C.1781).
9. Transfers for nursing home care; adult day health care (38 U.S.C. 1720).
10. Treatment and rehabilitation for alcohol or drug dependence or abuse disabilities (38 U.S.C. 1720A).
11. Aid to States, counties, and tribal organizations for establishment, expansion, and improvement of veterans cemeteries (38 U.S.C. 2408).
12. Assistance in establishing new state medical schools; grants to affiliated medical schools; assistance to health manpower training institutions (38 U.S.C. Chapter 82).
13. Department of Veterans Affairs health professional scholarship program (38 U.S.C. 7611-7619).
14. Emergency veterans job training (Pub. L. 98-77, 97 Stat. 443-452).
5. Amend Appendix B to Subpart A of Part 18 by removing paragraph (d).
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Mojave Desert Air Quality Management District (MDAQMD or “District”) portion of the California State Implementation Plan (SIP). These revisions concern prohibitory rules that regulate emissions of volatile organic compounds (VOCs) and oxides of nitrogen (NO
Comments must be received on or before July 27, 2026.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2026-4489 at
La Kenya Evans-Hopper, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105; telephone number: (415) 972-3245; email address:
Throughout this document, “we,” “us,” and “our” refer to the EPA.
Under the CAA, the EPA has established National Ambient Air Quality Standards (NAAQS) for certain pervasive air pollutants, including, among others, ozone and particulate matter (PM). Under CAA section 110(a), states are required to adopt and submit SIPs to implement, maintain, and enforce the NAAQS. Under CAA section 107(d), the EPA has designated all areas
The MDAQMD regulates sources of air pollution within California's “Mojave Desert Air Basin,” which lies within the previously-designated “Southeast Desert Air Basin.”
In 1972, when the original California SIP was submitted and approved by the EPA, the San Bernardino County Air Pollution Control District (SBCAPCD) had jurisdiction over stationary sources within all of San Bernardino County, and Riverside County Air Pollution Control District (RCAPCD) had jurisdiction over stationary sources within all of Riverside County. On July 16, 1975, the Los Angeles County Air Pollution Control District (LACAPCD), Orange County Air Pollution Control District (OCAPCD), RCAPCD, and SBCAPCD were unified into the Southern California Air Pollution Control District (SoCalAPCD). On February 1, 1977, California split the SoCalAPCD into four agencies. The western coastal area became regulated by the South Coast Air Quality Management District (SCAQMD) and the remaining eastern desert portions of Los Angeles, San Bernardino, and Riverside Counties were seperated back into air pollution control districts for each county (
The Southeast Desert Air Basin portion of Riverside County was added to the SCAQMD on December 1, 1977. Effective December 1, 1977, under state law, all SCAQMD Rules and Regulations became applicable within the Southeast Desert Air Basin portion of Riverside County.
An outgrowth of the complicated regulatory history of the MDAQMD is that the applicable portion of the California SIP for the area the District regulates consists of a mixture of rules from current and former agencies. Rules adopted by MDAQMD apply “District-wide,” meaning to the desert portion of San Bernardino County and the Palo Verde Valley area in the far eastern portion of Riverside County, while SBCAPCD rules apply only in the San Bernardino County portion of the District and rules adopted by the RCAPCD, SoCalAPCD or the SCAQMD apply only in the Riverside County portion of the District.
The California Air Resources Board (CARB) submitted revisions to the MDAQMD portion of the California SIP, including MDAQMD rules and rescissions, to the EPA for approval on the following dates: September 10, 2024,
Table 1 lists rules submitted for District-wide applicability with the dates they were adopted by the MDAQMD, previously approved by the EPA, and re-submitted to the EPA by CARB to extend applicability throughout the District. Table 2 lists the rules submitted for rescission from the Riverside County portion of the MDAQMD portion of the SIP that are covered by this proposed action with the dates that they were adopted by the MDAQMD, the dates they were submitted by CARB, and the dates (and associated
As noted previously, the far eastern portion of Riverside County, referred to as the Palo Verde Valley, joined the MDAQMD effective July 1, 1994. Because the EPA approved the rules in Table 1 as part of the California SIP after July 1, 1994, the date on which Palo Verde Valley portion of Riverside County left the SCAQMD and joined the MDAQMD, these rules already apply throughout the entire present jurisdiction of the MDAQMD. No further action by the EPA is needed to address the request to apply these rules District-wide in the SIP.
As part of the November 15, 2024 SIP submission, the District and CARB also requested acknowledgement by the EPA that certain previously-approved SCAQMD Rules listed in Table 3 have already been removed from the Riverside County portion of the MDAQMD portion of the California SIP.
As to SCAQMD Rule 1107, “Miscellaneous Metal Parts, Products and Coating Operations,” (amended August 2, 1991) we confirm that the rule was superseded in the Riverside County portion of MDAQMD by approval of MDAQMD Rule 1115, “Metal Parts and Products Coating Operations,” (amended June 8, 2020) on December 23, 1997 (62 FR 67002; promulgated at 40 CFR 52.220(c)(239)(i)(A)(2)); see also, 40 CFR 52.220(c)(193)(i)(A)(4). No further action is required by EPA to confirm this prior action. As to SCAQMD Rule 1122, “Solvent Metal Cleaners (Degreasers),” (amended July 8, 1983) we confirm that the rule was superseded in the Riverside County portion of the MDAQMD in part by approval of MDAQMD Rule 1104, “Organic Solvent Degreasing Operations,” (adopted September 28, 1994) on April 30, 1996 (61 FR 18962; promulgated at 40 CFR 52.220(c)(207)(i)(D)(2)) and later in final part by approval of MDAQMD Rule 442, “Usage of Solvents,” (amended February 27, 2006) on September 17, 2007 (72 FR 52791; promulgated at 40 CFR 52.220(c)(347)(i)(C)(1)). This
The September 10, 2024 SIP submission,
Emissions of VOCs and NO
CAA section 110(a) requires States to submit regulations that control emissions of criteria air pollutants or their precursors, including VOC and NO
The EPA's technical support document (TSD) has more information about these rules.
Under CAA section 110(l), SIP revisions must be adopted by the state, and the state must provide for reasonable public notice and hearing prior to adoption.
Generally, SIP rules must require implementation of Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document as well as each major source of VOCs and NO
Guidance and policy documents that we used to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:
1. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).
2. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).
3. Letter dated February 12, 1990, from Johnnie L. Pearson, Chief Regional Activities Section, ROB, to Chief, Air Branch, Region I-X, Subject: “Review of State Regulation Recodifications.”
As noted above, the purpose for the submission of the MDAQMD rules and rescissions is to align the versions of the rules that are part of the SIP with the versions found in the current District rulebook. Below, we summarize our evaluation of the rescission requests for the SCAQMD rules in Table 2 for which there are no applicable sources and are replaced with SIP-approve MDAQMD rules. Then we considered the rescission requests for the SCAQMD rules in Table 3 for which there are corresponding MDAQMD rules. The EPA's TSD contains additional details about our evaluation.
The EPA has previously approved negative declarations certifying that the following types of sources are not located within the West Mojave Desert ozone nonattainment area: motor vehicle assembly plants and automotive manufacturing operations,
On that basis, we propose to approve the rescissions of SCAQMD Rules 1103, 1115, 1126, 1153, and 1159.
For the request to rescind SCAQMD Rule 1125, “Metal Container, Closure and Coil Coating Operations,” (amended August 2, 1991) (“SCAQMD Rule 1125”) the MDAQMD concluded that, in light of previous EPA-approved negative declarations for certain types of coating operations, existing SIP-approved MDAQMD Rule 1115 adequately covers the provisions of SCAQMD Rule 1125 for the coating operations not otherwise certified to be absent within the District.
The EPA has confirmed the absence of applicable sources for surface coating of cans and coils in the Riverside County portions of the District using CARB's facility CEIDARS emission database and SIC codes. The EPA notes that the approved negative declarations do not address surface coating of drums. However, the EPA finds that the requirements for such coatings in MDAQMD Rule 1115 are essentially the same as the corresponding requirements for drums in SCAQMD Rule 1125.
Since MDAQMD Rule 1115 is already approved as part of the California SIP the limits and other requirements in SCAQMD Rule 1125 need not be retained in the SIP, and rescission of SCAQMD Rule 1125 would not interfere with attainment and RFP or any other requirement of the Act for the purposes of CAA section 110(l). For these reasons, the EPA is proposing to approve the rescission of SCAQMD Rule 1125 from the Riverside County portion of the MDAQMD portion of the California SIP.
For the request to rescind SCAQMD Rule 1151, “Motor Vehicle and Mobile Equipment Non-Assembly Line Coating Operations,” (amended September 6, 1991) (“SCAQMD Rule 1151”), the MDAQMD concludes that, in light of certain EPA-approved negative declarations for certain types of coating operations, MDAQMD Rule 1116, “Automotive Refinishing Operations,” (amended August 23, 2010) (“MDAQMD Rule 1116”) adequately covers the provisions of the SCAQMD Rule 1151 for the automotive coating operations not otherwise certified to be absent within the District.
The District concludes that the provisions of SCAQMD Rule 1151 are found in MDAQMD Rule 1116 and requests rescission on that basis. To document this conclusion, the District provides a detailed comparison between the requirements in MDAQMD Rule 1116 with those in SCAQMD Rule 1151.
MDAQMD Rule 1116 is approved as part of the SIP. As such, the requirements in SCAQMD Rule 1151 need not be retained in the SIP, and rescission of SCAQMD Rule 1151 would not interfere with attainment and RFP or any other requirement of the Act for the purposes of CAA section 110(l). For these reasons, the EPA is proposing to approve the rescission of SCAQMD Rule 1151 from the Riverside County portion of the MDAQMD portion of the California SIP.
Generally, SCAQMD Rule 1173, “Fugitive Emissions of Volatile Organic Compounds,” (amended December 7, 1990) (“SCAQMD Rule 1173”) is intended to control VOC leaks from
The MDAQMD states that the EPA approved negative declarations for petroleum refinery and chemical manufacturing industries in the MDAQMD. For these reasons, the District requests rescission of SCAQMD Rule 1173. In addition, the requirements in MDAQMD Rule 1102, “MDAQMD Fugitive Emissions of VOCs from Components at Pipeline Transfer Stations” (adopted October 26, 1994) (“MDAQMD Rule 1102”) and CARB's Oil and Gas Regulation
The EPA confirmed the absence of refineries, chemical plants, oil and gas production fields and natural gas processing plants operating within the District by using the relevant SIC codes and CARB's facility CEIDARS emissions database. However, there are pipeline transfer stations within the District. The EPA compared MDAQMD Rule 1102 and CARB's Oil and Gas Regulation with SCAQMD Rule 1173 and we agree with the District that the California SIP adequately address VOC leaks from components at pipeline transfer stations within the District. Although the EPA approved the District's negative declaration for the Oil and Natural Gas CTG
As such, the requirements in SCAQMD Rule 1173 need not be retained in the SIP, and rescission of SCAQMD Rule 1173 would not interfere with attainment and RFP or any other requirement of the Act for the purposes of CAA section 110(l). For these reasons, the EPA is proposing to approve the rescission of SCAQMD Rule 1173 from the Riverside County portion of the MDAQMD portion of the California SIP.
As authorized in section 110(k)(3) of the Act, the EPA proposes to approve the rescission of SCAQMD Rules 1103, 1115, 1125, 1126, 1151, 1153, 1159, and 1173 from the Riverside County portion of the MDAQMD portion of the California SIP because they are no longer needed to meet any CAA requirement and because the rescissions would not interfere with RFP or attainment of any of the NAAQS or with any other applicable requirement of the CAA. We will accept comments from the public on this proposal until July 27, 2026. If we take final action to approve the rule rescissions, our final action will rescind the rules from the federally enforceable SIP.
In this document, the EPA is proposing to include in a final EPA rule regulatory text that deletes certain rules that were previously incorporated by reference from the applicable California SIP. The rules that were previously incorporated by reference are SCAQMD Rules 1103, 1115, 1125, 1126, 1151, 1153, 1159, and 1173 as listed in Table 2 of this document. The EPA has made, and will continue to make, these materials available through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law, or rescissions of state law, as meeting federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this proposed action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Is not an Executive Order 14192 (90 FR 9065, February 6, 2025) regulatory action because this action is not significant under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it proposes to approve a state program;
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have Tribal implications and will not impose substantial direct costs on Tribal governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Office of Refugee Resettlement (ORR), Administration for Children and Families (ACF), U.S. Department of Health and Human Services (HHS).
Notice of proposed rulemaking.
This notice of proposed rulemaking (NPRM, or proposed rule) would establish certain additional requirements for sponsor suitability assessments related to proof of identity, proof of income, and other information required for background checks to promote the safe placement of unaccompanied alien children (UAC). This NPRM proposes acceptable documentation for proof of identity and would require proof of income from potential sponsors of UAC in ORR custody by reason of their immigration status, as described in the Homeland Security Act of 2002 (HSA) and the William Wilberforce Trafficking Victims Protection Reauthorization Act of 2008 (TVPRA). This NPRM also proposes amendments to background check requirements for sponsor suitability assessments and the conduct of examinations of UAC related to considerations of UAC dangerousness to self or others that align with the One Big Beautiful Bill Act. Finally, this NPRM proposes certain administrative updates to align numbering and terminology between proposals and existing regulations. The docket on
Consideration will be given to comments on this rulemaking received on or before August 25, 2026.
You may send comments, identified by Docket ID ACF-2026-0199 and/or RIN 0970-AD26, by any of the following methods:
•
•
Toby Biswas, Assistant Deputy Director-Policy, Unaccompanied Alien Children Bureau, Office of Refugee Resettlement, Administration for Children and Families, U.S. Department of Health and Human Services, Washington, DC, (202) 205-4440 or
This NPRM proposes to amend the Unaccompanied Children Program Foundational Rule (the Foundational Rule), 45 CFR part 410, by establishing certain additional requirements intended to promote the safety of UAC when they are released to sponsors. The NPRM proposes adding a new paragraph (h) to existing § 410.1103 to explicitly authorize ORR to examine UAC in its custody for visible gang-related and/or other criminal organization-related tattoos (hereafter “gang-related”) markings, and/or brandings as part of ORR's assessment of the UAC's potential dangerousness to self or others or potential to be a victim of trafficking in persons. It would also establish, at § 410.1202(b) and (c), additional requirements for sponsor suitability assessments regarding proof of identity, proof of income, and background checks. Specifically, this NPRM proposes the establishment of a new requirement to submit proof of income, updated requirements for background checks, and a list of acceptable documentation for potential sponsors of UAC to demonstrate proof of identity. ORR is proposing these requirements in response to concerns identified by external and internal investigations of the safety of UAC who have been released from ORR custody, which include instances of suspected document fraud, identity fraud, identity misrepresentation, alias use, shared contact information, and exploitation.
In this NPRM, ORR proposes additional proof of identity, proof of income, and background check requirements for sponsor suitability assessments in accordance with its statutory responsibilities. Pursuant to the TVPRA at 8 U.S.C. 1232(c)(3)(A), “an unaccompanied alien child may not be placed with a person or entity unless the Secretary of Health and Human Services makes a determination that the proposed custodian is capable of providing for the child's physical and mental well-being,” and “[s]uch determination shall, at a minimum, include verification of the custodian's identity and relationship to the child, if any, as well as an independent finding that the individual has not engaged in any activity that would indicate a potential risk to the child.” Under § 410.1202(b), ORR must conduct a suitability assessment of a potential sponsor that at minimum must “consist of review of the potential sponsor's application package, including verification of the potential sponsor's identity.” Further, § 410.1203(c) requires that potential sponsors of UAC submit supporting documentation, including identity documents, with a sponsor application. ORR may also require “verification of the employment, income, or other information provided by the potential sponsor as evidence of the ability to support the child” as part of the suitability assessment under § 410.1202(c). ORR is further required under § 410.1202(c) to conduct background and criminal record checks of all potential sponsors and adult residents (
As further explained below, both internal ORR investigations and external entities have identified continuing concerns related to the safety of UAC who have been released to sponsors from ORR custody. In response to these concerns, through this proposed rule, ORR proposes acceptable types of sponsor proof of identity documentation, to require proof of income, and certain required components of a background check to ensure the safety of UAC released to sponsors. Notwithstanding existing ORR policies in the ORR Unaccompanied Alien Children Bureau Policy Guide (ORR Policy Guide) as well as other sub-regulatory guidance concerning minimum requirements for vetting potential sponsors, which ORR has updated several times since its original publication in 2015,
For example, Congressional oversight requests and investigations have identified gaps and suggested enhancements to ORR's sponsor vetting process.
In March 2023, ORR established an Integrity & Accountability (I&A) Team as an independent body within ORR with defined responsibilities to detect, prevent, mitigate, and report potential fraud and exploitation in the sponsor application process. The I&A Team is responsible for reporting all suspected fraud-related incidents to the HHS Office of Inspector General (OIG) and to the U.S. Department of Homeland Security (DHS) for law enforcement assessment and, where appropriate, criminal investigation.
The I&A Team also identified several instances of attempted or successful extortion related to sponsorship of UAC. In several of these cases, an individual
The HHS OIG also investigated ORR's sponsor screening process and published its findings in February 2024.
Considering these concerning findings (
Notwithstanding the preliminary injunction, ORR believes that the identified risks to child welfare remain urgent, and that its current sponsor assessment requirements are inadequate to address the risks identified. Additionally, on January 20, 2025, President Trump issued Executive Order 14159, which specifically directs HHS to take “all appropriate action to stop the trafficking and smuggling of alien children into the United States.”
Based on concerning child welfare findings and Executive Order 14159, and pursuant to ORR's statutory responsibilities (see,
Additionally, Public Law 119-21, which was signed into law on July 4, 2025, provided additional funds to be used by ORR for enumerated purposes, including specific elements to be included as part of background checks for potential sponsors and for determinations of whether a UAC poses a danger to self or others.
This proposed rule would update the Foundational Rule with respect to considerations generally applicable to the placement of a UAC described at § 410.1103 and sponsor suitability requirements described at § 410.1202. Specifically, this proposed rule would establish that ORR may examine a UAC for gang-related tattoos and markings, and would establish additional requirements regarding proof of identity, proof of income, and background checks for sponsor suitability assessments. The proposals would update previous sub-regulatory guidance that was in place until March 7, 2025, as to proof of identity, and April 15, 2025, as to proof of income.
This section provides detailed discussion of the proposed updates to regulations at part 410, which would establish updated requirements for proof of identity documentation, proof of income, and background checks for potential sponsors and their adult household members, as well as assessment of UAC for dangerousness, and would make a revision to terminology.
Historically, ORR has accepted a wide variety of identity documents as proof of sponsor identity, including many documents issued by foreign governments. Before March 7, 2025, the ORR Policy Guide listed documentation that could be used to verify a potential sponsor's identity, including the following forms of identification that would not meet the proposed requirements in this NPRM: foreign passport that contains a photograph; birth certificate; marriage certificate; court order for name change; foreign national identification card; consular passport renewal receipt that contains a photograph; Mexican consular identification card; foreign driver's license that contains a photograph; Canadian border crossing card that contains a photograph; Mexican border crossing card that contains a photograph with valid Form I-94; and other similar documents (including ORR Verification of Release form with a photograph for individuals under the age of 21).
However, as identified by the ORR I&A Team and as further discussed below and at Section V., Rationale, ORR has encountered issues with respect to such documentation. First, at times ORR has had difficulty authenticating certain documents submitted by sponsors, especially in a timely manner. For example, ORR has relied on foreign consulates and embassies, often liaising with the support of the Department of State, to authenticate certain identification documents issued outside the United States, a process complicated by international relations and the stability of certain foreign States. Second, ORR is aware of reports of potential fraud with the use of such foreign documents. HHS's own internal investigations have revealed documented cases of criminal prosecutions related to the use of fraudulent foreign documents in sponsor applications in which former UAC became victims of crimes by their sponsors, including incidents of trafficking and sexual assault.
Therefore, ORR proposes to amend § 410.1202(b)(1) to state that ORR would accept only the following documentation as proof of identity for potential sponsors, unless a deviation from the standards at § 410.1202(b)(1) is supported by clear justification and determined on a case-by-case basis by HHS ORR headquarters: U.S. Passport or U.S. Passport Card; Permanent Resident Card or Alien Registration Receipt Card (Form I-551); Foreign passport that contains a temporary I-551 stamp or temporary I-551 printed notation on a machine-readable immigrant visa; Employment Authorization Document that contains a photograph (Form I-766); Foreign passport with Form I-94 or Form I-94A with Arrival-Departure Record, bearing the same name as on the passport; Passport from the Federated States of Micronesia (FSM), Republic of the Marshall Islands (RMI), or Republic of Palau with Form I-94 or Form I-94A indicating nonimmigrant admission under the Compact of Free Association Between the United States and the FSM, RMI, or Republic of Palau;
ORR notes that the documents proposed as acceptable proof of identity in this NPRM are generally consistent with the list currently established in its sub-regulatory guidance, as described in the ORR Policy Guide (Section 2.2.4 Required Documents for Submission with the Sponsor Application for Release). The documents proposed as acceptable proof of identity in this NPRM also, in many instances, mirror those identified in Lists A and B of USCIS Form I-9 as of the time of this rule's publication.
Given ORR's concerns about potential fraud under its prior identification requirements, its need to timely authenticate documents, the enhanced protections offered with the documents in its proposed list, and the fact that the documents it has proposed in many instances mirror those currently accepted to establish identity by USCIS in Lists A and B of the Form I-9, ORR believes that the updated documents list it has proposed above describe the most reliable forms of documentation for purposes of verifying a potential sponsor's identity, particularly where such documents are more readily authenticated through U.S. government records, trusted issuing authorities, or other reliable verification mechanisms. ORR believes that these proposed updates to its proof of identity requirements would mitigate risks of potential fraud in accordance with its statutory responsibility to protect UAC safety and to act in their best interests. ORR believes this would be a reasonable approach based both on findings of potential and actual harm to UAC through the release process and on its statutory responsibility to place UAC with sponsors who are capable of providing for UAC's physical and mental well-being as required of ORR by 8 U.S.C. 1232(c)(3)(A). ORR may
Generally aligning ORR's acceptable identity documentation requirements with Lists A and B from Form I-9 would enable ORR to ensure that both ORR and care provider staff could reliably review identity documents, as well as any photographs on the documents, to determine whether the individual submitting the identity document is in fact the subject of the identity document. ORR has considered the potential for disruption and/or delay in UAC release to sponsors due to the change in documentation requirements, and these factors are weighed below, along with other factors, under section V., “Rationale.”
For these reasons, ORR proposes to amend § 410.1202(b) to add paragraph (1) as follows:
(i) U.S. Passport or U.S. Passport Card;
(ii) Permanent Resident Card or Alien Registration Receipt Card (Form I-551);
(iii) Foreign passport that contains a temporary I-551 stamp or temporary I-551 printed notation on a machine-readable immigrant visa;
(iv) Employment Authorization Document that contains a photograph (Form I-766);
(v) Foreign passport with Form I-94 or Form I-94A with Arrival-Departure Record, bearing the same name as on the passport;
(vi) Passport from the Federated States of Micronesia (FSM), Republic of the Marshall Islands (RMI), or Republic of Palau with Form I-94 or Form I-94A indicating nonimmigrant admission under the Compact of Free Association Between the United States and the FSM, RMI, or Republic of Palau;
(vii) Driver's license or ID card issued by a U.S. State or outlying possession of the United States provided it contains a photograph and information such as a name, date of birth, sex, height, eye color, and address;
(viii) ID card issued by U.S. Federal, State or local government agencies or entities, provided it contains a photograph and information such as name, date of birth, sex, height, eye color, and address;
(ix) U.S. Military card or draft record;
(x) U.S. Military dependent's ID card;
(xi) U.S. Coast Guard Merchant Mariner Card;
(xii) Native American tribal document; or
(xiii) Driver's license issued by a Canadian government authority.
ORR also proposes to add new paragraph § 410.1202(b)(2), which would be consistent with current policy, and which would provide that any deviations from the standards in § 410.1202(b)(1) must be supported by clear justification and may be made on a case-by-case basis by HHS ORR headquarters, with appropriate documentation of the basis for the deviation and any additional verification steps taken.
ORR requests comment on its proposed updates to documents that it would accept as proof of identity as part of its sponsor suitability assessment.
Prior to 2014, ORR required potential sponsors to submit proof of income. This requirement was consistent with ORR's statutory responsibility to determine that a prospective sponsor is able to provide for a UAC's well-being consistent with 8 U.S.C. 1232(c)(3)(A). In addition, 6 U.S.C. 279(b)(1)(E) makes ORR responsible for implementing policies with respect to the care and placement of UAC.
In response to concerns related to the safety and well-being of UAC who have been released to sponsors from ORR custody, ORR now proposes to reestablish the requirement that potential sponsors submit proof of income to ORR to demonstrate they have the financial means to support the UAC. ORR would evaluate such proof of income, including financial documents, submitted alongside the sponsor application as part of the sponsor suitability assessment.
Sponsors who lack stable income or financial resources may be vulnerable to labor exploitation or trafficking situations—risks that are especially urgent now given findings from recent investigations by both outside entities and by ORR itself. If a sponsor is working in exploitative conditions, such as working excessive hours or experiencing wage theft, they may be unable to properly care for the UAC or provide them with a safe living environment. Further, when sponsors lack adequate income, UAC may be compelled to work in dangerous environments, work excessive hours, or may become targets for labor traffickers.
To maintain operational flexibility, ORR does not propose an enumerated list of acceptable forms of proof of income. ORR notes that it may, however, review documents such as the following, which would be submitted with the Sponsor Application: a previous year's tax return if the potential sponsor was present in the United States during the prior tax year; copies of paystubs for at least the past 60 continuous days; or an original letter from the potential sponsor's employer verifying their employment and salary
In line with the above, ORR proposes to amend § 410.1202(c) by removing “income” from the second sentence of paragraph (c), making the remainder of the second sentence of paragraph (c) a new paragraph (c)(1) and adding new paragraph (c)(2) to provide that ORR would require potential sponsors to submit proof of income as part of the suitability assessment.
ORR requests comments on these proposals related to submission of proof of income.
Currently, under § 410.1202(c), ORR requires background and criminal records checks as part of the sponsor suitability assessment, “which at minimum includes an investigation of public records sex offender registry conducted through the U.S. Department of Justice National Sex Offender public website for all sponsors and adult residents of the potential sponsor's household,” and which “may include a public records background check or a FBI National Criminal history check based on fingerprints for some potential sponsors and adult residents of the potential sponsor's household.” Under the ORR Policy Guide, ORR requires a public records background check, national criminal history Federal Bureau of Investigation (FBI) fingerprint background check, and proof of identity for all household members and adult care givers.
Given what it has learned in the internal and external investigations, ORR believes that waiving background check requirements exposes UAC to potential risk and abuse, even when the potential sponsor is a parent or legal guardian. ORR therefore proposes to amend § 410.1202(c) to add specific requirements regarding conducting background checks for all potential sponsors. Specifically, ORR proposes new paragraph (c)(4), which would require ORR to conduct background checks on all potential sponsors and all adult residents of the potential sponsor's household as part of the suitability assessment. ORR considers an adult resident to be anyone 18 years or older. In addition, in alignment with Public Law 119-21, title VIII, subtitle H, section 87001(b)(1), ORR proposes that sponsor background checks would include the collection, review, or completion of:
(i) the name of the potential sponsor and of all adult residents of the potential sponsor's household;
(ii) the Social Security number or taxpayer identification number of the potential sponsor and of all adult residents of the potential sponsor's household;
(iii) the date of birth of the potential sponsor and of all adult residents of the potential sponsor's household;
(iv) the validated location of the residence at which the UAC will be placed, which may include review of available records sufficient to confirm the residence and identify indicators of prior or multiple sponsorship activity associated with that location, where appropriate;
(v) an in-person or virtual interview with, and suitability study concerning, the potential sponsor and all adult residents of the potential sponsor's household, including resolution of discrepancies relating to identity, relationship claims, residence, employment, or other information submitted in support of the sponsorship request;
(vi) contact information for the potential sponsor and for all adult residents of the potential sponsor's household; and
(vii) the results of all background and criminal records checks for the potential sponsor and for all adult residents of the potential sponsor's household, which shall include, at a minimum, an investigation of the public records sex offender registry, a public records background check, and a national criminal history check based on fingerprints, as well as any additional lawful records checks or verification steps ORR deems necessary to resolve fraud, public safety, or child welfare concerns.
ORR also proposes to add new paragraph (c)(5), which would allow ORR to waive or modify the requirement to collect Social Security or taxpayer identification numbers, as described at paragraph (c)(4)(ii) of this section, with respect to potential sponsors who are parents or legal guardians, or adult household members of potential sponsors, provided that ORR would be able to collect sufficient alternative identifying information to complete appropriate vetting and resolve identity, and therefore ensure expeditious and safe placement of UAC. For example, ORR envisions instances in which a potential parent or legal guardian sponsor and/or an adult resident in their household has a legitimate reason for not having a Social Security number or taxpayer identification number.
ORR notes that these proposed changes are in addition to a proposed minor restructuring of the section which would move provisions already included in § 410.1202(c) into paragraphs (c)(1), (2), and (3), respectively.
ORR requests comments on its updated background check requirements.
In this NPRM, ORR proposes adding a new requirement to align with Public Law 119-21, title VIII, subtitle H, section 87001(b)(3), which provided funds for costs associated with
ORR requests comment on this proposal, specifically around which mechanisms ORR should use to determine whether a child may have been involuntarily tattooed or that a tattoo might be an indicator of potential exploitation, abuse, or trafficking of the child rather than an indication of the child's complicity in criminal activity. ORR also requests specific feedback on mechanisms that it may use to ensure the proper coverage of tattoos and markings while the UAC is in ORR care per the requirements of Public Law 119-21. Finally, ORR is requesting feedback regarding the general definition of “gang-related tattoos” or “gang-related markings” as well as the methodology HHS should use to determine whether a tattoo or marking is “gang-related.”
In the Foundational Rule, ORR finalized the definition of the term “unaccompanied child/children” to mean the same as the definition of “unaccompanied alien child” found in the HSA (6 U.S.C. 279(g)(2)), noting that ORR uses the terms synonymously. (89 FR 34385 and 34399). ORR now proposes to return to the terms used by the HSA, which defines “unaccompanied alien child,” as “a child who—(A) has no lawful immigration status in the United States; (B) has not attained 18 years of age; and (C) with respect to whom—(i) there is no parent or legal guardian in the United States; or (ii) no parent or legal guardian in the United States is available to provide care and physical custody.” To avoid confusion, and to clarify that the terms “unaccompanied alien child” and “unaccompanied child” may be used interchangeably, ORR proposes to revise the definition of “unaccompanied child/children” at § 410.1001 to also include “unaccompanied alien child/children”, such that each term would have the same definition as “unaccompanied alien child” at 6 U.S.C. 279(g)(2).
ORR requests comment on its proposal to amend this definition.
As discussed above, ORR has an affirmative duty to ensure the safe placement of UAC. Notwithstanding ORR's responsibility to “prompt[ly]” place UAC in the least restrictive setting, such placements must be in the UAC's best interests under the TVPRA at 8 U.S.C. 1232(c)(2)(A). The TVPRA at 8 U.S.C. 1232(c)(1) also requires HHS to “establish policies and programs to ensure that unaccompanied alien children in the United States are protected from traffickers and other persons seeking to victimize or otherwise engage such children in criminal, harmful, or exploitative activity.” Further, ORR has a responsibility under 8 U.S.C. 1232(c)(3)(A), before placing a UAC with a person or entity, to make “a determination that the proposed custodian is capable of providing for the child's physical and mental well-being,” where such determination “shall, at a minimum, include verification of the custodian's identity and relationship to the child, if any, as well as an independent finding that the individual has not engaged in any activity that would indicate a potential risk to the child.”
Pursuant to these responsibilities, and in light of the serious concerns ORR and others have identified (see section III., “Background and Scope of Regulatory Action—Authority and Background” above), ORR believes it has a compelling interest to propose modifications to its requirements concerning acceptable forms of proof of identity and proof of income submitted by potential sponsors and specific information to be collected for background checks on all potential sponsors. With respect to proof of identity, among other things, ORR's I&A Team, as discussed above, found multiple instances in which potential sponsors submitted altered photographs or documents to establish identity and relationship, in some instances to sponsor multiple UAC (as previously discussed under section III.A. above, ORR identified a case in which a woman and her partner submitted various fake documents in an attempt to sponsor 15 children over a five-year period, and in which at least seven of those attempts were successful, including three in which the woman claimed to be a parent or legal guardian of the UAC). ORR's field staff has also reported observing an increase in potential sponsor fraud, as well as age fraud perpetrated by individuals coming into ORR care, and recommended stricter document verification policies. Further, with respect to proof of income, ORR has found that verifying income can assist in identifying risks of labor trafficking and extortion by helping determine whether the existence of debt could be used against sponsors and other involved individuals. For example, the June 2024 U.S. Department of State
ORR also identified and weighed relevant factors in modifying these policies, including the potential that the proposed proof of identity and proof of income requirements could increase the time it takes to release UAC from ORR custody; the potential impact on reasonable reliance interests of UAC and sponsors; ORR's competing policy interests that could be impacted by these proposals; the potential to disadvantage certain stakeholders due to the particular changes proposed; ORR's statutory obligations to prevent fraud; ORR's statutory obligations to ensure the safety of UAC and to ensure public safety; and ORR's statutory obligations to act in the best interests of the UAC. ORR welcomes public comment on these considerations, discussed below.
Regarding time in ORR care, ORR contemplates that the proposals described in this proposed rule may increase the overall time a UAC spends in the custody and care of ORR. For example, the proposed changes mean
Nevertheless, ORR concludes that, in light of the safety concerns it has identified, its proposed additional documentation requirements are necessary to effectuate its statutory duties to protect UAC from trafficking and exploitation, even if these proposed additional requirements would result in additional time needed to approve the release of UAC to sponsors. As discussed above, the ORR I&A Team in February 2025 found an alarming number of incidents of confirmed and potential fraud and extortion and ORR is concerned that such incidents have been under-reported. As a result, ORR believes that the risk of additional time until release would be outweighed by the risk to UAC safety without additional safeguards, including the proof of identity, proof of income, and background check requirements proposed here. Beyond the harms of trafficking and exploitation, it would also be disruptive and traumatic for a UAC to re-enter ORR care due to a later-discovered sponsor issue, which could result in changing schools and leaving familiar surroundings and friends. This would negate any child welfare benefit of an initial lower length of care in ORR custody. Additionally, UAC re-entering ORR care due to later-discovered sponsor issues could create operational inefficiencies that could have been prevented with better vetting on the front-end. With respect to reliance interests, changes to sponsor vetting as announced herein may have an impact on UAC and sponsors who relied on prior documentation policies, including UAC who entered the United States before March 2025, and in particular, those who have not yet been placed with a sponsor and may not have chosen to enter the United States before March 2025 if they had known about these more stringent requirements for sponsor vetting. ORR does not, however, believe that documented safety and fraud concerns should be set aside in order to allow the use of less reliable documentation for UAC who may have relied upon older, less secure, and less safe standards for sponsor vetting. In addition, the updated documentation requirements described in this proposed rule would be similar to those ORR published in the ORR Policy Guide in March 2025 (with respect to proof of identity) and in April 2025 (with respect to proof of income), and therefore ORR believes that UAC and potential sponsors other than those who are part of the provisionally certified class in
ORR notes that it has supplemental protections in place for potential sponsors whose applications are denied if they are unable to meet either the proposed requirements or existing requirements for sponsorship. All potential sponsors who are parents, legal guardians, or close relatives have an opportunity to appeal denials of release to an independent arbiter within the HHS Departmental Appeals Board under § 410.1206. Further, an applicant has the opportunity to reapply for sponsorship without prejudice, should he or she have been unable to procure the requisite documents at the time of an initial sponsorship application. ORR acknowledges, however, that if potential sponsors' applications are denied due to these proposed requirements, there would be a concern about additional time that may be needed to approve a release.
ORR examined other interests that would weigh in favor of the updates proposed here. For example, UAC may come to the United States with the expectation that they would be released to safe sponsors pursuant to ORR's sponsor vetting process. Such expectations would fully accord with ORR's statutory responsibilities but, as discussed above, ORR has discovered that there has been potential fraud in the ORR release process. Alternatively, to the extent any UAC or potential sponsors entered the United States cognizant of gaps in ORR's sponsor vetting processes and planned to exploit them, ORR believes it would be justified in introducing updated requirements to address those vulnerabilities. Given ORR's findings of potential fraud, extortion, and other issues that risk the safety of UAC who are released from ORR custody, as well as ORR's belief that it has likely not been made aware of all such issues, ORR believes that it must propose updated requirements in order to effectively carry out its statutory responsibilities to protect the welfare of UAC and ensure all UAC are placed with adequate and fully vetted sponsors upon arrival to the United States.
When developing these proposed updates ORR also considered whether proposing stricter requirements could potentially reduce the number of sponsors willing to come forward, which could impact ORR's ability to safely place UAC with sponsors without unnecessary delay. ORR has, for example, considered whether sponsors who might be able to provide a secure and safe home for a UAC but who have a general unwillingness to interact with government officials or law enforcement (regardless of immigration status), or to provide documentation could have a chilling effect on available sponsors and could increase the number of UAC in ORR custody and the amount of time UAC spend in ORR custody. ORR also considered whether it would generally be in a UAC's best interest to be released to an individual who may wish to sponsor a UAC but is deterred by ORR's proposed documentation requirements or the prospect of interacting with government officials to obtain required documentation. In particular, ORR considered the likelihood of whether such an individual would be able to provide a UAC with a suitable home. For example, a sponsor must be able to provide stability for a UAC and therefore necessarily must engage in ongoing interactions with government officials to act as a sponsor and represent the UAC's best interests. ORR also weighed the possibility that a sponsor may be unwilling, for whatever reason, to engage with government
ORR further considered any potential disadvantages to certain stakeholders due to these proposed policy changes. Regarding the proposed identity documentation requirements, ORR recognizes that proposing to limit acceptable forms of identification to those that are similar to documents listed on the Form I-9 Lists A and B may disadvantage potential sponsors who, for example, possess only foreign identification documents. For income verification, ORR acknowledges that proposing to require formal documentation may disadvantage sponsors who work in cash-based employment. However, ORR believes that these potential disadvantages would be outweighed by the critical need to verify sponsor identity and financial capacity to support a UAC, as well as to conduct background checks on all adult members of a potential sponsor's household, based on its findings that prior policies have failed to adequately prevent significant and potentially under-reported risks to child welfare.
ORR also weighed its statutory obligation to prevent fraud pursuant to 8 U.S.C. 1232(c)(1), (c)(3)(A) and 6 U.S.C. 279(b)(2)(A)(ii). ORR's approach to preventing fraud includes verification of documents, background checks, and interviews with potential sponsors, but ORR recognizes that its current requirements are not sufficient to address the gaps identified in its processes and believes the proposed amendments to its requirements would thwart such attempts to perpetuate fraud and other behavior that would put UAC at risk. ORR recognizes that fraud risks may be identified through comparison across multiple sponsor applications and related records, including repeated use of the same addresses, telephone numbers, email addresses, employment information, or other identifiers. In the context of identity documentation, therefore, proposing the use of like documents to those listed on the Form I-9 would provide a standardized, verifiable set of identification documents that is also used by another government agency with specific expertise relevant to addressing the potential fraud concerns ORR has identified in its program. ORR understands that the identity documentation proposed to be required by this NPRM, like those in the Form I-9, are more difficult to falsify and may be more readily authenticated relative to documents ORR has accepted in the past, such as those with which ORR had to liaise with the Department of State, foreign consulates, and embassies to verify. ORR notes, with respect to foreign-issued documents, that it has historically had difficulty coordinating with foreign governments to authenticate documents and as further discussed below, not only do the practices of each government vary for authenticating documents, but so do foreign governments' responsiveness to ORR communications. Also, as discussed above, many of the forms of identification proposed here also contain additional security factors (
ORR also considered its statutory obligation pursuant to 8 U.S.C. 1232(c)(1) to ensure that “unaccompanied alien children in the United States are protected from traffickers and other persons seeking to victimize or otherwise engage such children in criminal, harmful, or exploitative activity.” The proposed identity documentation and background check requirements would help ensure that sponsors and their adult household members are who they claim to be and would reduce the risk of UAC being released to individuals using false identities, who have criminal backgrounds, and who may intend to exploit UAC. ORR also believes that the proposed income verification requirements would further help ensure that potential sponsors could demonstrate that they have legitimate means of support and are not involved in, or subject to, trafficking networks, or planning to exploit UAC for labor.
In addition, ORR considered its need to act in the best interest of the UAC pursuant to 8 U.S.C. 1232(c)(2)(A). While ORR recognizes that these proposed requirements could increase the time it may take to release some UAC from ORR's care, ORR believes that the protection from potential exploitation, trafficking, and other harms, including such as harms associated with UAC having to re-enter ORR care, would outweigh any temporary extension of time in ORR custody. The proposed identity documentation, income verification, and updated background check requirements would help ensure that UAC are placed in stable, safe environments with sponsors who have been properly vetted and who have the means to support them.
Given ORR's statutory obligations, and after weighing factors such as delay, reliance interests, competing policy interests, disadvantage to certain stakeholders, obligations to prevent fraud and ensure safety, and its requirement to act in the best interest of the UAC, ORR believes that the amended requirements proposed in this NPRM are necessary and appropriate.
ORR also considered potential alternatives to these proposed requirements. With respect to proof of identity, ORR considered whether the use of forms described in the Form I-9 would be appropriate in the UAC placement context and what other set of documents would balance the competing interests of avoiding unnecessary delay in placing UAC with sponsors and protecting UACs, including by preventing fraud. The Form I-9 is used to verify the identity and employment authorization of individuals hired for employment in the United States, is well-established and standardized, although it contains additional options that ORR believes would not be sufficient for its purposes and did not, therefore, propose to include. Another potential alternative, rather than updating ORR's documentation requirements, would be for ORR to instead rely on improvements in its document authentication process. ORR expects, however, that this alternative would require significant resources and would impose administrative burdens—
ORR notes that this proposed rule would reduce the number of foreign identity documents that it would accept for its sponsor suitability process. ORR proposed these changes on the basis that it is unable to reliably verify all forms of identification it previously accepted. For example, in practice, ORR attempts to authenticate foreign documents through communication with foreign governments, especially consulates. However, ORR has experienced high rates of delayed responses or, in many cases, non-responses to ORR requests to authenticate documents presented to ORR as proof of identity. In other cases, countries may respond but may themselves be unable to verify certain documents, or countries may communicate with ORR but only through certain messaging applications that ORR is not authorized to use. To ensure uniformity of practice, this proposed rule would permit fewer foreign identity documents as acceptable proof of identity, which would make ORR less reliant on foreign countries for authentication. As necessary, however, ORR expects that it may still seek authentication of certain foreign documents.
Finally, with respect to the proposed proof of income requirements, ORR considered the alternative of not requiring potential sponsors to submit proof of income. The TVPRA, however, requires ORR to determine whether a proposed sponsor is capable of providing for a UAC's physical and mental well-being (8 U.S.C. 1232(c)(3)(A)). ORR notes that, in addition, the Foundational Rule already provides, “As part of its suitability assessment, ORR may require such components as an investigation of the living conditions in which the unaccompanied child would be placed and the standard of care the unaccompanied child would receive, verification of the employment, income, or other information provided by the potential sponsor as evidence of the ability to support the child. . .” 45 CFR 410.1202(c). Given the potential cases of fraud and exploitation uncovered in oversight and investigations, ORR believes that it best serves the interest of child safety to propose a return to its pre-2014 practice of requiring proof of income from potential sponsors. ORR notes that it has identified this as an area for possible further policy development and anticipates that it may provide additional discussion or describe additional potentially acceptable documents in sub-regulatory guidance.
ORR encourages all interested parties to participate in this rulemaking by submitting written comments, views, and data on any or all aspects of this proposed rule. ORR also invites comments that relate to the economic, environmental, or federalism effects that might result from this proposed rule. All comments received will be posted without change to
Comments that will provide the most assistance to ORR will reference a specific portion of the proposed rule, explain the reason for any recommended change, and include data, information, or authority that supports such recommended change. If you submit comments, please indicate the specific section of this document to which each comment applies and provide a reason for each suggestion or recommendation. You may submit your comments and materials online or by email, but please use only one of these means. Comments submitted online via
For additional information, please read the “Privacy and Security Notice” that is available via the link in the footer of
ORR will consider all comments and materials received during the comment period and may change this rule based on your comments.
As stated above, please be aware that anyone can search the electronic form of comments received into any dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.).
ORR has examined the impacts of this proposed rule under Executive Order 12866, Executive Order 13132, Executive Order 13563, Executive Order 14192, the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Congressional Review Act/Small Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub. L. 104-121), the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4), the PRA, and the Treasury and General Government Appropriations Act of 1999.
Executive Orders 12866 and 13563 direct ORR to assess all benefits and costs of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits. This rule was determined to be significant under Section 3(f) of Executive Order 12866 and is subject to review by the Office of Management and Budget (OMB). Executive Order 14192 requires that any new incremental costs associated with significant new regulations “shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least ten prior regulations.” This proposed rule has a direct purpose of implementing a function performed by the U.S. Federal Government with respect to aliens, and thus is expressly exempt from the requirements of Executive Order 14192. Notwithstanding this, ORR believes that
The RFA generally requires Federal agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. ORR has discussed above its consideration of alternatives and determined that it would be more costly to require additional documentation than proposed or to conduct more extensive training; however, these additional costs would be relevant only to ORR. ORR notes that this proposed rule would update existing requirements related to sponsor suitability assessments, and these updates would not result in any incremental impact on small entities that is significant. Therefore, ORR certifies that this proposed rule would not have a significant economic impact on a substantial number of small entities.
The UMRA generally requires that each agency conduct a cost-benefit analysis; identify and consider a reasonable number of regulatory alternatives; and select the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule before promulgating any proposed or final rule that includes a Federal mandate that may result in expenditures of more than $100 million (adjusted for inflation) in at least one year by State, local, and tribal governments, in the aggregate, or by the private sector. Each agency issuing a rule with relevant effects over that threshold must also seek input from State, local, and tribal governments. The current threshold after adjustment for inflation using the Implicit Price Deflator for the Gross Domestic Product is $193 million, reported in 2025 dollars. This proposed rule would not result in an unfunded mandate in any year that meets or exceeds the UMRA threshold.
Under the PRA, HHS is required to provide notice in the
In accordance with section 6 of Executive Order 13132, ORR has determined that this proposed rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. This comports with the same determination made in the Foundational Rule at 89 FR 34583.
Section 654 of the Treasury and General Government Appropriations Act of 1999 requires Federal agencies to determine whether a policy or regulation may affect family well-being. If the agency's determination is affirmative, then the agency must prepare an impact assessment addressing criteria specified in the law. This regulation would not have an impact on family well-being as defined in this legislation, which asks agencies to assess policies with respect to whether the policy: strengthens or erodes family stability and the authority and rights of parents in the education, nurture, and supervision of their children; helps the family perform its functions; and increases or decreases disposable income.
Administrative Practice and Procedure, Aliens, Child Welfare, Immigration, Unaccompanied alien children.
For the reasons set forth in the preamble, ORR proposes to amend 45 CFR part 410 to read as follows:
6 U.S.C. 279, 8 U.S.C. 1232.2.
(1) Has no lawful immigration status in the United States;
(2) Has not attained 18 years of age; and
(3) With respect to whom:
(i) There is no parent or legal guardian in the United States; or
(ii) No parent or legal guardian in the United States is available to provide care and physical custody.
(h) In determining whether an unaccompanied alien child poses a danger to self or a danger to the community or others under paragraphs (b)(1) or (b)(2) of this section, ORR may examine an unaccompanied alien child for visible gang-related tattoos and other gang-related markings, and cover such tattoos or markings while the unaccompanied alien child is in the care of ORR.
(b) * * *
(1) Proof of Identity. ORR will accept the following as proof of identity for potential sponsors as part of the suitability assessment:
(i) U.S. Passport or U.S. Passport Card;
(ii) Permanent Resident Card or Alien Registration Receipt Card (Form I-551);
(iii) Foreign passport that contains a temporary I-551 stamp or temporary I-551 printed notation on a machine-readable immigrant visa;
(iv) Employment Authorization Document that contains a photograph (Form I-766);
(v) Foreign passport with Form I-94 or Form I-94A with Arrival-Departure Record, bearing the same name as on the passport;
(vi) Passport from the Federated States of Micronesia (FSM), the
(vii) Driver's license or ID card issued by a U.S. State or outlying possession of the United States provided it contains a photograph or information such as a name, date of birth, sex, height, eye color, and address;
(viii) ID card issued by U.S. Federal, State or local government agencies or entities, provided it contains a photograph or information such as name, date of birth, sex, height, eye color, and address;
(ix) U.S. Military card or draft record;
(x) U.S. Military dependent's ID card;
(xi) U.S. Coast Guard Merchant Mariner Card;
(xii) Native American tribal document; or
(xiii) Driver's license issued by a Canadian government authority.
(2) Any deviation from the standards in § 410.1202(b)(1) must be supported by clear justification and may be made on a case-by-case basis by HHS ORR headquarters.
(c) ORR's suitability assessment shall include taking all needed steps to determine that the potential sponsor is capable of providing for the unaccompanied alien child's physical and mental well-being. As part of the suitability assessment, ORR:
(1) May require such components as an investigation of the living conditions in which the unaccompanied alien child would be placed and the standard of care the unaccompanied alien child would receive, verification of the employment or other information provided by the potential sponsor as evidence of the ability to support the unaccompanied alien child, interviews with members of the household, and a home visit or home study as discussed at § 410.1204.
(2) Requires potential sponsors to submit proof of income.
(3) Shall take into consideration the wishes and concerns of the unaccompanied alien child.
(4) Conducts background checks on all potential sponsors, which shall include collection, review, or completion of:
(i) the name of the potential sponsor and of all adult residents of the potential sponsor's household;
(ii) the Social Security number or taxpayer identification number of the potential sponsor and of all adult residents of the potential sponsor's household;
(iii) the date of birth of the potential sponsor and of all adult residents of the potential sponsor's household;
(iv) the validated location of the residence at which the unaccompanied alien child will be placed, which may include review of available records sufficient to confirm the residence and identify indicators of prior and multiple sponsorship activity associated with that location, where appropriate;
(v) an in-person or virtual interview with, and suitability study concerning, the potential sponsor and all adult residents of the potential sponsor's household, including resolution of discrepancies relating to identity, relationship claims, residence, employment, or other information submitted in support of the sponsorship request;
(vi) contact information for the potential sponsor and for all adult residents of the potential sponsor's household; and
(vii) the results of all background and criminal records checks for the potential sponsor and for all adult residents of the potential sponsor's household, which shall include, at a minimum, an investigation of the public records sex offender registry, a public records background check, and a national criminal history check based on fingerprints, as well as any additional lawful records checks or verification steps ORR deems necessary to resolve fraud, public safety, or child welfare concerns.
(5) ORR may waive or modify the requirement to collect Social Security or taxpayer identification numbers, as described at paragraph (c)(4)(ii) of this section, with respect to potential sponsors who are parents or legal guardians, or adult household members of potential sponsors, provided that ORR would be able to collect sufficient alternative identifying information to complete appropriate vetting and resolve identity.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of proposed rulemaking.
NHTSA is proposing to amend Federal Motor Vehicle Safety Standard (FMVSS) No. 135, “Light vehicle brake systems.” The proposed modifications would distinguish how regulations apply to vehicles with and without manually operated driving controls. The proposed modifications would clarify definitions, telltale requirements, performance requirements, and test procedures in the standard and remove sections that are no longer relevant. The stopping distance performance requirements, which address the primary safety purpose of the standard, would still apply to all subject vehicles. This rulemaking would remove unnecessary regulatory burdens and costs without detriment to vehicle safety.
Comments should be submitted no later than July 27, 2026.
You may submit comments identified by the docket number in the heading of this document through any of the following methods:
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For technical issues, you may contact Ms. Lina Valivullah, Office of Automation Safety; Telephone: 202-366-1810; Email:
This rulemaking is intended primarily to modernize Federal Motor Vehicle Safety Standard No. 135, “Light vehicle brake systems,” to apply the standard's performance requirements to vehicles equipped with Automated Driving Systems (ADS) that do not have manually operated driving controls. Though these vehicles currently are not available for consumer purchase, there is considerable testing, development, and validation of these vehicles, as well as localized deployment by manufacturers and rideshare operators. Vehicle automation technology has the potential to reduce roadway crashes and fatalities while increasing mobility. As the technology is still maturing and many of the potential benefits are yet to be realized, NHTSA is engaging in a process to modernize existing FMVSS to remove unnecessary barriers to technological innovation while ensuring motor vehicle safety is not compromised.
In this document, NHTSA proposes to amend FMVSS No. 135 to clarify the requirements and test procedures for vehicles with and without manually operated driving controls, while retaining the existing requirements for stopping distance. NHTSA proposes to revise the current requirements that all light vehicles contain hand- or foot-operated brake controls, removing those requirements for vehicles designed never to be operated by a human. For vehicles without manually operated driving controls, the agency proposes application of existing performance requirements through alternative test procedures. The proposed changes also include language modifications, corrections of typographical errors, and removal of outdated information to clarify the braking performance requirements for all subject vehicles. NHTSA is not proposing changes to any stopping distance requirements in FMVSS No. 135. Regardless of the manner of brake control application, the brake systems must be capable of safely stopping the vehicle, as already required by the standard. This rulemaking would remove unnecessary regulatory burdens and costs with no negative impact to vehicle safety. For ADS-equipped vehicles that contain manually operated driving controls, the existing requirements of the standard would still apply.
Importantly, this proposal is intended to remove unintended design barriers that exist in FMVSS No. 135 and maintain existing brake performance requirements for designs that are newly enabled. The proposal would ensure that ADS-equipped vehicles without manually operated driving controls
This proposed rule is intended primarily to address ADS-equipped vehicles that do not have manually operated driving controls. An ADS commonly is considered to be a combination of hardware and software that can perform all real-time operational and tactical functions required to operate a vehicle on a sustained basis
NHTSA has published prior
NHTSA proposes amendments to the existing requirements to allow ADS-equipped vehicles that do not contain manually operated driving controls, and therefore cannot be driven by a human occupant, to be certified under FMVSS No. 135. ADS-equipped vehicles without manually operated driving controls currently face regulatory barriers presented by requirements for manual controls such as a foot-operated service brake pedal, which is unnecessary for operation of the vehicle by the ADS. Some ADS-equipped vehicles do have manually operated driving controls, especially if converted from a conventional vehicle or if equipped with controls only for specialized use. NHTSA maintains that any vehicle equipped with manually operated driving controls must continue to meet all existing safety requirements associated with manual controls, regardless of whether the vehicle is equipped with an ADS.
General updates and corrections to the regulatory text are also discussed in this document. The final rule establishing FMVSS No. 135, “Passenger car brake systems,” was published on February 2, 1995,
FMVSS No. 135, “Light vehicle brake systems,” specifies requirements for service brake and parking brake systems in passenger cars, multi-purpose passenger vehicles, trucks, and buses with a GVWR of 3,500 kilograms (7,716 pounds) or less. The purpose of the standard is to ensure safe braking performance under normal and emergency driving conditions. Brake performance is evaluated using the vehicle's
As stated, the intention of the standard is to ensure safe braking performance in a variety of conditions. Paragraph S5.3.1 currently requires independent manual controls for activation of the service brakes and the parking brake. In an ADS-equipped vehicle without manually operated driving controls, the ADS would perform the driving task and any vehicle occupants would be passengers. The ADS would operate the service brakes and the parking brake without the need for a foot-operated service brake pedal, or a hand- or foot-operated parking brake control. Therefore, some manufacturers may want the ability to remove these manual controls. It is NHTSA's expectation that if these controls are removed, passengers will still be provided with a means to direct an ADS-operated vehicle to come to a stop, though how a passenger would indicate they wanted the ADS-operated vehicle to stop
In some vehicles, the inclusion of a brake pedal that directly overrides ADS operation could pose a safety risk through intentional or unintentional misuse by a vehicle passenger. In addition, operation of the parking brake is the responsibility of the vehicle operator; a passenger that is not
To clarify the terminology in FMVSS No. 135 for vehicles with and without manually operated driving controls, NHTSA is proposing to add a definition for
NHTSA also proposes to modify the definition for
NHTSA is proposing minor edits to two other definitions to account for ADS-operated vehicles that do not have a driver, by changing “driver action” to “any driver action” in the definition of
For test procedures and performance requirements, NHTSA proposes changes to S7 to clarify application of the service brake control, as pedal force specifications do not apply to vehicles without hand- or foot-operated controls. The maximum pedal forces specified in S7 are intended to ensure that the brakes are easily operable by drivers of varying physical strength and will be retained for all brake systems with hand- or foot-operated brake controls. When muscular force is not used to apply the brake control, applied force specifications are unnecessary. For these reasons, and to account for design variations between different vehicles and ADSs, the proposed service brake test procedures state that manufacturer specifications are used for the brake control input when testing vehicles without manually operated driving controls. Regardless of the activation mechanism for the service brakes and the parking brake, all vehicles subject to FMVSS No. 135 would still need to meet the braking performance requirements of the standard; NHTSA is not proposing any ADS-specific changes to the stopping distance requirements.
The proposed modifications to the standard are intended to maintain the current level of safety performance while ensuring that the standard is not design restrictive. To ensure vehicle compliance with FMVSS No. 135, NHTSA would request data and demonstration of vehicle braking performance from vehicle manufacturers if unable to test the vehicles independently. Laboratory and regulatory compliance testing procedures may be developed and implemented over time as vehicles without manually operated driving controls become more common, including a potential standardized method for NHTSA to input braking commands during compliance testing. At this time, NHTSA intends to work with certifying entities as needed to ensure that all vehicles on public roadways meet the applicable safety requirements.
In addition to ADS-specific changes, NHTSA is proposing to streamline and make technical corrections to the standard. NHTSA proposes to remove the subsections of S7 that only apply to vehicles without ABS. This is because
As all vehicles subject to FMVSS No. 135 are equipped with ABS, NHTSA proposes to modify S5.3.2, by removing the language stating, “for vehicles equipped with ABS.” NHTSA also proposes to remove the word “manual,” to clarify that any control to disable the ABS is prohibited. As revised, S5.3.2 would read, “A control to disable the ABS, either fully or partially, is prohibited.” Likewise, the `if equipped' clause for ABS in S6.3.6 would be removed, resulting in, “The ABS is fully operational for all tests, except where specified in the following sections.” NHTSA will also simplify the language in the Application section for clarity, removing references to dates that have passed.
Other revisions throughout S7 would correct the erroneous notation for initial brake temperature (IBT) and pedal force specifications. Specifically, the lower bounds for IBT and pedal force are stated as maximum values rather than minimum values. Because the specifications are written correctly in the publicly available laboratory test procedure document
Section S5.5 of FMVSS No. 135 requires a brake system warning indicator that shall be in front of and in clear view of the driver and which shall be activated when the ignition switch is in the “on” position and whenever a variety of conditions occur, including gross loss of fluid or fluid pressure, electrical functional failure, application of the parking brake, brake lining wear-out, and other brake system or subsystem failures. The purpose of the brake system warning indicator is to inform the driver when there is a malfunction in the braking system and to provide feedback when the parking brake is engaged.
NHTSA proposes to rename “brake system warning indicator” to “brake system warning telltale” to align with the definitions of telltales and indicators found in FMVSS No. 101, “Controls and displays.” A telltale is defined in FMVSS No. 101 as “an optical signal that, when illuminated, shows the actuation of a device, a correct or improper functioning or condition, or a vehicle system's failure to function.” Each of the conditions in which the brake system warning indicator must be activated are conveying information related to improper functioning or failure to function (S5.5.1(a), (b), (d), (e), (f), and (g)), or the actuation of a device (S5.5.1(c)). Further, FMVSS No. 101 classifies display items related to brake system warnings as telltales. This change in language to be consistent with other telltale requirements clarifies meaning and reduces confusion.
Section S5.5 of FMVSS No. 135 requires the brake system warning telltale to be mounted in front of and in clear view of the driver. A driver is defined in 49 CFR part 571.3 as the occupant of a motor vehicle seated immediately behind the steering control system. By this definition, an ADS-equipped vehicle without manually operated driving controls does not have a driver because the vehicle is not equipped with manually operated driving controls, including a steering control system. As such, the occupants of a vehicle without manually operated driving controls would be designated as passengers.
Some stakeholders have indicated that telltales are relevant only to the driver, and the information merely needs to be conveyed to the ADS for vehicles designed not to be operated by a human driver. NHTSA tentatively disagrees with this approach. The agency believes that certain telltales provide safety critical information that is necessary to provide human occupants with contextual information about the risk they may incur should they use the vehicle. The brake system warning is one such telltale, as it provides information about the operational safety of the vehicle. This telltale is also among those NHTSA has consistently treated as requiring special prominence given the safety critical nature of the information this telltale conveys.
For vehicles with manually operated driving controls, the brake system warning telltale will still be required to be mounted in front of and in clear view of the driver. In addition, for all ADS-operated vehicles, NHTSA further encourages the use of supplemental notifications communicating safety-relevant information to passengers via app notifications, in-vehicle alerts, or other methods, in addition to the required telltales.
FMVSS No. 135 requires the brake warning system telltale to appear when the parking brake is activated to alert the driver and reduce the likelihood of driving with the parking brake activated. For ADS-equipped vehicles that do not have manually operated driving controls, NHTSA tentatively concludes that such an activation does not serve a safety purpose because the ADS would control and monitor the status of the parking brake as part of normal vehicle operation. NHTSA proposes to add a clause to S5.5.1(c) of FMVSS No. 135 excepting vehicles without manually operated driving controls from the requirement to activate the brake system warning telltale when application of the parking brake occurs.
Regardless of telltales for vehicle occupants, NHTSA expects an ADS to be aware of the operational status of each safety critical vehicle system and subsystem and respond appropriately to identified degradations, failures, and malfunctions that create risks to safe performance. In other words, NHTSA expects ADS-equipped vehicles to adjust their operation if a safety critical vehicle system is in a degraded state. As with any ADS-equipped vehicle, NHTSA will not hesitate to use its strong and broad defect enforcement authority to address unsafe ADS performance. NHTSA requests comment on whether a performance standard would be appropriate for ADS response in the event of a brake system degradation, failure, or malfunction. If so, how should such performance requirements be constructed? Comments containing supporting data are the most informative.
A
In the NPRM for FMVSS No. 135, published May 10, 1985,
Currently, UN Regulation No. 13, “Uniform provisions concerning the approval of vehicles of categories M, N and O with regard to braking,” and No. 13-H, “Uniform provisions concerning the approval of passenger cars with regard to braking,” require that the parking braking system in subject vehicles hold “by a purely mechanical device.” The UN regulations further require that the “parking braking systems shall act on braking surfaces connected to the wheels through components of adequate strength;” in practice, this language effectively requires a friction type system. There are no dynamic parking brake requirements. There is a proposed amendment to the regulations submitted by industry to allow use of “a park lock device as an alternative to or in combination with the means acting on the braking surfaces.” The amendment is under consideration but has not yet been adopted. Likewise, the Alliance for Automotive Innovation submitted
The purpose of the parking brake is to prevent inadvertent vehicle movement when parked. NHTSA maintains that the parking brake system must use solely mechanical means to retain engagement to meet the safety need. The parking brake is intended to keep the vehicle from unintended roll-away and must stay engaged regardless of the operational state of the vehicle, including potential loss of electric power. This precludes the adoption of fully electrically actuated parking brakes, which may lose the ability to hold the vehicle if power is lost. However, NHTSA agrees that the requirement for a friction-type system is unnecessarily restrictive, as there is no demonstrated need for the parking brake to be designed as a dynamic emergency brake, and other mechanisms have been designed that can perform the same function. The existing performance requirement for the parking brake system to hold the vehicle stationary for five minutes in both a forward and reverse direction on the grade would remain unchanged, as would the requirement that the system retain engagement through solely mechanical means. For these reasons, NHTSA proposes to remove the friction type specification for the parking brake system.
As provided by 49 U.S.C. 30111(d), an FMVSS may not become effective before the 180th day after the standard is prescribed or later than one year after it is prescribed. However, NHTSA may provide a different effective date after finding, for good cause shown, that a different effective date is in the public interest. NHTSA must publish the reasons supporting such a finding. Similarly, 5 U.S.C. 553(d) provides that a final rule cannot become effective until at least 30 days after the date of publication except, among other reasons, the rule grants or recognizes an exemption, relieves a restriction, or for good cause found and published with the rule. It is in the public interest for this proposed rule, if adopted, to be effective immediately. This proposed rule clarifies existing requirements and removes unnecessary regulatory requirements for ADS-equipped vehicles without manually operated controls. There is no need for lead time for regulated entities to comply with this proposed rule. NHTSA seeks comment on whether the rule could be made effective within a time period shorter than 180 days or upon publication of any final rule.
NHTSA seeks public comment on the proposed changes, including the proposed exceptions to the requirements for hand- and foot-operated brake controls, the proposed definitions, the proposed revisions to the test procedures, the proposed telltale requirements for vehicles without manually operated driving controls, and the proposed removal of the friction type parking brake requirement. NHTSA will submit a redline-change version of the standard in its entirety to the docket to facilitate review of the proposed changes.
NHTSA has considered the impact of this rulemaking action under Executive Orders 12866 and 14192. This action was reviewed by the Office of Management and Budget (OMB) as a significant regulatory action under section 3(f) of E.O. 12866. This proposed rule, if finalized as proposed, is expected to be an E.O. 14192 deregulatory action because it removes an unnecessary regulatory burden for the reasons discussed above. At this stage, the agency has not quantified any potential benefits or costs. For this rule, NHTSA does not anticipate any new regulatory costs, as it would remove unnecessary requirements and provide clarity and flexibility without adding any new requirements. NHTSA does not anticipate any safety disbenefits for the proposed changes. The benefits to this rule would be reduced compliance costs and potential safety benefits from removing the ability of an occupant to interfere with the safe operation of the vehicle by the ADS. However, given the still-developing nature of this market, NHTSA cannot quantify the number of vehicles that may be potentially affected by this proposed rule. Further, NHTSA believes that it is more likely that these vehicles would seek exemptions from this standard rather than include the unnecessary equipment. Though NHTSA could seek to quantify compliance costs on a per-vehicle basis, any estimate that was based on traditional vehicle configurations may not be accurate, given the different design and nature of ADS-equipped vehicles without manually operated driving controls. NHTSA requests comment on these assumptions and any other information that could help quantify their impacts in the final rule.
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601
The Department has analyzed the environmental impacts of this notice of proposed rulemaking pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
NHTSA has examined this rule pursuant to Executive Order 13132 (64 FR 43255, August 10, 1999) and has concluded tentatively that no additional consultation with States, local governments, or their representatives is mandated beyond the rulemaking process. The agency has concluded tentatively that this rule, does not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement. NHTSA expects that this rule, if adopted, would 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.”
NHTSA rules can have a preemptive effect in two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemption provision: When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter. 49 U.S.C. 30103(b)(1). It is this statutory command by Congress that preempts any non-identical State legislative and administrative law addressing the same aspect of performance. NHTSA is not aware of any State motor vehicle equipment or inspection laws or regulations that require ADS-equipped vehicles that do not have manual driving controls to be equipped with a brake pedal. However, NHTSA seeks comment on whether any such State requirements exist that would be preempted by this rule, if adopted.
The express preemption provision described above is subject to a savings clause under which compliance with a motor vehicle safety standard prescribed under this chapter does not exempt a person from liability at common law. 49 U.S.C. 30103(e). Pursuant to this provision, State common law tort causes of action against motor vehicle manufacturers that might otherwise be preempted by the express preemption provision generally are preserved.
NHTSA rules can also preempt State law if complying with the FMVSS would render the motor vehicle manufacturers liable under State tort law. Because most NHTSA standards established by an FMVSS are minimum standards, a State common law tort cause of action that seeks to impose a higher standard on motor vehicle manufacturers generally will not be preempted. If and when such a conflict does exist—for example, when the standard at issue is both a minimum and a maximum standard—the State common law tort cause of action is impliedly preempted. See
Pursuant to Executive Orders 13132 and 12988, NHTSA has considered whether this proposed rule would preempt State common law causes of action. The agency's ability to announce its conclusion regarding the preemptive effect of one of its rules reduces the likelihood that preemption will be an issue in any subsequent tort litigation. This rule addresses the application to vehicles without manually operated driving controls of requirements that a hand- or foot-operated service brake pedal be installed on the vehicle for operation by a human driver. As the requirement to meet stopping distance is not changed by this rule, NHTSA believes this change will have no effect on safety. Thus, NHTSA tentatively concludes that no conflict with State common law causes of action would occur. Without any conflict, there could not be any implied preemption of a State common law tort cause of action. NHTSA also seeks comment on this tentative conclusion.
With respect to the review of the promulgation of a new regulation, section 3(b) of Executive Order 12988, “Civil Justice Reform” (61 FR 4729; Feb. 7, 1996), requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) specifies whether administrative proceedings are to be required before parties file suit in court; (6) adequately defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement.
Pursuant to this Order, NHTSA notes as follows. The issue of preemption is discussed above. NHTSA notes further that there is no requirement that individuals submit a petition for reconsideration or pursue other administrative proceedings before they may file suit in court.
Please note that anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, as amended by Public Law 107-107 (15 U.S.C. 272), directs the agency to evaluate and use voluntary consensus standards in its regulatory activities unless doing so would be inconsistent with applicable law or is otherwise impractical. Voluntary consensus standards are technical standards (
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually (adjusted for inflation with base year of 1995). This NPRM would not result in a cost of $100 million or more when adjusted for inflation to either State, local, or tribal governments, in the aggregate, or the private sector. Thus, this NPRM is not subject to the requirements of sections 202 of the UMRA.
The policy statement in section 1 of Executive Order 13609 provides, in part: The regulatory approaches taken by foreign governments may differ from those taken by U.S. regulatory agencies to address similar issues. In some cases, the differences between the regulatory approaches of U.S. agencies and those of their foreign counterparts might not be necessary and might impair the ability of American businesses to export and compete internationally. In meeting shared challenges involving health, safety, labor, security, environmental, and other issues, international regulatory cooperation can identify approaches that are at least as protective as those that are or would be adopted in the absence of such cooperation. International regulatory cooperation can also reduce, eliminate, or prevent unnecessary differences in regulatory requirements.
The issue of severability of FMVSSs is addressed in 49 CFR 571.9. It provides that if any FMVSS or its application to any person or circumstance is held invalid, the remainder of the part and the application of that standard to other persons or circumstances is unaffected. Comments are requested on the severability of this proposed FMVSS.
The Department of Transportation assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.
As required by 5 U.S.C. 553(b)(4), a summary of this rule can be found in the Abstract section of the Department's Unified Agenda entry for this rulemaking at
Please see
• Your comments must be written in English.
• To ensure that your comments are correctly filed in the Docket, please include the Docket Number shown at the beginning of this document in your comments.
• Your comments must not be more than 15 pages long. (49 CFR 553.21). We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.
• If you are submitting comments electronically as a PDF (Adobe) File, NHTSA asks that the documents be submitted using the Optical Character Recognition (OCR) process, thus allowing NHTSA to search and copy certain portions of your submissions. Comments may be submitted to the docket electronically by logging onto the Docket Management System website at
• You may also submit two copies of your comments, including the attachments, to Docket Management at the address given above under
Please note that pursuant to the Data Quality Act, in order for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at
If you wish Docket Management to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, Docket Management will return the postcard by mail.
You should submit a redacted “public version” of your comment (including redacted versions of any additional documents or attachments) to the docket using any of the methods identified under
You also need to submit a request for confidential treatment directly to the Office of the Chief Counsel. Requests for confidential treatment are governed by 49 CFR part 512. Your request must set forth the information specified in part 512. This includes the materials for which confidentiality is being requested (as explained in more detail below); supporting information, pursuant to part 512.8; and a certificate, pursuant to part 512.4(b) and part 512, Appendix A.
You are required to submit to the Office of the Chief Counsel one unredacted “confidential version” of the information for which you are seeking confidential treatment. Pursuant to part 512.6, the words “ENTIRE PAGE CONFIDENTIAL BUSINESS INFORMATION” or “CONFIDENTIAL BUSINESS INFORMATION CONTAINED WITHIN BRACKETS” (as applicable) must appear at the top of each page containing information claimed to be confidential. In the latter situation, where not all information on the page is claimed to be confidential, identify each item of information for which confidentiality is requested within brackets: “[ ].”
You are also required to submit to the Office of the Chief Counsel one redacted “public version” of the information for which you are seeking confidential treatment. Pursuant to part 512.5(a)(2), the redacted “public version” should include redactions of any information for which you are seeking confidential treatment (
NHTSA is currently treating electronic submission as an acceptable method for submitting confidential business information to the agency under part 512. Please do not send a hardcopy of a request for confidential treatment to NHTSA's headquarters. The request should be sent to Dan Rabinovitz in NHTSA's Office of the Chief Counsel (NCC) at
We will consider all comments that Docket Management receives before the close of business on the comment closing date indicated above under
You may read the comments received by Docket Management at the address given above under
Please note that, even after the comment closing date, we will continue to file relevant information in the Docket as it becomes available. Further, some people may submit late comments. Accordingly, we recommend that you periodically check the Docket for new material.
Motor vehicle safety, Motor vehicles.
In consideration of the foregoing, NHTSA proposes to amend 49 CFR part 571 as set forth below.
49 U.S.C. 322, 30111, 30115, 30117, and 30166; delegation of authority at 49 CFR 1.95 and 501.8.
S1.
S2.
S3.
S4.
(1) Sensing the rate of angular rotation of the wheels;
(2) Transmitting signals regarding the rate of wheel angular rotation to one or more controlling devices which interpret those signals and generate responsive controlling output signals; and
(3) Transmitting those controlling signals to one or more modulator devices which adjust brake actuating forces in response to those signals.
S5.
S5.1.
S5.1.1.
S5.1.2.
(a) Acoustic or optical devices warning the driver at his or her driving position when lining replacement is necessary, or
(b) A means of visually checking the degree of brake lining wear, from the outside or underside of the vehicle, utilizing only the tools or equipment normally supplied with the vehicle. The removal of wheels is permitted for this purpose.
S5.1.3.
(a) For an EV equipped with RBS and a service brake pedal, the RBS is considered to be part of the service brake system if it is automatically activated by an application of the service brake pedal, if there is no means provided for the driver to disconnect or otherwise deactivate it, and if it is activated in all transmission positions, including neutral.
(b) For an EV equipped with RBS and without manually operated driving controls, the RBS is considered to be part of the service brake system.
(c) For an EV that is equipped with both ABS and RBS that is part of the service brake system, the ABS must control the RBS.
S5.2.
S5.3.
S5.3.1.
(a) The parking brake must be controlled independently of the service brakes.
(b) For vehicles with manually operated driving controls, the service brakes must be activated by means of a foot pedal, and the parking brake must be operable by either a hand or foot control.
(c) For vehicles without manually operated driving controls, the service brake control and parking brake control must be activated by on-board systems.
S5.3.2. A control to disable the ABS, either fully or partially, is prohibited.
S5.4.
S5.4.1.
S5.4.2.
S5.4.3.
(a) Permanently affixed, engraved or embossed;
(b) Located so as to be visible by direct view, either on or within 100 mm (3.94 inches) of the brake fluid reservoir filler plug or cap; and
(c) Of a color that contrasts with its background, if it is not engraved or embossed.
S5.4.4.
S5.5.
S5.5.1.
(a) A gross loss of fluid or fluid pressure (such as caused by rupture of a brake line but not by a structural failure of a housing that is common to two or more subsystems) as indicated by one of the following conditions (chosen at the option of the manufacturer):
(1) A drop in the level of the brake fluid in any master cylinder reservoir compartment to less than the recommended safe level specified by the manufacturer or to one-fourth of the fluid capacity of that reservoir compartment, whichever is greater.
(2) For vehicles equipped with a split service brake system, a differential pressure of 1.5 MPa (218 psi) between the intact and failed brake subsystems measured at a master cylinder outlet or a slave cylinder outlet.
(3) A drop in the supply pressure in a brake power unit to one-half of the normal system pressure.
(b) Any electrical functional failure in an antilock or variable brake proportioning system.
(c) Application of the parking brake, except in vehicles without manually operated driving controls.
(d) Brake lining wear-out, if the manufacturer has elected to use an electrical device to provide an optical warning to meet the requirements of S5.1.2(a).
(e) For a vehicle with electrically-actuated service brakes, failure of the source of electric power to those brakes, or diminution of state of charge of the batteries to less than a level specified by the manufacturer for the purpose of warning a driver of degraded brake performance.
(f) For a vehicle with electric transmission of the service brake control signal, failure of a brake control circuit.
(g) For an EV with a regenerative braking system that is part of the service brake system, failure of the RBS.
S5.5.2.
(a) All telltales must be activated as a check function by either:
(1) Automatic activation when the vehicle power (ignition or start) switch is transitioned to the “on” (“run”) state when the engine is not running, or when the vehicle power (ignition or start) switch is in a state between “on” (“run”) and “start” that is designated by the manufacturer as a check state, or
(2) A single manual action by the driver, such as momentary activation of a test button or switch mounted on the instrument panel in front of and in clear view of the driver, or, in the case of a telltale for application of the parking brake, by applying the parking brake when the vehicle power (ignition or start) switch is in the “on” (“run”) state.
(b) In the case of a vehicle that has an interlock device that prevents the engine from being started under one or more conditions, check functions meeting the requirements of S5.5.2(a) need not be operational under any condition in which the engine cannot be started.
(c) The manufacturer must explain the brake check function test procedure in the owner's manual.
S5.5.3.
S5.5.4.
S5.5.5.
(a) Each telltale must display a word or words in accordance with the requirements of Standard No. 101 (49 CFR 571.101) and this section, which must be legible to the driver under all daytime and nighttime conditions when activated. Unless otherwise specified, the words must have letters not less than 3.2 mm (
(b) Vehicles manufactured with a split service brake system may use a common brake warning telltale to indicate two or more of the functions described in S5.5.1(a) through S5.5.1(g). If a common telltale is used, it must display the word “Brake.”
(c) A vehicle manufactured without a split service brake system must use a separate telltale to indicate the failure condition in S5.5.1(a). This telltale must display the words “STOP—BRAKE FAILURE” in block capital letters not less than 6.4 mm (14 inch) in height.
(d) If separate telltales are used for one or more of the conditions described in S5.5.1(a) through S5.5.1(g), the telltales must display the following wording:
(1) If a separate telltale is provided for the low brake fluid condition in S5.5.1(a)(1), the words “Brake Fluid” must be used except for vehicles using hydraulic system mineral oil.
(2) If a separate telltale is provided for the gross loss of pressure condition in S5.5.1(a)(2), the words “Brake Pressure” must be used.
(3) If a separate telltale is provided for the condition specified in S5.5.1(b), the letters and background must be of contrasting colors, one of which is yellow. The telltale must be labeled with the words “Antilock” or “Anti-lock” or “ABS”; or “Brake Proportioning,” in accordance with Table 1 of Standard No. 101.
(4) If a separate telltale is provided for application of the parking brake as specified for S5.5.1(c), the single word “Park” or the words “Parking Brake” may be used.
(5) If a separate telltale is provided to indicate brake lining wear-out as specified in S5.5.1(d), the words “Brake Wear” must be used.
(6) If a separate telltale is provided for the condition specified in S5.5.1(g), the letters and background must be of contrasting colors, one of which is yellow. The telltale must be labeled with the symbol “RBS.” RBS failure in a system that is part of the service brake system may also be indicated by a yellow lamp that also indicates “ABS” failure and displays the symbol “ABS/RBS.”
(7) If a separate telltale is provided for any other function, the display must include the word “Brake” and the appropriate additional labeling.
S5.6.
(a) Detachment or fracture of any component of the braking system, such as brake springs and brake shoes or disc pad facings other than minor cracks that do not impair attachment of the friction facings. All mechanical components of the braking system must be intact and functional. Friction facing tearout (complete detachment of lining) must not exceed 10 percent of the lining on any single frictional element.
(b) Any visible brake fluid or lubricant on the friction surface of the brake, or leakage at the master cylinder or brake power unit reservoir cover, seal, and filler openings.
S6.
S6.1.
S6.1.1.
S6.1.2.
S6.2.
S6.2.1.
S6.2.2.
S6.2.3.
S6.3.
S6.3.1.
S6.3.1.1. For the tests at GVWR, the vehicle is loaded to its GVWR such that the weight on each axle as measured at the tire-ground interface is in proportion to its gross axle weight rating, with the fuel tank filled to 100 percent of capacity. However, if the weight on any axle of a vehicle at LLVW exceeds the axle's proportional share of the GVWR, the load required to reach GVWR is placed so that the weight on that axle remains the same as at LLVW.
S6.3.1.2. For the test at LLVW, the vehicle is loaded to its LLVW such that the added weight is distributed in the front passenger seat area.
S6.3.2.
S6.3.3.
S6.3.4.
S6.3.5.
S6.3.7.
S6.3.8.
S6.3.9.
S6.3.10.
S6.3.11.
S6.3.11.1. The state of charge of the propulsion batteries is determined in accordance with SAE Recommended Practice J227a (1976) (incorporated by reference, see § 571.5). The applicable sections of J227a (1976) are 3.2.1 through 3.2.4, 3.3.1 through 3.3.2.2, 3.4.1 and 3.4.2, 4.2.1, 5.2, 5.2.1 and 5.3.
S6.3.11.2. At the beginning of the burnish procedure (S7.1 of this standard) in the test sequence, each propulsion battery is at the maximum state of charge recommended by the manufacturer, as stated in the vehicle operator's manual or on a label that is permanently attached to the vehicle, of, if the manufacturer has made no recommendation, not less than 95 percent. During the 200-stop burnish procedure, the propulsion batteries are restored to the maximum state of charge determined as above, after each increment of 40 burnish stops until the burnish procedure is complete. The batteries may be charged at a more frequent interval during a particular 40-stop increment only if the EV is incapable of achieving the initial burnish test speed during that increment. During the burnish procedure, the propulsion batteries may be charged by external means or replaced by batteries that are at a state of charge of not less than 95 percent. For an EV having a manual control for setting the level of regenerative braking, the manual control, at the beginning of the burnish procedure, is set to provide maximum regenerative braking throughout the burnish.
S6.3.11.3. At the beginning of each performance test in the test sequence (S7.2 through S7.17 of this standard), unless otherwise specified, an EV's propulsion batteries are at the state of charge recommended by the manufacturer, as stated in the vehicle operator's manual or on a label that is permanently attached to the vehicle, or, if the manufacturer has made no recommendation, at a state of charge of not less than 95 percent. No further charging of any propulsion battery occurs during any of the performance tests in the test sequence of this standard. If the propulsion batteries are depleted during a test sequence such that the vehicle reaches automatic shut-down, will not accelerate, or the low state of charge brake warning lamp is illuminated, the vehicle is to be accelerated to brake test speed by auxiliary means. If a battery is replaced rather than recharged, the replacement battery is charged and measured for state of charge in accordance with these procedures.
S6.3.12.
(a) For an EV equipped with electrically-actuated service brakes deriving power from the propulsion batteries and with automatic shut-down capability of the propulsion motor(s), the propulsion batteries are at not more than five percent above the EV actual automatic shut-down critical value. The critical value is determined by measuring the state-of-charge of each propulsion battery at the instant that automatic shut-down occurs.
(b) For an EV equipped with electrically-actuated service brakes deriving power from the propulsion
(c) For a vehicle which has one or more auxiliary batteries that provides electrical energy to operate the electrically-actuated service brakes, each auxiliary battery is at not more than five percent above the actual state of charge at which the brake failure warning signal, required by S5.5.1(e) of this standard, is illuminated.
S6.3.13.
S6.3.13.1.
(a) For an EV equipped with an RBS that is part of the service brake system, the RBS is operational during the burnish and all tests, except for the test of a failed RBS.
(b) For an EV equipped with an RBS that is not part of the service brake system, the RBS is operational and set to produce the maximum regenerative braking effect during the burnish, and is disabled during the test procedures. If the vehicle is equipped with a neutral gear that automatically disables the RBS, the test procedures which are designated to be conducted in gear may be conducted in neutral.
S6.3.13.2. For tests conducted “in neutral,” the test operator of an EV with no “neutral” position (or other means such as a clutch for disconnecting the drive train from the propulsion motor(s)) does not apply any electromotive force to the propulsion motor(s). Any electromotive force that is applied to the propulsion motor(s) automatically remains in effect unless otherwise specified by the test procedure.
S6.4.
S6.5.
S6.5.1.
S6.5.2.
S6.5.3.
S6.5.3.1. The braking performance of a vehicle is determined by measuring
S6.5.3.2. Unless otherwise specified, the vehicle is stopped in the shortest distance achievable (best effort) on all stops. Where more than one stop is specified for a given set of test conditions, a vehicle is deemed to comply with the corresponding stopping distance requirements if at least one of the stops is made within the prescribed distance.
S6.5.3.3. In the stopping distance formulas given for each applicable test (such as S≤0.10V + 0.0060V
S6.5.4.
S6.5.4.1. The vehicle is aligned in the center of the lane at the start of each brake application. Steering corrections are permitted during each stop.
S6.5.4.2. Stops are made without any part of the vehicle leaving the lane and without rotation of the vehicle about its vertical axis of more than ±15° from the center line of the test lane at any time during any stop.
S6.5.5.
S6.5.5.1. For tests in neutral, a stop or snub is made in accordance with the following procedures:
(a) Exceed the test speed by 6 to 12 km/h (3.7 to 7.5 mph);
(b) Close the throttle and coast in gear to approximately 3 km/h (1.9 mph) above the test speed;
(c) Shift to, or select, neutral; and
(d) When the test speed is reached, apply the brakes.
S6.5.5.2. For tests in gear, a stop or snub is made in accordance with the following procedures:
(a) With the transmission selector in the control position recommended by the manufacturer for driving on a level surface at the applicable test speed, exceed the test speed by 6 to 12 km/h (3.7 to 7.5 mph);
(b) Close the throttle and coast in gear; and
(c) When the test speed is reached apply the brakes.
(d) To avoid engine stall, a manual transmission may be shifted to neutral (or the clutch disengaged) when the vehicle speed is below 30 km/h (18.6 mph).
S6.5.6.
S7.
S7.1.
S7.1.1.
S7.1.2.
(a) Vehicle load: GVWR only.
(b) Transmission position: In gear.
S7.1.3.
(a) IBT: ≤100 °C (212 °F).
(b) Test speed: 80 km/h (49.7 mph).
(c) Service brake control: Adjust service brake control as necessary to maintain specified constant deceleration rate.
(d) Deceleration rate: Maintain a constant deceleration rate of 3.0 m/s
(e) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(f) Number of runs: 200 stops.
(g) Interval between runs: The interval from the start of one service brake application to the start of the next is either the time necessary to reduce the IBT to 100 °C (212 °F) or less, or the distance of 2 km (1.24 miles), whichever occurs first.
(h) Accelerate to 80 km/h (49.7 mph) after each stop and maintain that speed until making the next stop.
(i) After burnishing, adjust the brakes as specified in S6.3.4.
S7.2. [Reserved]
S7.3. [Reserved]
S7.4. [Reserved]
S7.5.
S7.5.1.
(a) Vehicle load: GVWR and LLVW.
(b) Transmission position: In neutral.
S7.5.2.
(a) IBT: Between 65 °C (149 °F) and 100 °C (212 °F).
(b) Test speed: 100 km/h (62.1 mph).
(c) Service brake control: For vehicles with a service brake pedal, the applied pedal force is between 65 N (14.6 lbs) and 500 N (112.4 lbs). For vehicles without manually operated driving controls, the service brake control is activated in accordance with manufacturer specifications.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Number of runs: 6 stops.
(f) Test surface: PFC of 1.02.
(g) For each stop, bring the vehicle to test speed and then stop the vehicle under the specified conditions.
S7.5.3.
(a) Stopping distance for 100 km/h test speed: ≤70m (230 ft).
(b) Stopping distance for reduced test speed: S≤0.10V + 0.0060V
S7.6.
S7.6.1.
(a) Vehicle load: GVWR and LLVW.
(b) Transmission position: In gear.
S7.6.2.
(a) IBT: Between 65 °C (149 °F) and 100 °C (212 °F).
(b) Test speed: The test speed is 160 km/h (99.4 mph) or 80 percent of Vmax, whichever is slower.
(c) Service brake control: For vehicles with a service brake pedal, the applied pedal force is between 65 N (14.6 lbs) and 500 N (112.4 lbs). For vehicles without manually operated driving controls, the service brake control is activated in accordance with manufacturer specifications.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Number of runs: 6 stops.
(f) Test surface: PFC of 1.02.
S7.6.3.
Stopping distance: S≤0.10V + 0.0067V
S7.7.
S7.7.1.
S7.7.2.
(a) Vehicle load: GVWR only.
(b) Transmission position: In neutral.
(c) Vehicle engine: Off (not running).
(d) Vehicle power switch: May be returned to the “on” state after turning the engine off, or a device may be used to “kill” the engine while leaving the power switch in the “on” state.
(e) For an EV, this test is conducted with no electrical power supplied to the vehicle's propulsion motor(s), but with the RBS and brake power or power assist still operating, unless cutting off the supply of electrical power to the propulsion motor(s) also disables those systems.
S7.7.3.
(a) IBT: Between 65 °C (149 °F) and 100 °C (212 °F).
(b) Test speed: 100 km/h (62.1 mph).
(c) Service brake control: For vehicles with a service brake pedal, the applied pedal force is between 65 N (14.6 lbs) and 500 N (112.4 lbs). For vehicles without manually operated driving controls, the service brake control is activated in accordance with manufacturer specifications.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Number of runs: 6 stops.
(f) Test surface: PFC of 1.02.
(g) All system reservoirs (brake power and/or assist units) are fully charged and the vehicle's engine is off (not running) at the beginning of each stop.
S7.7.4.
(a) Stopping distance for 100 km/h test speed: ≤70m (230 ft.)
(b) Stopping distance for reduced test speed: S ≤0.10V + 0.0060V
S7.8.
S7.8.1.
(a) Vehicle loading: LLVW and GVWR.
(b) Transmission position: In neutral.
S7.8.2.
(a) IBT: Between 65 °C (149 °F) and 100 °C (212 °F).
(b) Test speed: 100 km/h (62.1 mph).
(c) Service brake control: For vehicles with a service brake pedal, the applied pedal force is between 65 N (14.6 lbs) and 500 N (112.4 lbs). For vehicles without manually operated driving controls, the service brake control is activated in accordance with manufacturer specifications.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Number of runs: 6 stops.
(f) Test surface: PFC of 1.02.
(g) Functional failure simulation:
(1) Disconnect the functional power source, or any other electrical connector that creates a functional failure when disconnected.
(2) Determine whether the brake system telltale is activated when any electrical functional failure of the antilock system is created.
(3) Restore the system to normal at the completion of this test.
(h) If more than one antilock brake subsystem is provided, repeat test for each subsystem.
S7.8.3.
(a) Stopping distance for 100 km/h test speed: ≤85 m (279 ft).
(b) Stopping distance for reduced test speed: S ≤0.10V + 0.0075V
S7.9.
S7.9.1.
(a) Vehicle load: LLVW and GVWR.
(b) Transmission position: In neutral.
S7.9.2.
(a) IBT: Between 65 °C (149 °F) and 100 °C (212 °F).
(b) Test speed: 100 km/h (62.1 mph).
(c) Service brake control: For vehicles with a service brake pedal, the applied pedal force is between 65 N (14.6 lbs) and 500 N (112.4 lbs). For vehicles without manually operated driving controls, the service brake control is activated in accordance with manufacturer specifications.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Number of runs: 6 stops.
(f) Test surface: PFC of 1.02.
(g) Functional failure simulation:
(1) Disconnect the functional power source or mechanical linkage to render the variable brake proportioning system inoperative.
(2) If the system utilizes electrical components, determine whether the brake system telltale is activated when any electrical functional failure of the variable proportioning system is created.
(3) Restore the system to normal at the completion of this test.
(h) If more than one variable brake proportioning subsystem is provided, repeat the test for each subsystem.
S7.9.3.
(a) Stopping distance for 100 km/h test speed: ≤110 m (361 ft).
(b) Stopping distance for reduced test speed: S ≤0.10V + 0.0100V
S7.10.
S7.10.1.
S7.10.2.
(a) Vehicle load: LLVW and GVWR.
(b) Transmission position: In neutral.
S7.10.3.
(a) IBT: Between 65 °C (149 °F) and 100 °C (212 °F).
(b) Test speed: 100 km/h (62.1 mph).
(c) Service brake control: For vehicles with a service brake pedal, the applied pedal force is between 65 N (14.6 lbs) and 500 N (112.4 lbs). For vehicles without manually operated driving controls, the service brake control is activated in accordance with manufacturer specifications.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Test surface: PFC of 1.02.
(f) Alter the service brake system to produce any single failure. For a hydraulic circuit, this may be any single rupture or leakage type failure, other than a structural failure of a housing that is common to two or more subsystems. For a vehicle in which the brake signal is transmitted electrically between the brake pedal and some or all of the foundation brakes, regardless of the means of actuation of the foundation brakes, this may be any single failure in any circuit that electrically transmits the brake signal. For an EV with RBS that is part of the service brake system, this may be any single failure in the RBS.
(g) Verify the brake warning telltale has been activated. For a hydraulic circuit failure, record the brake fluid level, differential pressure, or supply pressure drop necessary to activate the brake warning telltale.
(h) Number of runs: After the brake warning telltale has been activated, make the following stops depending on the type of brake system:
(1) 4 stops for a split service brake system.
(2) 10 consecutive stops for a non-split service brake system.
(i) For vehicles with a service brake pedal, each stop is made by a continuous application of the service brake control.
(j) Restore the service brake system to normal at the completion of this test.
(k) Repeat the entire sequence for each of the other subsystems.
S7.10.4.
(a) Stopping distance from 100 km/h test speed: ≤168 m (551 ft).
(b) Stopping distance for reduced test speed: S ≤0.10V + 0.0158V
S7.11.
S7.11.1.
S7.11.2.
(a) Vehicle load: GVWR only.
(b) Transmission position: In neutral.
S7.11.3.
(a) IBT: Between 65 °C (149 °F) and 100 °C (212 °F).
(b) Test speed: 100 km/h (62.1 mph).
(c) Service brake control: For vehicles with a service brake pedal, the applied pedal force is between 65 N (14.6 lbs) and 500 N (112.4 lbs). For vehicles without manually operated driving controls, the service brake control is activated in accordance with manufacturer specifications.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Number of runs: 6 stops.
(f) Test surface: PFC of 1.02.
(g) Disconnect the primary source of power for one brake power assist unit or brake power unit, or one of the brake power unit or brake power assist unit subsystems if two or more subsystems are provided.
(h) If the brake power unit or power assist unit operates in conjunction with a backup system and the backup system is automatically activated in the event of a primary power service failure, the backup system is operative during this test.
(i) Exhaust any residual brake power reserve capability of the disconnected system.
(j) Make each of the 6 stops. For vehicles equipped with a service brake pedal, stop the vehicle with a continuous application of the service brake control.
(k) Restore the system to normal at completion of this test.
(l) For vehicles equipped with more than one brake power unit or brake power assist unit, conduct tests for each in turn.
(m) For vehicles with electrically-actuated service brakes (brake power unit), this test is conducted with any single electrical failure in the electrically-actuated service brakes instead of a failure of any other brake power or brake power assist unit, and all other systems intact.
S7.11.4.
(a) Stopping distance from 100 km/h test speed: ≤168 m (551 ft).
(b) Stopping distance for reduced test speed: S ≤0.10V + 0.0158V
S7.12.
S7.12.1.
(a) Vehicle load: GVWR only.
(b) Transmission position: In neutral.
(c) Parking brake burnish:
(1) For vehicles with parking brake systems not utilizing the service friction elements, the friction elements of such a system are burnished prior to the parking brake test according to the published recommendations furnished to the purchaser by the manufacturer.
(2) If no recommendations are furnished, the vehicle's parking brake system is tested in an unburnished condition.
(d) Parking brake applications: 1 application and up to 2 reapplications, if necessary.
S7.12.2.
(a) IBT:
(1) Parking brake systems utilizing service brake friction materials are tested with the IBT ≤100 °C (212 °F) and have no additional burnishing or artificial heating prior to the start of the parking brake test.
(2) Parking brake systems utilizing non-service brake friction materials are tested with the friction materials at ambient temperature at the start of the test. The friction materials have no additional burnishing or artificial heating prior to or during the parking brake test.
(b) Parking brake control force for vehicles equipped with a hand- or foot-operated parking brake control: Hand control ≤400 N (89.9 lbs); foot control ≤500 N (112.4 lbs).
(c) Hand force measurement locations: The force required for actuation of a hand-operated brake system is measured at the center of the hand grip area or at a distance of 40 mm (1.57 in) from the end of the actuation lever as illustrated in Figure 3.
(d) Parking brake applications: 1 application and up to 2 reapplications, if necessary.
(e) Test surface gradient: 20 percent grade.
(f) Drive the vehicle onto the grade with the longitudinal axis of the vehicle in the direction of the slope of the grade.
(g) Stop the vehicle and hold it stationary by applying the service brake and place the transmission in neutral.
(h) With the service brake applied sufficiently to just keep the vehicle from rolling, apply the parking brake as specified in S7.12.2(i) or S7.12.2(j).
(i) For a vehicle equipped with mechanically-applied parking brakes, make a single application of the parking brake control with a force not exceeding the limits specified in S7.12.2(b). For a vehicle using an electrically-activated parking brake, apply the parking brake by activating the parking brake control.
(j) In the case of a parking brake system that does not allow application of the specified force in a single application, a series of applications may be made to achieve the specified force.
(k) Following the application of the parking brakes, release all force on the service brake control and, if the vehicle remains stationary, start the measurement of time.
(l) If the vehicle does not remain stationary, reapplication of a force to the parking brake control at the level specified in S7.12.2(b) as appropriate for the vehicle being tested (without release of the ratcheting or other holding mechanism of the parking brake) is used up to two times to attain a stationary position.
(m) Verify the operation of the parking brake application telltale.
(n) Following observation of the vehicle in a stationary condition for the specified time in one direction, repeat the same test procedure with the vehicle orientation in the opposite direction on the same grade.
S7.12.3.
S7.13.
S7.13.1.
S7.13.2.
(a) Vehicle load: GVWR only.
(b) Transmission position: In gear.
S7.13.3.
(a) IBT:
(1) Establish an IBT before the first brake application (snub) between 55 °C (131 °F) and 65 °C (149 °F).
(2) IBT before subsequent snubs are those occurring at the distance intervals.
(b) Number of snubs: 15.
(c) Test speeds: The initial speed for each snub is 120 km/h (74.6 mph) or 80 percent of Vmax, whichever is slower. Each snub is terminated at one-half the initial speed.
(d) Deceleration rate:
(1) Maintain a constant deceleration rate of 3.0 m/s
(2) Attain the specified deceleration within one second and maintain it for the remainder of the snub.
(e) Service brake control: Adjust as necessary to maintain specified constant deceleration rate.
(f) Time interval: Maintain an interval of 45 seconds between the start of brake applications (snubs).
(g) Accelerate as rapidly as possible to the initial test speed immediately after each snub.
(h) Immediately after the 15th snub, accelerate to 100 km/h (62.1 mph) and commence the hot performance test.
S7.14.
S7.14.1.
S7.14.2.
(a) Vehicle load: GVWR only.
(b) Transmission position: In neutral.
S7.14.3.
(a) IBT: Temperature achieved at completion of heating snubs.
(b) Test speed: 100 km/h (62.1 mph).
(c) Service brake control:
(1) For vehicles with a service brake pedal, the first stop is done with an average pedal force not greater than the average pedal force recorded during the shortest GVWR cold effectiveness stop. For vehicles without a service brake pedal, the first stop is done with an average control input not greater than the average control input recorded during the shortest GVWR cold effectiveness stop.
(2) For vehicles with a service brake pedal, the second stop is done with a pedal force not greater than 500 N (112.4 lbs). For vehicles without a service brake pedal, the manufacturer's recommended input is used for the second stop.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Number of runs: 2 stops.
(f) Immediately after the 15th heating snub, accelerate to 100 km/h (62.1 mph) and commence the first stop of the hot performance test.
(g) If the vehicle is incapable of attaining 100 km/h, it is tested at the same speed used for the GVWR cold effectiveness test.
(h) Immediately after completion of the first hot performance stop, accelerate as rapidly as possible to the specified test speed and conduct the second hot performance stop.
(i) Immediately after completion of the second hot performance stop, commence S7.15.
S7.14.4.
(a) For the first hot stop, the stopping distance must be less than or equal to a calculated distance which is based on 60 percent of the deceleration actually achieved on the shortest GVWR cold effectiveness stop. The following equations are used in calculating the performance requirement:
(b) In addition to the requirement in S7.14.4(a), the stopping distance for at least one of the two hot stops must be S ≤89 m (292 ft) from a test speed of 100 km/h (62.1 mph) or, for reduced test speed, S ≤0.10V + 0.0079V
S7.15.
S7.15.1.
S7.15.2.
(a) Vehicle load: GVWR only.
(b) Transmission position: In gear.
S7.15.3.
(a) IBT: Temperature achieved at completion of hot performance.
(b) Test speed: 50 km/h (31.1 mph).
(c) Service brake control: Adjust as necessary to maintain specified constant deceleration rate.
(d) Deceleration rate: Maintain a constant deceleration rate of 3.0 m/s
(e) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(f) Number of runs: 4 stops.
(g) Immediately after the hot performance stops drive 1.5 km (0.93 mi) at 50 km/h (31.1 mph) before the first cooling stop.
(h) For the first through the third cooling stops:
(1) After each stop, immediately accelerate at the maximum rate to 50 km/h (31.1 mph).
(2) Maintain that speed until beginning the next stop at a distance of 1.5 km (0.93 mi) from the beginning of the previous stop.
(i) For the fourth cooling stop:
(1) Immediately after the fourth stop, accelerate at the maximum rate to 100 km/h (62.1 mph).
(2) Maintain that speed until beginning the recovery performance stops at a distance of 1.5 km (0.93 mi) after the beginning of the fourth cooling stop.
S7.16.
S7.16.1.
S7.16.2.
(a) Vehicle load: GVWR only.
(b) Transmission position: In neutral.
S7.16.3.
(a) IBT: Temperature achieved at completion of cooling stops.
(b) Test speed: 100 km/h (62.1 mph).
(c) Service brake control: For vehicles equipped with a service brake pedal, the average pedal force is no greater than the average pedal force recorded during the shortest GVWR cold effectiveness stop. For vehicles without a service brake pedal, the average control input is no greater than the average control input recorded during the shortest GVWR cold effectiveness stop.
(d) Wheel lockup: No lockup of any wheel is allowed for longer than 0.1 seconds at speeds greater than 15 km/h (9.3 mph).
(e) Number of runs: 2 stops.
(f) Immediately after the fourth cooling stop, accelerate at the maximum rate to 100 km/h (62.1 mph).
(g) Maintain that speed until beginning the first recovery performance stop at a distance of 1.5 km (0.93 mi) after the beginning of the fourth cooling stop.
(h) If the vehicle is incapable of attaining 100 km/h, it is tested at the same speed used for the GVWR cold effectiveness test.
(i) Immediately after completion of the first recovery performance stop accelerate as rapidly as possible to the specified test speed and conduct the second recovery performance stop.
S7.16.4.
The stopping distance, S, for at least one of the two stops must be within the following limits:
where d
S7.17.
(a) The service brake system for detachment or fracture of any components, such as brake springs and brake shoes or disc pad facings.
(b) The friction surface of the brake, the master cylinder or brake power unit reservoir cover, and seal and filler openings, for leakage of brake fluid or lubricant.
(c) The master cylinder or brake power unit reservoir for compliance with the volume and labeling requirements of S5.4.2 and S5.4.3. In determining the fully applied worn condition, assume that the lining is worn to
(1) rivet or bolt heads on riveted or bolted linings or
(2) within 0.8 mm (1/32 inch) of shoe or pad mounting surface on bonded linings or
(3) the limit recommended by the manufacturer, whichever is larger relative to the total possible shoe or pad movement. Drums or rotors are assumed to be at nominal design drum diameter or rotor thickness. Linings are assumed adjusted for normal operating clearance in the released position.
(d) The brake system telltales, for compliance with operation in various key positions, lens color, labeling, and location, in accordance with S5.5.
Issued in Washington, DC, under authority delegated in 49 CFR 1.95 and 501.7.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM); response to petition for reconsideration.
NHTSA published a final rule on September 17, 2024 that amended the regulation on seat belt assembly anchorages. The final rule updated the test procedure for existing test devices and added an alternative test device as a compliance option. In response to the 2024 final rule, the agency received a petition for reconsideration from the Truck and Engine Manufacturers Association. After considering the petition, NHTSA is proposing to delay the compliance date from September 1, 2027 to September 1, 2030 for vehicles with a Gross Vehicle Weight Rating (GVWR) of greater than 4,536 kg.
Comments must be received by July 27, 2026.
You may submit comments to the docket number identified in the heading of this document by any of the following methods:
•
•
•
Regardless of how you submit your comments, please mention the docket number of this document.
For technical issues, you may contact Joshua McNeil, Office of Crashworthiness Standards (
In this notice of proposed rulemaking (NPRM), NHTSA responds to a petition for reconsideration of a final rule published September 17, 2024 that amended Federal Motor Vehicle Safety Standard (FMVSS) No. 210, “Seat Belt Assembly Anchorages.”
NHTSA received a petition for reconsideration from the Truck and Engine Manufacturers Association (EMA). NHTSA is proposing to grant the petition from EMA to extend the lead time from September 1, 2027 to September 1, 2030 for heavy vehicles (vehicles with a gross vehicle weight rating (GVWR) greater than 10,000 pounds) to apply the updated test procedures. NHTSA would continue to allow early compliance if the manufacturer chooses to certify to the updated test procedures.
FMVSS No. 210, “Seat belt assembly anchorages,” establishes requirements for seat belt anchorages, which are the part of the vehicle that transfers seat belt loads to the vehicle structure. The standard sets out requirements for seat belt anchorages, including performance requirements that ensure the anchorages are strong enough to remain attached to the vehicle structure in a crash. The standard applies to passenger cars, multipurpose passenger vehicles, trucks, and buses, irrespective of weight. The standard requires seat belt anchorages to withstand specified forces when tested according to the test procedures in S5. Prior to the 2024 final rule, the standard specified only that the test forces be applied to the seat belts by test devices referred to as “body blocks,” which essentially take the place of an occupant. The body blocks are placed on the seat, secured with the seat belt, and attached to a force actuator that applies the specified test forces. The standard has included the anchorage strength requirements and body blocks since its inception in 1967.
On September 17, 2024, NHTSA published a final rule that amended FMVSS No. 210 by modifying the test procedures for evaluating seat belt anchorage strength in passenger cars, multipurpose passenger vehicles, trucks, buses, and school buses. The changes added an optional Force Application Device (FAD), which simulates the human form, and refined the existing “body block” test method.
The 2024 final rule set a compliance date of September 1, 2027, at which time manufacturers would be required to certify to either the updated test procedure for the body blocks or the test procedure for the FAD(s), with optional early compliance permitted. NHTSA previously issued an NPRM,
In response to the 2024 final rule, the Truck and Engine Manufacturers Association (EMA) submitted a petition for reconsideration on November 1, 2024.
EMA is a trade association representing manufacturers of commercial motor vehicles that design and manufacture vehicles with a gross vehicle weight rating (GVWR) greater than 4,536 kg (10,000 pounds). EMA states that these heavy-duty vehicles are highly customized to perform a wide variety of commercial functions such as interstate trucking, regional freight shipping and intracity pickup and delivery.
EMA requested that NHTSA exclude vehicles with a GVWR over 4,536 kg (10,000 pounds) from the rule pending further research to ensure the rule is practicable for those vehicles. Alternatively, EMA requested that
EMA stated that the modified FMVSS No. 210 test procedures impose a significant compliance burden, which could require thousands of person-hours for engineering analyses, simulations, and physical re-certification across long-lifecycle heavy-duty platforms. Despite NHTSA's assertion that the updated zones will not affect test outcomes, EMA maintained that manufacturers must proactively validate designs against new potential loading scenarios at the zone perimeters. EMA noted that if performance issues emerge under the refined procedure, heavy vehicle manufacturers would be forced into costly redevelopment, as positioning body blocks at the zone perimeters may subject anchorages to unrealistic loads for which they were not originally designed.
EMA also raised concerns about the feasibility of the body block zones for heavy vehicles. EMA stated that deriving the zones from light-duty passenger vehicle data fails to account for the distinct seat, belt, and cab geometries unique to heavy vehicles. EMA argued that NHTSA's validation of the zones relied on light-duty passenger vehicles and that the school bus and motorcoach seats used by NHTSA in the validation are not sufficiently representative of the broad heavy vehicle category.
For the reasons explained below, NHTSA is proposing to grant EMA's alternative request that the compliance date for heavy-duty vehicles be extended to September 1, 2030.
Upon consideration of EMA's petition for reconsideration, NHTSA recognizes the potential for unforeseen challenges and re-evaluation costs for heavy-duty vehicle manufacturers. The heavy vehicles covered by FMVSS No. 210 rely on longer-lived platforms and smaller, more variable production runs than light passenger vehicles. Accordingly, to allow for validation across the wide variety of configurations of heavy vehicles, NHTSA is proposing to grant EMA's petition request to extend the lead time for heavy vehicles (those with a GVWR over 10,000 pounds) by three years to September 1, 2030, with optional early compliance permitted. A five-year lead time would better align with production cycles and allow manufacturers of heavy vehicles to plan the use of resources strategically such that serviceable heavy vehicles can remain in use.
NHTSA does not grant EMA's petition or propose to exclude vehicles with a GVWR over 10,000 pounds from the updated test procedures in FMVSS No. 210. FMVSS No. 210 has been effective in addressing a critical failure point. Even the best seat belt design would be useless if the anchorage points fail during a crash. By requiring the anchorages to withstand forces of 3,000 pounds at the torso and pelvic body block for Type 2 seat belts and 5,000 pounds for Type 1 seat belts, the standard ensures that seat belts remain attached. Strong anchorage requirements have enabled the development of more advanced restraint systems, including pretensioners and load limiters. Excluding heavy vehicles could result in a decrease in safety.
In the 2024 final rule, Figures 7 and 8 contained incorrect shoulder-to-shoulder and pelvis width dimensions for the FADs, despite being for illustration only. For FAD1 (Figure 7), NHTSA is proposing to correct the shoulder width to 457.22 mm (from 440.29 mm) and the pelvis width to 386.70 mm (from 369.70 mm). For FAD2 (Figure 8), NHTSA is proposing to correct the shoulder width to 299.34 mm (from 209.34 mm), while the pelvis width remains 249.35 mm. These corrections align the figures with the drawing packages incorporated by reference (IBR) in the 2024 final rule. This issue was brought to NHTSA's attention by a vehicle manufacturer, who sought to verify the dimensional accuracy of the FAD illustrations. These proposed amendments ensure the visual representations of FAD1 and FAD2 in FMVSS No. 210 match the dimensions in the referenced engineering drawings, clarifying the intended FAD dimensions.
NHTSA has considered the impact of this proposal under Executive Order (E.O.) 12866 and E.O. 14192. This NPRM is not considered to be significant under E.O. 12866 and was not reviewed by the Office of Information and Regulatory Affairs within the Office of Management and Budget. The proposed amendment to the compliance dates is an E.O. 14192 deregulatory action.
The proposed changes in compliance dates for heavy-duty vehicles would not result in additional costs; any additional costs associated with compliance would simply be delayed. In addition, there may be a cost savings associated with the proposed delay in compliance dates any costs associated with re-certification can be deferred. There is not enough information available to quantify any effects on the cost or benefits due to the delayed compliance dates, but NHTSA would expect any effects to be minimal, because the 2024 final rule simply clarified the existing test procedures and introduced an optional new test device; it was not intended to make any substantive changes to the standard.
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) (as amended by the Small Business Regulatory Enforcement Fairness Act (SBREFA) of 1996; 5 U.S.C. 601
The proposed delay in the compliance date would reduce the burden on small entities by providing more time to comply with the new requirements. Manufacturers producing vehicles that weigh greater than 10,000 pounds would have until September 1, 2030 to prepare their vehicles for testing with the updated procedures. For these reasons, I certify that this rulemaking action would not have a significant economic impact on a substantial number of small entities.
NHTSA has examined this rule pursuant to E.O. 13132 (64 FR 43255, Aug. 10, 1999) and concluded that no additional consultation with States, local governments, or their representatives is mandated beyond the rulemaking process. The agency has concluded that this rule, does not have sufficient federalism implications to warrant consultation with State and local officials or the preparation of a federalism summary impact statement.
NHTSA rules can have a preemptive effect in two ways. First, the National Traffic and Motor Vehicle Safety Act contains an express preemption provision: When a motor vehicle safety standard is in effect under this chapter, a State or a political subdivision of a State may prescribe or continue in effect a standard applicable to the same aspect of performance of a motor vehicle or motor vehicle equipment only if the standard is identical to the standard prescribed under this chapter. 49 U.S.C. 30103(b)(1). It is this statutory command by Congress that preempts any non-identical State legislative and administrative law addressing the same aspect of performance. The express preemption provision described above is subject to a savings clause under which compliance with a motor vehicle safety standard prescribed under this chapter does not exempt a person from liability at common law. 49 U.S.C. 30103(e). Pursuant to this provision, State common law tort causes of action against motor vehicle manufacturers that might otherwise be preempted by the express preemption provision are generally preserved.
NHTSA rules can also preempt State law if complying with the FMVSS would render the motor vehicle manufacturers liable under State tort law. Because most NHTSA standards established by an FMVSS are minimum standards, a State common law tort cause of action that seeks to impose a higher standard on motor vehicle manufacturers will generally not be preempted. If and when such a conflict does exist—for example, when the standard at issue is both a minimum and a maximum standard—the State common law tort cause of action is impliedly preempted.
Pursuant to E.O. 13132 and E.O. 12988, NHTSA has considered whether this rule preempts State common law causes of action. The agency's ability to announce its conclusion regarding the preemptive effect of one of its rules reduces the likelihood that preemption will be an issue in any subsequent tort litigation. To this end, the agency has examined the nature (
With respect to the review of the promulgation of a new regulation, section 3(b) of E.O. 12988, “Civil Justice Reform” (61 FR 4729, Feb. 7, 1996), requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) clearly specifies the preemptive effect; (2) clearly specifies the effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct, while promoting simplification and burden reduction; (4) clearly specifies the retroactive effect, if any; (5) specifies whether administrative proceedings are to be required before parties file suit in court; (6) adequately defines key terms; and (7) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. This document is consistent with that requirement.
NHTSA has reviewed this rulemaking action and determined that it conforms to the applicable standards in section 3(b)(2) of E.O. 12988, Civil Justice Reform. The issue of preemption is discussed above in connection with E.O. 13132 (Federalism). NHTSA believes that this proposed rule specifies clearly the changes to FMVSS No. 210, defines any necessary key terms, and provides a clear legal standard for manufacturers to follow. The amendments do not take effect retroactively. NHTSA notes further that there is no requirement that an individual submit a petition for reconsideration or pursue other administrative proceedings before they may file suit in court.
The policy statement in section 1 of E.O. 13609, “Promoting International Regulatory Cooperation,” provides that the regulatory approaches taken by foreign governments may differ from those taken by the United States to address similar issues, and that in some cases the differences between them might not be necessary and might impair the ability of American businesses to export and compete internationally. It further recognizes that in meeting shared challenges involving health, safety, and other issues, international regulatory cooperation can identify approaches that are at least as protective as those that are or would be adopted in the absence of such cooperation and can reduce, eliminate, or prevent unnecessary differences in regulatory requirements.
The September 2024 final rule differs from comparable foreign regulations for the reasons described in the preamble to the September 2024 final rule. Specifically, these differences are necessary to ensure the standard is enforceable in the U.S. and to give manufacturers additional compliance options. Because the changes in this final rule are extending the compliance date for some vehicles and not changing the requirements for seat belt assembly anchorages, they do not implicate any issues regarding international regulatory cooperation.
The Department has analyzed the environmental impacts of this notice of proposed rulemaking pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
Under the Paperwork Reduction Act of 1995, a person is not required to respond to a collection of information by a Federal agency unless the collection displays a valid control number from the Office of Management and Budget (OMB). The proposed rule does not have any requirements that are considered to be information collection requirements as defined by the OMB in 5 CFR part 1320.
Under the National Technology Transfer and Advancement Act of 1995 (NTTAA), “all Federal agencies and departments shall use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities determined by the agencies and departments.” However, if the use of such technical standards would be “inconsistent with applicable law or otherwise impractical, a Federal agency or department may elect to use technical standards that are not developed or adopted by voluntary consensus standards bodies.” Voluntary consensus standards are technical standards (
The agency identified an SAE standard (J384, Rev. 2014) that has testing recommendations for seat belt anchorages. The standard recommends the use of body blocks, similar to those currently specified in FMVSS No. 210, for applying the required test loads. SAE J384 specifies test procedures for seat belt anchorages. It is nearly identical to FMVSS No. 210, with similar body block specifications (the torso body block has the same dimensions, but also includes a pull arm), test loads, and the option to replace the seat belt webbing with other material. The standard specifies a preload of 10 percent. The body blocks are positioned at each DSP and the seat belts are positioned around the blocks “to represent design intent routing.”
The SAE standard does not specify a zone for body block placement, nor does it permit the use of the FAD. The preamble to the 2024 final rule explained why NHTSA believes these deviations from consensus standards are justified. In short, the body block placement zones are necessary to ensure that the standard is enforceable. With respect to the FAD, manufacturers may continue to certify to the requirements as tested with the body blocks if they do not want to use this new test device, though NHTSA believes that the FAD does have advantages over the body blocks, including that the FADs require significantly less effort and time to install in a test vehicle.
The Unfunded Mandates Reform Act of 1995 (UMRA) requires Federal agencies to prepare a written assessment of the costs, benefits, and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of $206 million (the value equivalent of $100 million in 1995, adjusted for inflation to 2025) or more in any one year. This proposed rule does not contain Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local and Tribal governments, or the private sector of $206 million or more in any one year. Thus, the analytical requirements of the UMRA do not apply to this action.
E.O. 13175 requires Federal agencies to consult and coordinate with Tribes on a government-to-government basis on policies that have Tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that 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. NHTSA has assessed the impact of this rule on Indian Tribes and determined that this rule does not have tribal implications that require consultation under Executive Order 13175.
NHTSA is committed to complying with the E-Government Act, 2002 to promote the use of the internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes. The E-Government Act of 2002 (Pub. L. 107-347, sec. 208, 116 Stat. 2899, 2921, Dec. 17, 2002) requires Federal agencies to conduct a privacy impact assessment for new or substantially changed technology that collects, maintains, or disseminates information in an identifiable form. No new or substantially changed technology would collect, maintain, or disseminate information as a result of this proposed rule. Accordingly, NHTSA has not conducted a privacy impact assessment.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its decision-making process. DOT posts these comments, without edit, including any personal information the commenter provides, to
E.O. 12866 and E.O. 13563 require each agency to write all rules in plain language. Application of the principles of plain language includes consideration of the following questions:
• Have we organized the material to suit the public's needs?
• Are the requirements in the rule clearly stated?
• Does the rule contain technical language or jargon that isn't clear?
• Would a different format (grouping and order of sections, use of headings, paragraphing) make the rule easier to understand?
• Would more (but shorter) sections be better?
• Could we improve clarity by adding tables, lists, or diagrams?
• What else could we do to make the rule easier to understand?
NHTSA has considered these questions and attempted to use plain language in writing this rule. If readers have suggestions on how we can improve our use of plain language, please write us.
DOT assigns a regulation identifier number (RIN) to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. You may use the RIN contained in the heading at the beginning of this document to find this action in the Unified Agenda.
Your comments must be written and in English. To ensure that your comments are filed correctly in the Docket, please include the docket number indicated in this document in your comments.
Your comments must not be more than 15 pages long. (49 CFR 553.21). We established this limit to encourage you to write your primary comments in a concise fashion. However, you may attach necessary additional documents to your comments. There is no limit on the length of the attachments.
If you are submitting comments electronically as a PDF (Adobe) file, NHTSA asks that the documents be submitted using the Optical Character Recognition (OCR) process, thus allowing NHTSA to search and copy certain portions of your submissions. Please note that pursuant to the Data Quality Act, for substantive data to be relied upon and used by the agency, it must meet the information quality standards set forth in the OMB and DOT Data Quality Act guidelines. Accordingly, we encourage you to consult the guidelines in preparing your comments. OMB's guidelines may be accessed at
If you wish the Docket to notify you upon its receipt of your comments, enclose a self-addressed, stamped postcard in the envelope containing your comments. Upon receiving your comments, the Docket will return the postcard by mail.
You should submit a redacted “public version” of your comment (including redacted versions of any additional documents or attachments) to the docket using any of the methods identified under
You also need to submit a request for confidential treatment directly to the Office of Chief Counsel. Requests for confidential treatment are governed by 49 CFR part 512. Your request must set forth the information specified in part 512. This includes the materials for which confidentiality is being requested (as explained in more detail below); supporting information, pursuant to section 512.8; and a certificate, pursuant to section 512.4(b) and part 512, appendix A.
You are required to submit to the Office of Chief Counsel one unredacted “confidential version” of the information for which you are seeking confidential treatment. Pursuant to section 512.6, the words “ENTIRE PAGE CONFIDENTIAL BUSINESS INFORMATION” or “CONFIDENTIAL BUSINESS INFORMATION CONTAINED WITHIN BRACKETS” (as applicable) must appear at the top of each page containing information claimed to be confidential. In the latter situation, where not all information on the page is claimed to be confidential, identify each item of information for which confidentiality is requested within brackets: “[ ].”
You are also required to submit to the Office of Chief Counsel one redacted “public version” of the information for which you are seeking confidential treatment. Pursuant to section 512.5(a)(2), the redacted “public version” should include redactions of any information for which you are seeking confidential treatment (
NHTSA is currently treating electronic submission as an acceptable method for submitting confidential business information to the agency under part 512. Please do not send a hardcopy of a request for confidential treatment to NHTSA's headquarters. The request should be sent to Dan Rabinovitz in the Office of the Chief Counsel at
We will consider all comments received before the close of business on the comment closing date indicated above under
You may read the comments received by the docket at the address given above under
Imports, Motor vehicle safety, Motor vehicles.
For the reasons discussed in the preamble, the National Highway Traffic Safety Administration proposes to amend 49 CFR part 571 as follows:
49 U.S.C. 322, 30111, 30115, 30117, and 30166; delegation of authority at 49 CFR 1.95.
The revisions read as follows:
S4.2.1
(a) For vehicles with a GVWR less than or equal to 4,536 kg manufactured before September 1, 2027, and vehicles with a GVWR greater than 4,536 kg manufactured before September 1, 2030, except as provided in S4.2.5, the anchorages, attachment hardware, and attachment bolts for any of the following seat belt assemblies shall withstand a 22,241 N force when tested in accordance with, at the choice of the manufacturer, S5.1(a), (b), or (c):
(1) Type 1 seat belt assembly; and
(2) Lap belt portion of either a Type 2 or automatic seat belt assembly, if such seat belt assembly is equipped with a detachable upper torso belt.
(b) For vehicles with a GVWR less than or equal to 4,536 kg manufactured on or after September 1, 2027, and vehicles with a GVWR greater than 4,536 kg manufactured on or after September 1, 2030, except as provided in S4.2.5, the anchorages, attachment hardware, and attachment bolts for any of the following seat belt assemblies shall withstand a 22,241 N force when tested in accordance with, at the choice of the manufacturer, S5.1(b) or S.5.1(c):
(1) Type 1 seat belt assembly; and
(2) Lap belt portion of either a Type 2 or automatic seat belt assembly, if such seat belt assembly is equipped with a detachable upper torso belt.
S4.2.2
(a) For vehicles with a GVWR less than or equal to 4,536 kg manufactured before September 1, 2027, and vehicles with a GVWR greater than 4,536 kg manufactured before September 1, 2030, except as provided in S4.2.5, the anchorages, attachment hardware, and attachment bolts for any of the following seat belt assemblies shall withstand a 13,345 N force applied to the lap belt portion of the seat belt assembly simultaneously with a 13,345 N force applied to the shoulder belt portion of the seat belt assembly, when tested in accordance with, at the choice of the manufacturer, S5.2(a), (b), or (c):
(1) Type 2 and automatic seat belt assemblies that are installed to comply with Standard No. 208 (49 CFR 571.208); and
(2) Type 2 and automatic seat belt assemblies that are installed at a seating position required to have a Type 1 or Type 2 seat belt assembly by Standard No. 208 (49 CFR 571.208).
(b) For vehicles with a GVWR less than or equal to 4,536 kg manufactured on or after September 1, 2027, and vehicles with a GVWR greater than 4,536 kg manufactured on or after September 1, 2030, except as provided in S4.2.5, the anchorages, attachment hardware, and attachment bolts for any of the following seat belt assemblies shall withstand a 13,345 N force applied to the lap belt portion of the seat belt assembly simultaneously with a 13,345 N force applied to the shoulder belt portion of the seat belt assembly, when tested in accordance with, at the choice of the manufacturer, S5.2(b) or S5.2(c):
(1) Type 2 and automatic seat belt assemblies that are installed to comply with Standard No. 208 (49 CFR 571.208); and
(2) Type 2 and automatic seat belt assemblies that are installed at a seating position required to have a Type 1 or Type 2 seat belt assembly by Standard No. 208 (49 CFR 571.208).
Issued under authority delegated in 49 CFR 1.95.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice of proposed rulemaking; withdrawal.
This action withdraws the notice of proposed rulemaking (NPRM) published in the
The NPRM published in the
National Highway Traffic Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE, West Building, Washington, DC 20590.
Ms. Lina Valivullah at
On January 15, 2025, NHTSA published an NPRM (90 FR 4130) proposing to establish the ADS-equipped Vehicle Safety, Transparency, and Evaluation Program (AV STEP). This would have been a voluntary program in which participating entities agreed to certain reporting requirements and public disclosures about their operations. The comment period for the proposal closed on March 17, 2025. In total, NHTSA received 37 comments. The commenters expressed a variety of perspectives about various aspects of the program. A central theme of the comments was that the program was not likely to be as effective or comprehensive a regulatory tool as originally intended. For example, certain entities that would have been eligible to participate in the program expressed low interest in voluntarily participating in a program with requirements they characterized as stringent. Certain other stakeholders, including some safety advocates, expressed concern that the program likely would not provide NHTSA with sufficient oversight to ensure an appropriate level of safety. Commenters also noted that the proposal was complex and would have required adding an entirely new part, with multiple subparts, to NHTSA's regulations. Thus, these commenters believed that the proposal would not achieve its objective of encouraging robust participation while providing NHTSA with effective oversight mechanisms. In addition, several of the key goals of the proposal, such as improving NHTSA's exemption programs, have been furthered recently through separate initiatives as part of the Automated Vehicle (AV) Framework announced in April 2025.
The NPRM proposed a voluntary program for vehicle manufacturers and ADS developers, as well as fleet operators and system integrators of ADS-equipped vehicles. Two levels of participation were proposed, based largely on the extent to which a vehicle relied on an ADS in its operations. Entities could have applied to participate with vehicles that met all applicable NHTSA Federal Motor Vehicle Safety Standards (FMVSS) or
The program included specific application and participation requirements, such as:
•
•
•
•
NHTSA received 37 comments in response to the NPRM from a diverse range of stakeholders, including safety advocates, State and local governments, original equipment manufacturers (OEMs), ADS developers and suppliers, trade associations, policy centers, labor unions, and elected officials. The comments reflected varying levels of support and concern regarding the program's voluntary structure and its reporting requirements.
The comments revealed that neither industry stakeholders, who viewed the program as overly burdensome for a voluntary initiative, nor safety advocates, labor unions, and others, who argued the program was insufficient because it lacked mandatory requirements, felt the proposal would accomplish its objectives of stimulating participation while ensuring an appropriate level of safety oversight. Industry groups, such as the Alliance for Automotive Innovation, warned that the costs of participation might outweigh the benefits, stating, “There is a high likelihood that for most potential applicants, the burdens of the current reporting requirements would outweigh the benefit of program participation.” Similarly, the ACES Mobility Coalition argued that the proposal “introduces unnecessary reporting burdens and new operational restrictions, without providing any meaningful regulatory or safety benefits.” Conversely, safety organizations like the National Safety Council (NSC) contended that given the unproven nature of the technology, “NSC recommends shifting this program from voluntary to mandatory,” noting that “[n]ovel, `unproven' technology should not be able to operate on public roads where operating conditions are not predictable . . . .” The Owner-Operator Independent Drivers Association (OOIDA) echoed this skepticism regarding voluntary measures, arguing that “mostly voluntary federal reporting requirements leave truckers and the general public in the dark about the safety and reliability of autonomous technologies.” Because the intent of the program was to be voluntary, comments suggested that it would have sparse participation and indicated that the expected value of a final program would be low.
Another central theme of the comments was whether the proposal appropriately balanced Federal regulation against potentially overlapping State and local requirements. Industry commenters suggested that the proposal would have maintained an undesirable lack of consistent State laws and regulations for ADS because its requirements would have been on top of any State or local requirements. For example, Mercedes-Benz Research and Development North America, Inc. and Mercedes-Benz USA, LLC (Mercedes-Benz) advocated for any program to avoid a “patchwork of state regulations,” stating that a “unified federal approach would eliminate these barriers, providing regulatory certainty and enhancing efficiencies.” The Alliance for Automotive Innovation similarly urged that “[p]reempting the patchwork of state and local frameworks for program participants could encourage participation in AV STEP . . . .” In contrast, local and State officials emphasized the need to retain local oversight. For instance, The National Association of City Transportation Officials (NACTO) expressed concern that “[a]s proposed, AV STEP allows the industry near-complete oversight of vehicle design, deployment, operations, and the definition of safety—leaving consumers, riders, and the general traveling public in the dark.” NACTO further argued that it is the “local government officials who are most often held accountable for traffic safety.”
Commenters also debated the efficacy and integrity of the proposed independent safety assessments and data reporting protocols. The Transport Workers Union of America (TWU) criticized the concept of independent assessors, arguing the proposal would “effectively outsource the Administration's safety oversight to pay-to-play contractors” and critiqued the approach as “rife with pay-to-play incentives.” Senators Richard Blumenthal and Edward J. Markey expressed concern regarding enforcement, noting that “a voluntary reporting structure only works when its participants follow through on their reporting” and citing previous instances where manufacturers failed to submit required crash reports.
The independent assessment was an essential element of the proposal, with many of the application and oversight requirements depending on a robust and reliable assessment of an entity's ADS operations, including their conformity with applicable industry standards. The proposal recognized, however, that the independent assessment and industry standards landscapes for ADS are in the “early stages” and are evolving. An additional complicating factor was the apparent lack of an established group of third parties with experience assessing ADS operations. Though the proposal sought to overcome these challenges by adding flexibility to the assessment requirements, the comments indicate that the requirements were viewed as confusing and potentially challenging to meet. For example, the Alliance for Automotive Innovation expressed concern that certain aspects of the independent assessment proposal lacked sufficient clarity. Similarly, the North Carolina Department of Transportation cautioned that participants could experience difficulties from other proposed requirements that “lack[ed] clear guidance.”
After careful consideration of the feedback and a revised assessment of the program's alignment with current Agency priorities, NHTSA is not proceeding with the AV STEP proposal. A key intention of the proposal was to establish a regulatory program that resulted in NHTSA overseeing a substantial volume of ADS operations. Industry comments suggested that participation in the program would have been minimal, which would have lowered the value of the program. Other stakeholders, such as safety advocates, expressed concern that a voluntary program would not offer a sufficiently comprehensive regulatory tool. Upon further consideration, NHTSA believes
As noted, several important aims of the proposal, such as expanding and improving exemption processes for noncompliant ADS-equipped vehicles, have already been addressed in furtherance of the AV Framework announced in April 2025.
• Prioritizing the safety of ongoing AV operations on public roads
• Unleashing innovation by removing unnecessary regulatory barriers that do not promote safety
• Enabling commercial deployment of AVs to enhance safety and mobility for the American public.
The NPRM contained in docket number NHTSA-2024-0100, as published in the
Issued under authority delegated in 49 CFR 1.95 and 501.4.
Federal Transit Administration (FTA), Department of Transportation (Department or DOT).
Notice of proposed rulemaking (NPRM).
The Federal Transit Administration (FTA) is proposing amendments to its bus testing regulation. The proposed changes will improve the efficiency of the testing program for stakeholders, enhance the value of bus testing reports for consumers, and assist in removing outdated test reports.
Comments on this proposed rule must be received on or before August 25, 2026. FTA will consider comments received after that date to the extent practicable.
Please submit your comments (identified by the agency name and DOT Docket ID Number FTA-2024-0012) by any of the following methods:
For technical information, Marcel Belanger, Bus Testing Program Manager, Office of Research, Demonstration, and Innovation (TRI), (202) 366-0725,
The Federal Transit Administration (FTA) provides financial assistance to State and local agencies operating public transportation systems, covering eighty or eighty-five percent (80-85%) of a vehicle's capital cost, while the State or local government provides a fifteen or twenty percent (15-20%) matching share. As part of its
FTA and other stakeholders have gained experience since the most recent Bus Testing Program final rule, which was published in 2016 (81 FR 50367). That final rule initiated the assignment of scores and pass/fail ratings to tested buses, as required by the Moving Ahead for Progress in the 21st Century Act (MAP-21; Pub. L. 121-141), as well as administrative changes. Today's NPRM proposes to build on this experience by modifying certain existing FTA Bus Testing Program procedures and policies to make them more effective, efficient, and clear. Some of the changes that FTA is proposing would increase the rigor of testing to address gaps, while others would relax certain program requirements to reduce the regulatory burden without weakening the overall effectiveness of the FTA Bus Testing Program. FTA is also seeking to increase flexibility within the Bus Testing Program to accommodate changes in bus technology that could require modification of some testing protocols.
This NPRM is not a comprehensive re-statement of all FTA policies, procedures, and interpretations under the Bus Testing Program. Therefore, as a general guideline, policies, procedures, and guidelines that are impacted by any Final Rule that may result from this NPRM will be updated, while policies, procedures, and guidelines that are not impacted will carry forward with little or no change.
Prior to publishing this NPRM, FTA engaged in a stakeholder listening session on September 8, 2022, about FTA's Bus Testing Program. In accordance with the Department's Guidance on Communication with Parties outside of the Federal Executive Branch (Ex Parte Communications),
Section 317 of the Surface Transportation and Uniform Relocation Assistance Act of 1987 (STURAA, Pub. L. 100-17) provided that no funds appropriated or made available under the Urban Mass Transportation Act of 1964, as amended, were to be obligated or expended for the acquisition of a new model bus after September 30, 1989, unless a bus of such model had been tested to ensure that the vehicle “will be able to withstand the rigors of transit service” (H. Rept. 100-27, p. 230). In subsection 317(b), Congress mandated seven specific test categories—maintainability, reliability, safety, performance, structural integrity, fuel economy, and noise—augmenting those tests with the addition of braking performance and emissions testing through section 6021 of the Intermodal Surface Transportation Efficiency Act of 1991 (Pub. L. 102-240). These requirements were subsequently codified at 49 U.S.C. 5318.
Section 5318 has been amended several times throughout the years. Significantly, in 2012, Section 20014 of MAP-21 added new requirements to subsection 5318(e), Acquiring New Bus Models, including a bus model scoring system and a pass/fail standard based on the weighted aggregate score for each of the existing performance standards. Section 20014 retained the existing Bus Testing categories of maintainability, reliability, safety, performance, structural integrity, fuel economy, emissions, and noise in the existing 49 U.S.C. 5318(a). In response to MAP-21, FTA updated 49 CFR part 665 by issuing a new pass/fail standard and new aggregated scoring system. In addition, FTA made other revisions to the regulation, including requiring bus manufacturers to provide country-of-origin information for test unit bus components.
Since then, FTA has had two reauthorizations that continued the Bus Testing Program, the Fixing America's Surface Transportation Act (FAST Act) (Pub. L. 114-94) and the Infrastructure Investment and Jobs Act (IIJA) (Pub. L. 117-58). While the FAST Act did not amend 49 U.S.C. 5318, Section 30008 of the IIJA amended 49 U.S.C. 5318 by adding subsection (f) Capital Equipment. This subsection adds that the bus testing facilities operated and maintained under 49 U.S.C. 5318 may use funds made available under this section for the acquisition of equipment and capital projects related to testing new bus models.
Today's proposed rule does not address the minimum safety performance standards for public transportation vehicles authorized under 49 U.S.C. 5329(b)(2)(C) as referenced in 49 U.S.C. 5318(e)(1)(B)(ii). At this time, the safety performance standards in the National Public Transportation Safety Plan are voluntary standards.
Additional details of the key steps in the creation and evolution of the Bus Testing Program are available at
The primary benefit of the proposed rule is that Bus Testing Reports less than 10 years old would more accurately reflect the safety, reliability, and other characteristics of today's bus models than older reports. Some bus manufacturers are using Bus Testing Reports from over 20 years ago to sell buses to FTA recipients while still complying with the current regulation. By requiring retesting, FTA can help ensure that Bus Testing Reports accurately represent bus models in production. In addition, FTA has improved testing requirements over the years, including testing related to safety; setting expiration dates would allow for bus testing that incorporates the improvements. For example, buses tested before 2010 were not subject to FTA's emissions and braking performance tests, which were added to the full testing requirements in that year.
The primary cost of the proposed rule is the additional bus testing required after setting expiration dates for the reports. Figure 1 summarizes the economic effects of the proposed rule
FTA is proposing non-substantive changes to this section.
FTA is not proposing any changes to this section.
FTA is proposing to add and modify several definitions in this section.
FTA seeks comments on proposed new definitions for failure, failure mode, and uncorrected failure. These terms are referenced in the description of certain tests in § 665.27(h), including the Reliability test and Safety test. For example, the Reliability test records all failures and breakdowns during testing. These terms are, therefore, very important in making pass/fail ratings of buses under test, but they are not defined clearly in the current regulation. FTA is therefore adding these definitions for clarity and to codify FTA's existing practice.
FTA also seeks comments on whether a definition for corrected failure should be provided in the regulation. That term is not used in the regulatory text but is often used in Bus Testing determinations and Bus Testing Reports. FTA is considering defining corrected failure as:
“Corrected failure means a failure mode that occurred during testing that was resolved through design, manufacturing process, quality control, or other improvement(s) by the manufacturer and successfully validated by sufficient subsequent testing. FTA may announce general guidelines for how it will validate that certain types of failures have been addressed, however each determination of whether a failure mode has been corrected will be made by FTA.”
FTA is proposing definitions for four failure classes assigned during testing (“Class 1” through “Class 4”). It has been the Bus Testing Program's longstanding practice to utilize failure classes to describe the severity of a failure that occurs during testing. However, the four failure classes were not previously defined in the definitions section of the regulation. FTA is proposing to codify these failure classes to communicate the interpretations that have been used for testing for many years more clearly.
FTA seeks comment on its proposed definition for recurring failure. Through experience administering the Bus Testing Program, FTA has observed that some bus models have repeated failures that, while they may or may not be individually serious, may cumulatively have an adverse effect on bus availability or life-cycle costs. This new definition would provide a way to call attention to repeated occurrences of the same failure mode.
FTA proposes new definitions for baseline (bus) model and baseline report, and clarifying adjustments to the definitions for bus testing report and partial testing report. For example, FTA proposes amending the definition of bus testing report to clarify that a full testing report for a zero-emission vehicle includes all test procedures except for the Emissions test. These proposed definitions are added to clarify existing requirements and practice. However, FTA notes that these definitions would allow for the possibility that the Operator could create a complete “composite” test report by combining report “modules” corresponding to each test result (
FTA proposes to modify the definition of curb weight to clarify that curb weight does not include the weight of a driver for the Check-in test procedure described in § 665.27(a), because the Check-in procedure is performed on an empty bus. However, curb weight includes the driver's actual weight for the Structural Durability test and any other test that is performed with a driver. This is a clarifying change that would not result in a change to FTA's existing practice.
FTA proposes clarifications to the definitions of major change in design, major change in components, and major change in configuration to bring them into consistency with longstanding practice. The updated definitions would better reflect FTA's established policy that additional testing of a modified bus model is required when the changes could result in obtaining significantly different test data compared to the baseline bus model. The updated definitions also would clarify that the changes described in the definitions are examples, rather than a complete list. These clarifications would not result in changes in practice.
FTA proposes to delete the definitions for modified third party chassis or van and small bus manufacturer because those terms are not used in the regulatory text.
FTA proposes to amend the definition for unmodified mass-produced van to require FTA to determine which models meet this definition. FTA would do so by developing and maintaining a list of which vehicle models are eligible for “unmodified mass-produced vehicle/van/chassis” designations. FTA believes that this would reduce uncertainty for recipients and TVMs regarding which vehicles are eligible for this designation. FTA seeks comments on the advantages and disadvantages of this proposal. FTA also proposes to clarify that such vehicles must be in the 4-year/100,000-mile useful life category, which is
FTA proposes to change the definition of unmodified third-party chassis to reflect the fact that original equipment manufacturers (OEMs) no longer publish official chassis modification guidelines. Under this proposal, buses built on chassis modified by the final stage manufacturer would generally require testing going forward.
Some vehicle manufacturers have invested significant non-recurring engineering hours during testing of a bus model that have resulted in changes to the bus model that were validated through subsequent testing to have addressed the root cause of a failure mode. Due to this practice, FTA is proposing a new definition for non-recurring engineering hours and proposes that such hours should not be counted toward unscheduled maintenance hours, which also has a newly-proposed definition in § 665.5. FTA's rationale for this is that the riding public, recipients, and taxpayers are better served by a manufacturer taking time to resolve a design flaw than by FTA's regulation incentivizing the manufacturer to make a quick repair to be able to finish Bus Testing without exceeding the allowable number of unscheduled maintenance hours. This proposal relates to a stakeholder comment that FTA received during its 2022 Bus Testing listening session. This stakeholder stated that FTA's unscheduled maintenance hours standard should account for product improvements, noting that a manufacturer should not be penalized for making such changes. FTA seeks comments on the advantages of this proposed approach, as well as the potential risks up to and including whether manufacturers should be barred from making any modifications at all to a bus model during a test.
FTA notes that the data obtained during testing of a bus model generally are not affected by the cosmetic condition of the bus. Therefore, FTA generally has allowed test buses to be submitted unpainted, with non-matching upholstery, etc., because these do not affect the data obtained. Similarly, FTA also has not counted as unscheduled maintenance hours any time needed to prepare and paint repaired components to restore their original appearance. However, FTA recognizes that transit operators typically will have to invest labor hours to restore the cosmetics of a bus that has experienced damage and repairs to body panels, doors, window frames, and similar components. FTA seeks comment, particularly from transit operators, on whether the definition of unscheduled maintenance hours should include time needed to restore the appearance of repaired bus components, and if it should, whether the unscheduled maintenance hour performance standards should stay the same or be adjusted to accommodate cosmetic repair time.
The useful life category of a bus model is an essential concept in Bus Testing and FTA-funded vehicle procurements. FTA proposes to add a definition for useful life category that references the useful life categories defined in the current version of FTA Circular 5010. This term is synonymous with “service life category,” the term that had traditionally been used by the Bus Testing Program. FTA notes that “useful life category” is now the preferred term. Accordingly, FTA proposes replacing “service life category” with “useful life category” throughout part 665. In certain contexts where only the expected life of the bus is being discussed rather than the useful life classification, the word “category” may be omitted. None of these clarifications of terminology would represent a change in FTA's practice.
FTA also proposes a minor clarification to the definition for final acceptance to specify that the vehicle has met its key bid specifications and the recipient has released FTA funding to the vehicle manufacturer. This change would codify FTA's longstanding interpretation of this term.
FTA also proposes minor clarifications to other definitions, including automotive, gross weight, hybrid, new bus model, and regenerative braking system.
FTA proposes adding a sentence in § 665.7(a) stating that a recipient may only certify compliance under § 665.7 based on a bus testing report that has not expired pursuant to § 665.13(g) at the time of initial contract award. If the base contract is awarded before the applicable bus testing report (or both the applicable baseline full bus testing report and partial testing report) expires, the recipient may exercise options on that contract, even after the report(s) expire.
Since the original Bus Testing Regulation was published in 1989, § 665.7(b) has said that the recipient is responsible for determining whether a vehicle to be acquired requires full testing or partial testing or has already satisfied the requirements of part 665. However, since the earliest days of the Bus Testing Program, bus manufacturers, not recipients, have contacted FTA for determinations of testing requirements. This is now the way that all parties understand the program to work, and this approach makes sense for several reasons. First, the bus manufacturers know their vehicle in much greater detail than the typical recipient. Second, parties may view FTA as an impartial participant in the determination process. Third, having FTA make a single determination is more efficient than having potentially dozens of recipients coming to different conclusions about testing requirements at different times.
To bring the regulatory text into consistency with the way that determinations of Bus Testing requirements have been made over the life of the Program, FTA proposes clarifying changes to § 665.7(b) and the addition of a new § 665.7(c). This new paragraph would convey that when a bus manufacturer or recipient is uncertain about whether testing is required, the bus manufacturer should be the party requesting FTA's review and determination of testing requirements for the bus model. Procedures for requesting a determination of Bus Testing requirements and a checklist of the information about the bus model that is required to make a determination are posted on FTA's Bus Testing website. FTA seeks comments on these proposed changes.
FTA is proposing to simplify the language in § 665.11(a)(5) to state that a test article bus must be substantially representative of subsequent production buses of that model. The existing part 665 language includes a short list of features of a bus that must be the same (“techniques, tooling, and materials”), but listing some features suggests that unlisted features (
FTA proposes moving the existing requirement to identify the manufacturing point of origin of key components of a test bus out of § 665.11(a)(5) into a new § 665.11(a)(6), which also would use simplified language. For purposes of this requirement, key components of the bus still would include, but are not limited to, axles, braking systems, propulsion power systems, auxiliary power systems, primary energy storage and delivery systems, and any other components essential to the function of the bus model. This proposal would be a simplification of the regulatory text, not a change in policy.
FTA is not proposing changes to § 665.11(c). However, FTA still encourages manufacturers to seek a full testing report as a baseline for future variants of a bus model built on a third-party chassis. FTA also notes that new bus models built on previously tested third-party chassis, even if eligible for partial testing, will usually require at least the Structural Durability test. The Structural Durability test alone represents 57 percent of the cost and 83 percent of the time required for a full test in the 7-year/200,000-mile useful life category.
FTA notes that third-party chassis manufacturers typically make evolutionary updates to their chassis every few years. This has caused disruptions in the transit bus industry in the past, when every manufacturer building on a chassis with significant changes had to re-test their bus model(s) built on that chassis. Considering this, FTA is proposing to re-number existing § 665.11(d) as § 665.11(d)(1) and add a new § 665.11(d)(2). This new paragraph states that a bus model that has previously satisfied Bus Testing requirements would not require additional testing solely due to model year updates to an unmodified third-party chassis made by a third-party chassis manufacturer. This new paragraph also would keep open the possibility that FTA could issue an industry-wide determination requiring additional testing of affected bus models if major changes are made to a chassis.
FTA proposes minor, non-substantive edits to § 665.11(e) for clarity.
Some bus models have multiple significant modes of operation. For example, hybrid-electric buses may have significant engine-off driving range. FTA proposes a new § 665.11(g) that, subject to feasibility and practicality, would require testing of and reporting on all of a bus model's significant proposed modes of operation. FTA envisions that “significant” could include, but not be limited to, operational modes that the manufacturer touts in its advertising of that bus model's capabilities.
FTA seeks comments on these proposals.
FTA is proposing clarifying edits to § 665.13(d).
The data obtained in the course of Bus Testing often is valuable to transit research conducted or sponsored by FTA. FTA is proposing a modification to § 665.13(f) to allow FTA to use anonymized or aggregated Bus Testing data to support FTA-conducted or sponsored research. Data attributable to a particular bus model or manufacturer would still be limited to release in a bus testing report that the manufacturer has authorized for publication. FTA seeks comments on this proposal.
FTA is proposing a new § 665.13(g), which would provide that full and partial bus testing reports shall expire 10 years after the date of publication. Several bus models are being sold to FTA recipients based on bus testing reports that are decades old. FTA believes it is highly likely that most if not all bus models will have undergone significant changes over such a long time. Manufacturers often make improvements to designs, specifications, materials, and suppliers. Even if each of those changes is not significant enough to trigger partial testing by itself, the accumulation of many small changes over time results in a potentially significant overall change. In addition, bus technologies and components are continually evolving. Third-party chassis manufacturers implement minor changes regularly and may implement more significant changes every few years, and sometimes do not notify bus manufacturers of these changes. Manufacturers and suppliers may have changes in corporate priorities, management, and workers. Furthermore, FTA updates its testing and reporting procedures from time-to-time, such as with the introduction of the Emissions and Braking Performance tests, or the implementation of scoring and pass/fail ratings. Bus testing reports do not reflect changes in test procedures implemented after they were published. For each of these reasons, FTA believes that it is appropriate to propose that full and partial bus testing reports should expire after 10 years. Stakeholders that participated in the September 8, 2022, listening session did not express concerns with having bus testing reports expire after 10 years. FTA proposes that the 10-year expiration provision would become effective three years after publication of the final rule to give manufacturers sufficient time to plan and implement their testing schedules.
FTA seeks comments on the advantages and disadvantages of implementing report expiration dates, whether the time until expiration should be the same or different for different types of buses, what the appropriate time(s) until expiration should be, and whether three years is an appropriate period to phase in expiration dates for Bus Testing Reports.
Proposed § 665.21(a) no longer would direct manufacturers to submit test requests to the FTA Bus Testing Program Manager. Instead, it would direct test requests to be submitted in the manner and form prescribed by FTA. FTA has historically included applicable instructions and a checklist on FTA's Bus Testing website. Since April 2022, the Bus Testing website has directed submitters to use the FTA Bus Testing Portal to submit requests for determinations of Bus Testing requirements and requests for FTA authorization to begin testing a bus model. The Portal is a web-based system that provides greater structure, clarity, convenience, and consistency for manufacturers to submit their requests and for FTA to respond to them more efficiently. The intent of the revised § 665.21(a) is to require submitters to use the Portal, while allowing flexibility for FTA to enhance, migrate, or replace the Portal if that should be needed in the future. The website lists alternative ways to contact FTA for any unusual inquiries that are not suitable for submission using the Portal.
FTA has proposed minor edits to paragraphs (b) through (d) to increase clarity and for consistency with current practices. For example, the Operator is able to view authorizations in the FTA Bus Testing Portal, so manufacturers now only need to reference an FTA testing authorization when scheduling a bus for testing. In addition, FTA has removed an outdated URL for the Operator's website and stated that FTA will link the Operator's website from the FTA Bus Testing website.
FTA proposes to amend § 665.23(c) to clarify that once the manufacturer's fee has been expended, the Operator must seek FTA approval to continue testing only in cases where the Operator has concerns about continuing the test. In
Since FTA began issuing pass/fail ratings, a small number of bus models have started and been withdrawn from testing multiple times due to poor performance of the test bus. To prevent manufacturers from conducting multiple taxpayer-subsidized tests until a bus obtains a passing score, and to encourage manufacturers to ensure that their bus model is ready for the rigors of testing and transit service, FTA is proposing a new § 665.23(d). This new provision would require a manufacturer to pay the total applicable full or partial testing fee up-front when resubmitting a bus model that had previously started and been withdrawn from testing. When, or if, that bus model obtains a passing score, the bus manufacturer will be reimbursed upon publication of the report for FTA's share of the testing fee for the test that resulted in a published passing report.
Under this proposal, manufacturers would continue to pay only the manufacturer's share of the testing fee the initial time a bus model is submitted for testing. The Time and Fee Schedule for testing reflects the 20 percent manufacturer's share of the testing fee set forth by statute in 49 U.S.C. 5318.
Figure 2 illustrates the manufacturer's contribution to the testing fee under various scenarios applicable to the proposed new provision in § 665.23(d). Figure 2 reflects FTA's assumption and experience that a manufacturer will never approve publication of a Bus Testing Report with a failing score, since manufacturers have the option to withdraw a bus from testing at any point prior to publication of the report.
FTA is proposing minor changes to this section to clarify that manufacturers are responsible for transporting their vehicle to and from the Bus Testing Center as needed at any point in testing, including if a manufacturer withdraws, re-submits a vehicle, or both. This is a clarification, not a change. FTA anticipates that in most cases, transportation of a test vehicle will occur only prior to the start of testing, and at the completion of testing.
FTA proposes to clarify that inspections and checks that the Operator performs under § 665.27(a) may occur during testing, and not only “upon receipt” of a bus approved by FTA for testing. This is not a change, but rather a clarification of existing practice.
FTA is proposing a new § 665.27(a)(5) directing the Operator to identify any safety concerns as part of its pre-test inspection of a test bus. The Operator already does this informally, but this new provision would enable the Operator to increase the rigor and authority of its safety inspection.
Similarly, FTA is proposing a new § 665.27(a)(6) directing the Operator to identify any concerns with the fundamental suitability or fitness of the bus for transit service. Examples could include, but are not limited to, a bus that is not equipped with a reasonable number of seats or has an impassable aisle.
Section 665.27(b) currently prevents the start of testing and requires FTA authorization to begin testing if a bus does not comply with the checks enumerated in § 665.27(a). Through experience administering the Bus Testing Program, FTA has found that the issues enumerated in paragraph (a) sometimes arise and require correction not only before testing starts, but also during testing. Accordingly, FTA is proposing to expand § 665.27(b) to pause testing and require FTA authorization to continue a test if a bus is found to be non-compliant with those requirements at any time during testing. This is not a change, but rather a proposed codification of existing practice. FTA would retain its existing practice that testing may begin again after five business days if FTA does not provide a response.
FTA proposes minor edits to § 665.27(e) for clarity and to state that the Operator shall investigate occurrences of unauthorized maintenance or repairs with FTA, if necessary. This is not a change to FTA's current practice.
Manufacturers sometimes request permission to make one or more modifications to a bus in testing to address problems that were uncovered by testing. FTA historically has allowed reasonable modifications to test buses but has required that the modifications are validated with sufficient testing after the modification has been made, and that the modification is implemented in future production buses of that model and is documented in the Bus Testing Report. All of those requirements are necessary to ensure that Bus Testing Reports contain information that is representative of the buses that FTA recipients will obtain. Accordingly, FTA is proposing to incorporate these procedures into § 665.27(f), which pertains to when a manufacturer requests to make a modification to a bus already in testing to address a problem discovered during testing. These proposed edits are not new policies; rather they would clarify and standardize FTA's existing procedures. FTA notes that allowing manufacturers to correct a problem with a root-cause fix and validate that change during testing may benefit all stakeholders by resulting in better production buses. However, FTA alternatively requests comments on whether modifications to a test bus should be prohibited once a bus has begun testing.
FTA seeks comment on its proposed updates, enhancements, and modifications to the Bus Testing protocols and procedures in § 665.27(h), as discussed below.
FTA proposes edits to § 665.27(h) to clarify that the Operator must develop
FTA is proposing several adjustments to the Maintainability test described in § 665.27(h)(1) to allow greater flexibility for buses that have non-standard designs, components, or capabilities. FTA proposes revising the language regarding removal and reinstallation of certain components to specify that this requirement applies to a representative sample of bus components that are likely to require removal and replacement during the useful life of the bus. Examples of components that would be removed and replaced could include the transmission, engine, propulsion motor, alternator, starter, high-voltage and low voltage battery, and windshield wiper motor. The proposed language would allow flexibility for bus models with novel technologies—for example, the Operator might remove and replace the fuel cell on a fuel cell powered bus, since that component is analogous to an engine on a conventional bus.
FTA is also proposing to specify that required repair actions must be reported in the Maintainability test during any type of partial testing, not just when the Structural Durability test is performed. This would be a change from prior practice. To date, repairs have only been reported when Structural Durability testing is performed. However, servicing and repairs may be required during any of the tests that are performed. FTA believes that information about these repair actions is necessary for recipients to have a complete understanding of the maintainability of a bus. Accordingly, FTA is proposing that servicing, preventative maintenance, and repairs that are required at any point in a full or partial test of a bus model must be reported. For example, if a bus is submitted for the relatively brief Fuel Economy test and the transmission fails on the dynamometer while simulating normal operation, FTA believes that recipients would find that information valuable. Finally, FTA proposes to delete the sentence regarding the Operator seeking advice from the bus manufacturer because it is redundant with the following sentence regarding the Operator carrying out routine and corrective maintenance in accordance with the manufacturer's specifications and guidance.
FTA is proposing to change the performance standard for unscheduled maintenance (USM) hours in § 665.27(h)(1)(ii) to make the required maintainability more consistent across useful life categories. Under FTA's current regulation, the performance standard is 125 hours regardless of the useful life category of a bus. As depicted in Figure 3 below, FTA proposes to change this performance standard to a number that decreases as the useful life decreases. The proposed standards are “round” numbers that result in a maximum USM hours rate that is more consistent and increases only slightly as the useful life gets shorter. Under the current performance standard, the USM hours rate for the 12-year useful life category is 10.42, which is significantly lower than the rate of 31.25 for the 4-year useful life category. The rates under FTA's proposal are much more consistent and equitable across useful life categories. FTA believes that this proposal is appropriate, as it serves to mitigate the greater weight of a single failure on the overall number of USM hours during a shorter test.
FTA analyzed historical data about the performance of buses on the Maintainability test and has determined that the proposed changes would not result in a significant impact to the passing rate of buses on the Maintainability test. As shown in Figure 4, only a minimal number of buses (shown with columns) that performed poorly in the test exceeded the proposed new USM hour limits (shown with horizontal lines), and those were from prior to the implementation of pass/fail testing in 2016. FTA notes that a small number of buses have been withdrawn from pass/fail testing because they were having extensive failures and were
FTA also proposes that the USM hours limit must apply to any test, not just a full test, because failures that occur and repairs that are required during short-duration and relatively low-stress tests are at least as concerning as those that occur during the high-stress Structural Durability test.
FTA proposes minor edits to the Reliability test in § 665.27(h)(2) to clarify that the test includes failures that occur during any test, including partial tests that do not include the Structural Durability test. FTA and the Operator would adjust their determinations of Bus Testing requirements and reporting, respectively, to include Reliability testing in all determinations and bus testing reports going forward. FTA also proposes to revise the Reliability test description to remove the definition of Class 1 and Class 2 failures. These failure classifications have been moved to the definitions section of the regulation, as FTA believes this is the most natural place for readers to find defined terms. FTA also proposes to revise the Reliability performance standard to remove the reference to Class 1 failures, as these failures are addressed in the Safety test.
FTA proposes expanding the Safety test in § 665.27(h)(3)(i) to require a description in the bus testing report of any safety concerns on a bus model, and the actions taken to correct those concerns. There have been several cases where the Operator has refused to begin or resume testing a bus model until its manufacturer corrected safety deficiencies. FTA believes that it is necessary to include this information in the bus testing report for recipients to have a complete understanding of the safety of a bus.
FTA is proposing to simplify the language of the double lane change test in § 665.27(h)(3)(ii) to state that safe execution of the maneuver must be at 45 mph to pass. This would not be a substantive change from the current regulation, which requires that the maneuver must occur at “no less than 45 mph.” FTA notes that the Operator's detailed Safety test procedure defines unsafe execution of the double lane change test as unstable vehicle handling or a wheel coming off the ground. FTA also notes that the top speed of certain limited-performance vehicles is under 45 mph. In such cases, the proposed new language in § 665.27(h) regarding new technologies, features, capabilities and limitations would enable FTA to adjust the performance standard for limited-performance vehicles to negotiating the lane change course safely at the lesser of 45 mph or the vehicle's top speed. FTA is also proposing to delete unnecessary detail regarding the dimensions of the lane change course, which are described in the test procedure document developed by the Operator. FTA is not proposing to change the procedure or dimensions of the lane change test.
In § 665.27(h)(3)(iii), FTA is proposing to clarify FTA's current practice, which is that the performance standard for stopping distance is “based on” the requirements of FMVSS 105 or 121 due to the complexity of those regulatory requirements.
The descriptions of the Safety test in § 665.27(h)(3)(iv) formerly included definitions of failure classes and corrected failures. As explained in the discussion above, FTA proposes moving those definitions to § 665.5.
In § 665.27(h)(4), FTA proposes modifying the Performance test description regarding a vehicle's maximum acceleration and speed because higher-performing vehicles may not need to be accelerated during this test to the top speed they can reach. FTA also proposes that the performance test may calculate a vehicle's acceleration, speed, and gradeability
FTA proposes several changes to the Structural Integrity tests in § 665.27(h)(5). FTA proposes removing unnecessary and restrictive detail from the description of the Structural Integrity tests and adding clarifying details, and renumbering subparagraphs to conform to
FTA proposes to clarify the test description and the performance standards for the Structural Distortion test in § 665.27(h)(5)(i)(A). The language in the existing regulation saying “all four wheels” is not compatible with motorcoaches, articulated buses, or any vehicle with other than four wheels. The change to “each wheel” would make the regulatory text consistent with longstanding practice. FTA notes that the passenger escape mechanisms that must remain operable under§ 665.27(h)(5)(i)(A)(
FTA also proposes a new safety performance standard for the water leak test: No uncorrected safety hazards during the test. Because of the wide range of potential hazards from water leaking into unintended places on a bus, neither FTA nor the Operator can anticipate all the possible hazards that may occur, so the performance standard proposed in the regulatory text is non-specific. FTA anticipates providing examples of potentially failing safety hazards in the test procedure documents, and on the FTA Bus Testing website. Examples could include, but are not limited to, water shorting out an electrical power or control circuit and causing a fire, smoke, or other improper functioning of safety-critical systems, or water making the bus aisle extremely slippery. FTA is only proposing to fail buses for significant water leakage that could impact the safety of occupants or the operation of the bus, and that is not successfully corrected and validated by successfully repeating the water leak test. Based on experience, FTA anticipates that this performance standard would rarely, if ever, be triggered. However, FTA believes that if an uncorrected safety hazard does occur, that situation should be serious enough to fail the bus.
FTA has proposed minor edits to the description of the Static Towing test in § 665.27(h)(5)(i)(B). FTA proposes to delete the modifier “permanent” from the description of the Static Towing test performance standard and replace it with the term “significant.” This is not intended to be a substantive change in practice. FTA notes that “significant” includes damage or deformation that is permanent, while the proposed change would remove the implication that trivial permanent deformation could cause a bus to fail this performance standard.
Similarly, in proposed revisions to § 665.27(h)(5)(i)(C), the modifier “permanent” has been deleted from the description of the Dynamic Towing test and performance standard. FTA notes that the term “significant damage” in the performance standard includes damage that is permanent, while the proposed change would remove the implication that trivial permanent deformation could cause a bus to fail this performance standard. This is not intended to be a substantive change in practice. The phrases “heavy wrecker” and “standard commercial vehicle wrecker” have been replaced by “tow truck” for conciseness. FTA also proposes deleting the details about the length and speed of the Dynamic Towing test, as these are described in the detailed test procedure document developed by the Operator.
FTA proposes revising the performance standard for the Dynamic Towing test in § 665.27(h)(5)(i)(C) to state that the vehicle must be “safely” towable. This is a clarification of existing practice.
For clarity, FTA proposes replacing the phrase “standard commercial vehicle hydraulic jack” with “hydraulic floor jack” in the Jacking test in § 665.27(h)(5)(i)(D). The performance standard has been clarified to specify that a tire is fully deflated, and that the vehicle must be capable of being lifted “safely, securely, and without damage.” This is a clarification of existing practice.
In proposed revisions to § 665.27(h)(5)(i)(E), the Hoisting test has been updated to add the term “wheel lifts” because wheel lifts are now typically used rather than a two-post lift. The performance standard for Hoisting has been clarified to include explicitly the raising and lowering of the vehicle in addition to being supported on jack stands. This is not a substantive change, because a vehicle cannot safely be supported on jackstands unless it can also be safely raised and lowered.
FTA is proposing minor clarifying edits to the Structural Durability test in § 665.27(h)(5)(ii). FTA intends that these changes will have no substantive effect in practice.
FTA proposes that the Fuel Economy test description in § 665.27(h)(6) include energy efficiency and driving range in addition to fuel economy, to accommodate the diverse range of vehicle propulsion systems now available, especially the increasingly common battery-electric buses. The Fuel Economy test procedure description also includes minor clarifying edits, including that the results be presented in metrics that are accepted by the transit community.
In § 665.27(h)(6)(i), the existing regulatory text states that the Fuel Economy test results “are not comparable” to data from other agencies, such as the U.S. Environmental Protection Agency (EPA). The intent of this was that the Bus Testing Program would not require testing with the same high degree of rigor as EPA and might not produce the same exact results, not that FTA's testing would not be similar. Therefore, FTA proposes to clarify the description by changing this language to “intended to be independent of.” This is not a change in practice and would have no effect on the way that the Bus Testing Program tests fuel economy or energy efficiency and range.
The existing regulatory text in § 665.27(h)(6)(ii) states that the fuel economy performance standard “shall be” that of the National Highway Traffic Safety Administration (NHTSA) Medium and Heavy-Duty Fuel Efficiency Program in 49 CFR part 535. Due to the complexity of part 535, and the fact that any engine available for application in the U.S. transit bus market must comply with part 535 and is therefore considered by the Bus Testing Program to have satisfied the fuel economy performance standard, FTA proposes to change this language to state, “the vehicle is compliant with” part 535. This is consistent with how the performance standard is described in Table A of the existing appendix A to part 665, which says “Compliant with 49 CFR part 535 . . .” The proposed edit to § 665.27(h)(6)(ii) therefore is simply a clarifying change.
A proposed new § 665.27(h)(6)(iii) has been added to state that scoring for the Fuel Economy test will be pro-rated for vehicles powered by more than one fuel or energy type. This would better convey the fuel economy of dual-fuel vehicles.
FTA proposes revising the Noise test in § 665.27(h)(7) to clarify FTA's existing practice, which includes the reporting of notable audible vibrations or rattles during operation on the roadway segments between the Altoona Bus Testing Center and the Test Track. FTA also proposes to clarify that the performance standards for the Noise test include acceleration, which is
FTA proposes to revise the Emissions test in § 665.27(h)(8) with clarifying edits to remove unnecessary specificity. The existing regulatory text says that the Emissions test results “are not directly comparable” to data from other agencies, such as the U.S. Environmental Protection Agency (EPA). The intent of this was that the Bus Testing Program would not require testing with the same high degree of rigor as EPA and might not produce the same exact results, not that FTA's testing would not be similar. Therefore, FTA proposes to clarify the description to “need not be directly comparable.” Any engine available for application in the U.S. transit bus market must comply with 40 CFR part 86 and 40 CFR part 1037 and is therefore presumed by the Bus Testing Program to have satisfied the emissions performance standard. There have been buses with emission control systems that have not operated properly during testing. In such cases, emissions are typically much higher than the performance standard. This will be considered an emissions control system reliability failure, and the date, corrective actions taken, and the USM hours will be documented in the Bus Testing Report. Once repairs are completed, the Emissions test can be repeated. A proposed new paragraph (iii) has been added that states that zero-emission vehicles are exempt from emissions testing under part 665. These proposed edits to the Emissions test are all clarifications of existing practice, and none of them will change the way that the Bus Testing Program tests emissions.
FTA proposes edits to Appendix A that mirror the proposed changes discussed above. In addition, FTA proposes changes for clarity and accuracy. For example, FTA has added “normal operation of steering mechanism” to capture the complete Distortion performance standard in § 673.25(h)(5)(i)(1).
FTA is looking ahead to consider future steps to improve the accuracy, rigor, and relevance of testing. FTA is interested in hearing from stakeholders about the assumed passenger weight and the distribution of load factors used for Bus Testing. FTA is also seeking stakeholder comments regarding bus testing procedures that may be needed in the future to address new bus technologies and new testing methods. FTA is not proposing in this NPRM to change the passenger weight used in the Bus Testing Program or the distribution of load factors used for testing, nor is FTA proposing to implement any new tests or methods asked about in this request for information section of this NPRM. FTA will use this information to inform future action, including potential future regulatory updates. Respondents may respond to any question and do not need to respond to all questions.
FTA selected the 150-pound assumed passenger weight that it currently utilizes in the FTA Bus Testing Program in 1989 based on the number used by the NHTSA in its calculation of Gross Vehicle Weight Rating at 49 CFR 567.4(g)(3).
FTA is interested in hearing from stakeholders about whether it should continue to utilize the 150-pound assumed passenger weight, or a different assumed passenger weight. FTA also seeks information about the 600-pound passenger weight that FTA currently assumes for wheelchair positions during bus testing. This issue was discussed during FTA's September 8, 2022 stakeholder listening session. A power wheelchair user who regularly rides transit commented during the listening session that 600 pounds can easily be exceeded by typical users plus their mobility devices, and suggested that all bus ramps/lifts/bus securement locations should be designed, built, and tested to accommodate up to 1,000 pounds. FTA seeks information about this issue as well.
Accordingly, FTA seeks information about the following:
1. Should FTA change the assumed passenger weight used for Bus Testing? Why or why not?
2. If FTA were to change the assumed passenger weight used in testing, what value should FTA use? What assumed passenger weight should FTA use for riders using mobility devices?
3. What data or information should FTA consider when assessing whether to change the assumed passenger weight?
4. What costs to the transit industry would changing the assumed passenger weight impose? Please provide data and sources, if possible.
5. What benefits to the transit industry would result from changing the assumed passenger weight? Please provide data and sources, if possible.
6. If FTA changes the average passenger weight, should FTA also change the average floor space assumed to be occupied by each standee passenger? Why or why not?
7. If FTA changes the average assumed floor space occupied by each standee passenger, what value should it use, and what is the basis for that value?
8. What costs to the transit industry would changing the average assumed floor space impose? Please provide data and sources, if possible.
9. What benefits to the transit industry would result from changing the average assumed floor space impose? Please provide data and sources, if possible.
10. If FTA were to change the assumed passenger weight or free floor space per standee, what would be a reasonable time for bus manufacturers to implement corresponding design and production changes in their vehicles before FTA began testing at the new weight and floor space values?
In summary, FTA seeks information, especially with citations, and comments on whether a different passenger weight or floor-space value should be used in the Bus Testing Program, and if so, what that weight or footprint should be, and what costs and benefits this would cause. FTA also seeks comments on an appropriate phase-in schedule if such changes are implemented.
FTA also seeks information about the relative durations of Structural Durability testing at each of the loading conditions used for testing. The loading conditions and durations that are used in testing are as shown in Figure 5 below (as defined in part 665, GVW = gross vehicle weight, SLW = seated load weight, and CW = curb weight):
While FTA believes that peak load factors in the real world often reach and may even exceed GVW, FTA understands that the experience of various transit agencies with regard to average passenger loads may be less in some cases. Therefore, FTA seeks data with citations, other information, and comments, on the following:
11. Should the number of miles run at each loading condition be kept as-is or should they be adjusted? Why or why not?
12. If FTA should adjust these values, what adjustments would be appropriate? For example, should fewer miles be run at GVW and more at SLW? Should some of the miles be run at an additional loading condition between SLW and CW? If so, what would the basis for those adjustments be, and what might appropriate values for the loading and distance be?
Table A in Appendix A to part 665 defines the bus model scoring system, which consists of base scores for meeting the minimum performance standards, and additional pro-rated points apportioned to some test procedures when a bus model exceeds the minimum performance standards. FTA notes that the additional points for some tests are not equivalent for all bus configurations. For example, a relatively inefficient small 12-passenger shuttle bus could earn more bonus points in the fuel economy test than a highly-efficient large 50-seat articulated bus under the current scoring system. FTA was aware of this scoring discrepancy when the current part 665 was promulgated. Our assumption at that time was that this is acceptable because transit operators were unlikely to be cross-shopping shuttle buses with articulated buses. However, it is not unlikely that transit agencies might be comparing acquiring a fleet of 40 sixty-foot buses rather than a fleet of 60 forty-foot buses. FTA seeks feedback on the benefits and costs of normalizing the bus model scoring system so that the relative performance of different bus configurations may be more readily compared, and specific or general suggestions of what changes should be made to the bonus point formulas for any of the test procedures in the bus model scoring system.
FTA notes that 49 U.S.C. 5318 requires FTA to test a complete bus model as an integrated system, not a modified bus, and not bus components. With this in mind, FTA is interested in stakeholder views about new transit bus technologies that may need to be tested under the Bus Testing Program in the future. For example, whether and how to test vehicles that feature varying degrees of automated operation. FTA is also interested in stakeholder feedback about whether new or modified test procedures and methods may be needed or preferable in the future to test existing and new-technology bus models for maintainability, reliability, safety, performance (including braking performance), structural integrity, fuel economy, emissions, and noise. For example, testing the energy efficiency and range of buses under simulated climate variations by applying empirical adjustment factors to dynamometer data and/or performing dynamometer testing in a climate-controlled chamber (FTA does not have current plans or budget to build and equip a climate-controlled dynamometer lab).
Finally, FTA is interested in stakeholder feedback and comment regarding any other issues that may have a direct and significant impact on implementation of the Bus Testing Program.
FTA invites stakeholders to submit views and comments about these issues.
The proposed rule would revise testing requirements for transit buses submitted to the FTA Bus Testing Program. The proposed rule would assign a 10-year expiration date to full and partial bus testing reports, lower the threshold for allowable unscheduled maintenance (USM) hours for some useful life categories during a test, require manufacturers to pay testing fees up front if they resubmit a bus model that failed earlier testing, and update terms in the regulation to reflect current practice. The proposed rule would apply to all bus manufacturers that wish bus models to be eligible for procurement with FTA grant funds.
Currently, there is no expiration date for Bus Testing Reports or retesting requirement for bus models subject to the FTA Bus Testing Program. FTA has determined that bus models tested through its Bus Testing Program can be subject to design, specification, and manufacturing changes over time. While these changes may or may not be individually minor, they could over time or cumulatively result in significant changes to a model as well as to testing data and scores, leading to inaccurate information for transit agencies selecting bus models covered by outdated reports. Expiration dates are an efficient way of ensuring that Bus Testing Reports accurately reflect the bus models currently available. FTA does not have the authority or resources to perform regular detailed engineering audits of bus models and assess the changes that have been made to them since they were last tested, in order to determine whether a report still accurately describes its subject bus model.
The proposed rule would also revise payment requirements for testing by
In the baseline scenario, bus manufacturers submit new bus models for testing at the same rate they did over the past 20 years. The Altoona Bus Research and Testing Center would conduct an average of eleven full and five partial tests with passing results, as well as an estimated three tests with failed results, per year. USM hours allowed during testing would remain the same, and manufacturers would continue to pay testing fees after tests are conducted.
The proposed rule would lead to greater overall testing by requiring manufacturers to retest models every 10 years should they wish to keep them eligible for FTA grant funding. The proposed rule could also lead to an increase in testing by lowering the USM threshold for some useful life categories. To assess the effects of the proposed rule, FTA used information from the Altoona Bus Research and Testing Center, including bus testing reports,
The primary benefit of the proposed rule is that testing reports less than 10 years old would more accurately reflect the safety, reliability, and other characteristics of bus models than older reports. By requiring retesting, FTA can ensure that Bus Testing Reports accurately represent bus models in production. In addition, FTA has improved testing requirements, including testing related to safety, in recent years; setting expiration dates would allow for bus testing that incorporates the improvements. For example, buses tested before 2010 were not subject to FTA's emissions and braking performance tests, which were added to the full testing requirements in that year.
FTA does not currently have information to quantify or monetize the effects of these benefits. To quantify benefits, FTA would need information on accidents, service disruptions, or increased maintenance costs involving buses with outdated testing reports.
The primary costs of the proposed rule stem from the additional bus testing required after setting expiration dates for reports. The proposed rule would lead to greater overall testing by requiring manufacturers to retest models every 10 years should they wish to keep them eligible for FTA grant funding. The lower USM threshold could also lead to a modest increase in the number of failed tests by less durable buses. The cost of a full test ranges from $111,000 to $223,000 depending on a bus's useful life and which tests are conducted. FTA subject matter experts estimate that the average partial bus test costs $62,000.
When the requirement goes into effect, 278 Bus Testing Reports older than ten years would immediately expire, although many of those models are no longer being offered to FTA recipients. To prevent the Bus Testing Center from becoming overloaded and to allow manufacturers time to prepare for and complete retesting, FTA proposes a three-year phase-in period before the 10-year expiration provision goes into effect. A manufacturer with Bus Testing Report(s) that would expire within the first three years after the final rule is enacted has until the end of that three-year phase-in period to retest its affected bus model(s). FTA estimates that manufacturers would retest 68 bus models over the first three years and 120 models total over the first ten years.
Figure 6 shows the number of bus testing reports in each useful life category from active bus manufacturers that would expire from 2027 to 2036, the first ten years after the proposed rule goes into effect. FTA assumes that manufacturers would seek new tests for expired models throughout the phase-in period, for an average of 28 bus models retested per year. FTA does not expect that this provision would result in additional failed tests because the retested models already successfully completed Bus Testing.
Lowering the threshold for allowable USM hours and expanding the provision to partial tests may lead to more failed tests, which would increase testing costs. To capture an upper bound of these costs, FTA used historical testing data to estimate the annual average number of bus tests that would fail testing and require retesting. FTA anticipates that a very small number of seven-year and 10-year useful life bus models—less than one model per year—would fail testing due to the lower threshold, for an average annual cost of $82,447. In practice, retesting costs may be even lower because some manufacturers may be able to perform USM more efficiently without incurring additional costs.
The proposed rule would require manufacturers to pay testing fees up front if they withdraw and resubmit a bus model for testing. While the change is a transfer rather than a cost or benefit, the change could result in less testing—and lower economic costs—if it leads manufacturers to learn from testing failures and make meaningful improvements to their buses before requesting additional testing.
The proposed rule would also change and clarify several definitions in regulation to reflect current practice and terminology used in bus testing. These changes are not expected to have an economic effect.
Figure 7 shows total undiscounted costs for each year of the proposed rule. During the three-year phase-in period from 2027 to 2029, costs are higher, ranging from $3.7 million to $5.6 million per year. From 2027 onward, costs are lower, although costs for 2036 may be understated due to a lack of complete testing data for 2026 at the time of this proposed rulemaking.
Figure 8 summarizes the economic effects of the proposed rule over the ten-year analysis period. At a three percent discount rate, the proposed rule would have total costs of $18.3 million in 2024 dollars and annualized costs of $2.0 million discounted to 2024. At a seven percent discount rate, the proposed rule would have total costs of $14.6 million in 2024 dollars and annualized costs of $1.7 million discounted to 2024. To assess net benefits, FTA would need information to quantify benefits for requiring more recent bus testing reports.
E.O. 12866 (“Regulatory Planning and Review”), as supplemented by E.O. 13563 (“Improving Regulation and Regulatory Review”), directs Federal agencies to assess the benefits and costs of regulations, to select regulatory approaches that maximize net benefits when possible, and to consider economic, environmental, and distributional effects. It also directs the Office of Management and Budget (OMB) to review significant regulatory actions, including regulations with annual economic effects of $100 million or more. OMB has determined that the proposed rule is not significant within the meaning of E.O. 12866 and has not reviewed it under that order.
E.O. 14192 (“Unleashing Prosperity Through Deregulation”) requires that for “each new [E.O. 14192 regulatory action] issued, at least ten prior regulations be identified for elimination.” Implementation Guidance for E.O. 14192, issued by OMB (Memorandum M-25-20, March 25, 2025) defines an E.O. 14192 regulatory action as “a significant regulatory action as defined in Section 3(f) of E.O. 12866 that has been finalized and that imposes total costs greater than zero.”
This proposed rule, if finalized, is not expected to be a significant regulatory action under E.O. 12866 and therefore is not expected to be an E.O. 14192 regulatory action.
The Regulatory Flexibility Act of 1980 (RFA) (5 U.S.C. 601
The primary cost of the proposed rule is the additional bus testing required after setting expiration dates for the reports. Using historical testing data and information on the bus manufacturing industry, FTA estimates that 32 bus manufacturers would submit models for retesting during the 10-year analysis period. Each manufacturer would submit an average of 1.9 tests over the 10-year period, for an annual average cost of $32,700. FTA has therefore determined that the proposed rule would not have a significant effect on a substantial number of small entities.
FTA has determined that this proposed rule does not impose unfunded mandates, as defined by the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, March 22, 1995, 109 Stat. 48). This proposed rule does not include a Federal mandate that may result in expenditures of $100 million or more in any one year (when adjusted for inflation) for either State, local, and Tribal governments in the aggregate, or by the private sector. In addition, the definition of “Federal mandate” in the Unfunded Mandates Reform Act excludes financial assistance of the type in which State, local, or Tribal governments have authority to adjust their participation in the program in accordance with changes made in the program by the Federal Government. The Federal Transit Act permits this type of flexibility.
E.O. 13132 requires agencies to assure meaningful and timely input by State and local officials in the development of regulatory policies that may 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. This action has been analyzed in accordance with the principles and criteria contained in E.O. 13132 dated August 4, 1999, and FTA determined this action will not have a substantial direct effect or sufficient federalism implications on the States. FTA also determined this action will not preempt any State law or regulation or affect the States' ability to discharge traditional State governmental functions.
The regulations implementing E.O. 12372 regarding intergovernmental consultation on Federal programs and activities apply to this program.
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C.
The Department has analyzed the environmental impacts of this notice of proposed rulemaking pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
FTA has analyzed this proposed rule under E.O. 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights. FTA does not believe this proposed rule affects a taking of private property or otherwise has taking implications under Executive Order 12630.
This proposed rule meets applicable standards in sections 3(a) and 3(b)(2) of E.O. 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
FTA has analyzed this proposed rule under E.O. 13045, Protection of Children from Environmental Health Risks and Safety Risks. FTA certifies that this action will not cause an environmental risk to health or safety that might disproportionately affect children.
FTA has analyzed this proposed rule under E.O. 13175, dated November 6, 2000, and believes that it will not have substantial direct effects on one or more Indian Tribes; will not impose substantial direct compliance costs on Indian Tribal governments; and will not preempt Tribal laws. Therefore, a Tribal summary impact statement is not required.
FTA has analyzed this action under E.O. 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. FTA has determined that this action is not a significant energy action under that order and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. Therefore, a Statement of Energy Effects is not required.
A Regulation Identifier Number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this proposed rule with the Unified Agenda.
Buses, Grant programs—transportation, Motor vehicle safety, Public transportation, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Federal Transit Administration proposes to revise and republish 49 CFR part 665 to read as follows:
49 U.S.C. 5318 and 49 CFR 1.91.
An applicant for Federal financial assistance for the purchase or lease of buses with funds obligated by the Federal Transit Administration (FTA) shall certify to FTA that any new bus model acquired with such assistance has been tested and has received a passing test score in accordance with this part. This part contains the information necessary for a recipient to ensure compliance with this provision.
This part shall apply to an entity receiving Federal financial assistance under 49 U.S.C. chapter 53.
As used in this part—
Class 1—A failure that represents a serious safety hazard such as a high risk of passenger, driver, or bystander injury, or major property damage.
Class 2—A failure in which the vehicle cannot be operated and requires maintenance personnel to perform an on-road repair, or tow the vehicle to a maintenance facility.
Class 3—A failure that requires prompt repair to the vehicle, but the vehicle can be driven to a maintenance facility.
Class 4—A failure that degrades the functionality of the vehicle but does not require prompt repair.
(1) For those vehicles that are not manufactured on a third-party chassis, a change in a vehicle's engine, axle, transmission, suspension, or steering components;
(2) For those that are manufactured on a third-party chassis, a change in the vehicle's chassis from one major design to another.
(1) Has not been used in public transportation service in the United States before; or
(2) Has been used in public transportation service in the United States but which is being produced with a major change in configuration or a major change in components.
(a) In each application to FTA for the purchase or lease of any new bus model, or any bus model with a major change in configuration or components to be acquired or leased with funds obligated by FTA, the recipient shall certify that the bus model was tested at the Bus Testing Facility and that the bus received a passing test score as required in this part. A recipient may only certify under this section based on a bus testing report, or a combination of a baseline full bus testing report and a partial testing report, that each have not expired pursuant to § 665.13(g) at the time of initial contract award. The recipient shall receive the appropriate full bus testing report and any applicable partial testing report(s) before final acceptance of the first vehicle.
(b) The recipient shall be responsible for determining whether a vehicle to be acquired has satisfied the requirements of this part.
(c) When a bus manufacturer or recipient is uncertain whether full or partial testing is required for a bus model, the bus manufacturer should request an FTA review and determination of Bus Testing requirements for that bus model.
(a) In order to be tested at the Bus Testing Facility, a new model bus shall—
(1) Be a single model that complies with NHTSA requirements at 49 CFR part 565
(2) Have been produced by an entity whose Disadvantaged Business Enterprise (DBE) goals have been submitted to FTA pursuant to 49 CFR part 26;
(3) Identify the maximum rated quantity of standee passengers on the interior bulkhead in 2 inch tall or greater characters;
(4) Meet all applicable Federal Motor Vehicle Safety Standards, as defined by the National Highway Traffic Safety Administration in part 571 of this title;
(5) Be substantially representative of subsequent production buses of that model; and
(6) Identify the manufacturing point of origin for the bus structure and key components of the bus in the testing authorization request submitted to FTA.
(b) If the new bus model has not previously been tested at the Bus Testing Facility, then the new bus model shall undergo the full testing requirements for Maintainability, Reliability, Safety, Performance (including Braking Performance), Structural Integrity, Fuel Economy, Noise, and Emissions.
(c) If the new bus model has not previously been tested at the Bus Testing Facility and is being produced on a third-party chassis that has been previously tested on another bus model at the Bus Testing Facility, then the new bus model may undergo partial testing in place of full testing.
(d) Changes in chassis or components.
(1) If the new bus model has previously been tested at the Bus Testing Facility but is subsequently manufactured with a major change in chassis or components, then the new bus model may undergo partial testing in place of full testing.
(2) Unless FTA issues a written determination to the contrary, a bus model built on an unmodified third-party chassis that has previously satisfied Bus Testing requirements will not require additional testing solely due to model year updates to that chassis made by its third-party chassis manufacturer.
(e) Buses shall be tested according to the useful life category.
(f) Tests performed in a higher useful life category (
(g) Unless FTA determines that it is impractical, or insignificant, a bus model shall be tested in all of its significant modes of operation, and the resulting data shall be included in the bus testing report.
(a) The Operator of the Bus Testing Facility shall implement the performance standards and scoring system set forth in this part.
(b) Upon completion of testing, the Operator of the facility shall provide the scored test results and the resulting test report to the entity that submitted the bus for testing and to FTA. The test report will be available to recipients only after both the bus manufacturer and FTA have approved it for release. If the bus manufacturer declines to release the report, or if the bus did not achieve a passing test score, the vehicle will be ineligible for FTA financial assistance.
(c) Release of test reports.
(1) A manufacturer or dealer of a new bus model or a bus produced with a major change in component or configuration shall provide a copy of the corresponding full bus testing report and any applicable partial testing report(s) to a recipient during the point in the procurement process specified by the recipient, but in all cases before final acceptance of the first bus by the recipient.
(2) A manufacturer who releases a report under paragraph (c)(1) of this section also shall provide notice to the Operator of the facility that the test results and the test report are to be made available to the public.
(d) If a tested bus model with a bus testing report undergoes a subsequent major change in component or configuration, the manufacturer or dealer shall advise the recipient during the procurement process and shall include a description of the change. Any party may ask FTA for a determination regarding the effect of the change on the applicability of the existing bus testing report(s).
(e) A bus testing report or partial testing report shall be available publicly once the bus manufacturer makes it available during a recipient's procurement process. The Operator of the facility shall have copies of all the publicly available reports available for distribution. The Operator shall make the final test results from the approved report available electronically and accessible over the internet.
(f) The full or partial bus testing report and the test results are the only official information and documentation that shall be made publicly available in connection with any bus model tested at the Bus Testing Facility, however FTA may use anonymized Bus Testing data, aggregated Bus Testing data, or a combination to support FTA research.
(g) Effective three years after the effective date of the final rule, each full or partial bus testing report shall expire 10 years after the date of publication of such report.
(a) All requests for testing, including requests for full, partial, or repeat testing, shall be submitted to FTA in the manner and form prescribed by FTA prior to scheduling with the Operator of the Bus Testing Facility.
(b) FTA will review the request and provide an initial response within five (5) business days. FTA will then conduct a detailed review and provide a written response to the requester authorizing testing, or explaining why testing is not authorized.
(c) To schedule a bus for testing, a manufacturer shall contact the Operator of the Bus Testing Facility and reference or provide the written FTA testing authorization. Contact information and procedures for scheduling testing are available on the Operator's Bus Testing website, which will be linked from the FTA Bus Testing website.
(d) Upon contacting the Operator, the Operator shall provide the manufacturer with the following:
(1) A draft contract for the testing;
(2) A time and fee schedule; and
(3) The test procedures for the tests that will be conducted on the vehicle.
(e) The Operator shall process vehicles FTA has approved for testing in the order in which the contracts are signed.
(a) The operator shall charge fees in accordance with a schedule approved by FTA, which shall include different fees for partial testing.
(b) Fees shall be prorated for a vehicle withdrawn from the Bus Testing Facility before the completion of testing.
(c) The manufacturer's portion of the test fee shall be used first during the conduct of testing. If the Operator has concerns about continuing a test of a bus model, the Operator shall obtain approval from FTA prior to continuing testing of that bus model using the Bus Testing Program's share of the testing fee after the manufacturer's fee has been expended.
(d) A manufacturer that resubmits a bus model for testing after previously withdrawing that bus model from testing shall submit 100 percent of the applicable testing fee to the Operator prior to beginning each retest. If that bus model subsequently receives a passing score, the manufacturer shall be refunded upon publication of the resulting full or partial Bus Testing Report for FTA's share of the testing fee that was in effect when the contract was signed for the test that resulted in a published full or partial Bus Testing Report.
A manufacturer shall be responsible for transporting its vehicle to and from the Bus Testing Facility at the manufacturer's own risk and expense.
(a) Upon receipt or as early as practicable, and during testing of a bus approved by FTA for testing, the Operator shall:
(1) Inspect the bus design configuration and compare it to the configuration documented in the test authorization;
(2) Determine if the bus, when loaded to gross weight, does not exceed its gross vehicle weight rating, gross axle weight ratings, or tire load ratings;
(3) Determine if the bus is capable of negotiating the durability test track at curb weight, seated load weight, and gross vehicle weight;
(4) Determine if the bus is capable of performing the Fuel Economy and Emissions Test duty cycles within the established standards for speed deviation;
(5) Identify any safety concerns; and
(6) Identify any concerns that the bus is not suitable or fit for its intended transit service.
(b) The Operator shall present the results obtained from the activities of paragraph (a) of this section to the bus manufacturer and the FTA Bus Testing Program Manager for review and correction as needed prior to initiating testing using the Bus Testing Program funds, and any other time during testing that the bus is discovered to be non-compliant with those criteria. FTA will provide a written response within five (5) business days to authorize the start or continuation of testing or to request clarification for any discrepancies noted from the activities of (a). Testing may commence or continue after five (5) business days if FTA does not provide a response.
(c) The Operator shall perform all maintenance and repairs on the test vehicle, consistent with the manufacturer's specifications, unless the Operator determines that the nature of the maintenance or repair is best performed by the manufacturer under the Operator's supervision.
(d) The manufacturer shall be permitted to observe all tests. The manufacturer shall not provide maintenance or service unless requested to do so by the Operator.
(e) The Operator shall investigate any occurrence of unauthorized maintenance or repairs and together with FTA, if necessary, determine the potential impact to the validity of the test results. Tests where the results could have been impacted must be repeated at the manufacturer's expense.
(f) If a manufacturer requests permission to make a modification to a test vehicle to address a problem discovered during testing, the Operator shall perform the modification on the test vehicle consistent with the manufacturer's specifications, unless the Operator determines that the nature of the modification is best performed by the manufacturer under the Operator's supervision. All vehicle modifications performed after a test has started will first require review and approval by FTA. If a modification is determined to be a major change, some or all of the tests already completed shall be repeated or extended at FTA's discretion. Any modification made to a test bus will be documented in the Bus Testing Report and must be applied to future production buses of that model for such bus model to be acquired with FTA financial assistance.
(g) The Operator shall halt testing after any occurrence of unapproved, unauthorized, or unsupervised test vehicle modifications. Following an occurrence of unapproved or unsupervised test vehicle modification, the vehicle manufacturer shall submit a new test request to FTA that addresses all the requirements in § 665.11 to reenter the Bus Testing Program.
(h) The Operator shall perform tests on new bus models in the categories specified by 49 U.S.C. 5318. The tests and their corresponding performance standards are summarized in the following paragraphs, and in appendix A to this part. The Operator shall develop detailed testing procedures, which must be approved by FTA. The Operator shall make any testing procedures publicly available. If a bus model has new technologies, features, capabilities, or limitations, FTA may work with the Operator to modify the testing and reporting for such bus model to the extent necessary to meet the intent of 49 U.S.C. 5318 and this part. If a bus model has limitations that affect the testing that could be performed, the resulting full or partial bus testing report shall prominently note on the cover that the bus model has limitations that may affect its suitability for certain types of public transportation service. The report shall provide details on the nature and degree of such limitations.
(1)
(i) The Maintainability Test Report shall include the frequency, personnel hours, and replacement parts or supplies required for each action during the test. The accessibility of selected components and other observations that could be important to a bus purchaser shall be included in the report.
(ii) The performance standard for Maintainability is that no greater than the following hours of total unscheduled maintenance shall be accumulated over the execution of a test:
(A) 12-year/500,000-mile useful life category: 125 hours.
(B) 10-year/350,000-mile useful life category: 110 hours.
(C) 7-year/200,000-mile useful life category: 80 hours.
(D) 5-year/150,000-mile useful life category: 60 hours.
(E) 4-year/100,000-mile useful life category: 50 hours.
(2)
(3)
(i) The Bus Testing Report shall discuss any safety concerns discovered by the Operator and the actions taken to address those concerns prior to starting or resuming testing.
(ii) The Handling and Stability test shall be an obstacle avoidance double-lane change test performed on a smooth and level test track. The performance standard is that the test vehicle can safely negotiate and remain within the lane change test course at a speed of 45 mph.
(iii) The functionality and performance of the service, regenerative (if applicable), and parking brake systems shall be evaluated at the test track. The test bus shall be subjected to a series of brake stops from specified speeds on high, low, and split-friction surfaces. The parking brake shall be evaluated with the bus parked facing both up and down a steep grade. There are three performance standards for braking. The stopping distance from a speed of 45 mph on a high friction surface shall be based on the bus stopping distance requirements of FMVSS 105 or 121 as applicable. The bus shall remain within a standard 12-foot lane width during split coefficient brake stops. The parking brake shall hold the test vehicle stationary on a 20 percent grade facing up and down the grade for a period of 5 minutes.
(iv) A review of all the Class 1 failures that occurred during the test shall be conducted as part of the Safety test. The performance standard is that the vehicle completes testing with no uncorrected Class 1 failure modes.
(4)
(5)
(i)
(A)
(
(
(
(B)
(C)
(D)
(E)
(ii)
(6)
(i) The Fuel Economy test shall be designed only to enable FTA recipients to compare the relative fuel economy, or energy efficiency and driving range, of buses operating at a consistent loading condition on the same set of typical transit driving cycles. The results of this test are intended to be independent of fuel economy estimates by other agencies, such as the National Highway Traffic Safety Administration (NHTSA) or the U.S. Environmental Protection Agency (EPA) or for other purposes.
(ii) The performance standard for the Fuel Economy test is that the vehicle shall be compliant with the prevailing model year fuel consumption standards for heavy-duty vocational vehicles outlined in NHTSA's Medium and
(iii) Scoring for the Fuel Economy test shall be pro-rated for vehicles that use more than one fuel type or energy source. Plug-in hybrid vehicles will be pro-rated using industry standards, otherwise, dual-fuel or multi-fuel vehicles will be pro-rated by each fuel source equally for scoring purposes.
(7)
(8)
(i) The Emissions test is not a certification test and is designed only to enable FTA recipients to compare the relative emissions of buses operating on the same set of typical transit driving cycles. The results of this test need not be directly comparable to emissions measurements reported to other agencies, such as the EPA, or for other purposes.
(ii) The emissions performance standard shall be based on the prevailing EPA emissions requirements for heavy-duty vehicles outlined in 40 CFR part 86 and 40 CFR part 1037.
(iii) Buses that are defined by EPA as “zero-emission vehicles” are categorically exempt from the Emissions test of this part.
The Bus Model Scoring System shall be used to score the test results using the performance standards in each category. A bus model that fails to meet a minimum performance standard shall be deemed to have failed the test and will not receive an aggregate score. For buses that have passed all the minimum performance standards, an aggregate score shall be generated and presented in each bus testing report. A bus model that just satisfies the minimum baseline performance standard and does not exceed any of the standards shall receive a score of 60. The maximum score a bus model shall receive is 100. The minimum and maximum points available in each test category shall be as shown below in Table A. The bus testing report will include a scoring summary table that displays the resulting scores in each of the test categories and subcategories. The scoring summary table shall have a disclaimer footnote stating that the use of the scoring system is not mandatory, only that the bus being procured receive a passing score.
The passing standard shall be a score of 60. Bus models that fail to meet one or more of the minimum baseline performance standards will be ineligible to obtain an aggregate passing score.
Fish and Wildlife Service, Interior.
Proposed rule.
The U.S. Fish and Wildlife Service (Service or we) is proposing changes to the administrative process for authorizing seasonal migratory game bird hunting in the United States. Migratory game bird hunting regulations are currently promulgated annually to provide opportunities for recreation and sustenance; aid Federal, State, and Tribal governments in the management of migratory game birds; and allow harvests at levels compatible with migratory game bird population status and habitat conditions.The Service proposes a more efficient administrative process for authorizing seasonal migratory game bird hunting. The Service would issue a memorandum for migratory game bird hunting once every 3 years. The Service would continue to make annual decisions on harvest levels and would update the memorandum sooner than 3 years if changes are prescribed by our decision frameworks. The process eliminates the need for subsequent annual Federal regulation promulgation and rulemaking and is expected to increase efficiency; better meet State, Tribal, and Federal rulemaking constraints; and reduce the complexity and costs. Our goal is to better serve State partners and the hunting public while continuing to meet the legal and conservation purposes of the Migratory Bird Treaty Act. Tribes are already authorized under a similar process.
You may comment on this proposed rule until July 27, 2026.
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Comments submitted through any method not authorized in this document, or sent to an address not listed here, will not be considered. We will not accept comments via email, fax, or hand delivery. We are not required to consider comments that are submitted after the comment period ends or that are submitted via a method outside of these instructions. Comments containing profanity, vulgarity, threats, or other inappropriate content will not be considered.
We will post all comments at
Jerome Ford, U.S. Fish and Wildlife Service, Department of the Interior, (703) 358-2606. Individuals in the United States who are deaf, deafblind, hard of hearing, or have a speech disability may dial 711 (TTY, TDD, or TeleBraille) to access telecommunications relay services. Individuals outside the United States should use the relay services offered within their country to make international calls to the point of contact in the United States. Please see Docket No. FWS-HQ-MB-2024-0206 on
Migratory game birds are species designated in the conventions between the United States and several foreign nations for the protection and management of migratory birds. The conventions restrict migratory game bird hunting to the fall-winter period (1 September-10 March) and not more than 3.5 months (interpreted as 107 days) for any species. Under the Migratory Bird Treaty Act (MBTA; 16 U.S.C. 703-712), the Secretary of the Interior is authorized and directed to determine when and to what extent “hunting, taking, capture, killing, possession, sale, purchase, shipment, transportation, carriage, or export of any such bird, or any part, nest, or egg” of migratory game birds can take place compatible with the terms of the conventions, and to adopt regulations for this purpose (16 U.S.C. 704(a)). The Secretary is authorized and directed to give “due regard to the zones of temperature and to the distribution, abundance, economic value, breeding habits, and times and lines of migratory flight of such birds” (16 U.S.C. 704(a)). This responsibility has been delegated to the Service as the lead Federal agency for managing and conserving migratory birds in the United States.
The Service established regulations governing migratory game bird hunting at title 50 part 20 of the Code of Federal Regulations (50 CFR 20). Currently, the Service publishes additional annual regulations (50 CFR 20 subpart K) to authorize migratory game bird hunting for the season. These regulations set the parameters for open seasons including season dates, season lengths, shooting hours, daily bag and possession limits, areas where hunting may occur, and other restrictions based on biological data. The annual regulations ensure that harvest occurs at levels compatible with migratory game bird population demographics, including production and survival, which vary in space and time with habitat conditions. These conditions may differ over North America, and within the United States. (For purposes of our regulations, and in this proposed rule, the term “States” includes the territories of Puerto Rico and the U.S. Virgin Islands, consistent with 50 CFR 10.12).
Migratory game birds use four primary migratory routes in North America. Because of the unique biological characteristics and the relative number of hunters in these routes, the Service adopted the flyway structure for administering migratory bird resources within the United States, referred to as the flyways (Atlantic, Mississippi, Central, and Pacific). The current annual migratory bird hunting regulations at 50 CFR part 20 subpart K establish regulations for each administrative flyway including all or portions of States in the 48 conterminous United States. We may have separate regulations in Alaska,
Each administrative flyway has a Flyway Council, a formal organization established through the Association of Fish and Wildlife Agencies. Flyway Councils are administrative bodies that forge cooperation among public wildlife agencies for the purpose of protecting and conserving migratory birds that inhabit North America. Flyway Councils are composed of one member from each State within the Flyway, as well as States in Mexico and Provinces in Canada that share migratory bird populations. The Flyway Councils coordinate and collect information on the status of migratory game birds, establish regulatory decision frameworks, review available biological information, and make recommendations for appropriate parameters for migratory game bird hunting regulations. However, voting members are only those representing States and Territories within the United States. Service representatives participate in the Flyway Councils. Meetings typically occur every March and September and are open to the public.
To support the annual regulation process, Service biologists gather, analyze, and interpret biological survey data and provide this information to all those involved in the process through a series of published status reports and presentations to Flyway Councils and other interested parties. The Service considers abundance of migratory game birds and other biological factors; and therefore, undertake several surveys throughout the year in conjunction with Service Regional Offices, the Canadian Wildlife Service, and State and Provincial wildlife management agencies. To determine the appropriate annual regulations authorizing hunting for certain game bird species and populations, we consider factors such as population size and trend, geographical distribution, reproductive capacity, condition of breeding and wintering habitat, number of hunters, and anticipated harvest.
The Service Migratory Bird Regulations Committee (SRC) and Flyway Councils recommend to the Service appropriate parameters for State and Tribal migratory game bird hunting regulations. The SRC conducts meetings, generally in the spring and fall, to review and discuss information on the status of migratory game birds and recommendations from the four Flyway Councils and the Service. The SRC then develops recommendations for parameters for annual State and Tribal migratory game bird hunting regulations. In accordance with current regulations at 50 CFR 20.153, these meetings are open to public observation, and observers may submit written comments to the Service on the matters to be discussed. The SRC then submits recommendations to the Service for review. If approved, they are published in one of the several annual rulemaking documents for public comment.
The current administrative process for authorizing seasonal migratory game bird hunting requires annual promulgation of State-specific Federal regulations to open the hunting season. These annual regulations expire at the end of the hunting season. The process involves publishing a series of at least four proposed and final rulemaking documents in the
(1) A proposed rule (preliminary) that provides the process, regulatory schedule, and initial proposals for seasons, limits, and other regulations for annual migratory game bird hunting.
(2) A proposed rule that proposes the parameters within which States may select hunting seasons. The parameters specify season dates, season lengths, shooting hours, daily bag and possession limits, areas where hunting may occur, and other restrictions.
(3) A final rule that establishes the final parameters within which States and Tribes may select hunting seasons, including season dates, season length, shooting hours, daily bag and possessions limits, areas where hunting may occur, and other restrictions. This final rule incorporates public comments received on the proposed frameworks rule and recommendations from the Flyway Councils.
(4) A final rule that sets forth the annual regulations in subpart K of 50 CFR part 20 to authorize the migratory game bird hunting seasons in each State. This final rule is developed based on a process where each State submits their selection of annual hunting seasons within our parameters.
The process of establishing annual migratory game bird hunting regulations is both complex and time intensive. It begins with extensive data collection from May through December of the preceding calendar year, followed by several months of coordination with state agencies through the Flyway Councils. These efforts culminate in regulatory decisions made by the SRC. Each phase of this process is tightly sequenced, limiting flexibility in the timing of regulatory actions. Additionally, the targeted opening date of September 1 for hunting seasons imposes a hard deadline under which regulations must be finalized through the federal rulemaking process before any seasons can legally begin. This provides only a few months to complete a 4-publication rulemaking process every year. The Service has narrowly met publication deadlines in the last 8 years (2018-2025 hunting seasons; average publication of final rule 7 days prior to the start of the hunting season), placing undue strain on States, the public, and the Service. We provided a detailed overview of the current process and administrative schedule in our August 6, 2015, proposed rule for the 2016-17 migratory game bird hunting season (80 FR 47388).
To alleviate the time constraint issues, the Service proposes to change the process for authorizing seasonal migratory game bird hunting. We propose to codify in Federal regulations a streamlined annual process for authorizing migratory game bird hunting. This would replace the need for annual Federal regulation promulgation and reduce the need for future rulemaking in the
(1) The process for determining the parameters (“authorization conditions”) within which States and Tribes may establish their annual regulations;
(2) The process for communicating the authorization conditions to States and Tribes through a Migratory Game Bird Hunting (MGBH) memorandum and notice of availability in the
(3) Authorization for States and Tribes to establish migratory game bird hunting regulations in accordance with the authorization conditions set forth in the MGBH memorandum and regulations at 50 CFR part 20.
Federal regulation of migratory game bird hunting has been in place since 1918 under the MBTA, which directs the Secretary of the Interior to authorize hunting based on periodic assessments of bird population status and habitat conditions. The original regulatory process was straightforward due to limited biological information and relatively low hunter participation. As scientific understanding, data availability, and hunter participation increased, the regulatory process expanded in complexity to ensure resultant regulations were based on
Over time, the annual rulemaking process has become increasingly burdensome for States, the public, and the Service due to compressed publication timelines, administrative inefficiencies, and the growing volume of technical material required to support annual updates. These challenges have constrained transparency and limit the ability of States, Tribes, and the public to plan effectively.
The proposed process maintains all statutory obligations under the MBTA while improving administrative efficiency. Section 704(a) grants the Secretary broad discretion to issue regulations governing take and does not require annual rulemaking. Likewise, section 704(c)(3) imposes no annual requirement and ensures consistency with amendments enacted in the Dingell Act of 2019, including the January 31 framework closing date for hunting ducks, mergansers, and coots. Together, these provisions allow continued flexibility in how regulatory decisions are issued while fully adhering to statutory direction. The new approach retains annual biological assessments and decision-making but eliminates unnecessary repetition in the administrative process, thereby enhancing timeliness, clarity, and public accessibility.
By codifying these provisions in regulations, annual rulemaking would no longer be required to authorize seasonal migratory game bird hunting. Future rulemaking would be infrequent and undertaken only if changes to the underlying process are warranted. The proposed process is similar to that established for Tribes (50 CFR 20.110) where Tribes are authorized to establish hunting regulations within our basic regulations and annual parameters. The proposed process also aligns with the regulations at 50 CFR 92 authorizing Alaska subsistence hunting, where the regulations do not expire and thus do not have to be established annually before seasonal hunting may occur.
We are not proposing any changes to the biological approach or the process used to determine the appropriate parameters from which States and Tribes may establish their migratory game bird hunting regulations. The Service will continue biological monitoring and assessment consistent with the programmatic document, “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (EIS 20130139).
This rulemaking proposes changes to the administrative process for authorizing seasonal migratory game bird hunting. We propose these changes to increase efficiency; better meet Federal, State, and Tribal rulemaking constraints; and reduce the complexity and costs associated with promulgating annual migratory game bird hunting regulations. Our goal is to better serve State and Tribal partners and the hunting public while continuing to meet the legal and conservation purposes of the MBTA.
The nationwide economic effects generated by migratory game bird hunting are substantial, as detailed in the most recent annual rulemaking, estimated at about $2.7 billion in associated economic activity. Small, incremental adjustments made to Federal migratory bird hunting authorization conditions (limits) are not expected to materially alter those underlying economic inputs nor impose additional Federal costs. As a result, preparing a full Regulatory Impact Analysis for every annual MGBH memorandum would provide limited additional value for Federal decision-making. Annual adjustments to season lengths or bag limits have historically produced minimal and highly variable economic effects, and available evidence shows hunter participation remains stable despite such changes. As all previous annual rulemakings under the current administrative process have been “economically significant” actions under section 3(f)(1) of E.O. 12866, we intend to continue preparing a full Regulatory Impact Analysis, following the directives in E.O. 12866 for economically significant actions and the guidelines in Circular A-4, for the primary MGBH memorandum issued every 3 years under the new process to ensure continued sustainable harvest levels while also minimizing negative economic impacts.
Table 1 provides a comparison between the existing and proposed new processes for each major component in the process of authorizing seasonal migratory game bird hunting. The following sections describe the proposed changes in greater detail.
We propose the following changes to 50 CFR 20 subparts H, K, and N. In subpart H, we would revise §§ 20.71 and 20.72 to provide that a violation of our regulations or of any State or Tribal law or regulation for migratory game bird hunting constitutes a violation of Federal law. However, we would retain existing language in subpart H that prohibits take of migratory game birds except as provided in Federal, State, and Tribal hunting regulations.
In subpart K, we would remove the regulations at §§ 20.100-20.107 (annual seasons and limits) and replace them with the procedures and provisions most recently adopted in earlier rules for establishing annual regulations for migratory game bird hunting, and we would no longer establish these through an annual rulemaking process. We propose to retain in subpart K the current regulations in § 20.108 (nontoxic shot zones) and § 20.110 (regulations for certain Federal Indian reservations and ceded lands), as the regulations in these sections are outside the scope of this rulemaking action. We also propose to codify in our regulations at § 20.109 (extended seasons for taking migratory game birds by falconry) the unchanged parameters for special falconry seasons previously specified annually in preambles to rulemaking documents since at least the 2000-01 season. For the most recent final rule adopting the season parameters see 89 FR 68500 at 68518 (under Q. Special Falconry Regulations, August 26, 2024).
We would eliminate subpart N by moving the existing regulations regarding the Service Migratory Bird Regulations Committee and Flyway Councils to subpart K, which describes the administrative process for authorizing States and Tribes to establish their regulations for migratory game bird hunting.
We are also proposing minor, nonsubstantive terminology changes to subpart B at § 20.11, subpart C at § 20.21 and § 20.23, and subpart K at § 20.110 to align with the new process. At § 20.11, we propose additional nonsubstantive edits to correct two typographical errors. We would further update subpart C at § 20.21 to recognize the split of cackling goose (
The Service would publish the Migratory Game Bird Hunting (MGBH) memorandum and notice in the
The MGBH memorandum would authorize seasonal hunting for certain designated migratory game bird groups or species of in the conterminous United States, Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands. Migratory game birds are defined in regulations at 50 CFR part 20, subpart B, at § 20.11 as those species included in the terms of the Conventions for the protection of migratory birds and belonging to five families of birds and for which open seasons are authorized in 50 CFR part 20. Open hunting seasons may include certain designated members of the avian families Anatidae (ducks, geese, and swans); Columbidae (doves and pigeons); Gruidae (cranes); Rallidae (rails, coots, and gallinules); and Scolopacidae (shorebirds including woodcock and snipe). The Service maintains a list at 50 CFR 10.13 of all species considered migratory birds and protected by the MBTA, and we review and update this list regularly (see 88 FR 49310, July 31, 2023, for the most recent update). There are currently 185 migratory game bird species that may be subject to open hunting seasons based on the game bird families identified in § 20.11 and associated species at § 10.13. The regulations for the 2024-25 hunting seasons established open hunting seasons in at least some part of the United States for 93 of these species. We would not authorize hunting through the MGBH memorandum for any migratory game bird species group (
To determine the authorization conditions, we would apply the most current information on game bird demographics and habitat conditions to the decision frameworks previously adopted through rulemaking or notice published in the
We would make available the MGBH memorandum at the address indicated in
The notice of availability of the MGBH memorandum in the
States and Tribes would establish regulations for migratory game bird hunting seasons through their own development processes that are within the Federal authorization conditions set forth in the MGBH memorandum and in accordance with Federal regulations. State and Tribal regulations for migratory game bird hunting would be federally authorized provided they are within the Federal authorization conditions provided in the MGBH memorandum and notice in the
The Service would no longer continue the current practice of publishing State annual hunting regulations as Federal regulations. We recognize that this may be a transition for some states. Therefore, the Service may continue to publish State annual hunting regulations for up to 3 years for those few States that do not currently have their own processes for issuing annual migratory game bird hunting regulations. These State annual regulations would be published as a Federal policy memorandum, separate from the MGBH memorandum, available at the address indicated in
The Service will continue to have public Flyway and SRC meetings, public review of notifications in the
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Like the current administrative process, we propose to determine authorization conditions using decision frameworks based on the U.S. Code and the Code of Federal Regulations or adopted in the
The authorization conditions for 24 species or species groups are currently established based on 16 decision frameworks, and some have been in use for 30 years. For example, adaptive harvest management (AHM) decision frameworks for duck harvest management, a specific kind of decision framework including a formal mechanism for reducing uncertainty over time, were first implemented in 1995. The decision frameworks for determination of authorization conditions for hunting migratory game birds are listed in Table 2 below. We propose maintaining a list of current decision frameworks used to determine authorization conditions and post these on the Service's website
Currently, determination of some authorization conditions depends on Flyway Council recommendations based on formal Council harvest strategies (
As with the current administrative process, this proposed process applies biological data (
We note that the Service and Flyway Councils have not recommended deviation from the prescriptions of the general duck season decision frameworks since they were first implemented in 1995. Thus, for nearly 30 years, we have applied current biological data to established decision frameworks and accepted the outcomes as the authorization conditions for the general duck seasons. However, a notable example of a more restrictive deviation from a species-specific decision framework occurred for the northern pintail season in 2002 (67 FR 59110, September 19, 2002) and 2003 (68 FR 55784, September 26, 2003), when unforeseen circumstances (record low numbers, combined with the poor production forecast) indicated that a departure from the pintail decision framework was justified and consistent with the Council recommendations we received in those years. The Councils and Service revised the decision framework for northern pintails in 2004 to incorporate the new information (69 FR 52970, August 30, 2004). Also, the Atlantic Flyway Council and Service
The two cases of restrictive deviations from decision frameworks in at least the last 30 years indicate that such departures are unlikely. Restrictive deviations are unlikely because unforeseen circumstances rarely occur given the long-term nature of monitoring programs, some since 1955, and our decision frameworks are developed based on observed long-term demographic data. If the Councils and SRC recommend any liberalization beyond the authorization conditions prescribed by the decision framework, those changes would be reviewed by the Service, and, if supported, we would initiate a rulemaking to revise the decision framework.
In some cases, for reasons outside our control, we may need to temporarily and minimally deviate from our decision frameworks to address missing data. For example, due to the coronavirus pandemic and associated travel restrictions and human health concerns in the United States and Canada, certain migratory bird monitoring surveys were cancelled in 2020 and 2021. As such, the Waterfowl Breeding Population and Habitat Survey, which provides status information for many species of waterfowl, including those used in our AHM decision frameworks, were cancelled during those years. When unforeseen data gaps occur, as in 2020 and 2021, the Service may need to use time series forecasting tools and population and habitat models to make inference to current population status as needed in established decision frameworks. Such deviations would be limited to those necessary to determine appropriate authorization conditions in existing decision frameworks. Any deviation would be described in the MGBH memorandum, with any longer-term adjustments to decision frameworks addressed through future rulemaking. Temporary deviations from decision frameworks to address data gaps fall within the scope of existing regulatory authority and maintain intent of established decision frameworks. These temporary adjustments apply the best available data and scientific methods within the established framework and are critical to making informed decisions about appropriate authorization conditions for the current season when this would otherwise not be possible in the case of missing data. The compulsory, minimal, and urgent nature of these temporary deviations are appropriately communicated through the MGBH memorandum rather than through a separate rulemaking.
Any technical updates or adjustments to the federally established decision frameworks would be published in a notice in the
These technical updates are discussed at public meetings including the Flyway Council and SRC meetings and are open to public comment. After receiving support from the Flyway Councils and SRC, technical updates or changes to decision frameworks would be published in a
We periodically publish reports that provide detailed information on the status and harvest of certain migratory game bird species. These reports contain descriptions of species population segments referenced in status assessments. These reports are available at the address indicated in
We would use the most recently published reports in the development of annual authorization conditions for migratory game bird hunting. These reports currently include the following:
• Adaptive Harvest Management;
• American Woodcock Population Status;
• Band-tailed Pigeon Population Status;
• Migratory Bird Hunting Activity and Harvest;
• Mourning Dove Population Status;
• Status and Harvests of Sandhill Cranes, Mid-continent, Rocky Mountain, Lower Colorado River Valley and Eastern Populations; and
• Waterfowl Population Status.
Additional information, status reports, and special assessments may be provided by the Service and each of the four Flyway Councils.
Our long-term objectives continue to include providing opportunities to harvest portions of certain migratory game bird populations and to limit harvests to levels compatible with each population's ability to maintain healthy, viable numbers. The Service's goals and objectives for migratory game bird harvest management are specified in a 2013 supplemental environmental impact statement (notice of availability published at 78 FR 32686, May 31, 2013) and the proposed rule that published at 52 FR 7900, March 13, 1987. Migratory game bird hunting seasons provide opportunities for recreation and sustenance, and aid Federal, State, and Tribal governments in the management of migratory game birds.
We periodically receive recommendations on the authorization conditions and other policies and regulations for migratory game bird hunting from the four Flyway Councils at the SRC meetings, generally held in spring and fall. We may also receive public comments from the SRC meetings and notices published in the
We will continue to use our AHM decision frameworks to determine appropriate regulatory alternatives for annual duck hunting as described in earlier rulemaking for annual migratory game bird hunting regulations (89 FR 68500, August 26, 2024). AHM is a tool that permits sound resource decisions in the face of uncertain regulatory impacts and provides a mechanism for reducing that uncertainty over time. We use an AHM decision framework to evaluate four regulatory alternatives, each with a different expected harvest level, and choose the optimal alternative for duck hunting authorization conditions based on the status and demographics of mallards for the Mississippi, Central, and Pacific Flyways, and based on the status and demographics of four duck species (green-winged teal, common goldeneye, ring-necked duck, and wood duck) in the Atlantic Flyway. We have species-specific AHM decision frameworks that guide appropriate authorization conditions for species of special concern, including black ducks, scaup, northern pintails, and mallards in the Atlantic Flyway (eastern mallards), within the general duck hunting regulations. These protocols have species-specific regulatory alternatives but share some aspects of the regulatory alternatives for the general duck seasons.
We currently use independent optimizations to determine the appropriate regulatory alternative based on the status of mallards in the Mississippi, Central, and Pacific Flyways and status of the four duck species mentioned above in the Atlantic Flyway. This means that we develop authorization conditions for mid-continent mallards, western mallards, and eastern ducks independently based on the breeding ducks that contribute primarily to each Flyway. These species-populations are a surrogate for the status of ducks in general in each flyway. We provided an overview of the AHM decision frameworks for general duck hunting authorization conditions in each Flyway in an August 26, 2024, rule (89 FR 68500).
The regulatory alternatives considered in the general duck season AHM decision frameworks associated with each flyway were described in a January 21, 2025, proposed rule (90 FR 7056). Regulatory alternatives include opening and closing dates, season lengths, daily bag limits, and shooting hours. Current regulatory alternatives for each of the four flyways include restrictive (relatively short seasons and low daily bag limits), moderate (intermediate season lengths and daily bag limits), liberal (longer seasons, higher daily bag limits), and closed seasons. The authorization conditions within each of these alternatives may vary by flyway. The differences in season lengths and daily bag limits among flyways reflect the historic differences in waterfowl abundance and hunter numbers in these regions. Each regulatory alternative has an associated target harvest rate for one or more species as a representative of all duck species.
AHM decision frameworks are used with the most current population status, habitat, and harvest survey data to govern the selection of one of the regulatory alternatives (
The basic structure of the current regulatory alternatives for AHM was adopted in 1997 (beginning with the 1997-98 general duck hunting season; 62 FR 31298, June 6, 1997). Changes to these alternatives have been infrequent and are detailed in the January 21, 2025, proposed rule (90 FR 7056). The alternatives were last revised beginning with the 2021-22 hunting season based on recommendations of the Flyway Councils (85 FR 51854, August 21, 2020).
We anticipate that, under the AHM approach, the regulatory alternatives will remain the same over time, because the optimization process assumes that the expected harvest rates resulting from the various alternatives remain constant over long-term (about 100 years) forecasting. That process accounts for the uncertainty resulting from the difference between projected harvest rates and actual harvest rates in any given year. Recognizing that constituents may favor periodic adjustments to the regulatory alternatives, we propose adopting a regular process to review and incorporate possible modifications.
Although in the past the Service adopted the regulatory alternatives annually, that process does not account for the need to maintain predictable harvest projections for the optimization step in the current AHM process. We expect annual changes to the regulatory alternatives to have a negative impact on our ability to predict the harvest associated with each regulatory alternative. This approach would result in greater uncertainty in forecasting the impacts of the regulatory alternatives for a given set of environmental and biological conditions.
We propose adopting in regulations the same regulatory alternatives for the general duck seasons that have been in effect since the 2021-22 season. (See 90 FR 17300 at 17302 (under B. Regulatory Alternatives), April 24, 2025, for the most recent rulemaking document that adopted the alternatives used prior to this proposed rule and 90 FR 7056 at 7061 (under B. Regulatory Alternatives), January 21, 2025, for a description of the alternatives and their history.) We also propose to codify in regulations restrictions on the frequency of changes to these regulatory alternatives because of the need to maintain predictable harvest projections for the optimization step in the AHM decision frameworks. We intend to have the first open review and possible modification of these regulatory alternatives no sooner than 2026. The last modification occurred in 2021. Establishing duck regulatory alternatives for 5-year periods was the preferred alternative in the “Second Final Supplemental Environmental Impact Statement: Issuance of Annual
The intent for open review and possible modification of these regulatory alternatives should begin with an announcement of the intent by either the Service or Flyway Councils at an SRC meeting at least 1 year prior to possible adoption of modifications. The modification of the regulatory alternatives for general duck seasons would be a rulemaking process with both proposed and final rules. We would include a regulatory impact analysis as part of these periodic rulemakings and continue work to expand the robustness of the analyses we completed in earlier rulemaking actions under the current hunting regulations process (see the 2025-26 hunting season final rule, 90 FR 40178 at 40192, August 18, 2025, and economic analysis at
We note that we are proposing to codify alternatives for general duck hunting in regulations. However, regulatory alternatives from other decision frameworks are specified only in the preambles to rulemaking documents, not in the Code of Federal Regulations. We are proposing to codify the duck hunting alternatives because the alternatives for general duck hunting apply in some aspects to multiple decision frameworks including those for duck species of special concern (
Zones and split seasons are designed to distribute hunting opportunities and harvests according to temporal, geographic, and demographic variability in waterfowl and other migratory game bird populations. For ducks, States have been allowed the option of splitting their allotted hunting days into two or three temporal segments to take advantage of species-specific peaks of abundance or to satisfy hunters in different areas who want to hunt during the peak of waterfowl abundance in their area. However, the split-season option does not fully satisfy many States that wish to provide a more equitable distribution of harvest opportunities. Therefore, we also have allowed the establishment of independent seasons in up to four geographic zones within States for the purpose of providing more equitable distribution of harvest opportunity for hunters throughout the State.
In 1978, we prepared an environmental assessment (EA) on the use of zones to set duck hunting regulations. A primary tenet of the 1978 EA was that zoning would be used to provide equitable distribution of duck hunting opportunities within a State or region. The intent was not to increase total annual waterfowl harvest in the zoned areas; target harvest levels were to be adjusted downward if they exceeded traditional levels because of zoning.
In 1990, we conducted a review of the use of zones and split seasons. We determined that the ability to detect the impacts of zones and splits on waterfowl demographics and harvest was poor because of the absence of adequate study designs and experimental controls, limitations in monitoring capacities, imprecise parameter estimates, and low power to detect changes in parameter estimates. Substantial concern remained about the unknown consequences of zones and split seasons on duck populations and harvest redistribution among States and flyways, potential reduced effectiveness of regulations (season length and bag limit) to reduce duck harvest if needed, and the administrative burden associated with changing regulations annually. Consequently, we established guidelines to provide a framework for controlling the proliferation of zones and split seasons. The guidelines identified a limited number of zone and split-season configurations that could be used for duck hunting and restricted the frequency of changes in State selection among these configurations to the first year of each 5-year interval (
In 2011, we prepared a new EA analyzing proposed changes to the guidelines for zones and split seasons. Revised guidelines were finalized in the preamble to a 2011 proposed rule (76 FR 53536, August 26, 2011). In 2020, at the request of the four Flyway Councils, we modified the existing guidelines for duck zones and split seasons to allow an additional configuration including two zones with up to three season segments per zone for use beginning with the 2021 duck hunting season (85 FR 51854, August 21, 2020). States that select this new configuration must conduct an evaluation of impacts to hunter dynamics (
Previously, we established guidelines for duck zones and split seasons for each 5-year period via rulemaking (proposed and final rules) regardless of changes to the guidelines. We now propose to codify the existing guidelines for duck zones and split seasons (85 FR 51854, August 21, 2020), with minor clarifications, in our regulations. By codifying existing guidelines in regulations, we would need to undertake rulemaking only if we decide to modify the guidelines. To modify the guidelines for duck zones and split seasons, we would initiate a new rulemaking and issue proposed and final rules. Any changes to the guidelines would apply beginning the first year of the subsequent 5-year interval to maintain consistency in configurations within the intervals. At least 1 year prior to the possible adoption of any modifications, either the Service or Flyway Councils would announce at an SRC meeting their intent to review and possibly modify the guidelines.
When we first implemented guidelines for duck zones and split seasons in 1991, several States had completed experiments with zone and
(1) The new arrangement must conform to one of the currently allowable configurations; and
(2) The State may not revert to the special case arrangement that it previously had in place.
The following guidelines for zones and split seasons apply only for the regular duck season:
(1) A zone is a geographic area or portion of a State, with a contiguous boundary, for which independent dates may be selected for the regular duck season.
(2) States wishing to change their duck zone and split-season configurations may do so the first year of the 5-year period that it would apply (
(3) Once a zone and split-season configuration is selected, it must remain in place for 5 consecutive years.
(4) Only minor (less than one county in size) zone boundary changes are allowed for any special case arrangement, and such changes are allowed only the first year of the 5-year period during which it would apply.
(5) Minor (less than one county in size) zone boundary changes may be allowed for any State to resolve law enforcement or other boundary clarification issues resulting from implication of a new configuration. Changes would be evaluated on a case-by-case basis and must be approved by the respective Flyway Council and the SRC.
(6) Consideration of changes for management-unit boundaries is not subject to the guidelines and provisions governing the use of zones and split seasons for ducks.
Any State may continue their zone and split-season configuration used in the previous 5-year period. If changes are made, the zone and split-season configuration must conform to one of the following five options:
(1) One zone (same as no zones) with up to three season segments;
(2) Two zones with up to two season segments in each zone;
(3) Two zones with up to three season segments in each zone;
(4) Three zones with up to two season segments in each zone; or
(5) Four zones with a continuous season (
Because the two zones and three season segments configuration is new, States that select this configuration must conduct a one-time evaluation of impacts to hunter dynamics (
For the States that have a recognized management unit (Columbia Basin Management Unit in the Pacific Flyway, High Plains Management Unit in the Central Flyway) and include a non-management unit portion, an independent two-segment duck season with no zones can be selected for the management unit. The remainder of the State in the non-management unit portion can be zoned and have split seasons according to existing guidelines. In the Central Flyway, additional duck season days afforded to the management unit must occur on or after the Saturday nearest December 10.
States wishing to change their duck hunting zone and split-season configuration selection from within our established guidelines must provide their selected configuration and zone descriptions to the Service's Migratory Bird Program by the end of August in the year prior to the first year of the 5-year period that the selection would apply. However, we encourage States to submit their selections and zone boundaries as soon as possible. The Service's Migratory Bird Program will approve State selections once they are determined to be consistent with the above guidelines and zones and split-season configurations and boundary descriptions are complete. Any discrepancies between the State selections and the zone and split-season guidelines and configurations would be addressed by the SRC at their fall meeting, generally held in October. States may continue their zone and split-season configuration used in the previous 5-year period, and we will assume this is the case unless we receive configuration selections and zone descriptions from the State by the deadline for requesting configuration changes. We propose to publish State-selected duck zone and split-season configurations and zone descriptions in the MGBH memorandum.
In 2004, we recognized the need to work with the States to review our current policy regarding zoning for dove hunting (69 FR 52970, August 30, 2004). We asked the Flyway Councils and Mourning Dove Management Unit Technical Committees to review the current policies regarding the use of zones and split seasons for dove hunting, with a view toward establishing guidelines for the use of these harvest-management tools, as has been done for ducks. Items considered included the number of zone and split-season configurations among which each State may choose, the frequency with which each State may change their configuration selection, and the need for a restricted framework opening date in southern zones. In 2006, we adopted a set of guidelines for dove zones and split seasons applicable in the Eastern and Central Mourning Dove Management Units (EMU and CMU) based on recommendations of the Atlantic, Mississippi, and Central Flyway Councils for use beginning with the 2007 hunting season and conforming to those 5-year periods used for ducks, for example, 2021-25 hunting seasons (71 FR 51406, August 29, 2006). These guidelines were not extended to the Western Management Unit (WMU) at the time because they were not endorsed by the Pacific Flyway Council and no dove zones occurred in the WMU. Furthermore, the framework season length in the WMU was 30 consecutive days, except in Arizona and California where the season length was 60 days and could be split into two segments.
The season length in the WMU was expanded to 60 days beginning with the 2014 hunting season (78 FR 52658 at 52662, August 23, 2013, and 79 FR 51402 at 51405, August 28, 2014). The Pacific Flyway Council requested the same flexibility for zones and split seasons that we have afforded the EMU and CMU, with the exception that the WMU would be allowed only two season segments in one or both zones rather than three. Thus, in 2020, we extended the guidelines for dove zones and split seasons to the WMU, with the exception that seasons may be split into no more than two segments (85 FR 51854, August 21, 2020).
Similar to the situation for ducks, described above, we previously established guidelines for dove zones and split seasons for each 5-year period via rulemaking (proposed and final rules) regardless of changes to the guidelines. We now propose adopting
When we first implemented the guidelines for dove zones and split seasons in 2006, some States had completed experiments with zone and split-season arrangements different from our original options. We offered those States a one-time opportunity to continue those arrangements (special case), with the stipulation that only minor changes could be made to zone boundaries. If any of those States now wish to change their zone and split arrangement:
(1) The new arrangement must conform to one of the currently allowable configurations; and
(2) The State may not revert to the special case arrangement that it previously had in place.
The following guidelines for zones and split seasons apply only for the regular dove season:
(1) A zone is a geographic area or portion of a State, with a contiguous boundary, for which independent seasons may be selected for the regular dove season.
(2) States wishing to change their dove zone and split-season configurations may do so the first year of the 5-year period that it would apply (
(3) Once a zone and split-season configuration is selected, it must remain in place for 5 consecutive years.
(4) Only minor (less than one county in size) zone boundary changes would be allowed for any special case arrangement, and such changes are allowed only beginning the first year of the 5-year period during which it would apply.
(5) Minor (less than one county in size) zone boundary changes may be allowed for any State to resolve law enforcement or other boundary clarification issues resulting from implication of a new configuration. Changes would be evaluated on a case-by-case basis and must be approved by the respective Flyway Council and the SRC.
Any State may continue their dove zone and split-season configuration selected in the previous 5-year period. If changes are made, the zone and split-season configuration must conform to one of the following two options:
(1) One zone (same as no zones) with up to three season segments; or
(2) Two zones with up to three season segments in each zone, except in the WMU where the season in one or both zones may be split into two segments.
The process for States to select their dove hunting zone and split-season configuration is the same as that for selecting the duck hunting zone and split-season configuration. States wishing to change their dove zone and split-season configuration selection from within our established guidelines must provide their selected configuration and zone descriptions to the Service's Migratory Bird Program by the end of August in the year prior to the first year of the 5-year period that the selection would apply. However, we encourage States to submit their selections and zone boundaries as soon as possible. As proposed, the Service's Migratory Bird Program will approve State selections once they are determined to be consistent with the above guidelines and zones and split-season configurations and boundary descriptions are complete. Any discrepancies between the State selections and the zone and split-season guidelines and configurations would be addressed by the SRC at their fall meeting, generally held in October. States may continue their zone and split-season configuration used in the previous 5-year period, and we would assume this is the case unless we receive configuration selections and zone descriptions from the State by the deadline for requesting configuration changes. We propose to publish State-selected dove zone and split-season configurations and zone descriptions in the MGBH memorandum.
Special seasons may be used for species considered to be underutilized, to address nuisance problems with overabundant species, or to provide special hunting opportunities. Special seasons differ from regular seasons in that they entail additional hunting opportunity outside the established regular seasons but within the 107-day limit mandated by the MBTA. Special seasons are used only for species whose migration and distribution provide opportunities outside the period in which regular seasons are held and when harvest can be achieved without appreciable impacts to nontarget species. An important tenet of special seasons is that harvest pressure can be effectively directed primarily at target species or population segments that can be temporally and geographically isolated to avoid nontarget take. Currently, special seasons include: (1) Early teal seasons in the Atlantic, Mississippi, and Central Flyways; (2) bonus blue-winged teal bag limits in certain States in the Mississippi and Central Flyways; (3) early teal and wood duck seasons in Florida, Kentucky, and Tennessee; (4) waterfowl hunting days for youth and veterans—active military personnel; and (5) early seasons on overabundant resident Canada and cackling geese.
The Service has required that States implementing special seasons conduct experiments to assess the biological impacts of those seasons on both target and nontarget species. However, the Service eliminated experimental evaluation requirements for special seasons on overabundant resident Canada and cackling geese, except: (1) in areas where previous evaluations indicate an unacceptable level of take of migrant Canada and cackling geese; and (2) in areas where evaluations have not been conducted and one could reasonably expect an unacceptable level of take of migrant Canada and cackling geese (
Experimental seasons are used to evaluate expansion of regular seasons to new areas; the use of zones and splits in duck, dove, and, in some cases, goose seasons; special seasons; and alternative regulations for regular or special seasons. The Service may require implementing States to conduct research for at least 3 years to assess the environmental effects of experimental seasons, including on target and nontarget species. The Service may also require a memorandum of understanding with any State that implements experimental seasons. Experimental seasons may be authorized for up to 5 years, after which a new request must be submitted. A season may be offered on an experimental basis or change from experimental status to operational status upon approval by the respective Flyway Council(s) and the SRC. Any new experimental season would be established through a new rulemaking process, which we expect to be infrequent, involving a proposed and final rule. Change in season status from experimental to operational would be included in the MGBH memorandum.
Crows are in the family Corvidae and were not initially identified as a migratory bird in the four bilateral conventions for the protection of migratory birds. The family was added to the list of migratory birds with the convention amendment with Mexico in 1972. However, crows were not identified as a game bird; Corvidae are not one of the five families that comprise migratory game birds. At the time Federal protection was extended to Corvidae, some States had existing hunting seasons for crows. Therefore, Federal regulations were established to allow crow hunting; see 50 CFR part 20, subpart L, at § 20.133, hunting regulations for crows. Federal regulations allow States to establish dates and durations of hunting seasons, bag and possession limits, and methods of taking crows, subject to limitations defined in § 20.133. The hunting season on crows can have a maximum of 124 days within a calendar year because of specific provisions included in the convention with Mexico and must be outside the peak crow nesting period. Some States allow crow hunting 4 days a week, extending the open season nearly 8 months. Most States have no daily bag limit on crows. Crows may also be taken under a depredation order as defined in § 21.150, the depredation order for blackbirds, cowbirds, crows, grackles, and magpies.
Migratory bird hunting regulations at 50 CFR part 20 apply to game birds and crows. Thus, we make the distinction in our regulations between migratory bird hunting (crows included) and migratory game bird hunting (crows excluded). Thus, crow hunting regulations (§ 20.133) are not affected by this proposed rulemaking regarding the administrative process for authorizing migratory game bird hunting. However, we are proposing in this rulemaking action to revise § 20.133 to authorize Tribes to establish crow hunting regulations along with the States to be consistent with our Tribal migratory game bird hunting regulations at § 20.110 (see 88 FR 60375, September 1, 2023).
We generally establish the authorization conditions for migratory game bird hunting for the conterminous U.S. States by flyway or management unit/region. We propose to include the authorization conditions for Alaska, Hawaii, Puerto Rico, and the U.S. Virgin Islands in separate sections near the end of the MGBH memorandum. The States included in the flyways and management units/regions are described below:
We invite interested persons to submit written comments, suggestions, or recommendations regarding this proposed rule. Before promulgating final regulations, we will take into consideration all comments we receive. These comments, and any additional information we receive, may lead to final regulations that differ from this proposal. Although we will consider each comment received, we may not respond in detail to nonsubstantive comments. We will summarize all relevant, substantive comments we receive during the comment period for this proposed rule and respond to them when we develop the final rule. In particular, we are interested in comments relating to the following questions:
(1) Is the 3-year frequency of publication of the MGBH memorandum
(2) Are there other regulatory changes in 50 CFR part 20 that would increase efficiency and streamline the process for authorizing seasonal migratory game bird hunting?
You may submit your comments and materials concerning this proposed rule by one of the methods listed in
The programmatic document, “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (EIS 20130139),” filed with the Environmental Protection Agency (EPA) on May 24, 2013, addresses criteria of the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
This proposed rule is administrative in nature and is categorically excluded. It revises the process for transmitting authorization conditions for seasonal migratory game bird hunting to States and Tribes. Importantly, it does not alter the substantive annual biological monitoring and assessment process that determines those conditions.
The categorical exclusion determination is based on primarily 43 CFR 46.210(i) (in addition to 43 CFR 46.205 and 46.215), which provides that policies, directives, regulations, and guidelines of administrative, financial, legal, technical, or procedural nature qualify for categorical exclusion. The environmental effects of this action are too broad or speculative to lend themselves to meaningful analysis and are addressed in an environmental action statement, which is part of the record for this proposed rule and available for public inspection as provided in
Section 7 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
E.O. 12866 provides that the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) reviews all significant rules as defined by that E.O. This rulemaking action would serve only to change the administrative process for authorizing States and Tribes to establish their regulations for migratory game bird hunting. OIRA has determined that this rule is significant under section 3(f) of E.O. 12866.
E.O. 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the Nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. E.O. 13653 directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. By eliminating annual rulemaking, the Service will save about $80,000 per year in printing costs, reduce staff workload by at least 50 percent, and reduce 200 hours of managerial workload reviewing and surnaming documents.
We have developed this proposed rule in a manner consistent with these requirements. This proposed rule is an E.O. 14192 deregulatory action.
Under the Regulatory Flexibility Act (5 U.S.C. 601
We have examined this proposed rule's potential effects on small entities as required by the Regulatory Flexibility Act and determined that this action would not have an economic impact on any small entities. This proposed rule is administrative in nature, and the affected entities are State and Tribal governments. The proposed action changes only our internal administrative process for authorizing States and Tribes to establish seasonal migratory game bird hunting regulations. The annual process is largely a cooperative effort between the Service and the States and Tribes. The change in our administrative process eliminates the need for annual rulemaking and is expected to increase efficiency; better meet State, Tribal, and Federal rulemaking constraints; and reduce the complexity and costs associated with promulgating annual migratory game bird hunting regulations.
We are required by E.O. 12866 and 12988 and by the Presidential memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in
This proposed rule does not contain any new collection of information that requires approval by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C.
• 1018-0019, “North American Woodcock Singing Ground Survey” (expires 02/28/2027).
• 1018-0023, “Migratory Bird Surveys, 50 CFR 20.20” (expires 09/30/2028). Includes Migratory Bird Harvest Information Program, Migratory Bird Hunter Surveys, Sandhill Crane Survey, and Parts Collection Survey.
• 1018-0171, “Establishment of Annual Migratory Bird Hunting Seasons, 50 CFR part 20” (expires 10/30/2027).
You may view the information collection request(s) at
We have determined and certify, in compliance with the requirements of the Unfunded Mandates Reform Act, 2 U.S.C. 1502
The Department, in promulgating this proposed rule, has determined that this rulemaking action would not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of E.O. 12988.
In accordance with E.O. 12630, this proposed rule, authorized by the MBTA, does not have significant takings implications and does not affect any constitutionally protected property rights. This proposed rule would not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. In fact, this proposed rulemaking action would allow hunters to exercise otherwise unavailable privileges and, therefore, would reduce restrictions on the use of private and public property.
E.O. 13211 requires agencies to prepare statements of energy effects when undertaking certain actions. This rule is not likely to have a significant adverse effect on the supply, distribution, or use of energy and has not been designated by OIRA as a significant energy action. Therefore, no statement of energy effects is required.
In accordance with E.O. 13175 (“Consultation and Coordination with Native American Indian Tribal Governments”) and the Department of the Interior's manual at 512 DM 2, we considered possible effects of this proposed rule on federally recognized Indian Tribes with respect to impacts to Tribes' treaty rights to hunt waterfowl. We have determined that there are de minimis effects on Indian Tribes for that aspect of their treaty rights. Through this process to establish and announce authorization conditions for migratory game bird hunting, we regularly coordinate with Tribes that are affected. Tribes could attend spring and fall Flyway Council meetings, participate in SRC meetings, and provide comments on
This proposed rule is administrative in nature and does not directly affect any specific Tribal lands, treaty rights, or Tribal trust resources. In addition, this proposed rule would not interfere with the ability of Tribes to manage themselves or their funds or to regulate migratory bird activities on Tribal and ceded lands. Therefore, we preliminarily conclude that this rulemaking action does not have “Tribal implications” under section 1(a) of E.O. 13175. Thus, formal government-to-government consultation is not required by E.O. 13175 and related policies of the Department of the Interior. We will continue to collaborate with Tribes on concerns related to migratory game bird hunting regulations.
We routinely provide
Due to the migratory nature of certain species of birds, the Federal Government has been given responsibility over these species by the MBTA. We prescribe authorization conditions from which States and Tribes may establish their annual regulations for migratory game bird hunting seasons. This proposed rule changes only the Federal internal administrative process for establishing the authorization conditions and preserves the ability of the States and Tribes to establish hunting seasons that meet their individual needs. We maintain our regulations at 50 CFR 20.110 (Regulations for certain Federal Indian reservations and ceded lands) recognizing Tribal sovereignty to exercise reserved hunting rights and, for some Tribes, recognition of their authority to regulate hunting by both Tribal and nontribal members on their reservation. Consistent with our longstanding policy, we continue to recognize that, in certain cases, conflicts may arise between specific States and Tribes on aspects of Tribal treaty rights. The Service actively supports the parties reaching a mutually agreeable solution to such conflicts.
Any State or Tribe may be more restrictive in its regulations than the Federal authorization conditions and regulations at any time. The authorization conditions are developed in a cooperative process with the States and the Flyway Councils. This process allows States to participate in the development of the authorization conditions from which they will establish their own hunting regulations. This proposed rule would 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. Therefore, in accordance with E.O. 13132, these regulations do not have federalism implications and do not warrant the preparation of a federalism summary impact statement.
Lockie, S., and S. Rockloff. 2005. Decision Frameworks: Assessment of the social aspects of decision frameworks and development of a conceptual model. Coastal CRC Discussion Paper. Norman Gardens, Australia: Central Queensland University.
Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, for the reasons described in the preamble, the U.S. Fish and Wildlife Service proposes to amend title 50, chapter I, subchapter B, part 20, of the Code of Federal Regulations as set forth below:
16 U.S.C. 703
These revisions read as follows:
In addition to definitions contained in part 10 of this chapter, as used in this part, the following terms will be construed, respectively, to mean and to include:
(a)
(b) * * *
(2) A hunting season only for Canada and cackling geese during the period of September 1 to September 30, provided:
(i) The season occurs within the Atlantic, Central, and Mississippi Flyways (see § 20.107 for definitions of the flyways);
(ii) All other waterfowl and crane hunting seasons, excluding falconry, are closed; and
(iii) The State notifies the Service's Migratory Bird Program by May 31 each year of its intention to authorize the additional hunting method in its regulations for the seasonal hunting of migratory game birds.
(g) * * *
(2) A hunting season only for Canada and cackling geese during the period of September 1 to September 30, provided:
(i) The season occurs within the Atlantic, Central, and Mississippi Flyways (see § 20.107 for definitions of the flyways);
(ii) All other waterfowl and crane hunting seasons, excluding falconry, are closed; and
(iii) The State notifies the Service's Migratory Bird Program by May 31 each year of its intention to authorize the additional hunting method in its regulations for the seasonal hunting of migratory game birds.
No person may take migratory game birds except during the hours open to shooting, which includes hawking (taking by falconry), as prescribed in subpart K of this part and 50 CFR 21.180 and 21.183 of this chapter.
No person shall at any time, by any means or in any manner, take, possess, transport, or export any migratory bird, or any part, nest, or egg of any such bird, in violation of any act of Congress or any regulation, including the regulations in this part and the authorization conditions (see § 20.107 for a definition) for migratory bird hunting and in accordance with § 20.125(a), issued pursuant thereto.
No person shall at any time, by any means or in any manner, take, possess, transport, or export any migratory bird, or any part, nest, or egg of any such bird, in violation of any applicable law or regulation of any State or Tribe. A
(a) The taking, possession, transportation, and other uses of migratory birds is prohibited unless it is specifically provided for in regulations developed in accordance with the Migratory Bird Treaty Act. Consequently, migratory game bird hunting is prohibited except as authorized in regulations in this part and in accordance with the authorization conditions (see § 20.107 for a definition) for State and Tribal migratory bird hunting regulations.
(b) Authorization conditions will be based on data including, but not limited to, migratory game bird population status and trends, habitat conditions, and anticipated harvest. The authorization conditions will be periodically adjusted to account for bird abundance and other biological factors.
(c) In the Atlantic Flyway States of Connecticut, Maine, Maryland, Massachusetts, New Jersey, North Carolina, and Pennsylvania, if Sunday hunting of migratory game birds is prohibited statewide by State law or regulation, all Sundays are closed to the take of all migratory game birds.
For the purpose of this subpart, the following terms will be construed, respectively, to mean and to include:
(1) The selected regulatory alternatives may change periodically based on the status of populations and environmental conditions and will include the regulatory parameters most directly related to maintaining harvests at levels compatible with a game bird population's ability to be self-sustaining.
(2) Authorization conditions specify the bracket dates, season lengths, shooting hours, bag and possession limits, areas where hunting may occur, and other restrictions, conditions, and requirements associated with the seasonal hunting of migratory game birds.
(1) Atlantic Flyway is Connecticut, Delaware, Florida, Georgia, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, North Carolina, Pennsylvania, Rhode Island, South Carolina, Vermont, Virginia, and West Virginia.
(2) Mississippi Flyway is Alabama, Arkansas, Illinois, Indiana, Iowa, Kentucky, Louisiana, Michigan, Minnesota, Mississippi, Missouri, Ohio, Tennessee, and Wisconsin.
(3) Central Flyway is Colorado (east of the Continental Divide), Kansas, Montana (Counties of Blaine, Carbon, Fergus, Judith Basin, Stillwater, Sweetgrass, Wheatland, and all counties east thereof), Nebraska, New Mexico (east of the Continental Divide except the Jicarilla Apache Indian Reservation), North Dakota, Oklahoma, South Dakota, Texas, and Wyoming (east of the Continental Divide).
(4) Pacific Flyway is Arizona, California, Idaho, Nevada, Oregon, Utah, Washington, and those portions of Colorado, Montana, New Mexico, and Wyoming not included in the Central Flyway.
(1) The Council recommends actions necessary for science-based and sustainable harvest management of migratory birds to the Service.
(2) The Flyway Councils are advised by the Flyway technical committees, which evaluate population and habitat information and make recommendations to the Councils on matters of migratory bird conservation.
Beginning September 1, 1991, the contiguous 48 United States, and the States of Alaska and Hawaii, the Territories of Puerto Rico and the Virgin Islands, and the territorial waters of the United States, are designated for the purpose of § 20.21(j) as nontoxic shot zones for hunting waterfowl, coots, and certain other species. “Certain other species” refers to those species, other than waterfowl or coots, that are affected by reason of being included in aggregate bags and concurrent seasons.
(a) In accordance with 50 CFR 21.82, falconry is a permitted means of taking migratory game birds in any State except for Hawaii. General hunting regulations, including seasons and shooting hours, apply to falconry.
(b) States and Tribes may establish an extended season for taking migratory game birds in accordance with the following:
(1) Bracket dates: September 1-March 10.
(2) Season lengths: For all hunting methods combined, the combined length of the extended season, regular season, and any special or experimental seasons must not exceed 107 days for any species or group of species in a geographical area. Each extended season may be split into three segments.
(3) Daily bag limits: Falconry daily bag limits for all permitted migratory game birds must not exceed 3 birds in the aggregate during extended falconry seasons, any special or experimental seasons, and regular hunting seasons in each State or Tribe, including those that do not establish an extended falconry season. Regular season bag limits do not apply to falconry. The falconry bag limit is not in addition to shooting limits.
(4) Hawking hours: One-half hour before sunrise until sunset except as otherwise restricted by State or Tribal regulations.
(a)
(b)
(c)
(1) Tribes may establish on-reservation hunting regulations, for both Tribal and nontribal members, with hunting seasons that may differ from those in the State(s) in which the reservations are located.
(i)
(ii)
(A) For a short-term experimental hunting season, a Tribe and the Service may formally agree on allowed methods of take, notwithstanding the regulations in § 20.21, for on-reservation and ceded lands hunting by Tribal members. The Service will make public any such formal agreement.
(B) A Tribe that would like to make an additional hunting method operational would need to provide data to the Service for consideration. If the Service agrees with the Tribe's proposal, the Service will conduct rulemaking to amend the regulations in this part to allow Tribal members to use the additional hunting method.
(2) Tribes may establish off-reservation hunting regulations by Tribal members on ceded lands, with hunting seasons that may differ from the authorization conditions for season dates, season length, and daily bag and possession limits.
(d)
Below are the alternative combinations of zones and season segments that a State may use for duck and dove hunting in a 5-year period. The SRC may approve a deviation from the 5-year period length for all four flyways.
(a) Duck hunting zone and split-season configurations include:
(1) One zone (same as no zones) with up to three season segments;
(2) Two zones with up to two season segments in each zone;
(3) Two zones with up to three season segments in each zone;
(4) Three zones with up to two season segments in each zone; or
(5) Four zones with a continuous season (
(b) Dove hunting zone and split-season configurations include:
(1) One zone (same as no zones) with up to three season segments; or
(2) Two zones with up to three season segments in each zone, except in the Western Management Unit where the season in one or both zones may be split into two segments.
For the general duck season authorization conditions, each Flyway has four possible regulatory alternatives (closed, restrictive, moderate, and liberal), each with a different expected harvest level. The open season alternatives are specified as:
(a) Atlantic Flyway:
(b) Mississippi Flyway:
(c) Central Flyway:
(d) Pacific Flyway, except Alaska:
(e) Alaska:
(f) Shooting and hawking hours are from one-half hour before sunrise to sunset daily.
(g) In the Central Flyway High Plains Mallard Management Unit, the season length may be extended 12 additional days in the restrictive alternative and 23 additional days in the moderate and liberal alternatives; additional days
(h) In the Pacific Flyway Columbia Basin Mallard Management Unit, the season length may be extended 7 additional days in the restrictive and moderate alternatives.
(i) Additional species-specific restrictions may be established in the authorization conditions.
(j) Duck season regulatory alternatives are fixed for a period of not less than 5 years.
(a) The authorization conditions will be determined using available biological and habitat information and decision frameworks. A list of current decision frameworks is posted on the Service's website with the Migratory Game Bird Hunting Memorandum. The Service will apply available biological and habitat information to the relevant decision framework for that species and will announce the outcomes as the authorization conditions within which States and Tribes may establish their migratory game bird hunting regulations in accordance with the regulations in this part and other applicable Federal regulations.
(b) Consistent with the Migratory Bird Treaty Act, the authorization conditions for any migratory game bird season must:
(1) Not start prior to September 1;
(2) Not end after March 10, except the season for ducks, mergansers, and coots may not end later than January 31 (16 U.S.C. 704(c)(1)(B)); and
(3) Not exceed 107 days.
(c) The Service and Flyway Councils may establish decision frameworks for the determination of authorization conditions that are more restrictive than the provisions in the Migratory Bird Treaty Act.
(a) The Service will communicate the authorization conditions in the Migratory Game Bird Hunting Memorandum. The memorandum and any supporting documentation will be made publicly available in the
(b) The Service may update the Migratory Game Bird Hunting Memorandum and notice of availability annually if changes are prescribed by decision frameworks. Updates would occur no later than February 28 of each calendar year. If the Service does not issue a new memorandum and notice of availability by February 28, then the authorization conditions in the most recent memorandum will remain in effect.
(c) The notice of availability will open a public comment period of not less than 30 days. The Service may revise the Migratory Game Bird Hunting Memorandum based on public comment and, if so, the revised memorandum will be made publicly available in the
(a) Special seasons authorize additional hunting opportunity outside the regular season but within the 107-day limit mandated by the MBTA. Special seasons are authorized to promote harvest of underutilized species, address overabundance of nuisance species, or provide special hunting opportunities. Experimental seasons are authorized to evaluate expansion of regular and special seasons to new areas, evaluate use of zones and splits, or evaluate alternative seasons.
(b) Special or experimental season requests may be made by the Flyway Council(s) or requested by a State. Requests must be submitted by September 1 prior to the requested hunting season. If the Service approves a special or experimental season, it will be authorized in the Migratory Game Bird Hunting Memorandum.
(c) To approve special and experimental seasons, the Service must find:
(1) The Flyway Council(s) where the hunting will take place endorse the special or experimental season;
(2) Species migration and distribution provide sufficient hunting opportunity outside the regular season;
(3) There is no or negligible impact to nontarget species; and
(4) Authorizations are consistent with existing environmental compliance determinations.
(d) Approved experimental seasons may be valid for up to 5 years, after which a new request must be submitted. The Service may require implementing States to collect data for at least 3 years to assess the environmental effects of special or experimental seasons, including effects on target and nontarget species.
(a) States may authorize migratory game bird hunting provided the State establishes hunting regulations in accordance with Federal authorization conditions and regulations. State hunting regulations must be at least as restrictive as the Federal authorization conditions and regulations. Hunting that occurs outside the State regulations or Federal authorization conditions and regulations constitutes a violation of Federal law pursuant to § 20.71.
(b) No later than May 31 of each calendar year, States must submit their proposed migratory game bird hunting regulations implementing the Federal authorization conditions to the Service's Migratory Bird Program for review.
(c) Areas and zones for which open seasons are specified in a State's hunting regulations must be described, delineated, and designated as such in each State's hunting regulations, and these areas must also be included in the Migratory Game Bird Hunting Memorandum.
(d) Unless otherwise specified, States may establish hunting seasons by zones as defined in § 20.107. Zones for certain duck seasons (and associated youth and veterans-active military waterfowl hunting days, gallinule seasons, and snipe seasons) and dove seasons must comply with Federal zone and split-season configurations. Changes among configurations may occur in the first year of the 5-year period that it would apply and according to the following guidelines:
(1) States seeking to change their duck or dove hunting zone and split-season configuration selection must provide their selection and zone descriptions to the Service by August 31 of the year prior to the 5-year interval during which they would apply.
(2) States with approved special case arrangements to change their zone and split-season configuration must conform to the current configurations and may not revert to the special case arrangements that they previously had in place.
(3) Only minor (less than one county in size) zone boundary changes will be allowed for any special case arrangement, and such changes are allowed only in the first year of the 5-year period during which it would apply.
(4) Minor (less than one county in size) zone boundary changes may be allowed for any State to resolve law enforcement or other boundary clarification issues resulting from implication of a new configuration. Changes will be evaluated on a case-by-case basis and must be approved by the respective Flyway Council and the Service Migratory Bird Regulations Committee.
(5) Consideration of changes for management-unit boundaries is not subject to the guidelines and provisions
(d) States may issue hunting permits for migratory game bird hunting at levels predicted to result in the amount of take authorized by the authorization conditions. Federally authorized, State-issued hunting permits are valid only for the individual whose name and address appears on the hunting permit and must specify a take authorization.
(e) States may select 2 days per duck-hunting zone, designated as “Youth Waterfowl Hunting Days,” and 2 days per duck-hunting zone, designated as “Veterans and Active Military Personnel Waterfowl Hunting Days,” in addition to their regular duck seasons.
(1) The days may be held concurrently or may be nonconsecutive. Days may be held up to 14 days before or after any regular duck-season bracket dates in the authorization conditions or within any split of a regular duck season, or within any other open season on migratory game birds. Youth Waterfowl Hunting Days must be held outside any regular duck season on weekends, holidays, or other non-school days when youth hunters would have the maximum opportunity to participate.
(2) Youth hunters must be younger than 18 years of age. States may specify a more restrictive age definition. An adult 18 years of age or older must accompany the youth hunter into the field. This adult may not duck hunt but may participate in other seasons that are open on the special youth day. Permitted species may be taken only by participants possessing applicable hunting permits.
(3) Veterans (as defined in 38 U.S.C. 101) and members of the U.S. Armed Forces on active duty, including members of the National Guard and Reserves on active duty (other than for training), may participate. Permitted species may be taken only by participants possessing applicable hunting permits.
(a) Any individual hunting must comply with the regulations in this part, Federal authorization conditions, and any applicable State or Tribal hunting regulations. Violation of any applicable Federal, State, Tribal, or local law or regulation is a violation of Federal law pursuant to § 20.71 and § 20.72.
(b) Any individual hunting under a federally authorized, State-issued hunting permit must adhere to the provisions of the hunting permit, Federal regulations, and State regulations. The hunting permit must be carried by the permittee when exercising the provisions of the hunting permit and must be presented to any law enforcement officer upon request. The hunting permit specifies the individual's name and address. The hunting permit is not transferable or assignable to any other person, and may not be sold, bartered, traded, or otherwise provided to any other person. The hunting permit will be invalid if it is altered or defaced in any way.
(a)
(b)
(c)
Notice of each meeting of a Flyway Council to be attended by any official of the Department of the Interior will be announced online on the Service's Migratory Bird Program website at least 2 weeks before the meeting or as soon as practicable after the Department of the Interior learns of the meeting. The notice will state the time, place, and general subject(s) of the meeting.
(a) Crows may be taken, possessed, transported, exported, or imported, only in accordance with such laws or regulations as may be prescribed by a State or Tribe pursuant to this section.
(b) Except in the State of Hawaii, where take of crows is prohibited, States and Tribes may by statute or regulation prescribe a hunting season for crows. Such State and Tribal statutes or regulations may set forth the method of taking, the bag and possession limits, the dates and duration of the hunting season, and such other regulations as may be deemed appropriate, subject to the following limitations for each State or Tribe:
(1) Crows must not be hunted from aircraft;
(2) The hunting season or seasons on crows must not exceed a total of 124 days during a calendar year;
(3) Hunting must not be permitted during the peak crow nesting period within a State; and
(4) Crows may be taken only by firearms, bow and arrow, and falconry.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding: whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques and other forms of information technology.
Comments regarding this information collection received by July 27, 2026 will be considered. 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
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Woodsy Owl is America's symbol for the conservation of the environment. The public service campaign slogans associated with Woodsy Owl are “Give a Hoot, Don't Pollute” and “Lend a Hand, Care for the Land.” The mission statement of the Woodsy Owl's conservation campaign is to help young children discover the natural world and join in life-long actions to care for that world.
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments are requested regarding; whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; ways to enhance the quality, utility and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments regarding this information collection received by July 27, 2026 will be considered. 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
The
John Frye at
In the
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of citric acid and certain citrate salts (citric acid) from India. The period of investigation is January 1, 2025, through December 31, 2025. Interested parties are invited to comment on this preliminary determination.
Applicable June 26, 2026.
Thomas Schauer or Erin Howard, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0410 and (202) 482-3453, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). On February 10, 2026, Commerce published the notice of initiation of this countervailing duty (CVD) investigation.
For a complete description of the events that followed the initiation of this investigation,
The products covered by this investigation are citric acid and certain citrate salts from India. For a complete description of the scope of this investigation,
In accordance with the
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
Commerce notes that, in making these findings, it relied, in part, on facts available and, because it finds that the Government of India did not act to the best of its ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available. Commerce also relied in part on facts available and, because it finds the Government of the People's Republic of China (China) did not respond to requests for information, it must use facts otherwise available when appropriate. For further information, see the “Use of Facts Otherwise Available and Adverse Inferences” section in the Preliminary Decision Memorandum.
As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final CVD determination of this investigation with the final determination in the companion antidumping duty (AD) investigation of sales of citric acid and certain citrate salts from India based on a request made by the petitioners.
Sections 703(d) and 705(c)(5)(A) of the Act provide that in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of publication of this notice in accordance with 19 CFR 351.224(b).
Consistent with 19 CFR 351.224(e), Commerce will analyze and, if appropriate, correct any timely allegations of significant ministerial errors by amending the preliminary determination. However, consistent with 19 CFR 351.224(d), Commerce will not consider incomplete allegations that do not address the significance standard under 19 CFR 351.224(g) following the preliminary determination. Instead, Commerce will address such allegations in the final determination together with issues raised in the case briefs or other written comments.
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. A timeline for the submission of case briefs and written comments will be notified to interested parties at a later date. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case
As provided under 19 CFR 351.309(c)(2)(iii) and (d)(2)(iii), we request that interested parties provide at the beginning of their briefs a public executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants and whether any participant is a foreign national, and a list of the issues to be discussed. Oral presentations at the hearing will be limited to issues raised in the briefs. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the U.S. International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will determine, before the later of 120 days after the date of this preliminary determination or 75 days after the final determination, whether imports of citric acid from India are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The merchandise covered by this investigation includes all grades and granulation sizes of citric acid, sodium citrate, and potassium citrate in their unblended forms, whether dry or in solution, and regardless of packaging type. The scope also includes blends of citric acid, sodium citrate, and potassium citrate, as well as blends with other ingredients, such as sugar, where the unblended form(s) of citric acid, sodium citrate, and potassium citrate constitute 40 percent or more, by weight, of the blend.
The scope also includes all forms of crude calcium citrate, including dicalcium citrate monohydrate, and tricalcium citrate tetrahydrate, which are intermediate products in the production of citric acid, sodium citrate, and potassium citrate. The scope includes the hydrous and anhydrous forms of citric acid, the dihydrate and anhydrous forms of sodium citrate, otherwise known as citric acid sodium salt, and the monohydrate and monopotassium forms of potassium citrate. Sodium citrate also includes both trisodium citrate and monosodium citrate which are also known as citric acid trisodium salt and citric acid monosodium salt, respectively.
The scope includes merchandise matching the above description that has been processed in a third country, including by commingling, diluting, introducing or removing additives, or performing any other processing that would not otherwise remove the merchandise from the scope of the investigation if performed in the subject country. The scope also includes merchandise matching the above description that is commingled or blended with citric acid, sodium citrate, and potassium citrate from sources not subject to this investigation. Only the subject component of such commingled products is covered by the scope of this investigation.
The scope does not include calcium citrate that satisfies the standards set forth in the United States Pharmacopeia and has been mixed with a functional excipient, such as dextrose or starch, where the excipient constitutes at least two percent, by weight, of the product.
Citric acid and sodium citrate are classifiable under 2918.14.0000 and 2918.15.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), respectively. Potassium citrate and crude calcium citrate are classifiable under 2918.15.5000 and, if included in a mixture or blend, 3824.99.9397 of the HTSUS. Blends that include citric acid, sodium citrate, and potassium citrate are classifiable under 3824.99.9397 of the HTSUS. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of citric acid and certain citrate salts (citric acid) from Canada. The period of investigation is January 1, 2025, through December 31, 2025. Interested parties are invited to comment on this preliminary determination.
Applicable June 26, 2026.
Harrison Tanchuck or Madeline Robinson, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-7421 or (202) 482-0585, respectively.
This preliminary determination is made in accordance with section 703(b)
For a complete description of the events that followed the initiation of this investigation,
The products covered by this investigation are citric acid and certain citrate salts from Canada. For a complete description of the scope of this investigation,
In accordance with the
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
Commerce notes that, in making these findings, it relied, in part, on facts available and, because it finds that one or more respondents did not act to the best of their ability to respond to Commerce's requests for information, it drew an adverse inference where appropriate in selecting from among the facts otherwise available.
As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final determination in this investigation with the final determination in the companion antidumping (AD) investigation of citric acid from Canada based on a request made by the petitioners. Consequently, the final CVD determination will be issued on the same date as the final AD determination, which is currently scheduled to be issued no later than November 2, 2026, unless postponed.
Sections 703(d) and 705(c)(5)(A) of the Act provide that, in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any rates that are zero,
Commerce calculated an individual estimated countervailable subsidy rate for Jungbunzlauer Canada Inc. (JBL Canada), the only individually examined exporter/producer in this investigation. Because the only individually calculated rate is not zero,
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(2) of the Act, Commerce will direct U.S. Customs and Border Protection (CBP) to suspend liquidation of entries of subject merchandise as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement or, if there is no public announcement, within five days of the date of this notice in accordance with 19 CFR 351.224(b).
Consistent with 19 CFR 351.224(e), Commerce will analyze and, if appropriate, correct any timely allegations of significant ministerial errors by amending the preliminary determination. However, consistent with 19 CFR 351.224(d), Commerce will not consider incomplete allegations that
As provided in section 782(i)(3) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. A timeline for the submission of case briefs and written comments will be notified to interested parties at a later date. Rebuttal briefs, limited to issues raised in the case briefs, may be filed not later than five days after the date for filing case brief.
As provided under 19 CFR 351.309(c)(2)(iii) and (d)(2)(iii), we request that interested parties provide at the beginning of their briefs a public, executive summary for each issue raised in their briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the U.S. International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination whether imports of citric acid from Canada are materially injuring, or threaten material injury to, the U.S. industry.
This determination is issued and published in accordance with sections 703(f) and 777(i)(1) of the Act, and 19 CFR 351.205(c).
The merchandise covered by this investigation includes all grades and granulation sizes of citric acid, sodium citrate, and potassium citrate in their unblended forms, whether dry or in solution, and regardless of packaging type. The scope also includes blends of citric acid, sodium citrate, and potassium citrate, as well as blends with other ingredients, such as sugar, where the unblended form(s) of citric acid, sodium citrate, and potassium citrate constitute 40 percent or more, by weight, of the blend.
The scope also includes all forms of crude calcium citrate, including dicalcium citrate monohydrate, and tricalcium citrate tetrahydrate, which are intermediate products in the production of citric acid, sodium citrate, and potassium citrate. The scope includes the hydrous and anhydrous forms of citric acid, the dihydrate and anhydrous forms of sodium citrate, otherwise known as citric acid sodium salt, and the monohydrate and monopotassium forms of potassium citrate. Sodium citrate also includes both trisodium citrate and monosodium citrate which are also known as citric acid trisodium salt and citric acid monosodium salt, respectively.
The scope includes merchandise matching the above description that has been processed in a third country, including by commingling, diluting, introducing or removing additives, or performing any other processing that would not otherwise remove the merchandise from the scope of the investigations if performed in the subject country. The scope also includes merchandise matching the above description that is commingled or blended with citric acid, sodium citrate, and potassium citrate from sources not subject to this investigation. Only the subject component of such commingled products is covered by the scope of this investigation.
The scope does not include calcium citrate that satisfies the standards set forth in the United States Pharmacopeia and has been mixed with a functional excipient, such as dextrose or starch, where the excipient constitutes at least two percent, by weight, of the product.
Citric acid and sodium citrate are classifiable under 2918.14.0000 and 2918.15.1000 of the Harmonized Tariff Schedule of the United States (HTSUS), respectively. Potassium citrate and crude calcium citrate are classifiable under 2918.15.5000 and, if included in a mixture or blend, 3824.99.9397 of the HTSUS. Blends that include citric acid, sodium citrate, and potassium citrate are classifiable under 3824.99.9397 of the HTSUS. Although the HTSUS subheadings are provided for convenience and customs purposes, the written description of the merchandise is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable June 26, 2026.
Deborah Cohen, AD/CVD Operations,
On March 16, 2026, the U.S. Department of Commerce (Commerce) initiated a less-than-fair-value (LTFV) investigation of large diameter graphite electrodes from the People's Republic of China (China).
Section 733(b)(1)(A) of the Tariff Act of 1930, as amended (the Act), requires Commerce to issue the preliminary determination in an LTFV investigation within 140 days after the date on which Commerce initiated the investigation. However, section 733(c)(1) of the Act permits Commerce to postpone the preliminary determination until no later than 190 days after the date on which Commerce initiated the investigation if: (A) the petitioner makes a timely request for a postponement; or (B) Commerce concludes that the parties concerned are cooperating, that the investigation is extraordinarily complicated, and that additional time is necessary to make a preliminary determination. Under 19 CFR 351.205(e), the petitioner must submit a request for postponement 25 days or more before the scheduled date of the preliminary determination and must state the reasons for the request. Commerce will grant the request unless it finds compelling reasons to deny the request.
On June 5, 2026, Resonac Graphite America Inc. and Tokai Carbon GE LLC (the petitioners) submitted a timely request that Commerce postpone the preliminary determination in the LTFV investigation of large diameter graphite electrodes from China.
For the reasons stated above, and because there are no compelling reasons to deny the request, Commerce, in accordance with section 733(c)(1)(A) of the Act and 19 CFR 351.205(e), is postponing the deadline for the preliminary determination by 50 days (
This notice is issued and published pursuant to section 733(c)(2) of the Act and 19 CFR 351.205(f)(1).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) finds that revocation of the countervailing duty (CVD) order on twist ties from the People's Republic of China (China) would be likely to lead to continuation or recurrence of countervailable subsidies at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Applicable June 26, 2026.
David De Falco, Trade Agreements Policy and Negotiations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: 202-482-2178.
On April 14, 2021, the U.S. Department of Commerce (Commerce) published the
On March 16, 2026, Commerce received a notice of intent to participate in this review from Bedford Industries, Inc. (Bedford) (the domestic interested party), within the deadline specified in 19 CFR 351.218(d)(1)(i).
On March 31, 2026, Commerce received an adequate substantive response from Bedford, within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).
The product covered by this
A complete discussion of all issues raised in this sunset review, including
Pursuant to sections 751(c) and 752(b) of the Act, Commerce determines that revocation of the
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials, or conversion to judicial protective, orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act, and 19 CFR 351.221(c)(5)(ii).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) finds that revocation of the countervailing duty (CVD) order on silicon metal from Kazakhstan would be likely to lead to continuation or recurrence of countervailable subsidies at the levels indicated in the “Final Results of Sunset Review” section of this notice.
Applicable June 26, 2026.
David De Falco, Trade Agreements Policy and Negotiations, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: 202-482-2178.
On April 19, 2021, the U.S. Department of Commerce (Commerce) published the
On March 17, 2026, Commerce received a notice of intent to participate in this review from Ferroglobe USA, Inc. (Ferroglobe) and Mississippi Silicon LLC (Mississippi Silicon) (the domestic interested parties), within the deadline specified in 19 CFR 351.218(d)(1)(i).
On April 1, 2026, Commerce received an adequate substantive response from the domestic interested parties, within the 30-day deadline specified in 19 CFR 351.218(d)(3)(i).
The product covered by this
A complete discussion of all issues raised in this sunset review, including the likelihood of continuation or recurrence of subsidization and the countervailable subsidy rates likely to prevail if the
Pursuant to sections 751(c) and 752(b) of the Act, Commerce determines that revocation of the
This notice also serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305. Timely notification of the return or destruction of APO materials, or conversion to judicial protective, orders is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results in accordance with sections 751(c), 752(b), and 777(i)(1) of the Act, and 19 CFR 351.221(c)(5)(ii).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) received scope ruling applications, requesting that scope inquiries be conducted to determine whether identified products are covered by the scope of antidumping duty (AD) and/or countervailing duty (CVD) orders and that Commerce issue scope rulings pursuant to those inquiries. In accordance with Commerce's regulations, we are notifying the public of the filing of the scope ruling applications listed below in the month of April 2026.
Applicable June 26, 2026.
Yasmin Bordas, AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-3813.
In accordance with 19 CFR 351.225(d)(3), we are notifying the public of the following scope ruling applications related to AD and CVD orders and findings filed in or around the month of April 2026. This notification includes, for each scope application: (1) identification of the AD and/or CVD orders at issue (19 CFR 351.225(c)(1)); (2) concise public descriptions of the products at issue, including the physical characteristics (including chemical, dimensional and technical characteristics) of the products (19 CFR 351.225(c)(2)(ii)); (3) the countries where the products are produced and the countries from where the products are exported (19 CFR 351.225(c)(2)(i)(B)); (4) the full names of the applicants; and (5) the dates that the scope applications were filed with Commerce and the name of the ACCESS scope segment where the scope applications can be found.
Narrow Woven Ribbons with Woven Selvedge from the People's Republic of China (China) (A-570-952/C-570-953); Blanket Binding;
Raw Flexible Magnets from China (A-570-922/C-570-923); Fun with Letters Magnet Activity Set, Set of 144+ Board, Magnetic Place Value Disks & Headings: Grades 1-3, Magnetic Numerals, Set of 100, Magnetic Place Value Disks & Headings: Grades 3-6, Set of 147, and Giant Magnetic Calendar Set;
Mattresses from China (A-570-092/C-570-128); Upholstered Sofa Beds with Integrated Mattresses;
Mattresses from Mexico (A-201-859); Foams;
Crystalline Silicon Photovoltaic Cells, Whether or Not Assembled into Modules from China (A-570-979/C-570-980); Crystalline Silicon Photovoltaic Cells, and Modules, Laminates, and Panels, Consisting of Crystalline Silicon Photovoltaic Cells, Whether or Not Partially or Fully Assembled Into Other Products;
This list of scope ruling applications is not an identification of scope inquiries that have been initiated. In accordance with 19 CFR 351.225(d)(1), if Commerce has not rejected a scope ruling application nor initiated the scope inquiry within 30 days after the filing of the application, the application will be deemed accepted and a scope inquiry will be deemed initiated the following day—day 31.
In accordance with 19 CFR 351.225(m)(2), if there are companion AD and CVD orders covering the same merchandise from the same country of origin, the scope inquiry will be conducted on the record of the AD proceeding. Further, please note that pursuant to 19 CFR 351.225(m)(1), Commerce may either apply a scope ruling to all products from the same country with the same relevant physical characteristics, (including chemical, dimensional, and technical characteristics) as the product at issue, on a country-wide basis, regardless of the producer, exporter, or importer of those products, or on a company-specific basis.
For further information on procedures for filing information with Commerce through ACCESS and participating in scope inquiries, please refer to the Filing Instructions section of the Scope Ruling Application Guide, at
Please note that this notice of scope ruling applications filed in AD and CVD proceedings may be published before any potential initiation, or after the initiation, of a given scope inquiry based on a scope ruling application identified in this notice. Therefore, please refer to the case segment on ACCESS to determine whether a scope ruling application has been accepted or rejected and whether a scope inquiry has been initiated.
Interested parties who wish to be served scope ruling applications for a particular AD or CVD order may file a request to be included on the annual inquiry service list during the anniversary month of the publication of the AD or CVD order in accordance with 19 CFR 351.225(n) and Commerce's procedures.
Interested parties are invited to comment on the completeness of this monthly list of scope ruling applications received by Commerce. Any comments should be submitted to Scot Fullerton, Acting Deputy Assistant Secretary for AD/CVD Operations, Enforcement and Compliance, International Trade Administration, via email to
This notice of scope ruling applications filed in AD and CVD proceedings is published in accordance with 19 CFR 351.225(d)(3).
Office of National Marine Sanctuaries (ONMS), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice.
NOAA hereby provides public notice that it is extending the temporary suspension of the special use permit (SUP) category for the continued presence of commercial submarine cables on or within national marine sanctuaries so that, for an additional two-year period until August 16, 2028, the SUP category does not apply to commercial submarine cables in sanctuaries designated after August 16, 2024. NOAA is continuing to evaluate options for permitting submarine cables in sanctuaries, including through a separate rulemaking action.
The end date of suspension per this notice is August 16, 2028.
Sophie De Beukelaer, NOAA Office of National Marine Sanctuaries, 1305 East West Highway, Silver Spring MD 20910, or
Under the National Marine Sanctuaries Act (NMSA), 16 U.S.C. 1431
NOAA has established categories of activities subject to the requirements of SUPs. One of the categories of activities is: “The continued presence of commercial submarine cables on or within the submerged lands of any national marine sanctuary.” 78 FR 25957 (May 3, 2013). NOAA's August 16, 2024 notice (89 FR 66689) modified this SUP category for the continued presence of commercial submarine cables such that, for a two-year period, the SUP category does not apply to commercial submarine cables in new sanctuaries designated after August 16, 2024. During this suspension, NOAA has not required or issued SUPs for the continued presence of commercial submarine cables on or within the submerged lands of newly designated sanctuaries. However, commercial submarine cables in national marine sanctuaries designated prior to August 16, 2024, continue to be subject to the requirements of this SUP category, including terms and conditions of any currently effective SUPs. Please refer to 89 FR 66689 for a further discussion of the NMSA, SUPs, and NOAA's need and rationale for establishing a temporary suspension of this SUP category in sanctuaries designated after August 16, 2024.
With this notice, the SUP category for the continued presence of commercial submarine cables continues to be modified so that, for an additional two-year period through August 16, 2028, the SUP category does not apply to commercial submarine cables in sanctuaries designated after August 16, 2024. During this timeframe, the continued presence of commercial submarine cables on or within the submerged lands in newly designated sanctuaries will continue to not be subject to the SUP requirements of section 310 of the NMSA or to 15 CFR 922.31. During this temporary suspension, NOAA will not require or issue SUPs for the continued presence of commercial submarine cables on or within the submerged lands of sanctuaries designated after August 16, 2024.
As discussed in 89 FR 66689, NOAA established this temporary suspension in order to afford NOAA time to evaluate if and how it needs to update the SUP category for the continued presence of commercial submarine cables on or within the submerged lands of any national marine sanctuary and NOAA's submarine cable permit guidance document. NOAA sought and received public comments on the issues addressed in 89 FR 66689, including the use of the SUP category and potential modifications to it and the submarine cable permit guidance.
At this time, NOAA is continuing to consider the issues discussed in 89 FR 66689, as well as issues identified through public comments. NOAA is continuing to evaluate options for permitting submarine cables in sanctuaries, including through a separate rulemaking action. NOAA will respond to all comments in a separate notice in the
This notice does not alter:
• The applicability of the SUP categories other than the category for the continued presence of commercial submarine cables beneath or on the seabed;
• The applicability of the SUP category for the continued presence of commercial submarine cables beneath or on the seabed in national marine sanctuaries designated prior to August 16, 2024; or
• The applicability of sanctuary permit types other than SUPs to submarine cables in national marine sanctuaries.
Commercial submarine cables in national marine sanctuaries designated prior to August 16, 2024, will continue to be subject to the requirements of this SUP category, including terms and conditions of any currently effective SUPs.
Any activities related to submarine cables that would violate NOAA regulatory prohibitions for national marine sanctuaries designated after August 16, 2024, which may include such activities as cable installation, maintenance, and repair, will still be prohibited unless approved by other NOAA approval mechanisms, such as certifications, authorizations, or general permits.
This suspension period may be subject to further extension, as appropriate, via subsequent notices.
NOAA has concluded this action will not have a significant effect, individually or cumulatively, on the human environment. This action is categorically excluded from the requirement to prepare an Environmental Assessment or Environmental Impact Statement in accordance with the NOAA Categorical Exclusion G7 in the NOAA NEPA Companion Manual, Appendix E and because there are no extraordinary circumstances precluding the application of this categorical exclusion. Specifically, this action is a notice of an administrative nature, and any future effects of subsequent actions are too broad, speculative, or conjectural to lend themselves to meaningful analysis and will be subject to later NEPA analysis. This action would temporarily pause the issuance of new special use permits for the continued presence of commercial submarine cables on or within the submerged lands of any
Notwithstanding any other provisions of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Office for Coastal Management, National Ocean Service, National Oceanic and Atmospheric Administration, Department of Commerce.
Notice of public meetings; opportunity to comment.
The National Oceanic and Atmospheric Administration (NOAA)'s Office for Coastal Management will hold both an in-person meeting and two virtual public meetings to solicit input for a performance evaluation of the California Coastal Management Program. These meetings are intended to provide the public with the opportunity to add to the input obtained from the previous public meeting held in August 2024. In particular, NOAA seeks any new input from relevant stakeholders regarding spaceport infrastructure, offshore oil production, pipeline maintenance, desalination projects, and undersea cables.
NOAA will hold an in-person public meeting from 2 p.m. Pacific Time (PT) to 6 p.m. PT on August 10, 2026. For specifics on the location of the in-person public meeting, please see the
Comments may be submitted by one of the following methods:
•
•
All comments NOAA receives are a part of the public record, and the entirety of the comments, including the name of the commenter, email address, attachments, and other supporting materials that were provided, will be publicly accessible. The names provided by each speaker making oral comments will also be published as part of the transcripts. NOAA will not respond during the meetings to oral comments or questions. To ensure full consideration by NOAA, oral comments must be in English. Comments that are not in English may not be transcribed or considered by NOAA.
Do not submit confidential business information or otherwise sensitive or personally identifiable information, such as account numbers and Social Security numbers. Comments that are not related to the performance evaluation of the California Coastal Management Program or that contain profanity, vulgarity, threats, or other inappropriate language will not be considered.
Josh Lott, Acting Chief, Policy, Planning, and Communications Division, by email at
Section 312 of the Coastal Zone Management Act (CZMA) requires NOAA to conduct a continuing review of the performance of federally approved coastal management programs. During the evaluation, NOAA will consider the extent to which the State of California has implemented and enforced the program approved by the Secretary, addressed the coastal management needs identified in the CZMA, and adhered to the terms of any grant, loan, or cooperative agreement funded under this chapter of the CZMA. These public meetings will add to the input obtained from the previous public meeting held in August 2024. In particular, NOAA seeks any new input from relevant stakeholders regarding spaceport infrastructure, offshore oil production, pipeline maintenance, desalination projects, and undersea cables. When the evaluation is complete, NOAA's Office for Coastal Management will place a notice in the
The Department of Commerce will submit the following information collection request 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. We invite 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. Public comments were previously requested via the
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
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; proposed incidental harassment authorizations; request for comments on proposed authorizations and possible renewals.
NMFS has received a request from U.S. Army Corps of Engineers (USACE) for authorization to take marine mammals incidental to 2 years of construction activities associated with the Bonneville Lock 1 Bridge Replacement (BLBR) Project on the Columbia River in Oregon. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue two consecutive incidental harassment authorizations (IHAs) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on possible one-time, 1-year renewals that could be issued under certain circumstances and if all requirements are met, as described in Request for Public Comments at the end of this notice. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorizations.
Comments and information must be received no later than July 27, 2026.
Comments should be addressed to the Permits and Conservation Division, Office of Protected Resources, NMFS and should be submitted via email to
Austin Demarest, Office of Protected Resources, NMFS, (301) 427-8401.
The MMPA prohibits the “take” of marine mammals, with certain exceptions. Section 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
Authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). If such findings are made, NMFS must prescribe the permissible methods of taking; other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to as “mitigation”); and requirements pertaining to the monitoring and reporting of the takings. The definitions of all applicable MMPA statutory terms used above are included in the relevant sections below (see also 16 U.S.C. 1362; 50 CFR 216.3, 216.103).
To comply with the National Environmental Policy Act of 1969 (NEPA; 42 U.S.C. 4321
This action is consistent with categories of activities identified in Categorical Exclusion B4 (IHAs with no anticipated serious injury or mortality) of the Companion Manual for NAO 216-6A, which do not individually or cumulatively have the potential for significant impacts on the quality of the human environment and for which we have not identified any extraordinary circumstances that would preclude this categorical exclusion. Accordingly, NMFS has preliminarily determined that the issuance of the proposed IHAs qualifies to be categorically excluded from further NEPA review.
We will review all comments submitted in response to this notice prior to concluding our NEPA process or making a final decision on the IHA requests.
On May 12, 2025, NMFS received a request from USACE for two consecutive IHAs to take marine mammals incidental to pile driving (installation and removal) associated with construction to replace the Bonneville Lock 1 Bridge on the Columbia River in Oregon. Following NMFS' review of the application, USACE submitted multiple revised versions on February 20, March 11, April 30, and May 27, 2026, with the final version submitted on May 29, 2026. The application was deemed adequate and complete on June 2, 2026. For the first year of construction activities (Year 1), USACE's request is for take of California sea lions, Steller sea lions, and harbor seals by Level A and Level B harassment. For the second year of construction activities (Year 2), USACE's request is for take of California sea lions, Steller sea lions, and harbor seals by Level B harassment only. Neither USACE nor NMFS expect serious injury or mortality to result from this either year of activities and, therefore, IHAs are appropriate.
The USACE proposes replacing the Bonneville Lock 1 Bridge at the Eastern boundary of the Lower Columbia River (LCR) at river mile (RM) 145. The USACE identified that the existing bridge has structural, geotechnical, and operational concerns in a recent Major Maintenance Report. Replacement of the bridge would resolve current structural
The USACE anticipates that the BLBR Project will occur over 2 years. The Year 1 proposed IHA would be valid for the statutory maximum of 1 year and would be effective from December 1, 2027, through November 30, 2028. The Year 2 proposed IHA would be valid for the statutory maximum of 1 year from the date of effectiveness, but not beginning later than 1 year from the date of expiration of the Year 1 IHA. Year 1 activities are expected to occur over 8 non-consecutive days between December 2027 and February 2028. Year 2 activities would occur over 8 non-consecutive days and are expected to occur between December 2028 and February 2029, as long as Year 1 construction activities are not delayed. In-water work for each year would occur for up to 10 hours per day, during daylight hours.
The LCR flows 146 miles (mi) or 235 kilometers (km) from Bonneville Dam to the Pacific Ocean. This reach of the river features a deep-draft shipping channel supporting major ports and connects major cities and towns in Oregon to the Pacific Ocean. The LCR serves as an important migratory corridor for salmonids, sturgeon, and eulachon (
The Bonneville Lock 1 Bridge spans the FNC, is located at RM 145 in the LCR, and is approximately 40 mi or 64 km east of Portland, Oregon (figure 1). The BLBR Project construction area is situated directly downstream from the Lower Bonneville Lock and Dam, and experiences frequent recreational and commercial vessel traffic, which all contribute to the in-air and underwater acoustic environment.
The BLBR Project is required to increase clearance for larger commercial vessels transiting the lock system and to address structural and geotechnical concerns. The existing swing bridge was constructed in 1932 and last modified in 1950; it will be replaced by a single-span steel girder bridge with a concrete deck.
Year 1 of BLBR Project would involve:
1.
2.
3.
4.
5.
For Year 1 construction for the BLBR Project, barge anchoring would involve the installation of eight 24-inch steel pipe piles. Construction of the cofferdam would involve the installation of 50 24-inch sheet piles and 8 14-inch steel pipe piles. All piles for barge anchoring and cofferdam construction would initially be driven with a vibratory hammer to the point of refusal, then seated into the substrate with an impact hammer. All pile installation activities are expected to occur over eight non-consecutive days (table 2). Activities 3, 4, and 5 do not produce sound characteristics likely to result in marine mammal harassment and are not discussed further. Activities 1 and 2 involve pile installation with vibratory and impact hammers, and sound produced from these activities has the potential to result in incidental take of marine mammals by Level A and Level B harassment.
Year 2 of the BLBR Project would involve:
1. Removing the 50 steel sheet and 8 steel pipe cofferdam piles after bridge demolition is complete; and
2. Removing the eight steel pipe piles used for barge anchoring.
Year 2 construction activities for the BLBR Project will involve the removal of 50 24-inch steel sheet piles, 8 14-inch steel pipe piles, and the 8 24-inch steel pipe piles installed during Year 1 construction activities. All piles for Year 2 construction will be removed with a vibratory hammer after Year 1 construction and bridge demolition is complete. The underwater sound produced from pile extraction has the potential to result in incidental take of marine mammals by Level B harassment only.
Both Year 1 and Year 2 in-water pile driving and removal activities will be restricted to the months of December through February due to USACE's consultation requirements related to Endangered Species Act (ESA)-listed fish species. Marine mammal abundance is also lower in the project area during this seasonal in-water work window.
Proposed mitigation, monitoring, and reporting measures are described in detail later in this document (please see Proposed Mitigation and Proposed Monitoring and Reporting).
Sections 3 and 4 of the application summarize available information regarding status and trends, distribution and habitat preferences, and behavior and life history of the potentially affected species. NMFS fully considered all of this information, and we refer the reader to these descriptions, instead of reprinting the information. Additional information regarding population trends and threats may be found in NMFS' Stock Assessment Reports (SARs;
Table 3 lists all species or stocks for which take is likely and proposed to be authorized for this activity and summarizes information related to the population or stock, including regulatory status under the MMPA and ESA and potential biological removal (PBR), where known. PBR is defined by the MMPA as the maximum number of animals, not including natural mortalities, which may be removed from a marine mammal stock while allowing that stock to reach or maintain its optimum sustainable population (as described in NMFS' SARs). While no serious injury or mortality is anticipated or proposed to be authorized here, PBR and annual mortality and serious injury (M/SI) from anthropogenic sources are included here as gross indicators of the status of the species or stocks and other threats.
Marine mammal abundance estimates presented in this document represent the total number of individuals that make up a given stock or the total number estimated within a particular study or survey area. NMFS' stock abundance estimates for most species represent the total estimate of individuals within the geographic area, if known, that comprises that stock. For some species, this geographic area may extend beyond U.S. waters. All managed stocks in this region are assessed in NMFS' U.S. Alaska and Pacific SARs. All values presented in table 3 are the most recent available at the time of publication and are available online at:
As indicated above, all three species (with three managed stocks) in table 3 temporally and spatially co-occur with the specified activity to the degree that take is likely to occur. All species that could potentially occur in the proposed project area are included in table 6 of the IHA application. In addition to what was included in sections 3 and 4 of USACE's application, the SARs (
Since the mid-1980s, increasing numbers of California sea lions have been documented feeding on fish along the Washington coast and—more recently—in the LCR as far upstream as Bonneville Dam, at RM 146. However, the total number of California sea lions observed at Bonneville Dam has been in decline, ranging from 195 individuals in 2015 to 24 individuals in 2021, and 50 individuals in 2023 (Braun
In recent years, California sea lions have been reported below Bonneville Dam (RM 146) feeding on returning white sturgeon (
Steller sea lions that occur in the LCR, including the project vicinity, are members of the eastern Distinct Population Segment (DPS), ranging from Southeast Alaska to central California, including both Oregon and Washington (Jeffries
Harbor seals in the LCR exhibit some seasonal movement upriver, including into USACE's proposed project area, to follow winter and spring runs of Pacific eulachon and outmigrating juvenile salmon (
Hearing is the most important sensory modality for marine mammals underwater, and exposure to anthropogenic sound can have deleterious effects. To appropriately assess the potential effects of exposure to sound, it is necessary to understand the frequency ranges marine mammals are able to hear. Not all marine mammal species have equal hearing capabilities
For more detail concerning these groups and associated frequency ranges, please see NMFS (2024) for a review of available information.
This section discusses how components of the specified activity may impact marine mammals and their habitat. The Estimated Take of Marine Mammals section later in this document includes a quantitative analysis of the number of individuals that are expected to be taken by this activity. The Negligible Impact Analysis and Determination section considers the content of this section, the Estimated Take of Marine Mammals section, and the Proposed Mitigation section, to draw conclusions regarding the likely impacts of these activities on the reproductive success or survivorship of individuals and whether those impacts are reasonably expected to, or reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
Acoustic effects on marine mammal during the specified activities for the BLBR Project could occur from impact pile driving and vibratory pile driving and removal. The effects of underwater noise from USACE's proposed activities have the potential to result in Level A and Level B harassment of marine mammals in the proposed action area during Year 1, and in Level B harassment only during Year 2.
The marine soundscape is comprised of both ambient and anthropogenic sounds. Ambient sound is defined as the all-encompassing sound in a given place and is usually a composite of sound from many sources both near and far (American National Standards Institute (ANSI), 1995). The sound level of an area is defined by the total acoustical energy being generated by known and unknown sources. These sources may include physical (
The sum of the various natural and anthropogenic sound sources at any given location and time—which comprise “ambient” or “background” sound—depends not only on the source levels (as determined by current weather conditions and levels of biological and shipping activity) but also on the ability of sound to propagate through the environment. In turn, sound propagation is dependent on the spatially and temporally varying properties of the water column and sea floor and is frequency-dependent. As a result of the dependence on a large number of varying factors, ambient sound levels can be expected to vary widely over both coarse and fine spatial and temporal scales. Sound levels at a given frequency and location can vary by 10-20 dB from day to day (Richardson
In-water construction associated with the proposed project would include impact and vibratory pile driving and removal. The sounds produced by these activities fall into one of two general sound types: impulsive and non-impulsive. Impulsive sounds (
Both impact and vibratory pile hammers would be used on the BLBR Project. Impact hammers operate by repeatedly dropping a heavy piston onto a pile to drive the pile into the substrate. Sound generated by impact hammers is characterized by rapid rise times and high peak levels, a potentially injurious combination (Hastings and Popper, 2005). Vibratory hammers install piles by vibrating them and allowing the weight of the hammer to push them into the sediment. Vibratory hammers
The likely or possible impacts of the USACE's proposed activities on marine mammals could involve both non-acoustic and acoustic stressors. Potential non-acoustic stressors could result from the physical presence of the equipment, vessel, and personnel; however, we expect that any animals that approach the project sites close enough to be harassed due to the presence of equipment or personnel would be within the Level B harassment zones from pile driving would already be subject to harassment from the in-water activities. Therefore, any impacts to marine mammals are expected to primarily be acoustic in nature. Acoustic stressors would be generated by heavy equipment operation during pile installation and removal (
The introduction of anthropogenic noise into the aquatic environment from impact and vibratory pile driving and removal is the primary means by which marine mammals may be harassed from the USACE's specified activities. Anthropogenic sounds cover a broad range of frequencies and sound levels and can have a range of highly variable impacts on marine life from none or minor to potentially severe responses depending on received levels, duration of exposure, behavioral context, and various other factors. Broadly, underwater sound from active acoustic sources, such as those in the Project, can potentially result in one or more of the following: temporary or permanent hearing impairment, non-auditory physical or physiological effects, behavioral disturbance, stress, and masking (Richardson
We describe the more severe effects of certain non-auditory physical or physiological effects only briefly as we do not expect that use of pile driving hammers (impact and vibratory) is reasonably likely to result in such effects (see below for further discussion). Potential effects from impulsive sound sources can range in severity from effects such as behavioral disturbance or tactile perception to physical discomfort, slight injury of the internal organs and the auditory system, or mortality (Yelverton
In general, animals exposed to natural or anthropogenic sound may experience physical and psychological effects, ranging in magnitude from none to severe (Southall
The degree of effect of an acoustic exposure on marine mammals is dependent on several factors, including, but not limited to, sound type (
Richardson
Below, we provide additional details regarding potential impacts on marine mammals and their habitat from noise in general, starting with hearing impairment, as well as from the specific activities the USACE plans to conduct, to the degree it is available.
Depending on the degree (elevation of threshold in dB), duration (
Many studies have examined noise-induced hearing loss in marine mammals (see Finneran (2015) and Southall
The amount and onset of TTS depends on the exposure frequency. Sounds at low frequencies, well below the region of best sensitivity for a species or hearing group, are less hazardous than those at higher frequencies, near the region of best sensitivity (Finneran and Schlundt, 2013). At low frequencies, onset-TTS exposure levels are higher compared to those in the region of best sensitivity (
Relationships between TTS and PTS thresholds have not been studied in marine mammals, but such relationships are assumed to be similar to those in humans and other terrestrial mammals. PTS typically occurs at exposure levels at least several dBs above that inducing mild TTS (
The BLBR Project involves vibratory and impact pile driving during Year 1 construction activities, and exclusively vibratory pile removal during Year 2. While both impact and vibratory driving may occur on the same day during Year 1, only one method will operate at any given time. Pile driving and removal activities are not expected to be continuous, and frequent operational pauses are likely. Because pinniped prey species may temporarily avoid the ensonified area during these activities, pinnipeds are also unlikely to remain within the project area for extended periods. This behavioral avoidance, combined with operational pauses, is expected to reduce the potential for TS.
California sea lions, Steller sea lions, and harbor seals have been documented hauling out on the northern side of Cascades Island, the southwestern end of Bedford Island, the northwestern end of Tower Island, and a nearby sea lion trap, with the closest haulout located approximately 260 m downstream of the project site. Animals using these sites may transit through the project area to and from the haulouts. Individuals swimming with their heads underwater would be exposed to pile driving noise, potentially increasing the risk of TS over multiple days of exposure. However, this risk is mitigated by the expectation that these animals will
Disturbance may result in changing durations of surfacing and dives, number of blows per surfacing, or moving direction and/or speed; reduced/increased vocal activities; changing/cessation of certain behavioral activities (such as socializing or feeding); visible startle response or aggressive behavior (such as tail/fluke slapping or jaw clapping); avoidance of areas where sound sources are located. Pinnipeds may increase their haul out time, possibly to avoid in-water disturbance (Thorson and Reyff, 2006). Behavioral responses to sound are highly variable and context-specific and any reactions depend on numerous intrinsic and extrinsic factors (
Disruption of feeding behavior can be difficult to correlate with anthropogenic sound exposure, so it is usually inferred by observed displacement from known foraging areas, the appearance of secondary indicators (
Airborne noise would primarily be an issue for pinnipeds that are swimming or hauled out near the project site within the range of noise levels elevated above the airborne acoustic harassment criteria. We recognize that pinnipeds in the water could be exposed to airborne sound that may result in behavioral harassment when swimming with their heads above water. Most likely, airborne sounds would cause behavioral responses similar to those discussed above in relation to underwater sound. For instance, anthropogenic sound could cause hauled out pinnipeds to exhibit changes in their normal behavior, such as reduction in vocalizations, or cause them to temporarily abandon the area and move further from the source. However, these animals would previously have been `taken' because of exposure to underwater sounds above the behavioral harassment thresholds, which are in all cases larger than those associated with airborne sound. Thus, the behavioral harassment of these animals is already accounted for in these estimates of potential take. Therefore, we do not believe that authorization of incidental take resulting from airborne sound for pinnipeds is warranted, and airborne sound is not discussed further here.
Neuroendocrine stress responses often involve the hypothalamus-pituitary-adrenal system. Virtually all neuroendocrine functions that are affected by stress—including immune competence, reproduction, metabolism, and behavior—are regulated by pituitary hormones. Stress-induced changes in the secretion of pituitary hormones have been implicated in failed reproduction, altered metabolism, reduced immune competence, and behavioral disturbance (
The primary distinction between stress (which is adaptive and does not normally place an animal at risk) and “distress” is the cost of the response. During a stress response, an animal uses glycogen stores that can be quickly replenished once the stress is alleviated. In such circumstances, the cost of the stress response would not pose serious fitness consequences. However, when an animal does not have sufficient energy reserves to satisfy the energetic costs of a stress response, energy resources must be diverted from other functions. This state of distress will last until the animal replenishes its energetic reserves sufficient to restore normal function.
Relationships between these physiological mechanisms, animal behavior, and the costs of stress responses are well-studied through controlled experiments and for both laboratory and free-ranging animals (
Under certain circumstances, marine mammals experiencing significant masking could also be impaired from maximizing their performance fitness in survival and reproduction. Therefore, when the coincident (masking) sound is man-made, it may be considered harassment when disrupting or altering critical behaviors. It is important to distinguish TTS and PTS, which persist after the sound exposure, from masking, which occurs during the sound exposure. Because masking (without resulting in TS) is not associated with abnormal physiological function, it is not considered a physiological effect, but rather a potential behavioral effect.
The frequency range of the potentially masking sound is important in determining any potential behavioral impacts. For example, low-frequency signals may have less effect on high-frequency echolocation sounds produced by odontocetes but are more likely to affect detection of mysticete communication calls and other potentially important natural sounds such as those produced by surf and some prey species. The masking of communication signals by anthropogenic noise may be considered as a reduction in the communication space of animals (
Masking affects both senders and receivers of acoustic signals and can potentially have long-term chronic effects on marine mammals at the population level as well as at the individual level. Low-frequency ambient sound levels have increased by as much as 20 dB (more than three times in terms of SPL) in the world's ocean from pre-industrial periods, with most of the increase from distant commercial shipping (Hildebrand, 2009). All anthropogenic sound sources, but especially chronic and lower-frequency signals (
Proposed construction for the BLBR Project could have localized, temporary impacts on marine mammal habitat, including prey, by increasing in-water SPLs and slightly decreasing water quality. Increased noise levels may affect acoustic habitat (see
Effects from turbidity and sedimentation are expected to be short-term, minor, and localized. Suspended solids in the water column should dissipate and quickly return to background levels in all construction scenarios. Turbidity within the water column has the potential to reduce the level of oxygen in the water and irritate the gills of prey fish species in the proposed project area. However, suspended sediment associated with the
Construction activities would produce continuous, non-impulsive (
Fish react to sounds which are especially strong and/or intermittent low-frequency sounds, and behavioral responses such as flight or avoidance are the most likely effects. Short duration, sharp sounds can cause overt or subtle changes in fish behavior and local distribution. The reaction of fish to noise depends on the physiological state of the fish, past exposures, motivation (
SPLs of sufficient strength have been known to cause injury to fish and fish mortality. However, in most fish species, hair cells in the ear continuously regenerate and loss of auditory function is likely restored when damaged cells are replaced with new cells. Halvorsen
The most likely impact on fishes from impact and vibratory pile driving and removal in project area would be temporary behavioral avoidance of the area. The duration of fish avoidance of the area after pile driving stops is unknown but a rapid return to normal recruitment, distribution, and behavior is anticipated. There are times of known seasonal marine mammal foraging when fish are aggregating but the impacted areas are small portions of the total foraging habitats available in the LCR. In general, impacts to marine mammal prey species are expected to be minor and temporary. Further, it is anticipated that preparation activities for pile driving (
Construction activities, in the form of increased turbidity, also have the potential to adversely affect forage fish in the project area. As discussed earlier, increased turbidity is expected to occur in the immediate vicinity (approximately 25 ft (7.6 m) or less) of construction activities (Everitt
In summary, given the short daily duration of sound associated with pile driving and removal and the relatively small areas being affected, pile driving and removal activities associated with the proposed project are not likely to have a permanent adverse effect on any fish habitat, or populations of fish species. Thus, we conclude that impacts of the specified activity are not likely to have more than short-term adverse effects on any prey habitat or populations of prey species. Further, any impacts to marine mammal habitat are not expected to result in significant or long-term consequences for individual marine mammals, or to contribute to adverse impacts on their populations.
This section provides an estimate of the number of incidental takes proposed for authorization through the IHAs, which will inform NMFS' consideration of “small numbers,” the negligible impact determinations, and impacts on subsistence uses.
Harassment is the only type of take expected to result from these activities. Except with respect to certain activities not pertinent here, section 3(18) of the MMPA defines “harassment” as any act of pursuit, torment, or annoyance, which (i) has the potential to injure a marine mammal or marine mammal stock in the wild (Level A harassment); or (ii) has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (Level B harassment).
Authorized takes for Year 1 construction would primarily be by Level B harassment, and for Year 2 construction would include only Level B harassment, as use of the acoustic sources (
As described previously, no serious injury or mortality is anticipated or proposed to be authorized for this activity. Below we describe how the proposed take numbers are estimated.
For acoustic impacts, generally speaking, we estimate take by considering: (1) acoustic criteria above which NMFS believes there is some reasonable potential for marine mammals to be behaviorally harassed or incur some degree of AUD INJ; (2) the area or volume of water that will be ensonified above these levels in a day; (3) the density or occurrence of marine mammals within these ensonified areas; and, (4) the number of days of activities. We note that while these factors can contribute to a basic calculation to provide an initial prediction of potential takes, additional information that can qualitatively inform take estimates is also sometimes available (
NMFS recommends the use of acoustic criteria that identify the received level of underwater sound above which exposed marine mammals would be reasonably expected to be behaviorally harassed (equated to Level B harassment) or to incur AUD INJ of some degree (equated to Level A harassment). Criteria for AUD INJ, and hearing group categories are available in NMFS' Updated Technical Guidance (NMFS 2024) and are reflected below in the Level A harassment section.
The USACE's proposed activities include the use of continuous (vibratory hammer) and impulsive (impact hammer) sources, and therefore the RMS SPL thresholds of 120 and 160 dB re 1 μPa are applicable.
The 2024 Updated Technical Guidance criteria include both updated thresholds and updated weighting functions for each hearing group. The thresholds are provided in the table below. The references, analysis, and methodology used in the development of the criteria are described in NMFS' 2024 Updated Technical Guidance, which may be accessed at:
Here, we describe operational and environmental parameters of the activity that are used in estimating the area ensonified above the acoustic thresholds, including source levels and transmission loss coefficient.
To calculate distances to the Level A and Level B harassment thresholds for BLBR Project, proxy source levels were identified from the literature. Source levels for vibratory and impact driving of steel pipe and steel sheet piles were derived from California Department of Transportation summary data (Caltrans 2015, 2020). Specifically, for the vibratory installation of 24-inch sheet piles, USACE used source levels from Caltrans (2020) instead of Caltrans (2015). This choice is likely conservative, as the Caltrans (2020) proxy source level is 3 dB higher for the RMS SPL. Table 6 shows the source levels used to calculate harassment zones for impact driving, vibratory driving, and vibratory removal. These proxies represent the most appropriate data available due to similarities in pile sizes, materials, and installation methods.
Transmission loss (TL) is the decrease in acoustic intensity as an acoustic pressure wave propagates out from a source until the source becomes indistinguishable from ambient sound. TL parameters vary with frequency, temperature, river conditions, current, source and receiver depth, water depth, water chemistry, and bottom composition and topography. The general formula for underwater TL is:
The recommended TL coefficient for most nearshore environments is the practical spreading value of 15. This value results in an expected propagation environment that would lie between spherical and cylindrical spreading loss conditions, which is the most appropriate assumption for the USACE's proposed activities in the absence of specific modeling. The spreadsheet inputs for pile size, type, and installation method for each project are included in table 7. The estimated Level B harassment zones for USACE's proposed activities are shown in tables 8 and 9 for Year 1 and Year 2 of the BLBR Project, respectively.
The ensonified area associated with Level A harassment is more technically challenging to predict due to the need to account for a duration component. Therefore, NMFS developed an optional User Spreadsheet tool to accompany the 2024 Updated Technical Guidance that can be used to relatively simply predict an isopleth distance for use in conjunction with marine mammal density or occurrence to help predict potential takes. We note that because of some of the assumptions included in the methods underlying this optional tool, we anticipate that the resulting isopleth estimates are typically going to be overestimates of some degree, which may result in an overestimate of potential take by Level A harassment. However, this optional tool offers a practical, alternative way to estimate isopleth distances when more sophisticated modeling methods are not available or practical. For stationary sources such as impact and vibratory driving, the optional User Spreadsheet tool predicts the distance at which, if a marine mammal remained at that distance for the duration of the activity, it would be expected to incur AUD INJ. Inputs used in the optional User Spreadsheet tool, and the resulting estimated isopleths, are reported below.
In this section we provide information about the occurrence of marine mammals, including density or other relevant information which will inform the take calculations.
For the BLBR Project, incidental take is expected to occur for harbor seals, California sea lions, and Steller sea lions. The occurrence of all three marine mammal species was derived from monitoring data collected by the USACE for salmonid predation monitoring below Bonneville Dam. In the initial application, the USACE estimated the occurrence of harbor seals, California sea lions, and Steller sea lions for the proposed project based on the 10-year
Following coordination between the USACE and NMFS, and subsequent revisions to the application, the USACE provided summary data on February 4, 2026, for the past 5 years of pinniped monitoring at Bonneville Dam from December through February, spanning 2020 through 2025 (Tidwell, pers. comm., 2026). The data provided by the USACE Portland District Fisheries Field Unit were binned temporally for the months of December through February to account for the in-water work window for the BLBR Project. The USACE then calculated the 3-year and 5-year average daily abundance of Steller sea lions for the months of December, January, and February (table 9). These data show that there is a wide range in variability for Steller sea lion abundance below Bonneville Dam during the proposed in-water work window for the BLBR Project. Given the project's brief 8-day duration for each year of construction, it is possible that all in-water work could be concentrated at the beginning of work window when Steller sea lion abundance is the highest. To account for this, NMFS utilized a daily occurrence of eight Steller sea lions per day of construction. This methodology accounts for the potential for all pile driving to occur during the month of December.
The data from the USACE Portland District Fisheries Field Unit also indicated that California Sea lions and harbor seals are relatively uncommon during the proposed in-water work window with only one sighting of each species at Bonneville Dam between December and February, spanning from 2020 through 2025 (Tidwell, pers. comm., 2026). Therefore, it is assumed that up to one California sea lion and one harbor seal could occur in the project area each day of pile driving or pile removal for both years of the BLBR Project.
Here we describe how the information provided above is synthesized to produce a quantitative estimate of the take that is reasonably likely to occur and proposed for authorization.
The USACE proposed to estimate Level A harassment of Steller sea lions based on the proportion of the largest pile driving isopleth (impact or vibratory) for each pile size relative to the average river channel width at the construction site for Year 1 construction (table 10). The largest pile driving isopleth between impact and vibratory pile driving is used below because vibratory and impact pile driving for each pile size is expected to occur on the same day. NMFS agrees that USACE's proposed approach would provide an accurate estimate for the number of individual Steller sea lions that could be incidentally taken by Level A harassment and presents more details about these methods below.
NMFS used the following formula to calculate take by Level A harassment for Steller sea lions for Year 1 of the BLBR Project:
During Year 1 of the BLBR Project, the largest Level A harassment Isopleth would occur during impact pile driving of 24-inch steel sheet piles. The Level A isopleth to Steller sea lions is 381.1 m. Dividing this by the average channel width of 795 m results in an isopleth ratio of 0.48 (table 10).
To estimate take, this ratio (0.48) was multiplied by the total duration of pile driving days for 24-inch steel sheet piles (4 days) and the 5-year average occurrence of Steller sea lions at Bonneville Dam during the month of December (rounded to the nearest whole number). This results in 15 takes by Level A harassment of Steller sea lions for the installation of 24-inch steel sheet piles. The same approach was used for each pile size, which were then added together and results in a rounded estimate of 19 takes by Level A harassment for Steller sea lions. Accordingly, NMFS proposes to authorize 19 takes by Level A harassment for Steller sea lions for Year 1 construction activities.
The calculated Level A harassment isopleths for Steller sea lions during Year 2 construction for the BLBR Project are small, with the largest harassment zone of 10 m. Therefore, no Level A harassment for Steller sea lions is expected or proposed for authorization for Year 2 (tables 11 and 12).
NMFS used the following formula to calculate Level B harassment per pile size for Steller sea lions for both Year 1 and Year 2 activities:
The total Level B harassment of Steller sea lions for Year 1 and Year 2 of the BLBR project was calculated by subtracting the predicted amount of take by Level A harassment from expected total exposures per pile size and then summing the remaining takes by Level B harassment for all pile types.
Harbor seals are relatively uncommon in the LCR below Bonneville Dam from December through February, with only one individual observed during USACE's pinniped monitoring during these months over the past 5 years. However, harbor seals could occur in the BLBR Project area daily during each year of the proposed activities. For Year 1 and Year 2 construction, the USACE estimated that one harbor seal will enter Level A or Level B harassment zones and remain in the zone long enough to be taken. USACE requested a combined total of 16 takes by Level A and Level B harassment over the 2 year construction period. NMFS agrees with USACE's estimate that one harbor seal may occur in the project area each day of construction.
However, larger Level A harassment zones would only occur during Year 1 impact pile driving. Because impact pile driving is scheduled to occur each day of in-water construction during Year 1, a harbor seal could enter and remain in Level A harassment zones long enough to be taken by Level A harassment. For Year 1, NMFS proposes to authorize 1 take by Level A harassment for harbor seals each day of construction, for a total of eight takes by Level A harassment.
For Year 2 of the BLBR Project, activities are limited to vibratory pile removal, and the resulting Level A harassment zones are relatively small (maximum calculated zone of 29.7 m). It is unlikely that harbor seals would enter and remain within these small Level A harassment zones long enough to incur Level A harassment. Therefore, Level A harassment of harbor seals during Year 2 is not anticipated or proposed for authorization.
Because harbor seals are relatively uncommon during the in-water work window and NMFS proposes to authorize eight takes by Level A harassment during Year 1, no additional takes by Level B harassment are proposed for Year 1. Any incidental take by Level B harassment occurring during Year 1 would be accounted for under the proposed take by Level A harassment, as Level B harassment is a less severe form of take. For Year 2 construction, no Level A harassment is proposed; however, harbor seals have the potential to enter Level B harassment zones each day of in-water work. Therefore, NMFS proposes to authorize eight takes by Level B harassment of harbor seals for Year 2.
Similar to harbor seals, California sea lions are uncommon in the Columbia River below Bonneville Dam from December through February, with only one individual observed by USACE over the past 5 years. Although uncommon, California sea lions have the potential to occur in the project area each day of in-water construction. USACE requested a total of 16 California sea lion takes across the two-year project but did not differentiate how the takes would be allocated between the two consecutive IHAs. NMFS agrees that it is reasonably likely that one California sea lion could occur in the project area each day of construction.
As previously described, impact pile driving will only occur during Year 1. Level A harassment zones are largest during impact pile driving, with the largest calculated zone of 381.1 m. Due to the size of this Level A harassment zone, a California sea lion could enter and remain in this zone long enough to incur take by Level A harassment. Accordingly, NMFS proposes to authorize a total of one take by Level A harassment for California sea lions for Year 1.
Conversely, Year 2 construction involves only vibratory pile removal, where the largest calculated harassment zone is 10 m. It is highly unlikely that a California sea lion would enter and remain within these small harassment zones long enough to be taken by Level A harassment. Therefore, take by Level A harassment for California sea lions during Year 2 is not anticipated or proposed for authorization.
To calculate take by Level B harassment for California sea lions during Year 1 and Year 2 construction, NMFS used the following formula:
Using the formula for Level B harassment above, the calculated take equates to seven takes of California sea lions for Year 1 and eight takes for Year 2. Therefore, NMFS proposes to authorize seven takes for Year 1 and eight takes for Year 2 by Level B harassment for California sea lions.
The total takes by Level A and Level B harassment proposed for authorization are presented in table 13 and table 14, for Year 1 and Year 2 of the BLBR Project, respectively.
In order to issue an IHA under section 101(a)(5)(D) of the MMPA, NMFS must set forth the permissible methods of taking pursuant to the activity, and other means of effecting the least practicable impact on the species or stock and its habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stock for taking for certain subsistence uses (latter not applicable for this action). NMFS regulations require applicants for incidental take authorizations to include information about the availability and feasibility (economic and technological) of equipment, methods, and manner of conducting the activity or other means of effecting the least practicable adverse impact upon the affected species or stocks, and their habitat (50 CFR 216.104(a)(11)).
In evaluating how mitigation may or may not be appropriate to ensure the least practicable adverse impact on species or stocks and their habitat, as well as subsistence uses where applicable, NMFS considers two primary factors:
(1) The manner in which, and the degree to which, the successful implementation of the measure(s) is expected to reduce impacts to marine mammals, marine mammal species or stocks, and their habitat. This considers the nature of the potential adverse impact being mitigated (likelihood, scope, range). It further considers the likelihood that the measure will be effective if implemented (probability of accomplishing the mitigating result if implemented as planned), the likelihood of effective implementation (probability implemented as planned); and
(2) The practicability of the measures for applicant implementation, which may consider such things as cost, impact on operations.
The mitigation requirements described in the following were proposed by USACE in its adequate and complete application or are the result of subsequent coordination between NMFS and USACE. USACE has agreed that all of the mitigation measures are practicable. NMFS has fully reviewed the specified activities and the mitigation measures to determine if the mitigation measures would result in the least practicable adverse impact on marine mammals and their habitat, as required by the MMPA, and has determined the proposed measures are appropriate. NMFS describes these below as proposed mitigation requirements, and has included them in the proposed IHAs. In addition to the measures described later in this section, the USACE would follow these general mitigation measures:
• Authorized take, by Level A and Level B harassment only, would be limited to the species and numbers listed in tables 13 and 14. Construction activities must be halted upon observation of either a species for which incidental take is not authorized or a species for which incidental take has been authorized but the authorized number of takes has been met, entering or is within the harassment zone.
• The taking by serious injury or death of any of the species listed in tables 13 and 14 or any taking of any other species of marine mammal would be prohibited and would result in the modification, suspension, or revocation of the IHAs, if issued. Any taking exceeding the authorized amounts listed in tables 13 and 14 would be prohibited and would result in the modification, suspension, or revocation of the IHAs, if issued.
• Ensure that construction supervisors and crews, the marine mammal monitoring team, and relevant USACE staff are trained prior to the start of all construction activities, so that responsibilities, communication procedures, marine mammal monitoring protocol, and operational procedures are clearly understood. New personnel
• The USACE, construction supervisors and crews, protected species observers (PSOs), and relevant USACE staff must avoid direct physical interaction with marine mammals during construction activity. If a marine mammal comes within 10 meters of such activity, operations must cease and vessels must reduce speed to the minimum level required to maintain steerage and safe working conditions, as necessary to avoid direct physical interaction;
• Employ PSOs and establish monitoring locations as described in Section 5 of the IHAs and the USACE's Marine Mammal Monitoring and Reporting Plan (see chapter 13 of the USACE BLBR Project IHA application). The USACE must monitor the project area to the maximum extent possible based on the required number of PSOs, required monitoring locations, and environmental conditions.
Additionally, the following mitigation measures apply to the USACE's in-water construction activities for Year 1 and Year 2 of the BLBR Project.
The USACE would establish shutdown zones with radial distances as identified in tables 15 and 16 for all construction activities. The purpose of a shutdown zone is generally to define an area within which shutdown of the activity would occur upon sighting of a marine mammal (or in anticipation of an animal entering the defined area). If a marine mammal enters or is observed within the shutdown zones indicated in tables 15 and 16, pile driving must be delayed or halted. Operations may only resume once the animal is visually confirmed outside the zone or 15 minutes have passed without a re-detection.
Construction supervisors and crews, PSOs, and relevant USACE staff must avoid direct physical interaction with marine mammals during construction activities. If marine mammals come within 10 m of such activity, operations must cease, to avoid direct interaction. If an activity is delayed or halted due to the presence of a marine mammal, the activity may not commence or resume until either the animal has voluntarily exited and been visually confirmed beyond the shutdown zone indicated in tables 15 and 16 or 15 minutes have passed without re-detection of the animal.
Finally, construction activities must be halted upon observation of a species for which incidental take is not authorized or a species for which incidental take has been authorized but the authorized number of takes has been met entering or within any shutdown zone. If a marine mammal species not covered under these IHAs enters a shutdown zone, all in-water activities would cease until the animal leaves the zone or has not been observed for at least 15 minutes. Pile driving may proceed if the unauthorized species is observed leaving the clearance and shutdown zone or if 15 minutes have passed since the last observation.
Soft-start procedures are used to provide additional protection to marine mammals by providing warning and/or giving marine mammals a chance to leave the area prior to an impact hammer operating at full capacity. The USACE would use soft-start techniques when impact pile driving. Soft-start procedures require contractors to provide an initial set of three strikes at reduced energy, followed by a 30-second waiting period, then two subsequent reduced-energy strike sets. A soft-start would be implemented at the start of each day's impact pile driving and at any time following cessation of impact pile driving for a period of 30 minutes or longer.
Based on our evaluation of the applicant's proposed measures, NMFS has preliminarily determined that the proposed mitigation measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance. NMFS conducted an independent evaluation of the proposed measures, and has preliminarily determined for each of the proposed IHAs that the proposed mitigation measures provide the means of effecting the least practicable impact on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance.
In order to issue an IHA for an activity, section 101(a)(5)(D) of the MMPA states that NMFS must set forth requirements pertaining to the
Monitoring and reporting requirements prescribed by NMFS should contribute to improved understanding of one or more of the following:
• Occurrence of marine mammal species or stocks in the area in which take is anticipated (
• Nature, scope, or context of likely marine mammal exposure to potential stressors/impacts (individual or cumulative, acute or chronic), through better understanding of: (1) action or environment (
• Individual marine mammal responses (behavioral or physiological) to acoustic stressors (acute, chronic, or cumulative), other stressors, or cumulative impacts from multiple stressors;
• How anticipated responses to stressors impact either: (1) long-term fitness and survival of individual marine mammals; or (2) populations, species, or stocks;
• Effects on marine mammal habitat (
• Mitigation and monitoring effectiveness.
The monitoring and reporting requirements described in the following were proposed by USACE in its adequate and complete application and/or are the result of subsequent coordination between NMFS and USACE. USACE has agreed to the requirements. NMFS describes these below as requirements and has included them in the proposed IHAs.
All PSOs must be NMFS-approved and have no other assigned tasks during monitoring periods. At least one PSO would have prior experience performing the duties of a PSO during construction activity pursuant to a NMFS-issued ITA or Letter of Concurrence.
During all in-water work for both years of the BLBR Project, a minimum of two PSOs would monitor Level A and Level B harassment zones to the extent practicable to document the marine mammal's presence and behavior. PSOs would monitor for marine mammals 30 minutes before, during, and 30 minutes after the specified activities from the construction barge and from the shore nearby that provides the best field of view. Additionally, observers would record all incidents of marine mammal occurrence, regardless of distance from activity, and would document any behavioral reactions in concert with distance from piles being driven or removed. Pile driving activities include the time to install or remove a single pile or series of piles, as long as the time elapsed between uses of the pile driving equipment is no more than 30 minutes.
PSOs should also have the following additional qualifications:
• Ability to conduct field observations and collect data according to assigned protocols;
• Experience or training in the field identification of marine mammals, including the identification of behaviors;
• Sufficient training, orientation, or experience with the construction operation to provide for personal safety during observations;
• Writing skills sufficient to prepare a report of observations including but not limited to the number and species of marine mammals observed; dates and times when in-water construction activities were conducted; dates, times, and reason for implementation of mitigation (or why mitigation was not implemented when required); and marine mammal behavior; and
• Ability to communicate orally, by radio or in person, with project personnel to provide real-time information on marine mammals observed in the area as necessary.
The USACE would be required to submit a draft report(s) on all construction activities and marine mammal monitoring results to NMFS within 90 days of the completion of monitoring, or 60 days prior to the requested issuance of any subsequent IHAs or similar activities at the same locations, whichever comes first. The information required to be collected and reported to NMFS is included in the draft IHAs available at
Specific proposed mitigation, monitoring, and reporting requirements can be found in the draft IHAs found at
NMFS has defined negligible impact as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival (50 CFR 216.103). A negligible impact finding is based on the lack of likely adverse effects on annual rates of recruitment or survival (
To avoid repetition, the discussion of our analysis applies to California sea lions, Steller sea lions, and harbor seal, given that the anticipated effects of this activity on these different marine mammal stocks are expected to be similar. There is little information about the nature or severity of the impacts, or the size, status, or structure of any of these species or stocks that would lead to a different analysis for this activity.
NMFS has identified key factors which may be employed to assess the level of analysis necessary to conclude whether potential impacts associated with a specified activity should be considered negligible. These include (but are not limited to) the type and magnitude of taking, the amount and importance of the available habitat for the species or stock that is affected, the duration of the anticipated effect to the species or stock, and the status of the species or stock. The following factors support negligible impact determinations for all affected stocks. Additionally, for both projects, pile driving will be restricted to daylight hours only. This allows animals to forage in the project area and use the habitat during nighttime hours without the potential for noise-related harassment.
Pile driving and removal activities associated with Year 1 and Year 2 of the BLBR Project, as outlined previously, have the potential to disturb or displace marine mammals. Specifically, the specified activities may result in take, in the form of Level A and Level B harassment, from underwater sounds generated by impact and vibratory pile driving, and vibratory pile removal. Potential takes could occur if individuals are present in the ensonified zone when these activities are underway.
For Year 1 of the BLBR Project, take by Level A harassment is proposed to be authorized for California sea lions, Steller sea lions, and harbor seals to account for the possibility that an animal could enter a Level A harassment zone prior to detection, and remain within that zone for long enough to incur AUD INJ,
For Year 1 of the BLBR project, NMFS proposes to authorize 1 take for California sea lions, 19 takes for Steller sea lions, and 8 takes for harbor seal by Level A harassment, representing a small portion of each species' stock abundance. Because the ensonified area is relatively small, confined, and does not span the entire width of the river channel, animals can transit through the area outside the ensonified zones or during construction breaks, thereby reducing their potential for Level A harassment.
For Year 2 of the BLBR Project, Level A harassment is extremely unlikely given the small size of the Level A harassment isopleths predicted and the required mitigation measures designed to minimize the possibility of injury to marine mammals. No serious injury or mortality is anticipated given the nature and duration of the activity.
As described above, NMFS expects that marine mammals would likely move away from an aversive stimulus, especially at levels that would be expected to result in AUD INJ, given sufficient notice through use of soft-start. The USACE would also be required to shut down pile driving activities if marine mammals approach within hearing group-specific zones (see tables 15 and 16), further minimizing the likelihood and degree of AUD INJ and more severe behavioral responses. Even absent mitigation, no serious injury or mortality from construction activities is anticipated and none is proposed to be authorized.
Effects on individuals that are taken by Level B harassment in the form of behavioral disruption, on the basis of reports in the literature as well as monitoring from other similar activities, would likely be limited to reactions such as avoidance, increased swimming speeds, increased surfacing time, or decreased foraging (if such activity were occurring) (
Additionally, and as noted previously, some subset of the individuals that are behaviorally harassed could simultaneously incur some small degree of TTS for a short duration of time. However, since the hearing sensitivity of individuals that incur TTS is expected to recover completely within minutes to hours, it is unlikely that the brief hearing impairment would affect the individual's long-term ability to forage and communicate with conspecifics, and would therefore not likely impact reproduction or survival of any individual marine mammal, let alone adversely affect rates of recruitment or survival of the species or stock.
The BLBR Project is not expected to have significant adverse effects on affected marine mammal habitats. The project activities would not modify existing marine mammal habitat for a significant amount of time. The activities may cause some fish to leave the area of disturbance, thus temporarily impacting marine mammals' foraging opportunities in a limited portion of the foraging range; but, because of the short duration of the activities and the relatively small area of the habitat that may be affected (with no known particular importance to marine mammals), the impacts to marine mammal habitat are not expected to cause significant or long-term negative consequences.
In the BLBR Project area, California sea lions, Steller sea lions, and harbor seals have been documented hauling out on Cascades, Bedford, and Tower Islands as well as the nearby sea lion trap. Although the construction site is approximately 260 m from the closest haulout, in water construction would be
Given the implementation of mitigation measures, the availability of alternative foraging areas and haulout sites in the Columbia River, the localized nature of the ensonified areas, and the projects short overall duration (8 days for Year 1 and 8 days for Year 2), the proposed activities are expected to have a negligible impact on the effected pinniped stocks.
Additionally, the BLBR project is a very small portion of each stock of California sea lions, Steller sea lions, and harbor seals overall range, with only a small portion of each stock expected to occur in the project area. Consequentially, the take requested does not represent a broad impact across the entire stock but rather repeated exposures to the same individuals. Although pinnipeds that haul out in the project area may experience short term exposure to elevated noise levels, such as intermittent disturbances, which are not expected to result in chronic stress or physical injury that would reduce fitness, survival, or reproductive success of any individual. Because the anticipated impacts are localized to a small subset of the population and are not expected to affect the health of those individuals, the take proposed for authorization would not reach a level of biological significance that would affect annual rates of recruitment or survival for the US stock of California sea lions, Eastern stock of Steller sea lions, and the Oregon/Washington coastal stock of harbor seals.
In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from the Year 1 specified activities are not expected to adversely affect any of the species or stocks through effects on annual rates of recruitment or survival:
• No serious injury or mortality is anticipated or proposed to be authorized;
• The intensity of anticipated takes by Level A and Level B harassment is low for all stocks and would not be of a duration or intensity to result in impacts on reproduction or survival;
• The anticipated incidents of Level A harassment (AUD INJ) is limited to a small degree of PTS and would only effect a small number of individuals;
• The ensonified areas are very small relative to the overall habitat ranges of all species and stocks, and would not adversely affect ESA-designated critical habitat for any species or any areas of known biological importance;
• The lack of anticipated significant or long-term negative effects to marine mammal habitat;
• The availability of nearby areas of similar habitat value (
• Impacts on marine mammal feeding are not expected to result in significant or long-term consequences for individuals, or to accrue adverse impacts on their populations;
• The USACE would implement mitigation measures, such as soft-starts for impact pile driving and shutdowns to minimize the numbers of marine mammals exposed to injurious levels of sound, and to ensure that take by Level A harassment, is at most, a small degree of auditory injury.
• Previous monitoring reports for similar activities in the LCR have documented little to no behavioral effect on individuals.
In summary and as described above, the following factors primarily support our preliminary determination that the impacts resulting from the Year 2 specified activities are not expected to adversely affect any of the species or stocks through effects on annual rates of recruitment or survival:
• No serious injury or mortality is anticipated or authorized;
• No take by Level A harassment are anticipated or proposed to be authorized;
• The anticipated incidents of Level B harassment would consist of, at worst, temporary modifications in behavior that would not result in fitness impacts to individuals;
• The intensity of anticipated takes by Level B harassment is low for all stocks and would not be of a duration or intensity to result in impacts on reproduction or survival;
• The ensonified areas are very small relative to the overall habitat ranges of all species and stocks, and would not adversely affect ESA-designated critical habitat for any species or any areas of known biological importance;
• The lack of anticipated significant or long-term negative effects to marine mammal habitat;
• The availability of nearby areas of similar habitat value (
• Impacts on marine mammal feeding are not expected to result in significant or long-term consequences for individuals, or to accrue adverse impacts on their populations; and
• Previous monitoring reports for similar activities in the LCR have documented little to no behavioral effect on individuals.
Based on the analysis contained herein of the likely effects of the specified activity on marine mammals and their habitat, and taking into consideration the implementation of the proposed monitoring and mitigation measures, NMFS preliminarily finds that:
1. The total marine mammal take from the proposed activities for the Year 1 IHA will have a negligible impact on all affected marine mammal species or stocks.
2. The total marine mammal take from the proposed activities for the Year 2 IHA will have a negligible impact on all affected marine mammal species or stocks.
As noted previously, only take of small numbers of marine mammals may be authorized under section 101(a)(5)(A) and (D) of the MMPA for specified activities other than military readiness activities. The MMPA does not define small numbers and so, in practice, where estimated numbers are available, NMFS compares the number of individuals taken to the most appropriate estimation of abundance of the relevant species or stock in our determination of whether an authorization is limited to small numbers of marine mammals. When the predicted number of individuals to be taken is fewer than one-third of the species or stock abundance, the take is considered to be of small numbers (see 86 FR 5322, January 19, 2021). Additionally, other qualitative factors may be considered in the analysis, such as the temporal or spatial scale of the activities.
Consistent with the small number finding required by MMPA, NMFS has determined that the number of takes proposed for authorization is small relative to the stock abundances. For both Year 1 and Year 2 of the BLBR Project, the number of takes proposed for all three species is well below one-third of the best available population estimates, representing less than 1 percent for California sea lions, Steller sea lions, and harbor seals.
Based on the analysis contained herein of the proposed activity
There are no relevant subsistence uses of the affected marine mammal stocks or species implicated by this action. Therefore, NMFS has determined for each IHA that the total taking of affected species or stocks would not have an unmitigable adverse impact on the availability of such species or stocks for taking for subsistence purposes.
Section 7(a)(2) of the ESA of 1973 (16 U.S.C. 1531
No incidental take of ESA-listed species is proposed for authorization or expected to result from this activity. Therefore, NMFS has determined that formal consultation under section 7 of the ESA is not required for this action.
As a result of these preliminary determinations, NMFS proposes to issue two consecutive IHAs to USACE for conducting the Bonneville Lock 1 Bridge Replacement Project in the Columbia River, provided the previously mentioned mitigation, monitoring, and reporting requirements are incorporated. Drafts of the proposed IHAs can be found at:
We request comment on our analyses, the proposed authorizations, and any other aspect of this notice of the two proposed IHAs for the proposed BLBR Project. We also request comment on the potential renewal of these proposed IHAs as described in the paragraph below. Please include with your comments any supporting data or literature citations to help inform decisions on the request for this IHA or a subsequent renewal IHA.
On a case-by-case basis, NMFS may issue a one-time, 1-year renewal IHA following notice to the public providing an additional 15 days for public comments when (1) up to another year of identical or nearly identical activities as described in the Description of Proposed Activity section of this notice is planned or (2) the activities as described in the Description of Proposed Activity section of this notice would not be completed by the time the IHA expires and a renewal would allow for completion of the activities beyond that described in the
• A request for renewal is received no later than 60 days prior to the needed renewal IHA effective date.
• The request for renewal must include the following:
1. An explanation that the activities to be conducted under the requested renewal IHA are identical to the activities analyzed under the initial IHA, are a subset of the activities, or include changes so minor (
2. A preliminary monitoring report showing the results of the required monitoring to date and an explanation showing that the monitoring results do not indicate impacts of a scale or nature not previously analyzed or authorized.
• Upon review of the request for renewal, the status of the affected species or stocks, and any other pertinent information, NMFS determines that there are no more than minor changes in the activities, the mitigation and monitoring measures will remain the same and appropriate, and the findings in the initial IHA remain valid.
Department of the Air Force, Department of Defense.
Notice of record of decision.
On June 10, 2026, the Department of the Air Force (DAF) signed the Record of Decision (ROD) for the Final Environmental Impact Statement (EIS) for T-7A Recapitalization at Vance AFB, OK.
Ms. Chinling Chen, NEPA Project Manager, by email at
The DAF will implement its Alternative 3 to recapitalize all T-38C aircraft at Vance AFB with up to 99 T-7A aircraft, limiting initial delivery to 46 per the Secretary of the Air Force Strategic Basing Decision approving Vance AFB as the fourth T-7A Main Operating Base. DAF will execute all portions of T-7A recapitalization at Vance AFB including the operations and changes to the number of personnel and dependents as defined for Alternative 3. Alternative 3 is selected to provide DAF with operational flexibility after considering the potential environmental consequences provided in the EIS for T-7A recapitalization at Vance AFB, the comments and concerns of the public and other key stakeholders, as well as other factors related to national defense, including current military operational needs and costs. The Final EIS was made available to the public through the project website (
The DAF decision documented in the ROD was based on matters discussed in the Final EIS, inputs from the public and regulatory agencies, and other relevant factors. Authority for this notice is 42 U.S.C. 4321,
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before August 25, 2026.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Carolyn Rose, 202-453-5967.
The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing an extension without change of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before August 25, 2026.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Carolyn Rose, 202-453-5967.
The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note
Department of Education.
Notice.
The Department announces competitions each year for its discretionary grant funding through Application Notice and Instruction documents published on
Lisa Gillette. Telephone: (202)260-1426. Email:
On an annual basis, the Department announces competitions for its discretionary grant funding through Application Notice and Instruction documents published on
In general, the Department will limit extensions and reopenings to no more than five business days. However, the Department will consider longer extensions or reopenings in the case of exceptional circumstances. In making our decision for each competition, the Department will consider the extent to which affected areas and affected applicants have been impacted and the feasibility of extending or reopening a competition.
The applicable federally declared major disaster area is the area in which assistance to individuals or public assistance has been authorized under a Federal Emergency Management Agency (FEMA) Major Disaster Declaration. Major Disaster Declarations are available at
When the Department extends or reopens a competition, an affected applicant that has already timely submitted an application under a competition may resubmit their application on or before the revised application deadline. However, the affected applicant is not required to take such a step. If a new application is not submitted, the Department will use the application that was submitted by the original deadline. If a new application is submitted, the Department will consider the application that is last submitted and timely received by 11:59:59 p.m., Eastern Time, on the revised transmittal of applications deadline date for the applicable competition.
Any application submitted by an affected applicant under the revised deadline must contain evidence (
The application period will not be extended for all eligible applicants when there is a federally declared major disaster. Applications from applicants that are not affected, as defined above, will not be accepted past the original transmittal of applications deadline.
All information in an application notice and instructions on
Federal Student Aid (FSA), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995, the Department is proposing a revision of a currently approved information collection request (ICR).
Interested persons are invited to submit comments on or before July 27, 2026.
Written comments and recommendations for proposed information collection requests should be submitted within 30 days of publication of this notice. Click on this link
For specific questions related to collection activities, please contact Carolyn Rose, (202) 453-5967.
The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
The One Big Beautiful Bill Act (OBBBA) signed into law on July 4, 2025, made statutory changes to Sections 455(a), 455(d), 455(e), 455(g), and 455(q), that impact borrower eligibility, terms and conditions, and borrowers' rights and responsibilities for Direct Loans received on or after July 1, 2026. Additionally, previous provisions regulated in 34 CFR 685.209 effective July 1, 2024, were invalidated as a result of court actions on March 10, 2026. This is a request for a revision of this collection to align the promissory note with the requirements of the OBBBA.
Hydrocarbons and Geothermal Energy Office, Department of Energy.
Notice of application.
The Hydrocarbons and Geothermal Energy Office (HGEO) of the Department of Energy (DOE) gives notice (Notice) of receipt of an application (Application), filed by Rio Grande LNG Train 6, LLC (RGLNG Train 6) on June 11, 2026. RGLNG Train 6 requests long-term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) in a volume equivalent to approximately 312.05 billion cubic feet (Bcf) of natural gas per year (Bcf/yr) from the proposed Rio Grande LNG Expansion Project (Project), to be located at and adjacent to the previously authorized Rio Grande LNG Terminal (RGLNG Terminal), along the Brownsville Ship Channel in Cameron County, Texas. RGLNG Train 6 filed the Application under the Natural Gas Act (NGA).
Protests, motions to intervene, or notices of intervention, as applicable, and written comments are to be filed electronically as detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, August 25, 2026.
Due to potential delays in DOE's receipt and processing of mail sent through the U.S. Postal Service, we encourage respondents to submit filings electronically to ensure timely receipt.
RGLNG Train 6 requests authorization to export domestically produced LNG from its
RGLNG Train 6 requests authorization to export the LNG in a volume equivalent to approximately 312.05 Bcf/yr of natural gas by ocean-going vessel on a non-additive basis to: (i) any country with which the United States has entered into a free trade agreement (FTA) requiring national treatment for trade in natural gas (FTA countries), and (ii) any other country with which trade is not prohibited by U.S. law or policy (non-FTA countries).
RGLNG Train 6 seeks this authorization on its own behalf and as agent for other entities that will hold title to the LNG at the time of export. RGLNG Train 6 requests authorization for a term extending through the later of December 31, 2050, or twenty years, following the commencement of commercial operation of the Project.
Additional details can be found in RGLNG Train 6's Application, posted on the DOE website at
In reviewing the Application, DOE will consider any issues required by law or policy under NGA section 3(a), DOE's regulations, and any other documents deemed appropriate.
Parties that may oppose the Application should address these issues and documents in their comments and/or protests, as well as other issues deemed relevant to the Application.
The National Environmental Policy Act (NEPA), 42 U.S.C. 4321
In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable, addressing the Application. Interested parties will be provided 60 days from the date of publication of this Notice in the
Any person wishing to become a party to this proceeding evaluating the Application must file a motion to intervene or notice of intervention.
Filings may be submitted using one of the following methods:
(1) Submitting the filing electronically at
(2) Mailing the filing to the Office of Global Energy Security at the address listed in the
(3) Hand delivering the filing to the Office of Global Energy Security at the address listed in the
For administrative efficiency, DOE prefers filings to be filed electronically. All filings must include a reference to “Docket No. 26-67-LNG” or “Rio Grande LNG Train 6, LLC Application” in the title line. Filings must be submitted in English to be considered.
For electronic submissions: Please include all related documents and attachments (
The Application, and any filed protests, motions to intervene, notices of intervention, and comments will be available electronically on the DOE website at
A decisional record on the Application will be developed through responses to this Notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this Notice, in accordance with 10 CFR 590.316.
Take notice that the Commission received the following Accounting Request 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:
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
Federal Energy Regulatory Commission.
Errata notice and request for comments.
In compliance with the requirements of the Paperwork Reduction Act of 1995, the Federal Energy Regulatory Commission (Commission or FERC) is soliciting public comment on the currently approved information collection, FERC-725B, (Mandatory Reliability Standards, Critical Infrastructure Protection (CIP)). This submission is for an extension request and changes to CIP-002-8. No comments were received on the 60-day notice. This notice corrects the 30-day notice published on June 12, 2026 (91 FR 35681) adjusting the estimates in the burden table.
Comments on the collection of information are due July 27, 2026.
Send written comments on FERC-725B to OMB through
Please submit a copy of your comments to the Commission via email to
•
•
Kayla Williams, (202) 502-6468.
On February 3, 2006, the Commission issued Order No. 672,
On January 18, 2008, the Commission issued Order No. 706,
A Cyber Asset that if rendered unavailable, degraded, or misused would, within 15 minutes of its required operation, mis-operation, or non-operation, adversely impact one or more Facilities, systems, or equipment, which, if destroyed, degraded, or otherwise rendered unavailable when needed, would affect the reliable operation of the Bulk Electric System. Redundancy of affected Facilities, systems, and equipment shall not be considered when determining adverse impact. Each BES Cyber Asset is included in one or more BES Cyber Systems.
On March 19, 2026, the order within RD25-8 approved Reliability Standard CIP-002-8 related to the identification and categorization of BES cyber systems and their associated BES cyber assets. The Commission approved the proposed Reliability Standard CIP-002-8 pursuant to section 215(d)(2) of the FPA because the Standard would advance reliability by revising the threshold for applicable transmission owners and transmission operators to categorize their BES cyber systems based on the impact to their associated facilities, systems, and equipment, which, if destroyed, degraded, misused, or otherwise rendered unavailable would affect the reliability of the BES. Also, to revise the definition of the term control center in the NERC Glossary to alleviate confusion from a lack of common understanding of the term “control” as opposed to “authority”.
The CIP Reliability Standards currently consist of 14 standards specifying a set of requirements that entities must follow to ensure the cyber and physical security of the Bulk-Power System. There is also one physical security standard.
• CIP-002-8 (formerly CIP-002-7) a Bulk Electric System Cyber System Categorization: requires entities to identify and categorize BES Cyber Assets for the application of cyber security requirements commensurate with the adverse impact that loss, compromise, or misuse of those BES Cyber Systems could have on the reliable operation of the BES.
• CIP-003-10 Security Management Controls: requires entities to specify consistent and sustainable security management controls that establish responsibility and accountability to protect BES Cyber Systems against compromise that could lead to mis-operation or instability in the BES.
• CIP-004-8 Personnel and Training: requires entities to minimize the risk against compromise that could lead to mis-operation or instability in the BES from individuals accessing BES Cyber Systems by requiring an appropriate level of personnel risk assessment, training, and security awareness in support of protecting BES Cyber Systems.
• CIP-005-8 Electronic Security Perimeter(s): requires entities to manage electronic access to BES Cyber Systems by specifying a controlled Electronic Security Perimeter in support of
• CIP-006-7.1 Physical Security of Bulk Electric System Cyber Systems: requires entities to manage physical access to BES Cyber Systems by specifying a physical security plan in support of protecting BES Cyber Systems against compromise that could lead to mis-operation or instability in the BES.
☐ CIP-007-7.1 System Security Management: requires entities to manage system security by specifying select technical, operational, and procedural requirements in support of protecting BES Cyber Systems against compromise that could lead to mis-operation or instability in the BES.
☐ CIP-008-7.1 Incident Reporting and Response Planning: requires entities to mitigate the risk to the reliable operation of the BES as the result of a cybersecurity incident by specifying incident response requirements.
☐ CIP-009-7.1 Recovery Plans for Bulk Electric System Cyber Systems: requires entities to recover reliability functions performed by BES Cyber Systems by specifying recovery plan requirements in support of the continued stability, operability, and reliability of the BES.
☐ CIP-010-5 Configuration Change Management and Vulnerability Assessments: requires entities to prevent and detect unauthorized changes to BES Cyber Systems by specifying configuration change management and vulnerability assessment requirements in support of protecting BES Cyber Systems from compromise that could lead to mis-operation or instability in the BES.
☐ CIP-011-4.1 Information Protection: requires entities to prevent unauthorized access to BES Cyber System Information by specifying information protection requirements in support of protecting BES Cyber Systems against compromise that could lead to mis-operation or instability in the BES.
☐ CIP-012-2 Communications between Control Centers: requires entities to protect the confidentiality and integrity of Real-time Assessment and Real-time monitoring data transmitted between Control Centers.
☐ CIP-013-3 Supply Chain Risk Management: requires entities to mitigate cybersecurity risks to the reliable operation of the BES by implementing security controls for supply chain risk management of BES Cyber Systems.
☐ CIP-014-3 Physical Security: Set out to identify and protect Transmission stations and Transmission substations, and their associated primary control centers, that if rendered inoperable or damaged as a result of a physical attack could result in instability, uncontrolled separation, or Cascading within an Interconnection.
☐ CIP-015-1 Internal Network Security Monitoring: purpose is to improve the probability of detecting anomalous or unauthorized network activity in order to facilitate improved response and recovery from an attack.
The CIP Reliability Standards, viewed as a whole, implement a defense-in-depth approach to protecting the security of BES Cyber Systems at all impact levels.
• Manager (Occupational Code: 11-0000): $83.41/hour; and
• Electrical Engineer (Occupational Code 17-2071): $71.19/hour. The estimated hourly cost (salary plus benefits) is a combination of the following categories from the Bureau of Labor Statistics (BLS) website, May 2025 http://www.bls.gov/oes/current/naics2_22.htm.
RD25-8 (Changes):
The Commission bases its paperwork burden estimates on the additional paperwork burden presented by the proposed revisions to Reliability Standard CIP-002-8. Reliability Standards are objective-based and allow entities to choose compliance approaches best tailored to their systems. The NERC Compliance Registry, as of June 2025, identifies approximately 1,673
Of this total, we estimate that 1,573 entities will face a minor increase in paperwork burden of two hours each for a total burden hours increase of 3,146 at $97
Additionally, we estimate that another 100 entities will have a burden of four hours each for a total burden hour increase of 400 at $97 per hour for a total burden of $38,800 for the first year and no ongoing burdens in addition to the burden already accounted for in the OMB control number for CIP Reliability Standards.
The responses and burden hours for Years 1-3 will total respectively as follows:
• Manager (Occupational Code: 11-0000): $83.41/hour; and
• Electrical Engineer (Occupational Code 17-2071): $71.19/hour. The estimated hourly cost (salary plus benefits) is a combination of the following categories from the Bureau of Labor Statistics (BLS) website, May 2025 http://www.bls.gov/oes/current/naics2_22.htm.
• Year 1-3 each: for proposed Reliability Standard CIP-002-8 will be 557.67 responses; 1,182 hours;
• The annual cost burden for each Year 1-3 is $101,803 for proposed Reliability Standard CIP-002-8.
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Emergency Planning and Community Right to Know Act (EPCRA) and Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) Continuous Release Reports” (EPA ICR Number 1445.16, OMB Control Number 2050-0086) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through April 30, 2027. This document allows for 60 days for public comments.
Comments must be submitted on or before August 25, 2026.
Submit your comments, referencing Docket ID No. EPA-HQ-SFUND-2015-0100, to EPA online using
Jennifer Barre, Office of Resource Conservation and Recovery, Mail Code 5303T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-9026; email address:
This is a proposed extension of the ICR, which is currently approved through April 30, 2027. 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.
This document allows 60 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate forms of information technology. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another
CRR allows the Federal government to determine whether a Federal response action is required to control or mitigate any potential adverse effects to public health, welfare, or the environment. The release information is also available to EPA program offices and other Federal agencies who evaluate the potential need for additional regulations, new permitting requirements for specific substances or sources, or improved emergency response planning. State and local government authorities and facilities subject to CRR use the release information for local emergency response planning. The public, which has access to release information through the Freedom of Information Act, may request release information on what types of releases are occurring in different localities and what actions, if any, are being taken to protect public health, welfare and the environment.
Environmental Protection Agency (EPA).
Notice.
The U.S. Environmental Protection Agency has submitted an information collection request (ICR), The 8th Drinking Water Infrastructure Needs Survey and Assessment (EPA ICR Number 7798.01, OMB Control Number 2040-NEW) to the Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act. This is a request for approval of a new collection. Public comments were previously requested via the
Comments may be submitted on or before July 27, 2026.
Submit your comments, referencing Docket ID Number EPA-HQ-OW-2024-0561, to EPA online using
The EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Submit written comments and recommendations to OMB for the proposed information collection within 30 days of publication of this notice to
Tirzah Glebes or John Towe, Drinking Water Infrastructure Development Division, Office of Ground Water and Drinking Water, 4606M, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; email address:
This is a request for approval of a new collection. 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.
Public comments were previously requested via the
The survey will collect the CWSs' 20-year capital improvement needs through their submission of project information and supporting documentation. In addition, the survey will collect supplemental question responses. Supplemental questions will ask CWSs to identify potential barriers to accessing DWSRF funding. The EPA
The capital improvement needs results of the DWINSA and the information provided through stakeholder engagement will be used by the EPA primarily as a basis for allotting DWSRF funds among states. A national assessment also improves the EPA's ability to gauge long-term (20-year) capital costs of SDWA regulations and the provision of safe drinking water to the public. The AI and ANV question responses will be used to inform the Agency of Tribal water operator certification program usage and needs, and other technical, managerial, and financial capability concerns of Tribal utilities.
Environmental Protection Agency (EPA)
Notice.
The U.S. Environmental Protection Agency (EPA) requests public nominations from qualified candidates to be considered for appointment to its Good Neighbor Environmental Board (GNEB) to fill approximately 11-15 vacancies.
Nominations should be submitted by August 10, 2026.
For information about this
The GNEB is a federal advisory committee chartered under the Federal Advisory Committee Act (FACA), Public Law 92-463. GNEB was created in 1992 by the Enterprise for the Americas Initiative Act, Public Law 102-532, 7 U.S.C. 5404. Implementing authority was delegated to the Administrator of the Environmental Protection Agency (EPA) under Executive Order 12916 and continued under the authority of Executive Order 14354, dated September 29, 2025.
The GNEB is charged by statute with submitting an annual report to the President on the need for implementation of environmental and infrastructure projects within the states contiguous to the United States (U.S.)-Mexico border. The statute calls for the GNEB to have representatives from U.S. Government agencies; the governments of the states of Arizona, California, New Mexico, and Texas; and tribal and private organizations with experience in environmental and infrastructure issues along the U.S.-Mexico border. Members are appointed by the EPA Administrator for a two-year term. The GNEB meets approximately three times annually either in person or via video/teleconference, and the average workload for committee members is approximately 10 to 15 hours per month. Members serve on the committee in a voluntary capacity. Although we are unable to offer compensation or an honorarium, members may receive travel and per diem allowances, according to applicable federal travel regulations and the agency's budget.
The EPA is seeking nominations from a variety of sectors along the U.S.-Mexico border including representatives from business and industry, academia, non-governmental organizations, and local, state, county, and tribal governments.
According to the mandates of FACA, committees are required to have balanced points of view across a broad range of constituencies, sectors, and groups.
To learn more about the GNEB, please visit
• Representative of a sector or group that helps to shape border-region environmental policy or represents a group that is affected by border-region environmental policy;
• Extensive professional knowledge and experience with the issues on the southern border, including the bi-national dimension in State and Tribal waste reuse initiatives and scrap industries in the border region including food, rubber, critical minerals, and precious metals.
• Demonstrates senior level experience that will bring a new and relevant approach to the board's deliberations.
• Ability to work in a consensus building process with a wide range of representatives from various constituencies.
• Ability to contribute approximately 10 to 15 hours per month to the GNEB's activities, that include attending full committee, administrative, and working group meetings and participating in the development of advice letters or researching topics to publish reports.
• Demonstrate the potential for active and constructive involvement in the GNEB's work.
• To be considered, the following information should be provided on the nomination: contact information for the person making the nomination; contact information for the nominee; the disciplinary and specific areas of expertise of the nominee; the nominee's
• Nominees from the academic sector should also provide a letter of support authorizing the applicant to represent the views of a particular school/college (
• Please be aware that EPA's policy is that, unless otherwise prescribed by statute, members generally are appointed for a two-year term. For appointment consideration, interested nominees should submit the application materials electronically via email to David B. Neill at
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), “Emergency Planning and Community Right-to-Know Act (EPCRA) Emergency Notifications” (EPA ICR Number 1395.11, OMB Control Number 2050-0092) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA). Before doing so, EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through March 31, 2027. This document allows for 60 days for public comments.
Comments must be submitted on or before August 25, 2026.
Submit your comments, referencing Docket ID No. EPA-HQ-SFUND-2005-0008, to EPA online using
EPA's policy is that all comments received will be included in the public docket without change including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
Jennifer Barre, Office of Resource Conservation and Recovery, Mail Code 5303T, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460; telephone number: (202) 564-9026; email address:
This is a proposed extension of the ICR, which is currently approved through March 31, 2027. 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.
This document allows 60 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at
Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate forms of information technology. EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval. At that time, EPA will issue another
Environmental Protection Agency (EPA).
Notice.
Public notice is hereby given that the State of New York has revised its approved Public Water System Supervision Program. New York has adopted drinking water regulations for the Long Term 2 Enhanced Surface Water Treatment Rule. The EPA has determined that New York's revised regulations meet all minimum Federal requirements, and that they are no less stringent than the corresponding Federal regulations. Therefore, the EPA has decided to tentatively approve the State program revisions. All interested parties may request a public hearing or submit comments.
Comments or request for public hearing must be received on or before July 27, 2026.
Comments or a request for a public hearing must be submitted to the Regional Administrator, U.S. Environmental Protection Agency, Region 2, 290 Broadway, FL 24, New York, NY 10007. All documents relating to this determination are available for inspection between the hours of 8:00 a.m. EST and 3:00 p.m. EST, Monday through Friday, at the following offices: U.S. Environmental Protection Agency, Region 2, Water Division, 290 Broadway, FL 24, New York, NY 10007-1823; and New York State Department of Health, Bureau of Water Supply Protection, Empire State Plaza—Corning Tower, Room 1110, Albany, New York 12237.
Katie Lynch; Water Division; Drinking Water and Municipal Infrastructure Branch; Environmental Protection Agency; Region 2; 290 Broadway, FL 24, New York, NY 10007-1823; telephone number: (212) 637-3808; email address:
Pursuant to 40 CFR 142.13(a), EPA is required to provide an opportunity for public comment before approving a State's request for primacy. All interested parties are invited to submit written comments on this determination and may request a hearing. All comments will be considered, and if necessary, EPA will issue a response. Frivolous or insubstantial requests for a hearing will be denied by the Regional Administrator. If a substantial request for a public hearing is made by July 27, 2026, a public hearing will be held. A request for public hearing shall include the following: (1) The name, address, and telephone number of the individual, organization, or other entity requesting a hearing; (2) a brief statement of the requesting person's interest in the Regional Administrator's determination and of information that the requesting person intends to submit at such hearing; and (3) the signature of the individual making the request; or, if the request is made on behalf of an organization or other entity, the signature of a responsible official of the organization or other entity.
Wednesday, July 1, 2026, 10:00 a.m. Eastern Time.
The meeting will be held at the Jacqueline A. Berrien Training Center, 131 M Street, NE, Washington, DC 20507. The meeting will also be held as a listen-only audio. The public may attend in person or connect to the audio-only by following the instructions that will be posted on
If you wish to attend the meeting in person, you must email
The meeting will be open to the public.
The following items will be considered at the meeting:
• EEOC Strategic Plan for Fiscal Years 2026-2030.
• Rescission of Guidelines on Affirmative Action Appropriate Under Title VII of the Civil Rights Act of 1964, as Amended.
• Rescission of Compliance Manual Section 607—Affirmative Action.
In accordance with the Sunshine Act, the public will be able to observe the Commission's deliberations and voting. (In addition to publishing notices on Commission meetings in the
Please telephone (202) 921-2705, or email
Raymond Windmiller, Executive Officer, (202) 921-2705.
2:00 p.m. on June 25, 2026.
This Board meeting will be open to public observation by webcast. Visit
Observers requiring auxiliary aids should email
Open to public observation via webcast.
The Federal Deposit Insurance Corporation's (FDIC) Board of Directors will meet to consider the following matters:
No substantive discussion of the above item is anticipated. The Board of Directors will resolve this matter with a single vote unless a member of the Board requests that the item be moved to the discussion agenda.
For further information, please contact Jennifer M. Jones, Deputy Executive Secretary, FDIC, at
Notice is given that a complaint has been filed with the Federal Maritime Commission (the “Commission”) by Aman Kaushik (the “Complainant”) against SFL Worldwide LLC (the “Respondent”). Complainant states that the Commission has jurisdiction over the complaint pursuant to the Shipping Act of 1984, as amended, 46 U.S.C. 40101
Complainant Aman Kaushik is an individual residing in Haryana, India, who contracted with Respondent for an international shipment of household goods.
Complainant identifies Respondent as a licensed ocean transportation intermediary operating as a non-vessel operating common carrier and an ocean freight forwarder with a business address in Farmers Branch, Texas.
Complainant alleges that Respondent violated 46 U.S.C. 41102(c). Complainant alleges these violations arose from,
An answer to the complaint must be filed with the Commission within 25 days after the date of service.
The full text of the complaint can be found in the Commission's electronic Reading Room at
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 July 13, 2026.
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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 July 27, 2026.
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Board of Governors of the Federal Reserve System.
Agency for Toxic Substances and Disease Registry (ATSDR), Department of Health and Human Services (HHS).
Notice with comment period.
The Agency for Toxic Substances and Disease Registry (ATSDR), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other federal agencies the opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled APPLETREE Performance Measures. ATSDR will use this data collection to manage the current cooperative agreement program under ATSDR's Partnership to Promote Local Efforts to Reduce Environmental Exposures (APPLETREE) Program.
ATSDR must receive written comments on or before August 25, 2026.
You may submit comments, identified by Docket No. ATSDR-2026-0067 by either of the following methods:
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To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE, MS H21-8, Atlanta, Georgia 30329; Telephone: 404-639-7570; Email:
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. In addition, the PRA also requires federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information 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 of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected;
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
APPLETREE Performance Measures (OMB Control No. 0923-0057, Exp. 10/31/2026)—Revision—Agency for Toxic Substances and Disease Registry (ATSDR).
The Agency for Toxic Substances and Disease Registry (ATSDR) seeks to build and sustain the capacity to evaluate exposures to hazardous waste across the country. Releases from hazardous waste sites are a major source of harmful exposures in homes, schools, workplaces, and communities. These exposures are often complex and can be difficult to identify and control, as hazardous waste sites may involve various toxic substances, exposure pathways, and health impacts. ATSDR's primary goal is to keep communities safe from harmful exposures and related diseases. To accomplish this, the agency works closely with partnering agencies to evaluate exposures at hazardous waste sites, educate communities, and seek innovative ways to better protect public health.
ATSDR's Partnership to Promote Local Efforts to Reduce Environmental Exposures (APPLETREE) Program is critical to accomplishing this mission nationwide. Recipients use APPLETREE funding to advance ATSDR's primary goal of keeping communities safe from harmful environmental exposures. The program provides recipients with resources to build capacity to assess and respond to site-specific issues involving human exposure to hazardous substances. Specifically, APPLETREE helps recipients identify exposure pathways at specific sites; educate affected communities about site contamination and potential health effects; make recommendations to prevent exposure; and review health outcome data to evaluate potential links between site contaminants and community health.
APPLETREE also facilitates the implementation of state-level programs to ensure that early care and education facilities are sited in areas free from harmful environmental exposures. Additionally, the program motivates recipients to innovate and implement progressive public health interventions. Leveraging the local connections and partnerships of APPLETREE recipients enhances community engagement and the successful implementation of health recommendations. This program is authorized under Sections 104(i)(15) of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended by the Superfund Amendments and Reauthorization Act (SARA) of 1986 [42 U.S.C. 9604(i)(15)].
Under the current five-year APPLETREE cooperative agreement (NOFO No. CDC-RFA-TS-23-0001), eligible applicants include federally recognized American Indian/Alaska Native tribal governments; American Indian/Alaska Native tribally designated organizations; political subdivisions of states (in consultation with states); and state and local governments or their bona fide agents. ATSDR technical project officers (TPOs) will assist 30 APPLETREE recipients in addressing site-specific issues involving human exposure to hazardous substances. Key recipient capacities include identifying human exposure pathways; educating affected communities and local health professionals; making appropriate recommendations to prevent exposure; reviewing health outcome data; and documenting the effects of environmental remediation on health.
This is a Revision information collection request (ICR) titled “APPLETREE Performance Measures,” previously approved under OMB Control No. 0923-0057 (Expiration Date 10/31/2026). ATSDR will continue to collect information related to recipient activities, as well as the process and outcome performance measures outlined by the cooperative agreement. Information will be used to monitor progress toward program goals and objectives, and for program quality improvement.
To monitor recipient performance and evaluate public health impacts, ATSDR utilizes 10 key information collection tools. To streamline reporting and reduce recipient burden, ATSDR has transitioned these collections into the electronic ATSDR Request Management Service System (ARMSS).
The following forms are now managed and submitted through ARMSS:
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The remaining forms are currently submitted via email using Microsoft Word or Excel, with plans for future migration to electronic systems to further simplify data collection. On an annual basis, recipients submit the Annual Performance Report (APR) to provide a comprehensive summary of progress, challenges, and updated work plans. This is submitted alongside the Choose Safe Places for Early Care and Education (CSPECE) Qualitative Narrative and CSPECE Quantitative forms, which detail the implementation, reach, and site-screening metrics of the safe siting program. Furthermore, recipients submit the Recommendation Follow-up Form annually to monitor the ongoing status of ATSDR recommendations. Finally, the SoilSHOP Form is submitted as needed to collect data on voluntary soil screening events, including the number of samples tested and health consultations provided.
Collectively, these data collection efforts enable ATSDR to monitor progress toward program goals and improve overall quality. For the 30 funded recipients, the total estimated annual time burden across all 10 forms is 269 hours, consistent with the previous approved hours in 2023. ATSDR funds 30 recipients. Recipient reporting is required to receive funding under the APPLTREE cooperative agreement.
In accordance with the Paperwork Reduction Act of 1995, the Centers for Disease Control and Prevention (CDC) has submitted the information collection request titled “Collaborating Center for Questionnaire Design and Evaluation for the National Center for Health Statistics” to the Office of Management and Budget (OMB) for review and approval. CDC previously published a “Proposed Data Collection Submitted for Public Comment and Recommendations” notice on March 09, 2026, to obtain comments from the public and affected agencies. CDC received one comment on March 27, 2026, expressing support for the program. This notice serves to allow an additional 30 days for public and affected agency comments.
CDC will accept all comments for this proposed information collection project. The Office of Management and Budget is particularly interested in comments that:
(a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to be collected;
(d) Minimize the burden of the collection of information on those who are to respond, including, through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(e) Assess information collection costs.
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570. Comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
The Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) (OMB Control No. 0920-0222)—Reinstatement—National Center for Health Statistics (NCHS), Centers for Disease Control and Prevention (CDC).
The Collaborating Center for Questionnaire Design and Evaluation Research (CCQDER) collection was created to evaluate questions for optimal design as well as to provide documentation supporting the validity of NCHS and other agencies' information collections. CCQDER obtains information about the interpretive processes used by respondents to formulate answers to survey questions. Findings are used: (1) to ensure question comparability across respondent groups; (2) to correct any identified problematic questions, for example, those which are vague or ambiguous, cannot be answered readily or accurately by the respondent, or otherwise contribute to the non-sampling errors of the survey; and (3) to provide data usage documentation regarding the phenomena considered by respondents, that is, the specific construct measured by individual questions. Data collection includes a mix of qualitative and quantitative methodologies, including cognitive interviewing, focus groups, usability testing, ethnography, and survey field tests/pilot interviews (in-person/telephone/web).
Section 306 of the Public Health Service (PHS) Act (42 U.S.C. 242k), as amended, authorizes that the Secretary of Health and Human Services (DHHS), acting through NCHS, shall undertake and support (by grant or contract) research, demonstrations, and evaluations respecting new or improved methods for obtaining current data to support statistical and epidemiological activities for the purpose of improving the effectiveness, efficiency, and quality of health services in the United States. CCQDER is the focal point within NCHS for questionnaire and survey development, pre-testing, and evaluation activities for CDC surveys such as; the National Survey of Family Growth (NSFG) (OMB No. 0920-0314), the Research and Development Survey (RANDS) (including RANDS COVID), and other federally sponsored surveys.
The CCQDER and other NCHS programs conduct cognitive interviews, focus groups, in-depth or ethnographic interviews, usability tests, field tests/pilot interviews, and experimental research in laboratory and field settings, both for applied questionnaire development and evaluation as well as more basic research on measurement errors and survey response. The CCQDER at NCHS is the only government facility that currently conducts testing and development of NCHS or other CDC questionnaires. Similar facilities at the Bureau of the Census and the Bureau of Labor Statistics bear the responsibility for testing survey questionnaires associated with their own agencies. The demand for CCQDER activities exceeds available resources. In order to identify duplication across federal agencies, CCQDER hosts a publicly accessible online searchable database, Q-Bank, that contains all CCQDER evaluation reports. CCQDER encourages all agencies to submit their evaluation reports so that it is possible to track the work done across agencies as well as to build in existing knowledge.
An average of 55,900 respondents participates in CCQDER activities in a given year and the average annual respondent burden is estimated to be 14,100 hours. Annualized estimates of respondent burden for each of the questionnaire development studies, over the course of data collection, are provided below. For most questionnaire development studies, it is anticipated that interviews will last one hour. For some questionnaire development studies, questionnaire administration is anticipated to frequently require less than an hour of a respondent's time (for example, a fifteen-minute interview may be conducted), and in rare cases, the burden may be more than one hour. Because the hours per response in questionnaire development studies are expected to vary, we will select the final sample size for each project in such a way that the total burden hours do not exceed the estimate listed above. For focus groups, the usual amount of time is 90 minutes (1.5 hours) which includes instructions and ancillary paperwork. For interviews in the laboratory, time required to travel to the lab is not covered, because distances and modes of transportation are unknown. No retrieval of information by respondents is anticipated; although it is possible that validation of data at some point may require respondents to check records, probably those kept at home. In that case, the study will be designed so that the response time includes record retrieval.
CDC requests OMB approval for an estimated 14,100 annual burden hours. There is no cost to respondents other than their time.
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 July 27, 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
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Office of Family Assistance, Administration for Children and Families, U.S. Department of Health and Human Services.
Request for public comments.
The Office of Family Assistance, Administration for Children and Families (ACF), U.S. Department of Health and Human Services, is proposing to collect data for state requests of Temporary Assistance for Needy Families (TANF) Contingency Fund provisional payments through the TANF Contingency Fund Application.
Comments due August 25, 2026.
In compliance with the requirements of the Paperwork Reduction Act of 1995, ACF is soliciting public comment on the specific aspects of the information collection described above. You can obtain copies of the proposed collection of information and submit comments by emailing
The TANF Contingency Fund Application for the 50 states and the District of Columbia will create an optional monthly burden with an average of 15 states responding although up to 50 states and the District of Columbia may be eligible. We estimate the annual burden to be an average of 3 hours per response, with an estimate of 7 responses per respondent each year.
Food and Drug Administration, Health and Human Services (HHS).
Notice; extension of effective date.
The Food and Drug Administration (FDA, Agency, or we) is extending the effective date of the notice published in the
The effective date of the May 27, 2026, notice (91 FR 31462) is extended to September 24, 2026.
For access to the docket to read background documents or the electronic and written/paper comments received, go to
The most relevant background documents regarding this matter are available in the docket. However, additional background documents are available upon request (see
Amber McKinley, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5172, Silver Spring, MD 20993-0002, 301-796-0061, email:
On May 27, 2026, FDA published a notice in the
The title of the May 2026 Notice mistakenly included reference to two products subject to this proceeding. However, because this proceeding is not specific to those two products, we have removed that language from the title of the current notice.
FDA has determined that additional time is needed before the May 2026 Notice takes effect in order to fully consider the issues raised by interested parties following publication of the May 2026 Notice. Accordingly, FDA is extending the effective date of the May 2026 Notice by 90 days, from June 26, 2026, to September 24, 2026.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) has determined that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
RECTIV (nitroglycerin) ointment, 0.4%, is the subject of NDA 021359, held by AbbVie Inc., and initially approved on June 21, 2011. RECTIV is indicated for the treatment of moderate to severe pain associated with chronic anal fissure.
In a letter dated March 27, 2026, AbbVie Inc. notified FDA that RECTIV (nitroglycerin) ointment, 0.4%, was being discontinued, and FDA moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.
Aurobindo Pharma USA, Inc., submitted a citizen petition dated April 23, 2026 (Docket No. FDA-2026-P-4566), under 21 CFR 10.30, requesting that the Agency determine whether RECTIV (nitroglycerin) ointment, 0.4%, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that RECTIV (nitroglycerin) ointment, 0.4%, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that RECTIV (nitroglycerin) ointment, 0.4%, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of RECTIV (nitroglycerin) ointment, 0.4%, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list RECTIV (nitroglycerin) ointment, 0.4%, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) has determined that prednisolone tablet, 5 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Neerja Razdan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
Prednisolone tablet, 5 mg, is the subject of ANDA 080326, held by Heather Drug Co. Inc., and initially approved on May 29, 1974. Prednisolone is indicated for endocrine disorders, rheumatic disorders, collagen diseases, dermatologic diseases, allergic states, ophthalmic diseases, respiratory diseases, hematologic disorders, neoplastic diseases, edematous states, gastrointestinal diseases, nervous system, and miscellaneous diseases or conditions.
In a letter dated April 28, 1992, Heather Drug Co. Inc., via its agent Lachman Consulting Services, Inc., notified FDA that prednisolone tablet, 5 mg was being discontinued. FDA then moved the drug product to the “Discontinued Drug Product List” section of the Orange Book.
Hyman, Phelps & McNamara, P.C., submitted a citizen petition dated October 21, 2025 (Docket No. FDA-2025-P-5535), under 21 CFR 10.30, requesting that the Agency determine whether prednisolone tablet, 5 mg, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that prednisolone tablet, 5 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that prednisolone tablet, 5 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of prednisolone tablet, 5 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list prednisolone tablet, 5 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that refer to this drug product. Additional ANDAs for this drug product may also be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice; extension of comment period.
The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice entitled “List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act” that appeared in the
FDA is extending the comment period on the notice published in the
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.” 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,
In the
The Agency has received a request for a 60-day extension of the comment period for the May 1, 2026
FDA has considered the request and is extending the comment period for the
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the revocation of the Emergency Use Authorizations (EUAs) (the Authorizations) issued to Becton, Dickinson and Company (BD) for the BD Veritor System for Rapid Detection of SARS-CoV-2, InBios International, Inc. for the SCoV-2
The revocation of the Authorizations for the Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2 was effective as of February 24, 2026, InBios International, Inc.'s SCoV-2
Submit written requests for a single copy of the revocations to the Office of Policy, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5441, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the revocations may be sent. See the
Kim Sapsford-Medintz, Office of Product Evaluation and Quality, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3216, Silver Spring, MD 20993-0002, 301-796-0311 (this is not a toll-free number).
Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5) allows FDA to strengthen the public health protections against biological, chemical, radiological, or nuclear agent or agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations.
On July 2, 2020, FDA issued the Authorization to Becton, Dickinson and Company (BD) for the BD Veritor System for Rapid Detection of SARS-CoV-2, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the
On October 22, 2021, FDA issued the Authorization to InBios International, Inc. for the SCoV-2
On May 2, 2020, FDA issued the Authorization to Roche Diagnostics for the Elecsys Anti-SARS-CoV-2, subject to the terms of the Authorization. Notice of the issuance of this Authorization was published in the
Subsequent updates to the Authorizations were made available on FDA's website. The authorization of a device for emergency use under section 564 of the FD&C Act may, pursuant to section 564(g)(2) of the FD&C Act, be revoked when the criteria under section 564(c) of the FD&C Act for issuance of such authorization are no longer met (section 564(g)(2)(B) of the FD&C Act), or other circumstances make such
In a request received by FDA on January 29, 2026, Becton, Dickinson and Company requested the withdrawal of, and on February 24, 2026, FDA revoked, the Authorization for the Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2. BD notified FDA as the date of the letter there are no viable BD Veritor System for Rapid Detection of SARS-CoV-2 reagents remaining in distribution in the United States, and requested FDA withdraw the Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2. FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization given that BD has fully transitioned to the BD Veritor System for SARS-CoV-2 product cleared under K243872.
In a request received by FDA on February 16, 2026, InBios International, Inc. requested the revocation of, and on February 24, 2026, FDA revoked, the Authorization for the InBios International, Inc.'s SCoV-2
In a request received by FDA on February 6, 2026, Roche Diagnostics requested the revocation of, and on March 2, 2026, FDA revoked, the Authorization for the Roche Diagnostics's Elecsys Anti-SARS-CoV-2. FDA understands that as the date of the letter there are no viable Elecsys Anti-SARS-CoV-2 reagents remaining in distribution in the United States, and requested FDA revoke the Roche Diagnostics's Elecsys Anti-SARS-CoV-2. FDA has determined that it is appropriate to protect the public health or safety to revoke this Authorization given that Roche Diagnostics has fully transitioned to the Elecsys Anti-SARS-CoV-2 product cleared under K250768.
An electronic version of this document and the full text of the revocations are available on the internet at
Having concluded that the criteria for revocation of the Authorizations under section 564(g)(2)(C) of the FD&C Act are met, FDA has revoked the EUA for Becton, Dickinson and Company's BD Veritor System for Rapid Detection of SARS-CoV-2, InBios International, Inc.'s SCoV-2
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by August 25, 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:
•
• 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.”
•
Anne Taylor, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-402-5683,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “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 provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
This information collection supports certain Agency regulations in part 330 (21 CFR part 330) regarding over-the-counter (OTC) human drugs and associated guidance. Specifically, FDA regulations in §§ 330.14 and 330.15 (21 CFR 330.14 and 330.15) establish additional criteria and procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded. These regulations provide that OTC drug products introduced into the U.S. market after the OTC drug review began in 1972 and OTC drug products without any marketing experience in the United States can be evaluated under the OTC monograph system if the conditions (
We developed the final guidance document entitled “Time and Extent Applications for Nonprescription Drug Products” (September 2011) (available from our website at
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act (Pub. L. 116-136, Stat. 281)) signed March 27, 2020, included provisions that govern the way certain OTC drugs are regulated in the United States. The CARES Act added section 505G to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h), which reforms and modernizes the OTC drug review process, including establishing new procedures for consideration of additions or changes to conditions covered in OTC monographs. As a result of these revised statutory provisions, we anticipate no submissions under § 330.14. Our OTC Monographs@FDA portal (
Consistent with section 505G(k)(3) of the FD&C Act, we plan to withdraw the regulations supporting the TEA provisions in part 330 and discontinue the related guidance document. When these actions occur, we will also request discontinuation of the information collection approved under OMB control number 0910-0688.
We estimate the burden of this collection of information as follows:
As previously stated, as a result of the CARES Act statutory provisions described above, we anticipate no TEA submissions. For purposes of burden calculation, we assume one respondent as a placeholder. The burden we attribute to reporting activities is assumed to be distributed among the individual elements.
Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.
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.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893, National Institutes of Health, HHS)
Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services.
Notice.
Periodically, SAMHSA will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, email the SAMHSA Reports Clearance Officer at:
SAMHSA is conducting the federally mandated Evaluation of the PATH program. The PATH grant program, created as part of the Stewart B. McKinney Homeless Assistance Amendments Act of 1990, is administered by SAMHSA's Center for Mental Health Services' Division of State and Community Systems Development. The PATH program is authorized under Section 521
The SAMHSA Assistant Secretary is required under Section 528 of the PHS Act to evaluate the expenditures of PATH grantees at least once every 3 years to ensure they are consistent with legislative requirements and to recommend changes to the program design or operations.
The primary task of the PATH evaluation is to meet the mandates of Section 528 of the PHS Act. The second task of the PATH evaluation is to conduct additional data collection and analysis to further investigate the sources of variation in key program output and outcome measures that are important for program management and policy development. The PATH evaluation builds on the previous evaluation which was finalized in 2016 and was conducted as part of the National Evaluation of SAMHSA Homeless Programs. Previously, the data collections activities also included PATH Intermediary Web Survey, a PATH Provider Web Survey, and a PATH Telephone Interview Guide. The current PATH evaluation will be limited to the State PATH Contact (SPC) Web Survey and PATH Site Visit Discussion Guides to facilitate the collection of information regarding the structures and processes in place at the grantee and provider level. The current PATH evaluation will use web surveys and site visits to facilitate the collection of information regarding the structures and processes in place at the grantee and provider level. Data regarding the outputs and outcomes of the PATH program will be obtained from grantee applications, providers' intended use plans and from PATH annual report data, which is also required by Section 528 of the PHS Act and is approved under OMB No. 0930-0205.
Web Surveys will be conducted with all SPCs. The Web Surveys will capture detailed and structured information in the following topics: selection, monitoring, and oversight of PATH providers; populations served; the PATH services provided; provision of training and technical assistance; implementation of Evidence Based Practices and innovative practices including the Supplemental Security Income/Social Security Disability Insurance Outreach, Access, and Recovery program; data reporting, use of data and the Homeless Management Information System; and collaboration, coordination and involvement with Continuums of Care and other organizations. The SPCs for all grantees (56) will be contacted to complete the web surveys. The Web Surveys will be administered once per triennial evaluation cycle.
Site Visits will be conducted with a purposive sample of PATH grantees and providers to collect more nuanced information than will be possible with the web survey. Semi-structured discussions will take place with the SPCs, grantee staff, PATH provider staff, outreach workers, case managers and other clinical treatment staff, and consumers. Five grantees will be selected for Site Visits and visited within each grantee will be one to two PATH providers. The Site Visits will be utilized to collect information on: provider and state characteristics; practices and priorities; context within which the grantees and providers operate; and services available within the areas the providers operate. The successes, barriers, and strategies faced by PATH grantees and providers will also be discussed. Focus groups will be held with current or former consumers of the PATH program to obtain consumer perspectives regarding the impact of the programs. The Site Visits will be conducted once per triennial evaluation cycle.
The estimated burden for the reporting requirements for the PATH evaluation is summarized in the table below.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to:
Substance Abuse and Mental Health Administration (SAMHSA), Department of Health and Human Services (HHS)
Request for information.
SAMHSA is seeking public comment to inform the development, implementation, and oversight of an independent accreditation system for Certified Community Behavioral Health Clinic Expansion (CCBHC-E) grant recipients. SAMHSA intends to establish a process for evaluating and approving accrediting bodies, transition certain CCBHC-E grant recipients to independent accreditation, develop a federal oversight framework, and provide technical assistance to states, providers, and accrediting organizations. Input received through this request for information will help SAMHSA design an accreditation system that promotes quality, reduces administrative burden, and supports consistent national standards.
Written comments will be accepted through 11:59PM EST on July 27, 2026.
Comments can be submitted in the following ways:
• Electronic submissions can be filed online at
• Written comments can be emailed to:
In the Joint Explanatory Statement accompanying the fiscal year 2026 Labor, HHS, Education Appropriations Bill,
SAMHSA is currently developing a national framework for independent CCBHC accreditation which is expected to:
1. Evaluate and approve independent accrediting bodies through a formal application and review process to ensure alignment with SAMHSA's established standards.
2. Transition CCBHC-E grant recipients who are not certified by their state under a Medicaid CCBHC program from self-attestation to independent accreditation.
3. Establish a structured system for ongoing federal oversight and coordination of approved accrediting bodies to ensure continued adherence to federal standards and to address disputes, appeals and conflicting determinations.
4. Provide targeted technical assistance and implementation support to states, CCBHCs, accrediting bodies, and other stakeholders to ensure effective operation of the CCBHC accreditation system.
SAMHSA seeks public input on the standards, processes, oversight mechanisms, timing, and supports needed to implement this accreditation system effectively. SAMHSA invites comments on the below areas. Respondents may address any or all topics and provide additional information beyond the questions listed.
• What elements should SAMHSA include in the standards governing accrediting bodies and their CCBHC accreditation processes?
• What specific aspects of the CCBHC model should be emphasized in accreditation?
• What expectations should SAMHSA establish for accrediting bodies in terms of their processes, basis for decision-making, fees and time frames for communications?
• What staffing, qualifications, and expertise should be required for accrediting bodies and/or for individuals conducting accreditation reviews?
• How can accreditation support continuous quality improvement at both the clinic and state levels?
• How can SAMHSA reduce administrative burden and cost for CCBHCs and states while supporting efficient and high-quality accreditation processes?
• How should SAMHSA structure oversight of accrediting bodies, including monitoring, reporting and coordination with states and providers?
• What data infrastructure would help support a federal accreditation system?
• How should SAMHSA approach appeals, disputes, or conflicting determinations between state certification and independent accreditation findings?
• How should SAMHSA address situations where CCBHCs are found out of compliance through accreditation?
a. Under what circumstances should SAMHSA prioritize remediation and within what timeframes?
b. Under what circumstances should accrediting bodies deny accreditation?
c. Should failure to achieve or maintain accreditation affect CCBHC-E grant funding, and if so, how?
• How should designated collaborating organizations be evaluated and included in accreditation site visits?
• What considerations should inform the timing of SAMHSA's application and approval process for accrediting bodies?
• How much time would providers need to prepare for accreditation, and what factors should SAMHSA consider when determining launch timelines?
• What timing considerations should apply to CCBHC-E grant recipients not certified by their states?
• Should SAMHSA consider provisional attestation, phased implementation, or other transition strategies for introducing accreditation?
• How can SAMHSA best partner with CCBHC-certifying states during accreditation implementation?
• How should SAMHSA address scenarios where state certification decisions differ from accreditation findings?
• What technical assistance and support would be most helpful for CCBHCs, states, accrediting bodies, and other stakeholders?
• What forms of TA-such as consultation, webinars, readiness tools, or checklists- would be most valuable?
• What additional considerations, concerns, or recommendations should SAMHSA consider in developing and implementing an independent CCBHC accreditation system?
• Are there experiences or examples from accreditation or certification processes in other sectors that may inform SAMHSA's approach?
Responses to this request for information will inform SAMHSA's development of standards, processes, oversight mechanisms, and technical assistance strategies for an independent CCBHC accreditation system. SAMHSA may use the information received to develop future guidance, program requirements, or related policy materials.
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, 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, email the SAMHSA Reports Clearance Officer at:
Comments are invited on: (a) whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (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 leveraging automated data collection techniques or other forms of information technology.
SAMHSA is requesting approval from the Office of Management and Budget (OMB) for changes to the revised annual PPR, PPR Instructions, and the ACR for the PAIMI program. The OMB clearance
The protection and advocacy (P&A) systems were established under the Developmental Disabilities Act of 1975 [42 U.S.C. 15001
The PAIMI Act at 42 U.S.C. 10805(7) requires that each P&A system prepare and transmit a report to the Secretary HHS and to the head of its state mental health agency, on January 1. This report describes the activities, accomplishments, and expenditures of the system during the most recently completed fiscal year, including a section prepared by the advisory council (the PAIMI Advisory Council or PAC) that describes the activities of the council and its independent assessment of the operations of the system.
The PAIMI Act at 42 U.S.C. 10801
In 2000, the PAIMI Act amendments created a 57th P&A system—the American Indian Consortium (the Navajo and Hopi Tribes in the Four Corners region of the Southwest). The American Indian Consortium can only be funded if the total funding for the PAIMI program is at least $25,000,000, according to 10822(a)(2)(D) The Act, at 42 U.S.C. 10804(d), states that a P&A system may use its allotment to provide representation to individuals with mental illness, as defined by section 42 U.S.C. 10804 (4) residing in the community, including their own home,
The Children's Health Act of 2000 (CHA) also referenced the state P&A system authority to obtain information on incidents of seclusion, restraint and related deaths [see, CHA, Part H at 42 U.S.C. 290ii-1]. PAIMI Program formula grants awarded by SAMHSA go directly to each of the 57 governor-designated P&A systems. These systems are located in each of the 50 states, the District of Columbia, the American Indian Consortium, American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Commonwealth of Puerto Rico, and the U.S. Virgin Islands.
SAMHSA proposes minimal changes to the current PPR/ACR to comply with all current Executive Orders and SAMHSA Strategic Priorities. The minimal changes to the current PPR/ACR included the following revisions:
• Replaced the word “Gender” with “Sex”;
• Maintained only the “male” and “female” response options for the question on “sex of PAC members” and removed other response options;
• Removed sexual orientation question from the annual program performance report;
• Removed a paragraph on “Gender Identity” and “Sexual Orientation” in the “Section A: General Program Information” of PAIMI PPR instructions; and
• Removed the words: culture, cultural barriers, diversity, disadvantaged individuals, individuals with English proficiency, and underserved and unserved populations.
The current report formats will be effective starting with FY 2026 PPR reports due on January 1, 2027. This request ensures the annual PAIMI PPR and ACR are approved for a three-year cycle until 2029.
The annual burden estimate is as follows:
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to:
U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The purpose of this notice is to allow an additional 30 days for public comments.
Comments are encouraged and will be accepted until July 27, 2026.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be submitted via the Federal eRulemaking Portal website at
USCIS, Office of Policy and Strategy, Regulatory Coordination Division, John R. Pfirrmann-Powell, Acting Deputy Chief, telephone number (240) 721-3000 (This is not a toll-free number; comments are not accepted via telephone message.). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS website at
The information collection notice was previously published in the
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information 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 of the proposed collection of information, including the validity of the methodology and assumptions used;
(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 through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
(1)
(2)
(3)
(4)
(5)
(6)
(7)
Bureau of Indian Affairs, Interior.
Notice.
The Assistant Secretary—Indian Affairs approved the Cachil DeHe Band of Wintun Indians of the Colusa Indian Community of the Colusa Rancheria, California, Leasing Ordinance under the Helping Expedite and Advance Responsible Tribal Homeownership Act of 2012 (HEARTH Act). With this approval, the Tribe is authorized to enter into leases without further Secretary of the Interior approval.
The Assistant Secretary—Indian Affairs issued the approval on June 22, 2026.
Ms. Carla Clark, Bureau of Indian Affairs, Division of Real Estate Services, 1001 Indian School Road NW, Albuquerque, NM 87104,
The HEARTH Act makes a voluntary, alternative land leasing process available to Tribes, by amending the Indian Long-Term Leasing Act of 1955, 25 U.S.C. 415. The HEARTH Act authorizes Tribes to negotiate and enter into surface leases of Tribal trust lands for various purposes. Participating Tribes develop Tribal Leasing regulations, including an environmental review process, and then must obtain the Secretary's approval of those regulations prior to entering into leases. The HEARTH Act requires the Secretary to approve Tribal regulations if the Tribal regulations are consistent with the Department of the Interior's (Department) leasing regulations at 25 CFR part 162 and provide for an environmental review process that meets requirements set forth in the HEARTH Act. This notice announces that the Secretary, through the Assistant Secretary—Indian Affairs, has approved the Tribal regulations for Cachil DeHe Band of Wintun Indians of the Colusa Indian Community of the Colusa Rancheria, California.
The Department's regulations governing the surface leasing of trust and restricted Indian lands specify that, subject to applicable Federal law, permanent improvements on leased land, leasehold or possessory interests, and activities under the lease are not subject to State and local taxation and may be subject to taxation by the Indian Tribe with jurisdiction.
Section 5 of the Indian Reorganization Act, 25 U.S.C. 5108, preempts State and local taxation of permanent improvements on trust land.
The strong Federal and Tribal interests against State and local taxation of improvements, leaseholds, and activities on land leased under the Department's leasing regulations apply equally to improvements, leaseholds, and activities on land leased pursuant to Tribal leasing regulations approved under the HEARTH Act. Congress's overarching intent was to “allow Tribes to exercise greater control over their own land, support self-determination, and eliminate bureaucratic delays that stand in the way of homeownership and economic development in Tribal communities.” 158 Cong. Rec. H. 2682 (May 15, 2012). The HEARTH Act was intended to afford Tribes “flexibility to adapt lease terms to suit [their] business and cultural needs” and to “enable [Tribes] to approve leases quickly and efficiently.” H. Rep. 112-427 at 6 (2012).
Assessment of State and local taxes would obstruct these express Federal policies supporting Tribal economic development and self-determination, and also threaten substantial Tribal interests in effective Tribal government, economic self-sufficiency, and territorial autonomy.
Similar to BIA's surface leasing regulations, Tribal regulations under the HEARTH Act pervasively cover all aspects of leasing.
Accordingly, the Federal and Tribal interests weigh heavily in favor of preemption of State and local taxes on lease-related activities and interests, regardless of whether the lease is governed by Tribal leasing regulations or 25 CFR part 162. Improvements, activities, and leasehold or possessory interests may be subject to taxation by Cachil DeHe Band of Wintun Indians of
Bureau of Indian Affairs, Interior.
Notice.
The Assistant Secretary—Indian Affairs approved the Caddo Nation of Oklahoma Leasing Ordinance under the Helping Expedite and Advance Responsible Tribal Homeownership Act of 2012 (HEARTH Act). With this approval, the Tribe is authorized to enter into leases without further approval from the Secretary of the Interior.
The Assistant Secretary Indian Affairs issued the approval on June 22, 2026.
Ms. Carla Clark, Bureau of Indian Affairs, Division of Real Estate Services, 1001 Indian School Road NW, Albuquerque, NM 87104,
The HEARTH Act makes a voluntary, alternative land leasing process available to Tribes, by amending the Indian Long-Term Leasing Act of 1955, 25 U.S.C. 415. The HEARTH Act authorizes Tribes to negotiate and enter into surface leases of Tribal trust lands for various purposes. Participating Tribes develop Tribal Leasing regulations, including an environmental review process, and then must obtain the Secretary's approval of those regulations prior to entering into leases. The HEARTH Act requires the Secretary to approve Tribal regulations if the Tribal regulations are consistent with the Department of the Interior's (Department) leasing regulations at 25 CFR part 162 and provide for an environmental review process that meets requirements set forth in the HEARTH Act. This notice announces that the Secretary, through the Assistant Secretary—Indian Affairs, has approved the Tribal regulations for Caddo Nation of Oklahoma.
The Department's regulations governing the surface leasing of trust and restricted Indian lands specify that, subject to applicable Federal law, permanent improvements on leased land, leasehold or possessory interests, and activities under the lease are not subject to State and local taxation and may be subject to taxation by the Indian Tribe with jurisdiction.
Section 5 of the Indian Reorganization Act, 25 U.S.C. 5108, preempts State and local taxation of permanent improvements on trust land.
The strong Federal and Tribal interests against State and local taxation of improvements, leaseholds, and activities on land leased under the Department's leasing regulations apply equally to improvements, leaseholds, and activities on land leased pursuant to Tribal leasing regulations approved under the HEARTH Act. Congress's overarching intent was to “allow Tribes to exercise greater control over their own land, support self-determination, and eliminate bureaucratic delays that stand in the way of homeownership and economic development in Tribal communities.” 158 Cong. Rec. H. 2682 (May 15, 2012). The HEARTH Act was intended to afford Tribes “flexibility to adapt lease terms to suit [their] business and cultural needs” and to “enable [Tribes] to approve leases quickly and efficiently.” H. Rep. 112-427 at 6 (2012).
Assessment of State and local taxes would obstruct these express Federal policies supporting Tribal economic development and self-determination, and also threaten substantial Tribal interests in effective Tribal government, economic self-sufficiency, and territorial autonomy. See
Similar to BIA's surface leasing regulations, Tribal regulations under the HEARTH Act pervasively cover all aspects of leasing.
Accordingly, the Federal and Tribal interests weigh heavily in favor of preemption of State and local taxes on lease-related activities and interests, regardless of whether the lease is governed by Tribal leasing regulations or 25 CFR part 162. Improvements, activities, and leasehold or possessory interests may be subject to taxation by Caddo Nation of Oklahoma.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Wage and Hour Division (WHD)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 27, 2026.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Nora Hernandez by telephone at 202-693-8633, or by email at
The Family and Medical Leave Act of 1993 (FMLA), 29 U.S.C. 2601, and its regulations at 29 CFR part 825, require private sector employers that employ 50 or more employees, all public and private elementary schools, and all public agencies to provide up to 12 weeks of unpaid, job-protected leave during any 12-month period to eligible employees for certain family and medical reasons. The Department has developed optional-use forms which can be used by employers to provide required notices to employees and by employees to provide certification of their need for leave for an FMLA-qualifying reason. The FMLA disclosures ensure that both employers and employees are aware of and can exercise their rights and meet their respective obligations under the FMLA. For additional substantive information about this ICR, see the related notice published in the
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) if the information will be processed and used in a timely manner; (3) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (4) ways to enhance the quality, utility and clarity of the information collection; and (5) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology. To help ensure appropriate consideration, comments should reference OMB Control Number 1235-0003.
This information collection is subject to PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number. See 5 CFR 1320.5(a) and 1320.6.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review. The Department of Labor seeks approval for the revision of this information collection to ensure effective administration of the laws administered by the WHD.
(Authority: 44 U.S.C. 3507(a)(1)(D))
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 27, 2026.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Michael Howell by telephone at 202-693-6782, or by email at
Data are used to monitor the impact of disqualification provisions to measure workload and to appraise the adequacy and effectiveness of state and Federal nonmonetary determination procedures. For additional substantive information about this ICR, see the related notice published in the
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Notice of availability; request for comments.
The Department of Labor (DOL) is submitting this Employment and Training Administration (ETA)-sponsored information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (PRA). Public comments on the ICR are invited.
The OMB will consider all written comments that the agency receives on or before July 27, 2026.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Michael Howell by telephone at 202-693-6782, or by email at
The ETA 5130, Benefit Appeals Report, contains information on the number of appeals and the resultant decisions classified by program, appeal level, cases filed and disposed of (workload flow), and decisions by level, appellant and issue. The data on this form is used to monitor the benefit appeals process in the state workforce agencies (SWAs). Data is also used for budgeting and workload data. For additional substantive information about this ICR, see the related notice published in the
Comments are invited on: (1) whether the collection of information is necessary for the proper performance of the functions of the Department, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden and cost of the collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information collection; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of automated collection techniques or other forms of information technology.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless the OMB approves it and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid OMB Control Number.
DOL seeks PRA authorization for this information collection for three (3) years. OMB authorization for an ICR cannot be for more than three (3) years without renewal. The DOL notes that information collection requirements submitted to the OMB for existing ICRs receive a month-to-month extension while they undergo review.
Weeks of June 29, July 6, 13, 20, 27, and August 3, 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 June 29, 2026.
There are no meetings scheduled for the week of July 6, 2026.
There are no meetings scheduled for the week of July 13, 2026.
There are no meetings scheduled for the week of July 27, 2026.
There are no meetings scheduled for the week of August 3, 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.
U.S. Office of Personnel Management.
Notice of a modified system of records.
In accordance with the Privacy Act of 1974, the Office of Personnel Management (OPM) proposes to modify and republish a new system of records previously titled “OPM/Central-9, Personnel Investigations Records” which will be renamed to “OPM/Central-9, OPM Suitability Adjudications Files.” The modification is necessary since the current system of records previously covered both background investigation records and suitability adjudication records. OPM has transferred the background investigation mission and associated records to the Defense Counterintelligence and Security Agency (DCSA) at the U.S. Department of Defense. DCSA published a new system of records notice for the personnel investigations records titled “Personnel Vetting Records System, DUSDI 02-DoD” (83 FR 52420 and 83 FR 52317). As a result, the personnel investigations records are no longer maintained in OPM/Central-9. Accordingly, OPM has modified the system to maintain only suitability adjudication, action, and appeals records. The system contains records used by OPM to make, document, and review suitability determinations and related actions for individuals seeking or holding covered Federal positions. These records support OPM's statutory and regulatory responsibilities to determine whether an individual is suitable for Federal employment and to adjudicate and process related appeals.
Submit comments on or before July 27, 2026. These changes are effective July 27, 2026.
You may submit written comments using the Federal eRulemaking Portal at
For general questions, please contact Joe Knouff, Suitability Director, by email at
In accordance with the Privacy Act of 1974, the OPM proposes to modify a system of records previously titled “OPM/Central-9, Personnel Investigations Records” which will be renamed to “OPM/Central-9, OPM Suitability Adjudications Files.”
Historically, the President has delegated to OPM and its predecessor, the Civil Service Commission, the authority to prescribe both qualifications standards and suitability standards, and to conduct both examinations of applicants' qualifications and investigations of suitability for appointment and continuing employment.
5 CFR part 731 is OPM's regulation implementing these delegations. It establishes investigation, continuous vetting, and reciprocity requirements for an appointment to a position in the competitive service, excepted service, and for career appointment in the Senior Executive Service. Contractor employee fitness and nonappropriated fund employee fitness, as addressed in sections 3(b) and 3(c) of Executive Order 13488, are also subject to position designation requirements, investigative standards, and reciprocity requirements outlined in the regulations. The regulations also establish the criteria for making determinations of suitability for the competitive service or career Senior Executive Service and the minimum standard of fitness for the excepted service. Additionally, the regulations establish procedures for taking suitability actions for positions in the competitive service or career Senior Executive Service.
OPM has largely delegated suitability responsibilities to agency heads while retaining jurisdiction in cases with evidence of material, intentional falsification or deception or fraud in examination or appointment, or other
OPM's prior role in the background investigation mission dates back to the agency's days as the Civil Service Commission. Under Executive Order (E.O.) 10450, issued in 1953, E.O. 10577, issued in 1954, and 5 U.S.C. 3301, OPM conducted background investigations of federal applicants, employees, and contractors to provide a basis for determining an individual's suitability or fitness for federal employment and to provide agencies with a basis for determining whether an individual should be granted a security clearance. At that time, OPM's role did not include conducting investigations for the Department of Defense. Then, Section 906 of Public Law 108-136, enacted on November 24, 2003, expanded OPM's background investigation mission to include conducting investigations on behalf of the Department of Defense. Subsequently, Section 925 of Public Law 115-91, December 12, 2017, and E.O. 13869 directed the transfer of OPM's entire background investigation mission, both its traditional mission and its investigations for the Department of Defense, back to the Department of Defense under DCSA, which took place in 2019. At that time, DCSA and OPM agreed to transfer the personnel investigations records to DCSA while the OPM suitability assessment, action, and appeals records remained with OPM. DCSA published a new system of records notice for the personnel investigations records titled “Personnel Vetting Records System, DUSDI 02-DoD” (83 FR 52420 and 83 FR 52317) so that information is no longer maintained in OPM/Central-9.
OPM's information collection and the suitability assessment process are designed to avoid collecting information related to how any individual exercises rights guaranteed by the First Amendment. Despite the effort not to collect such information, some individuals misunderstand questions and disclose information related to the exercise of rights guaranteed by the First Amendment. Additionally, if allegations arise that an individual is engaged in conduct that presents a suitability concern, the suitability assessment will attempt to discern whether the conduct actually falls under one of the specific suitability factors found in 5 CFR 731.202(b) or is a protected exercise of one's rights.
In accordance with 5 U.S.C. 552a(r), OPM has provided notice of a modified system of records to the Office of Management and Budget and to Congress. The modified system of records will be included in OPM's updated inventory of record systems.
The Director of OPM, Scott Kupor, reviewed and approved this document and has authorized the undersigned to electronically sign and submit this document to the Office of the Federal Register for publication.
U.S. Office of Personnel Management.
OPM/Central-9, OPM Suitability Adjudications Files.
Unclassified.
Suitability Executive Agent Program, Office of Personnel Management, National Training Center, 131 Rebecca Lane, Slippery Rock, PA 16057.
Suitability Director, Suitability Executive Agent Program, Office of Personnel Management, National Training Center, 131 Rebecca Lane, Slippery Rock, PA 16057.
E.O. 10577; E.O. 13467; E.O. 13488; E.O. 13764; E.O. 14210; 5 U.S.C. 1103, 1302, 3301, and 7301; 5 CFR parts 1, 2, 5, 6, 731, and 1201; Presidential Memorandum on Strengthening the Suitability and Fitness of the Federal Workforce (March 20, 2025); and E.O. 9397 as amended by E.O. 13478.
This system of records pertains to records on civilian federal applicants, appointees, and employees whose suitability for federal employment was reviewed by OPM as described and defined in 5 CFR 731.101. The records in the system are also used to support the creation of aggregate statistics about the suitability work to identify trends, evaluate workload, evaluate the quality and effectiveness of the program, and similar purposes.
Civilian federal applicants, appointees, and employees whose suitability for federal employment was reviewed by OPM as required by 5 CFR 731, either because of a referral by another federal agency, an OPM oversight activity, or a suitability appeal proceeding.
The records about a civilian federal applicant, appointee, or employee whose suitability for federal employment was reviewed by OPM may include:
• Name;
• Aliases;
• Date of birth;
• Place of birth;
• Social Security Number;
• Current and former personal and work contact information (
• Materials submitted when applying for federal positions;
• Employment history;
• Military history;
• Education and degrees earned;
• Criminal history;
• Civil court actions and publicly available information;
• Prior security clearances and investigative information;
• Mental health history;
• Records related to drug and alcohol use;
• Financial records;
• Information from the Internal Revenue Service pertaining to income tax returns;
• Credit reports;
• Information on foreign travel, contacts and activities;
• Information on people who associate with the individual (
• Citizenship and information on loyalty to the United States;
• Information on why a federal agency chose to refer a case to OPM and any records collected by the agency in connection with that case;
• Other information derived from the results of a personnel background investigation or source inquiries; and
• Correspondence relating to adjudication matters and the results of suitability decisions and appeals.
Information in this system may come from the individual, the individual's personal contacts or references, federal agencies, employers, educational institutions, police departments, courts, credit bureaus, probation officials, newspapers, magazines, periodicals, and other publications.
In addition to those disclosures generally permitted under 5 U.S.C.
a. In a proceeding before a court, grand jury, or administrative or adjudicative body, when OPM or another agency representing OPM determines that the records are relevant and necessary to the proceeding; or in a proceeding before an administrative or adjudicative body when the adjudicator determines the records to be relevant to the proceeding.
b. To the Department of Justice when (1) OPM, or any component thereof; (2) any OPM employee in their official capacity; (3) any OPM employee in their individual capacity where the Department of Justice has agreed to represent the employee; or (4) the United States, where OPM determines that litigation is likely to affect OPM or any of its components, is a party to litigation or has an interest in such litigation, and the use of such records by the Department of Justice is deemed by OPM to be relevant and necessary to the litigation.
Where a record, either alone or in conjunction with other information, indicates a violation or potential violation of law—criminal, civil, or regulatory in nature—the relevant records may be referred to the appropriate federal, state, local, territorial, tribal, or foreign law enforcement authority or other appropriate entity charged with the responsibility for investigating or prosecuting such violation or charged with enforcing or implementing such law.
c. To a member of Congress or staff acting upon the member's behalf, when the member or staff requests the information on behalf of, and at the request of, the individual to whom the record pertains.
d. To the National Archives and Records Administration (NARA) for records management inspections conducted under the authority of 44 U.S.C. 2904 and 2906.
e. To appropriate agencies, entities, and persons when (1) OPM suspects or has confirmed that there has been a breach of the system of records, (2) OPM has determined that as a result of the suspected or confirmed breach there is a risk of harm to individuals, OPM (including its information systems, programs, and operations), the Federal Government, or national security; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with OPM's efforts to respond to the suspected or confirmed breach or to prevent, minimize, or remedy such harm.
f. To another Federal agency or Federal entity, when OPM determines that information from this system of records is reasonably necessary to assist the recipient agency or entity in (1) responding to a suspected or confirmed breach or (2) preventing, minimizing, or remedying the risk of harm to individuals, the recipient agency or entity (including its information systems, programs, and operations), the Federal Government, or national security, resulting from a suspected or confirmed breach.
g. To contractors, grantees, experts, consultants, or volunteers performing or working on a contract, service, grant, cooperative agreement, or other assignment for OPM to the extent necessary to accomplish an agency function related to this system of records.
h. To another federal office when that office is trying to: conduct suitability, fitness, or security investigations; hire or retain employees; evaluate qualifications, suitability, fitness, or loyalty to the United States Government; grant access to classified information or restricted areas; issue an identity credential; or provide a service performed under a contract or other agreement.
i. To a source to acquire additional information OPM may need to make a suitability determination, but only the information the source needs to identify the individual, understand the purpose of OPM's request, and identify the information requested.
j. To the Department of Defense, Defense Counterintelligence and Security Agency, to help ensure the accuracy and completeness of government-wide records of investigations and adjudications.
k. To another federal agency when that agency is providing support to OPM in conducting studies and analyses for evaluating and improving the quality, effectiveness and efficiency of the suitability program.
The records in this system are stored electronically in a database and limited access network folders.
The records may be retrieved by the individual's name, Social Security Number, unique case serial number, or other unique personal identifiers available in this system of records.
Suitability adjudication files and the computerized data bases which show the initiation or completion of a suitability assessment are retained for 16 years from the date of closing or the date of the most recent suitability assessment activity, whichever is later, except for suitability assessments involving potentially actionable issue(s), which will be maintained for 25 years from the date of closing or the date of the most recent assessment activity. Suitability appeal files and the computerized databases which show the processing of a suitability appeal are retained for 7 years. Hard copy records are destroyed by shredding and recycling, and computerized records are destroyed by electronic erasure.
Several administrative, technical, and physical security measures protect the records in this system from unauthorized access and misuse. These measures include role-based access controls to limit access; multifactor log-in authentication including personal identity verification cards; network encryption to protect data transmitted over the network; masking of sensitive data as practicable; mandatory information assurance and privacy training for individuals who have access; detection and electronic alert systems for access to servers and other network infrastructure; and electronic intrusion detection systems. All these measures comply with the Federal Information Security Management Act of 2002, as amended by the Federal Information Security Modernization Act of 2014, Office of Management and Budget (OMB) policies, and standards and guidelines from the National Institute of Standards and Technology (NIST).
Individuals seeking access to their records in this system may email their request to
1. Include the words “Privacy Act Records Access Request”;
2. State that the request relates to “OPM/Central—9, OPM Suitability Adjudications Files”; and
3. Clearly describe the information requested.
The letter or email must also include the following information regarding the requesting individual:
1. Full name, and any former names;
2. Date of birth;
3. Preference for how they want to be contacted (home address, telephone number, and/or personal email);
4. Current or last federal agency where they worked, plus the dates they worked there; and
5. Signature.
Additional requirements regarding record access requests, including the rights of guardians and how records may be provided, may be found in 5 CFR part 297, Privacy Procedures for Personnel Records.
Along with the option to file a Privacy Act request to obtain access to one's records, individuals against whom OPM proposes a suitability action can also contact OPM's Suitability Executive Agent Programs office to request the materials that OPM relied upon when deciding to propose an action. Please see 5 CFR 731.302(a).
Individuals wishing to request an amendment of records about them may email their request to
1. A heading denoting that the request is a “Privacy Act Amendment Request”;
2. Statement that the request relates to “OPM/Central—9, OPM Suitability Adjudications Files”;
3. Description of records the individual wants to amend and why; and
4. Any documents which could help substantiate the request.
The letter or email must also include the following information related to the requesting individual:
1. Full name, and any former names;
2. Date of birth;
3. Preference for how they want to be contacted (home address, telephone number, and/or personal email);
4. Current or last federal agency where they worked, plus the dates they worked there; and
5. Signature.
Additional requirements regarding record access requests, including the rights of guardians and how records may be provided, may be found in 5 CFR part 297, Privacy Procedures for Personnel Records.
See “Record Access Procedures.”
In accordance with 5 U.S.C. 552a(k) and 5 CFR 297.501(b)(5), all information in this system which meets the criteria stated in 5 U.S.C. 552a(k) (1), (2), (3), (4), (5), (6), and (7) may be exempt from the requirements of 5 U.S.C. 552a(c)(3) and (d). A determination as to whether and which exemption applies will be made after a request for access or amendment is received.
Additionally, under 5 CFR 297.501(c), OPM reserves the right to assert exemptions for (a) records received from another agency that could be properly claimed by that agency in response to a request and (b) information compiled in reasonable anticipation of a civil action or proceeding.
81 FR 70191 (October 11, 2016) and 87 FR 5874 (February 2, 2022).
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.
2.
3.
This Notice will be published in the
Postal Service.
Notice; correction.
The Postal Service published a document in the
Lucy C. Trout, Secretary of the Board of Governors, U.S. Postal Service, 475 L'Enfant Plaza SW, Washington, DC 20260-1000. Telephone: (202) 268-4800.
In the
In the
In the
In the
1. Strategic Matters.
2. Financial and Operational Matters.
3. Administrative Matters.
1. Remarks of the Chairwoman of the Board of Governors.
2. Remarks of the Postmaster General and CEO.
3. Committee Reports.
4. Quarterly Financial Report.
5. Quarterly Service Performance Report.
6. Approval of the Meeting Minutes.
7. Approval of the Tentative Agenda for the August Open Meeting.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Commission is seeking to reinstate the Paperwork Reduction Act (“PRA”) information request for Form N-Q (17 CFR 249.332 and 274.130) under the Investment Company Act of 1940 (15 U.S.C. 80a-1
As detailed in the Reporting Modernization Release, the Commission rescinded Form N-Q because the portfolio information contained in reports on Form N-Q is also included in a different form, Form N-PORT. As a result, Form N-PORT rendered reports on Form N-Q unnecessarily duplicative. Form N-PORT is a form used by registered management investment companies, other than money market funds and SBICs, under section 30(b) of the Investment Company Act and sections 13(a) or 15(d) of the Exchange Act to file monthly reports of portfolio holdings pursuant to rule 30b1-9 of the Investment Company Act (17 CFR 270.30b1-9). Specifically, rule 30b1-9 requires a registered management investment company or exchange traded fund organized as a unit investment
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.
Written comments are invited on: (a) whether this proposed collection of information is necessary for the proper performance of the functions of the SEC, including whether the information will have practical utility; (b) the accuracy of the SEC's estimate of the burden imposed by the proposed collection of information, including the validity of the methodology 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, electronic collection techniques or other forms of information technology.
The public may view and comment on this information collection request at:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. § 3501
As part of the final set of rules to achieve a further shortening of the standard settlement cycle for securities transactions from two business days after the transaction date to one business day following the transaction date, Rule 17Ad-27 requires exempt entities that perform matching services to facilitate the settlement of securities transactions (referred to as a “central matching service provider” or “CMSP”) to establish, implement, maintain and enforce policies and procedures reasonably designed to facilitate straight-through processing for transactions involving broker-dealers and their customers.
Rule 17Ad-27 also requires a CMSP to submit every twelve months to the Commission a report that describes the following:
• A summary of its policies and procedures reasonably designed to facilitate straight-through processing, current as of the last day of the twelve-month period covered by the report;
• A qualitative description of its progress in facilitating straight-through processing during the twelve-month period covered by the report;
• A quantitative presentation of data that includes: (i) the total number of trades submitted to the clearing agency for processing; (ii) the total number of allocations submitted to the clearing agency; (iii) the total number of confirmations submitted to the clearing agency, as well as the total number of confirmations cancelled by a user; (iv) the percentage of confirmations submitted to the clearing agency that are affirmed on trade date, specifying to the extent practicable the relevant timeframe in which the affirmation is processed on trade date; (v) the percentage of allocations and confirmations submitted to the clearing agency that are matched and automatically confirmed through the clearing agency's services; and (vi) metrics concerning the use of manual and automated processes by the clearing agency's users with respect to its services that may be used to assess progress in facilitating straight-through processing; and
• A qualitative description of the actions it intends to take to facilitate straight-through processing during the twelve-month period that follows the period covered by the report.
In addition, data sets provided pursuant to Rule 17Ad-27 must be: (i) organized on a month-by-month basis, beginning with January of each year, for the twelve months covered by the report; (ii) separated, where applicable, between the use of central matching and electronic trade confirmation services offered by the clearing agency; (iii) separated, as appropriate, by asset class; (iv) separated by type of user; and (v) presented on an anonymized and aggregated basis.
Ongoing burdens imposed by Rule 17Ad-27 on a respondent CMSP are as follows: (i) ongoing monitoring and compliance activities with respect to the written policies and procedures required by the proposed rule; and (ii) ongoing documentation activities with respect to the required annual report. The Commission estimates that the
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.
The public may view and comment on this information collection request at:
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The purpose of Form N-PX is to meet the filing and disclosure requirements of rules under the Act and also to enable funds to provide investors with information necessary to evaluate overall patterns in the manager's voting behavior. This information collection is primarily for the use and benefit of investors. The information filed with the Commission also permits the verification of compliance with securities law requirements and assures the public availability and dissemination of the information. Form N-PX is also be used by institutional investment managers to meet the filing and disclosure requirements of section 14A under the Exchange Act.
The table below summarizes our estimates associated with Form N-PX:
Compliance with Form N-PX is mandatory. Responses to the collection of information requirements will not be kept confidential.
The estimate of average burden hours is made solely for the purposes of the
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.
The public may view and comment on this information collection request at:
Notice is hereby given that, under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 30e-1 (17 CFR 270.30e-1) under the Investment Company Act of 1940 (15 U.S.C. 80a-1
The table below summarizes our estimates associated with rule 30e-1.
Estimates of the average burden hours are made solely for the purposes of the Paperwork Reduction Act and are not derived from a comprehensive or even representative survey or study of the costs of Commission rules and forms.
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.
The public may view and comment on this information collection request at:
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 18(a)(2), 18(c) and 18(i) of the Act, under sections 6(c) and 23(c) of the Act for an exemption from rule 23c-3 under the Act, and for an order pursuant to section 17(d) of the Act and rule 17d-1 under the Act.
Applicants request an order to permit certain registered closed-end investment companies to issue multiple classes of shares and to impose asset-based distribution and/or service fees and early withdrawal charges.
Third Lake Partners Alternative Yield Strategy Fund and Third Lake Partners, LLC.
The application was filed on May 11, 2026.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at
The Commission:
Trace W. Rakestraw, Senior Special Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For Applicants' representations, legal analysis, and conditions, please refer to Applicants' application, dated May 11, 2026, which may be obtained via the Commission's website by searching for the file number at the top of this document, or for an Applicant using the Company name search field on the SEC's EDGAR system. The SEC's EDGAR system may be searched at
For the Commission, by the Division of Investment Management, under delegated authority.
Securities and Exchange Commission (“Commission” or “SEC”).
Notice.
Notice of an application under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 18(a)(2), 18(c) and 18(i) of the Act, under sections 6(c) and 23(c) of the Act for an exemption from rule 23c-3 under the Act, and for an order pursuant to section 17(d) of the Act and rule 17d-1 under the Act.
Applicants request an order to permit certain registered closed-end investment companies to issue multiple classes of shares and to impose asset-based distribution and/or service fees and early withdrawal charges.
Nilsine Partners NP1X Fund and Nilsine Partners, LLC
The application was filed on February 18, 2026, and amended on April 22, 2026, and June 1, 2026.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing on any application by emailing the SEC's Secretary at
The Commission:
Trace W. Rakestraw, Senior Special Counsel, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
For Applicants' representations, legal
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to the authority granted to the United States Small Business Administration under Section 309 of the Small Business Investment Act of 1958, as amended, and 13 CFR 107.1900 of the Code of Federal Regulations to function as a small business investment company under the Small Business Investment Company license number 08080154 issued to Wasatch Venture Fund II, LLC, said license is hereby declared null and void.
Notice is hereby given that TZP SBIC Partners I, L.P., 888 Seventh Ave., 20th Floor New York, NY 10106, Federal Licensee under the Small Business Investment Act of 1958, as amended (“the Act”), in connection with financings of a small business, has sought an exemption under Section 312 of the Act and 13 CFR 107.730,
The financing is brought within the purview of 13 CFR 107.730(a) of the regulations because TZP Capital Partners IV, L.P., Associate of TZP SBIC Partners I, L.P., owns more than ten percent of Results Group Holdings, LLC. TZP Capital Partners IV, L.P. and TZP SBIC Partners I, L.P. are Associates by virtue of Common Control, as those terms are defined in 13 CFR 107.50. Therefore, this transaction is considered a financing which constitutes a conflict of interest.
Notice is hereby given that any interested person may submit written comments on the transaction, within fifteen days of the date of this publication, to the Associate Administrator for Investment, U.S. Small Business Administration, 409 Third Street SW, Washington, DC 20416.
Pursuant to the authority granted to the United States Small Business Administration under Section 309 of the Small Business Investment Act of 1958, as amended, and 13 CFR 107.1900 of the Code of Federal Regulations to function as a small business investment company under the Small Business Investment Company license number 04040298 issued to Harbert Mezzanine Partners II SBIC, L.P., said license is hereby declared null and void.
Pursuant to the authority granted to the United States Small Business Administration under Section 309 of the Small Business Investment Act of 1958, as amended, and 13 CFR 107.1900 of the Code of Federal Regulations to function as a small business investment company under the Small Business Investment Company license number 07/07-0115 issued to FCP Fund II, L.P. said license is hereby declared null and void.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
(OMB) Office of Management and Budget, Attn: Desk Officer for SSA.
(SSA) Social Security Administration, OLCA, Attn: Reports Clearance Director, Mail Stop 3253 Altmeyer, 6401 Security Blvd., Baltimore, MD 21235, Fax: 833-410-1631, Email address:
Or you may submit your comments online through
SSA submitted the information collections below to OMB for clearance. Your comments regarding these information collections would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than July 27, 2026. Individuals can obtain copies of this OMB clearance package by writing to the
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(1) obtain the individual's consent to verify balances of financial institution (FI) accounts; and (2) obtain verification of such balances from the FI. Respondents are Medicare Part D program subsidy applicants or claimants, and their financial institutions.
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions and one extension of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
Or you may submit your comments online through
The information collections below are pending at SSA. SSA will submit them to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than August 25, 2026. Individuals can obtain copies of the collection instruments by writing to the above email address.
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• Is at least age 62 and under full retirement age in the month of the number holder's death; and
• Is receiving both reduced spouse's (or divorced spouse's) benefits and either retirement or disability benefits in the month before the month of the number holder's death.
To elect reduced widow(er) benefits, a recipient completes Form SSA-4111.
A modern, streamlined and responsive customer experience means: raising government-wide customer experience to the average of the private sector service industry; developing indicators for high-impact Federal programs to monitor progress towards excellent customer experience and mature digital services; and providing the structure (including increasing transparency) and resources to ensure customer experience is a focal point for agency leadership.
This information collection activity provides a means to garner customer
As discussed in the OMB guidance, agencies should identify their highest-impact customer journeys (using customer volume, annual program cost, and/or knowledge of customer priority as weighting factors) and select touchpoints/transactions within those journeys to collect feedback.
The agency will use these results to improve the delivery of Federal services and programs. It will also provide government-wide data on customer experience that can be displayed on
As a general matter, these information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private.
The Social Security Administration will only submit collections if they meet the following criteria.
• The collections are voluntary;
• The collections are low-burden for respondents (based on considerations of total burden hours or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government;
• The collections are non-controversial and do not raise issues of concern to other Federal agencies;
• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future;
• Personally identifiable information (PII) is collected only to the extent necessary and is not retained;
• Information gathered is intended to be used for general service improvement and program management purposes; and
• Upon agreement between OMB and the agency all or a subset of information may be released as part of A-11, Section 280 requirements only on
• Additional release of data must be done coordinated with OMB.
These collections allow for ongoing, collaborative and actionable communications between the Agency, its customers and stakeholders, and OMB as it monitors agency compliance on Section 280. These responses inform efforts to improve or maintain the quality of service offered to the public. If this information is not collected, vital feedback from customers and stakeholders on services will be unavailable.
The respondents are Individuals and Households, Businesses and Organizations, State, Local or Tribal Government.
Below we provide projected average estimates for the next three years:
Notice is hereby given of the following determinations: I hereby determine that a certain object being imported from abroad pursuant to an agreement with its foreign owner or custodian for temporary display in the exhibition “Georgia O'Keeffe Architecture” at the Detroit Institute of Arts, Detroit, Michigan, and at possible additional exhibitions or venues yet to be determined, is of cultural significance, and, further, that its temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
The Surface Transportation Board (Board) is publishing the annual deflator factor and inflation-adjusted railroad revenue thresholds for 2025. The deflator factor is used by the railroads to adjust their gross annual operating revenues for classification purposes. This indexing methodology ensures that railroads are classified based on real business expansion and not on the effects of inflation. Classification is important because it determines the extent to which individual railroads must comply with the Board's reporting requirements.
The Board's annual deflator factor is based on the annual average of the Producer Price Index (PPI) industry data for line-haul railroads published by the Bureau of Labor Statistics (BLS) and is used to deflate revenues for comparison with established revenue thresholds.
Application of the annual deflator factors for 2021-2025 results in the following annual revenue thresholds:
The annual inflation-adjusted deflator factor and revenue thresholds for 2025 are effective January 1, 2025. Notice of this decision will be published in the
By the Board, Martin Schlenker, Acting Director, Office of Economics.
900 Conshohocken Rail LLC (Conshohocken Rail), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to acquire an approximately 11-mile rail line in Conshohocken, Pa. (the Line), from Cleveland-Cliffs Railways Inc. d/b/a Upper Merion & Plymouth Railroad (CCRI).
According to the verified notice, Conshohocken Rail is a new, noncarrier subsidiary of MLP Ventures, LLC (MLP), that was formed for the purpose of acquiring the Line. The verified notice states that Conshohocken Rail and CCRI have entered an agreement pursuant to which Conshohocken Rail will acquire the Line and provide rail service as needed, either itself or through a contract service provider. The verified notice further states that transaction will be undertaken in connection with MLP's acquisition of the property of an idled steel plate finishing facility owned by Cleveland-Cliffs Plate LLC, an affiliate of CCRI. Conshohocken Rail expects to become a Class III carrier upon consummation of the transaction.
Conshohocken Rail certifies that the proposed acquisition of the Line does not involve an interchange commitment. Conshohocken Rail further certifies that its projected annual revenues as a result of this transaction are not expected to exceed $5 million and that the proposed transaction will not result in Conshohocken Rail becoming a Class I or Class II rail carrier.
The earliest this transaction may be consummated is July 12, 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 July 2, 2026 (at least seven days before the exemption becomes effective).
All pleadings, referring to Docket No. FD 36918, 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 Conshohocken Rail's representative, Thomas J. Litwiler, Fletcher & Sippel LLC, 29 North Wacker Drive, Suite 800, Chicago, IL 60606-3208.
According to Conshohocken Rail, 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.
Surface Transportation Board.
Notice tentatively approving and authorizing finance transaction.
TBL Group, Inc. (TBL Group), a noncarrier holding company that controls multiple interstate motor passenger carriers, has filed an application to acquire control of the primary assets of, or the member interest in, Escot Bus Lines, L.L.C. (Escot), a federally regulated motor passenger carrier. The Board is tentatively approving and authorizing the transaction. If no opposing comments are timely filed, this notice will be the final Board action.
Comments must be filed by July 27, 2026. If any comments are filed, TBL Group may file a reply by August 25, 2026. If no opposing comments are filed by July 27, 2026, this notice shall be effective on July 28, 2026.
Comments, referring to Docket No. MCF 21152, may be filed with the Board either via e-filing on the Board's website or in writing addressed to: Surface Transportation Board, 395 E Street SW, Washington, DC 20423-0001. In addition, send one copy of comments to TBL Group's representative: Andrew K. Light, Scopelitis, Garvin, Light, Hanson & Feary, P.C., 10 W Market Street, Suite 1400, Indianapolis, IN 46204.
Sarah Fancher at (202) 915-8445. If you require an accommodation under the Americans with Disabilities Act, please call (202) 245-0245.
On May 28, 2026, TBL Group filed an application under 49 U.S.C. 14303 and 49 CFR part 1182 for Board authority to acquire control of the primary assets of, or the member interest in, Escot. (Appl. 1.) According to TBL Group, either a newly created TBL Group subsidiary, TBL Newco, will acquire substantially all of Escot's motor carrier assets and become an interstate motor carrier, or TBL Group will acquire the membership interest of Escot directly. (
The application states that TBL Group is a Texas corporation, headquartered in Houston, Tex. (
On April 7, 2026, TBL Group filed an application with the Board seeking authority to acquire control of Chicago Classic Coach, LLC (Classic).
The application describes Escot as a Florida limited liability company headquartered in Largo, Fla. (Appl. 7-8.) According to the application, Escot provides traditional charter motor coach services for group, school and team travel, and meeting, event and convention shuttle services in central and south Florida, with three terminals: Orlando, Largo (Tampa/St. Petersburg metro area), and Medley (Miami metro area). (
Under 49 U.S.C. 14303(b), the Board must approve and authorize a transaction that it finds consistent with the public interest, taking into consideration at least (1) the effect of the proposed transaction on the adequacy of transportation to the public, (2) the total fixed charges resulting from the proposed transaction, and (3) the interest of affected carrier employees. TBL Group has submitted the information required by 49 CFR 1182.2, including information demonstrating that the proposed transaction is consistent with the public interest under 49 U.S.C. 14303(b),
TBL Group does not expect the proposed transaction to have any detrimental impact on the adequacy of transportation services available to the public in Escot's service area. (Appl. 10.) TBL Group anticipates that services available to the public will increase due to anticipated increased demand in Escot's service area. (
TBL Group states that the proposed transaction will increase fixed charges in the form of interest expense, explaining that funds will be borrowed to finance the transaction. (
TBL Group states that there is strong demand for passenger surface transportation in Escot's service area, with many service options available to passengers. (
TBL Group asserts that, with the exception of Echo East, Escot's service area is geographically dispersed from the service areas of the Affiliated Carriers, with no overlap in customer bases. (
Based on TBL Group's representations, the Board finds that the transaction proposed in the application is consistent with the public interest. The application will be tentatively approved and authorized. If any opposing comments are timely filed, these findings will be deemed vacated, and, unless a final decision can be made on the record as developed, a procedural schedule will be adopted to reconsider the application.
This action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available at
1. The proposed transaction is approved and authorized, subject to the filing of opposing comments.
2. If opposing comments are timely filed, the findings made in this notice will be deemed vacated.
3. This notice will be effective on July 28, 2026, unless opposing comments are filed by July 27, 2026. If any comments are filed, TBL Group may file a reply by August 25, 2026.
4. A copy of this notice will be served on: (1) the U.S. Department of Transportation, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE, Washington, DC 20590; (2) the U.S. Department of Justice, Antitrust Division, 10th Street & Pennsylvania Avenue NW, Washington, DC 20530; and (3) the U.S. Department of Transportation, Office of the General Counsel, 1200 New Jersey Avenue SE, Washington, DC 20590.
5. This notice will be published in the
By the Board, Board Members Fuchs, Hedlund, Kloster, and Schultz.
Seminole Gulf Railway, L.P. (SGLR) has filed a verified notice of exemption under 49 CFR part 1152 subpart F—
SGLR has certified that: (1) no local traffic has moved over the Line since 2008; (2) there is no overhead traffic because the Line is not a through line; (3) no formal complaint filed by a user of rail service on the Line (or by a state or local government on behalf of such user) regarding cessation of service over the Line is pending with either the Surface Transportation Board (Board) or any U.S. District Court or has been decided in favor of a complainant within the two-year period prior to the filing of the notice; and (4) the requirements at 49 CFR 1105.7(b) and 1105.8(c) (notice of environmental and historic reports), 49 CFR 1105.12 (newspaper publication), and 49 CFR 1152.50(d)(1) (notice to government agencies) have been met.
As a condition to this exemption, any employee adversely affected by the abandonment shall be protected under
Provided no formal expression of intent to file an offer of financial
All pleadings, referring to Docket No. AB 400 (Sub-No. 8X), 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 SGLR's representative, Eric M. Hocky, Clark Hill, PLC, Two Commerce Square, 2001 Market St., Suite 2620, Philadelphia, PA 19103.
If the verified notice contains false or misleading information, the exemption is void ab initio.
SGLR has filed a combined environmental and historic report that addresses the potential effects, if any, of the abandonment on the environment and historic resources. OEA will issue a Draft Environmental Assessment (Draft EA) by July 2, 2026. The Draft EA will be available to interested persons on the Board's website, by writing to OEA, or by calling OEA at (202) 245-0294. If you require an accommodation under the Americans with Disabilities Act, please call (202) 245-0245. Comments on environmental or historic preservation matters must be filed within 15 days after the Draft EA becomes available to the public.
Environmental, historic preservation, public use, or trail use/railbanking conditions will be imposed, where appropriate, in a subsequent decision.
Pursuant to the provisions of 49 CFR 1152.29(e)(2), SGLR shall file a notice of consummation with the Board to signify that it has exercised the authority granted and fully abandoned the Line. If consummation has not been effected by SGLR's filing of a notice of consummation by June 26, 2027, and there are no legal or regulatory barriers to consummation, the authority to abandon will automatically expire.
Board decisions and notices are available at
By the Board, Anika S. Cooper, Chief Counsel, Office of Chief Counsel.
Tennessee Valley Authority (TVA).
Notice of meeting.
The TVA Regional Energy Resource Council (RERC) will hold a meeting on July 14, 2026, to receive an update and provide advice on TVA's 2026 Integrated Resource Plan (IRP). The IRP provides strategic direction on how TVA will continue to provide low-cost, reliable, and resilient electricity to the 10 million residents of the Valley region.
The meeting will be held in Chattanooga, Tennessee, at the Caption by Hyatt on Tuesday, July 14, 2026, from 8:30 a.m. to 4:00 p.m. ET. RERC members are invited to attend the meeting in person. The public is invited to view the meeting virtually or attend in person. A one-hour public listening session for the public to present comments virtually or in person will be held July 14, 2026, at 1:30 p.m. ET. A link and instructions to view the meeting will be posted on TVA's RERC website at
The meeting will take place at the Caption by Hyatt at 105 W. Main St, Chattanooga, TN 37408. The meeting will also be available virtually to the public. Instructions to view the meeting will be posted at
Bekim Haliti,
The RERC was established to advise TVA on its energy resource activities and the priorities among competing objectives and values. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. 10.
The meeting agenda includes the following:
Federal Highway Administration (FHWA), DOT.
Notice and request for comments.
The FHWA has forwarded the information collection request described in this notice to the Office of Management and Budget (OMB) to approve a new information collection. We are required to publish this notice in the
Please submit comments by July 27, 2026.
You may submit comments identified by DOT Docket ID Number 0760 by any of the following methods:
Follow the online instructions for submitting comments.
Addison Coley and Christopher Douwes, (202) 366-4000 Office of Environment, Planning, and Realty, Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. Office hours are from 8 a.m. to 5 p.m., Monday through Friday, except Federal holidays.
We published a
FHWA received comments from four State Departments of Transportation (DOTs) (Washington, Florida, Texas, and North Carolina) and one anonymous commenter.
FHWA received a comment from the Texas DOT supporting the Estimated Average Burden per Response included in the 60 Day
These comments also included several suggested changes to the TAP and RTP reporting process, which are listed below and include FHWA's response.
(1) Eliminate the requirement for States to provide the annual TAP and RTP report to FHWA.
• FHWA is required under 23 U.S.C. 133(h)(8) to work with States and MPOs (responsible for carrying out 23 U.S.C. 133) to complete the TAP and RTP annual reports. This requirement can only be eliminated by changing the law.
• This suggestion came from the Florida DOT.
(2) Increase the usefulness of the TAP and RTP annual report to include documentation of obligated projects, documentation of completed projects, and before-and-after photographs.
• Per 23 U.S.C. 133(h)(8) and to minimize the burden on States for completing the required TAP and RTP annual reports, States are only required to document specific data regarding project applications and projects selections. States are not required to include obligation data or data on completed projects. Requests for this information should be directed to the appropriate State DOT.
• This suggestion came from an anonymous commenter, the North Carolina DOT, and the Washington DOT.
(3) Clarify the purpose and use of the report.
• The purpose of the report is to comply with 23 U.S.C. 133(h)(8), which requires FHWA to publicly post a report on TAP and RTP project applications and project selections.
• This suggestion came from the North Carolina DOT and the Washington DOT.
(4) Improve guidance on TAP and RTP annual report preparation, including how to document ADA-compliant ramp installation.
• Each year, FHWA makes updates to the TAP and RTP reporting instructions following any feedback provided by States. FHWA also offers annual reporting office hours with States to answer questions about the reporting process and regularly responds to inquiries about report preparation.
• The report is for TAP and RTP project applications and project selections for the given fiscal year. Other project phases are not documented in the report. This is stated in the reporting instructions and restated throughout the document. Documentation for the installation of multiple ADA-compliant ramps is addressed in row 28 of the FY 2025 TAP and RTP example template. Specific questions about the annual report template can be directed to the FHWA Division office in each State.
• This suggestion came from the North Carolina DOT.
(5) Prepare reports by individual Transportation Management Areas (TMAs) instead of States.
• In accordance with 23 U.S.C. 145(a), the Federal-aid program is a federally assisted State administered program. Per 23 U.S.C. 104(b), Federal-aid funds are apportioned to the State DOT. The State DOT serving as a pass-through entity is responsible for ensuring all Federal funds administered by its subrecipients (
• This suggestion came from the North Carolina DOT.
(6) Use the Fiscal Management Information System (FMIS) and Statewide Transportation Improvement Programs (STIPs) to prepare reports.
• Annual reporting on TAP and RTP project applications and project selections is required under 23 U.S.C. 133(h)(8). The FMIS provides information for obligated Federal-aid projects. The FMIS does not have data on applications received or selected. Of the applications received, many are not selected and those selected may not be obligated for one or more years after selection.
• The information in the STIPs does not include project applications, only projects selected to be funded. Additionally, STIPs may group similar projects, such as TAP and RTP projects (and may not have the level of detail required for individual projects in accordance with 23 U.S.C. 133(h)(8)).
• This suggestion came from the Washington DOT.
(7) Create a web platform for reports.
• A web format for creating, collecting, and sharing the TAP and RTP annual reports could improve usability for FHWA, State DOTs, MPOs, and other users reading the annual reports. Developing a web submission format will require significant time and resources and may be explored in the future.
• A web platform is not implementable for the FY 2025 report collection because it is more complex, necessitates more requirements gathering, and needs more security than the current Excel format.
• This suggestion came from the Texas DOT.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice and request for comments on a request for reinstatement with change of a previously approved information collection.
The National Highway Traffic Safety Administration (NHTSA) invites public comments about our intention to request approval from the Office of Management and Budget (OMB) for a reinstatement of a previously approved information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes a collection of information for which NHTSA intends to seek OMB approval and solicits public comments on continuation of the requirements on tire identification and recordkeeping and the accuracy of the agency's revised estimates of the burden of the information collections.
Written comments must be submitted on or before August 25, 2026.
You may submit comments [identified by Docket No. DOT-NHTSA-2026-1288] through one of the following methods:
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For additional information or access to background documents, contact Jesus Valentin-Ruiz, National Highway Traffic Safety Administration, telephone 202-366-1810, Department of Transportation, 1200 New Jersey Avenue SE, Washington, DC 20590. Please identify the relevant collection of information by referring to its OMB Control Number.
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The information is used by a tire manufacturer after the manufacturer or the agency determines that some of its tires either fail to comply with an applicable safety standard or contain a safety related defect. With the information, the tire manufacturer can notify the first purchaser of the tire and provide them with any necessary information or instructions to remedy the non-compliance situation or safety defect. Without this information, efforts to identify the first purchaser of tires that have been determined to be defective or nonconforming pursuant to Sections 30118 and 30119 of Title 49 U.S.C. would be impeded. Further, the ability of the purchasers to take appropriate action in the interest of motor vehicle safety may be compromised.
Since this ICR was last approved, the burden hours calculation has increased 188,480 hours (from 250,000 hours to 438,480 hours). The burden hours include hours associated with providing registration forms by the tire manufacturers and the provision of paper forms to purchasers by the independent distributors and dealers which were not included in the previous statements. In addition, the number of tires purchased increased from 54 million to 57 million.
The cost estimate decreased by $2,544,000 (from $4,950,000 to $2,499,000). The decrease in costs is due mainly to the estimate of increased use by purchasers of electronic registration means, thereby reducing the number of postage costs.
NHTSA estimates that the total burden hours associated with this ICR is 438,480 hours. The total burden hours for this collection consist of the time spent by consumers filling out a registration form, time spent by tire dealers and distributors collecting and transmitting registration information, and collection and electronic storage of data by tire and vehicle manufacturers. It is estimated that this collection affects approximately over nine million respondents annually. This group consists of approximately nine million consumers who choose to register their tire purchases with the tire manufacturers, 59,000 new tire dealers and distributors, 20 tire manufacturers, and 618 motor vehicle manufacturers. A response is required by motor vehicle manufacturers upon each sale of a new vehicle and by non-independent tire dealers with each sale of a new tire. A consumer may elect to respond when he or she purchases a new tire from an independent dealer.
The first information collection is for the requirement for motor vehicle manufacturers to maintain a record of the names and addresses of the first purchasers of new motor vehicles, together with the identification numbers of the tires on the new vehicles for a period of not less than five years. NHTSA estimates that there are 618 motor vehicle manufacturers that will need to comply with this requirement and that these 618 manufacturers will produce 17,600,000 vehicles in each of the next three years.
Irrespective of the statutory requirement, manufacturers collect and maintain new vehicle purchaser names and addresses for a number of commercial reasons, including for warranty and marketing purposes. As a practical matter, vehicle manufacturers are presently collecting purchaser information from their dealers and then maintaining that information for their own commercial reasons. Therefore, we do not believe that the requirement to collect and maintain this information as found in 49 U.S.C. 30117(b) imposes any additional burden on that community. Accordingly, NHTSA estimates that the burden associated with this collection is 0 hours.
The second information collection is for the requirement for tire manufacturers to provide tire registration forms to every distributor and dealer of its tires which offers new tires for sale or lease to tire purchasers. NHTSA calculates this burden by estimating the time to distribute the registration form. NHTSA uses an estimate of half a second per form to provide tire registration forms to distributors and dealers. NHTSA estimates there are 57,000,000 forms produced and distributed annually, which requires approximately 7,917 hours (0.5 seconds ÷ 3,600) × 57,000,000).
The third information collection is the requirement for tire manufacturers to maintain a record of each tire distributor and dealer that purchases tires directly from the manufacturer and sells them to tire purchasers, the number of tires purchased by each distributor or dealer, the number of tires for which reports have been received from each such distributor or dealer other than an independent distributor or dealer, the number of tires for which reports have been received from each such independent distributor or dealer, the total number of tires for which registration forms have been submitted to the manufacturer or its designee, and the total number of tires sold by the manufacturer. As in the first information collection, tire manufacturers routinely collect information from dealers and distributors, as well as independent dealers and distributors, and maintain that information for their own commercial reasons. Therefore, NHTSA considers that the requirement to collect and maintain this information as required at 49 CFR 574.7(c) does not impose any additional burden on tire manufacturers.
For the fourth information collection, which requires independent distributors and dealers of new tires to provide each tire purchaser with a paper tire registration form on which the distributor or dealer has recorded the entire tire identification number of the tire(s) sold or leased to the tire purchasers and the distributor's or dealer's name and address (in lieu of the street address, the distributor's email address or website may be recorded). NHTSA estimates that it takes approximately 45 seconds for independent distributors and dealers to provide their contact information and the TIN of each tire sold on the form. Independent tire dealers account for approximately 65.5% of the U.S. consumer tire retail market.
The fifth information collection requires distributors and dealers of new tires to provide registration forms (in hard copy or electronic) to the tire manufacturers with the purchaser's name and address, entire tire identification number of tire(s) sold or leased to the tire purchaser, and the distributor's or dealer's name or street address (in lieu of the street address, the distributor's email address or website may be recorded). Under 49 CFR 574.8(a)(ii) and (iii), distributors and dealers of new tires either provide registration forms in hard copy or electronic form to the tire manufacturers, and NHTSA estimates 90% of the 59,000 respondents employ electronic methods. NHTSA estimates that it takes an average of 45 seconds to submit the tire and purchaser information from sales and/or registration forms to tire manufacturers. NHTSA estimates there will be 10,000,000 annual responses and calculates the estimated annual burden hours at 125,000 hours ((10,000,000 forms × 45 seconds) ÷ 3,600).
Table 2 below details the estimated number of forms returned electronically and those returned using the paper form for the fifth and sixth information collections.
The sixth information collection concerns the voluntary submission of tire registration forms by first purchasers, which occurs when an independent distributor or dealer of tires chooses the compliance option to provide customers with a registration form that they can complete (by adding their names and addresses) and mail to the tire manufacturer at no charge to the purchaser. There are an estimated 9,000,000 tire purchasers annually who choose to submit their information by way of registration forms to tire manufacturers. NHTSA estimates
The final and seventh information collection is the requirement for tire manufacturers to maintain a record of first purchasers and name and address of the tire seller (as recorded and submitted on registration forms returned to the tire manufacturer) for a period of not less than five years. NHTSA estimates that there are 20 tire manufacturers that will need to comply with this requirement. NHTSA understands that these 20 manufacturers maintain this information on first purchasers and the sellers electronically for their own commercial reasons, and therefore there is no additional burden hours imposed by this collection.
A summary of the collection of information burden is detailed in Table 3 below:
The labor costs associated with the information collections of requirement for tire manufacturers to provide registration forms (2), option for independent distributors and dealers of tires to provide paper registration forms (4), and submission of registration forms to tire manufacturers by tire distributors and dealers (5), are estimated by using the Bureau of Labor Statistics (BLS) estimate of the average hourly wage for production and non-supervisory employees in the manufacturing industry, which is $29.51.
There are approximately nine million tire purchasers annually who choose to submit their information by way of registration forms to tire manufacturers. Above, NHTSA estimated that each tire purchaser spends on average 60 seconds or one minute per tire sale to record information on the registration form resulting in an estimated annual burden for all tire purchasers of 150,000 hours. To estimate the time value for tire purchasers to provide the required information, NHTSA uses the Bureau of Labor Statistics (BLS) to estimate that the average hourly wage for all employees in private non-farm industries is $37.02.
The total estimated costs for respondents to comply with this collection of information are estimated to be $2,499,000 annually and consist of the costs to print the paper tire registration forms and the postage for mailing the paper forms. NHTSA estimates that 90% of tire purchasers submit their forms electronically. Therefore, 900,000 purchasers (10%) mail in the paper forms. Currently, it costs 61 cents (a postcard stamp) to mail a form; therefore, the total postage can be estimated at $549,000 (= $0.61/form × 900,000 forms). NHTSA estimates that the cost to print the registration form is three and one-half cents a tire. Thus, the costs for 57 million tires are at most $1,995,000. (= $0.035/tire × 57,000,000 tires = $1,995,000). This is an overestimate because in many cases more than one tire are registered on one form. However, this overestimate also considers the loss resulting when forms are printed but not used to mail information to the tire manufacturer.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Notice and request for comments on a request for reinstatement with change of a previously approved information collection.
The National Highway Traffic Safety Administration (NHTSA) invites public comments about our intention to request approval from the Office of Management and Budget (OMB) for reinstatement with change of a previously approved information collection. Before a Federal agency can collect certain information from the public, it must receive approval from OMB. Under procedures established by the Paperwork Reduction Act of 1995, before seeking OMB approval, Federal agencies must solicit public comment on proposed collections of information, including extensions and reinstatements of previously approved collections. This document describes a collection of information for which NHTSA intends to seek OMB approval and solicits public comments on continuation of the requirements on tire identification and recordkeeping and the accuracy of the agency's revised estimates of the burden of the information collections. The cost estimate for this reinstatement has increased by $37,000, from $970,620 to $1,007,620. This rise is primarily due to an estimated increase in the number of vehicles from 19,000,000 to 20,000,000, which has raised the number of rims from 95,000,000 to 100,000,000. As a result, the total annual costs for recordkeepers associated with rims have grown from $703,000 to $740,000. The higher vehicle estimate also increases the annual burden for information collection by new tire manufacturers, retreaders, and rim manufacturers to 278,913 hours, up from 274,491 hours in the previous request.
Written comments should be submitted by August 25, 2026.
You may submit comments identified by the Docket No. NHTSA-2026-1289 through one of the following methods:
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Jesus Valentin-Ruiz, U.S. Department of Transportation, NHTSA, 1200 New Jersey Avenue SE, Washington, DC 20590. Mr. Valentin-Ruiz's phone number is (202) 366-1810. Please identify the relevant collection of information by referring to its OMB Control Number.
Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Federal Motor Vehicle Safety Standard (FMVSS) Nos. 109, 117, 119, 129, and 139 establish a fixed format for the labeling requirements to be placed into or onto both sidewalls of tires manufactured for use on motor vehicles. Each new tire manufacturer, brand name owner, and retreader must label each tire manufactured by engraving tire and retreaded tire molds with the appropriate labeling information.
FMVSS Nos. 110 and 120 specify a fixed format for the placard labeling requirements to be placed on each motor vehicle. In addition, FMVSS Nos. 110 and 120 require additional information be labeled onto the finished rim used on vehicles covered by this standard.
Since this request was last approved, the cost estimate has increased by $37,000 (from $970,620 to $1,007,620). The increase in costs is due mainly to the estimate increase in the number of vehicles (19,000,000 to 20,000,000), which increased the number of rims (95,000,000 to 100,000,000), therefore, increasing the total annual costs for recordkeepers associated with rims from $703,000 to $740,000.
Office of the Secretary (OST), Department of Transportation (DOT).
Notice and request for comments.
In compliance with the Paperwork Reduction Act of 1995, the Department of Transportation, Office of the Secretary invite the general public, industry and other governmental parties to comment on the Foreign Air Carrier Application for Statement of Authorization. The information collection request previously approved by the Office of Management and Budget (OMB) expires on June 30, 2026.
Written comments should be submitted by August 25, 2026.
You may submit a comment to Docket No. DOT-OST-2013-0074 through one of the following methods:
If you wish to receive confirmation of receipt of your written comments, please include a self-addressed, stamped postcard with the following statement: “Comments on Docket No. DOT-OST-2013-0074. The Docket Clerk will date stamp the postcard prior to returning it to you via the U.S. mail. Please note that due to delays in the delivery of U.S. mail to Federal offices in Washington, DC, we recommend that persons consider an alternative method (internet, fax, or professional delivery service) to submit comments to the docket and to ensure their timely receipt at U.S. DOT.
Darren Jaffe, (202) 366-2512, Office of International Aviation, U.S. Department of Transportation, 1200 New Jersey Avenue SE, Room W58-213, Washington, DC 20590. Office hours are from 9 a.m. to 5:30 p.m., Monday through Friday, except Federal holidays.
Foreign carriers will also have to provide evidence that their homeland government will afford reciprocity to U.S. carriers seeking authority for the similar fifth-, sixth- and seventh-freedom operations. Carriers may cite certifications submitted by carriers from the same homeland if that homeland issued such certification within the preceding six-month period.
We have no empirical data to indicate how much time is required for a person to complete OST Form 4540; however, anecdotal evidence reveals that respondents spend thirty (30) minutes or less completing the form and brief justification. In some cases, respondents spend a limited amount of time, less than ten (10) minutes, reviewing the form before sending it via facsimile or email to the Department. In the interest of providing a conservative estimate so as to not understate the burden hours, we estimate the hour burden for completing OST Form 4540 as thirty (30) minutes.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Office of Foreign Assets Control, Treasury.
Notice.
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the name of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them. Additionally, OFAC is publishing updates to the identifying information of one person currently included on the SDN List.
This action was issued on June 23, 2026. See
OFAC: Associate Director for Global Targeting, 202-622-2420; Assistant Director for Licensing, 202-622-2480; Assistant Director for Sanctions Compliance, 202-622-2490; or
The SDN List and additional information concerning OFAC sanctions programs are available on OFAC's website:
A. On June 23, 2026, OFAC determined that that the property and interests in property subject to U.S. jurisdiction of the following persons are blocked under the relevant sanctions authorities listed below.
Internal Revenue Service (IRS), Treasury.
Notice of determinations.
This notice of determinations modifies the list of taxable substances to include the following two substances: chloro-isobutene-isoprene rubber ((C
For purposes of the tax under section 4671 of the Internal Revenue Code (Code) this addition to the list of taxable substances is effective October 1, 2026. For purposes of refund claims under section 4662(e) of the Code, it is effective April 1, 2023.
Julia Barlow at (202) 317-6855 (not a toll-free number).
Section 4671(a) of the Code imposes an excise tax on the sale or use of a taxable substance by the importer thereof (section 4671 tax). Section 4672(a)(1) of the Code defines the term
Under section 4672(a)(2), an importer or exporter of any substance may request that the Secretary determine whether such substance should be added to the List as a taxable substance or should be removed from the List. Under section 4672(a)(2)(B) and (a)(4) and (b)(2), the Secretary is required to add a substance to the List if the Secretary determines that any taxable chemicals that are listed in section 4661(b) of the Code constitute more than 20 percent of the weight, or more than 20 percent of the value, of the materials used to produce such substance, which determination is required under section 4672(a)(2)(B) and (a)(4) to be made based on the predominant method of production
Section 4672(a)(3) includes an initial list of taxable substances. Section 4 of Notice 2021-66 (2021-52 I.R.B. 901) provides the list of 101 substances that the Secretary added to the List before November 15, 2021. On May 31, 2024, the Secretary published a Notice of Determination in the
Section 4671(b)(3) authorizes the Secretary to prescribe a tax rate for taxable substances in lieu of the tax rate specified in section 4671(b)(2). The tax rate prescribed by the Secretary for a substance added to the List is calculated by multiplying the conversion factor for each taxable chemical used in the production of the substance by the corresponding tax rate for that taxable chemical under section 4661(b), and adding those results together. Conversion factors are determined based on the predominant method of production of the substance.
Pursuant to Section 4672(a)(4), this notice of determinations modifies the List to include the two additional taxable substances listed in the Summary of Determinations section of this notice, as explained in the Requests to Add Substances to the List and General Explanation of Determinations sections of this notice. The determination for each specific substance added to the List is explained in parts 1 and 2 of the Modifications to the List of Taxable Substances section of this notice.
The updated List and prescribed tax rates for taxable substances will be included in the instructions to Form 6627,
On June 25, 2026, the Secretary determined to add the following substances to the List:
For each of the substances listed in the Summary of Determinations section of this notice, an importer or an exporter submitted a petition to the IRS in accordance with Rev. Proc. 2022-26 requesting a determination under section 4672(a)(2) to add the substance to the List. For each substance, the petition represented that taxable chemicals constitute more than 20 percent of the weight of materials used to produce the substance, based on the predominant method of production.
After reviewing the petitions for each of the substances listed in the Summary of Determinations section of this notice, the Secretary determined that taxable chemicals constitute more than 20 percent by weight of the materials used to produce the substance, based on the predominant method of production. Therefore, both of the substances are added to the List as required under section 4672(a)(2) and (4). The Secretary made the determinations to add these substances to the List in accordance with the requirements of section 4672(a)(2) and (4), and pursuant to the procedures set forth in Rev. Proc. 2022-26,
The relevant information for each taxable substance is provided in the specific determinations included in parts 1 and 2 of the Modifications to the List of Taxable Substances section of this notice. The tax rate for each taxable substance, as prescribed by the Secretary, is provided in paragraph (a)(6) of each specific determination. All scientific information provided in the specific determinations reflects the information provided by petitioners as published in each taxable substance's respective Notice of Filing.
Classification numbers proposed by each petitioner are included in paragraph (b) of each part, after each specific determination. The classification numbers provided with respect to a taxable substance are not part of the determination of whether it is added to the List and do not impact whether such substance is a taxable substance. Taxpayers may not rely on classification numbers for any purpose under sections 4661, 4662, 4671, and 4672, including (but not limited to) identification of a substance as a taxable substance on the List. Classification numbers may change over time. The Department of the Treasury (Treasury Department) and the IRS do not anticipate updating this document to reflect any such changes.
For purposes of the section 4671 tax, all the modifications in parts 1 and 2 of the Modifications to the List of Taxable Substances section of this notice are effective on and after October 1, 2026. For purposes of refund claims under section 4662(e), the modifications are effective April 1, 2023.
Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of chloro-isobutene-isoprene rubber ((C
(a)
(1)
(2)
(3)
The Secretary followed the process in section 4672(a)(2)(B) in making this determination. A review of the stoichiometric material consumption equation and other information in the petition shows that the taxable chemicals butylene, chlorine, and sodium hydroxide constitute more than 20 percent by weight of the materials used in the production of chloro-isobutene-isoprene rubber ((C
(4)
(5)
(i)
(ii)
(6)
(b)
(1)
(i)
(ii)
(iii)
(2)
Arlanxeo USA LLC and Arlanxeo Canada Inc., importers and exporters of ethylene-propylene-dicyclopentadiene rubber ((C
(a)
(1)
(2)
(3)
The Secretary followed the process in section 4672(a)(2)(B) in making this determination. A review of the stoichiometric material consumption equation and other information in the petition shows that the taxable chemicals ethylene and propylene constitute more than 20 percent by weight of the materials used in the production of ethylene-propylene-dicyclopentadiene rubber ((C
(4)
(5)
(i)
(ii)
(6)
(b)
(1)
(i)
(ii)
(iii)
(2)
Internal Revenue Service (IRS), Treasury.
Notice of meeting.
An open meeting of the Taxpayer Advocacy Panel's Joint Committee will be conducted. The Taxpayer Advocacy Panel is soliciting
The meeting will be held on Wednesday, July 15, 2026, at 2:00 p.m. Eastern Time.
Fred N. Smith, Jr. by email at
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988), that an open meeting of the Taxpayer Advocacy Panel's Joint Committee will be held on Wednesday, July 15, 2026, at 2:00 p.m. Eastern Time.
The public is invited to attend the meeting virtually, or by phone, and may provide oral comments or submit written statements for consideration. Due to meeting structure and time limitations, advance registration is required to attend or make public comments during the meeting. To register and receive meeting access information, please contact Fred N. Smith, Jr. at the contact information above no later than Friday, July 10, 2026.
Meeting materials, including the agenda and any handouts, will be made available prior to the meeting at
The agenda will include a committee discussion of new and continuing issues and other activities related to the new TAP year.
Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services (HHS).
Proposed rule.
This proposed rule would update and revise the End-Stage Renal Disease (ESRD) Prospective Payment System for calendar year 2027. This rule also proposes to update the payment rate for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. In addition, this rule proposes to update the requirements for the ESRD Quality Incentive Program.
To be assured consideration, comments must be received at one of the addresses provided below, by August 24, 2026.
In commenting, please refer to file code CMS-1846-P.
Comments, including mass comment submissions, must be submitted in one of the following three ways (please choose only one of the ways listed):
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
For information on viewing public comments, see the beginning of the
This rule proposes changes related to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) and payment for renal dialysis services furnished to individuals with acute kidney injury (AKI). This rule also proposes to update requirements for the ESRD Quality Incentive Program (QIP).
On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA, and amended by section 3401(h) of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148), established that beginning calendar year (CY) 2012, and each subsequent year, the Secretary of the Department of Health and Human Services (the Secretary) shall annually increase payment amounts by an ESRD market basket percentage increase, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. This rule proposes updates to the ESRD PPS for CY 2027, including a routine proposal to rebase and revise the ESRD Bundled (ESRDB) market basket. This rule also proposes to modify the ESRD PPS base rate to reflect the incorporation of phosphate binders
On June 29, 2015, the President signed the Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27). Section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) of the Act to an individual
The ESRD QIP is authorized by section 1881(h) of the Act. The Program establishes incentives for facilities to achieve high quality performance on measures with the goal of improving outcomes for ESRD beneficiaries. This proposed rule proposes the following changes to the ESRD QIP measure set beginning with PY 2029: replace the Hypercalcemia reporting measure with the Facility-Level Percentage of Chronic Hyperphosphatemia in Dialysis Patients (Hyperphosphatemia) clinical measure, update the National Healthcare Safety Network Bloodstream Infection (NHSN BSI) clinical measure, remove the Medication Reconciliation (MedRec) reporting measure, and remove the COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP) reporting measure. Finally, this proposed rule requests public comment on the inclusion of the Dialysis Facility Discussion of Patient Life Goals (D-PaLS) Patient-Reported Outcome Performance Measure (PRO-PM) in the ESRD QIP.
This proposed rule includes RFIs to solicit public input to inform potential future policy development related to increasing home dialysis uptake, improving palliative dialysis, and supporting alternative dialysis schedules. We seek to better understand how Medicare payment policy may support care for ESRD beneficiaries while maintaining the integrity of existing prospective payment systems, including the ESRD PPS, AKI dialysis payment, the Hospice benefit (section 1814(i) of the Act), and the Home Health PPS (section 1895 of the Act).
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We are proposing to replace the Hypercalcemia reporting measure with the Hyperphosphatemia clinical measure beginning with PY 2029. Beginning with PY 2029, we are proposing to update the NHSN BSI clinical measure to use the most recently available national baseline data and to update the risk adjustment methodology. We are proposing to remove the MedRec reporting measure and the COVID-19 Vaccination Coverage Among HCP reporting measure from the ESRD QIP measure set beginning with PY 2029. We are also including an RFI on the potential inclusion of the Dialysis Facility Discussion of Patient Life Goals Patient-Reported Outcome Performance measure (D-PaLS PRO-PM) in the ESRD QIP.
These RFIs solicit comments on increasing home dialysis uptake, improving palliative dialysis care, and supporting alternative dialysis schedules.
In section VIII.C.5. of this proposed rule, we set forth a detailed analysis of the impacts that the proposed changes would have on affected entities and beneficiaries. Table 1 summarizes the impacts of each proposed change in this proposed rule.
The impact table in section VIII.C.5.a. of this proposed rule displays the estimated change in Medicare payments to ESRD facilities in CY 2027 compared to estimated Medicare payments in CY 2026. The overall impact of the proposed CY 2027 payment changes is projected to be a 1.1 percent increase in Medicare payments. Hospital-based ESRD facilities would have an estimated 2.0 percent increase in Medicare payments compared with freestanding ESRD facilities with an estimated 1.1 percent increase. We estimate that the aggregate Medicare program payments under the ESRD PPS would increase by approximately $70 million in CY 2027 compared to CY 2026 because of the proposed payment policies in this rule. Because of the projected 1.1 percent overall payment increase, we estimate there would be an increase in beneficiary coinsurance payments of 1.1 percent in CY 2027, which translates to approximately $20 million. This overall $90 million estimated increase, or 1.1 percent, includes the estimated impact of the proposed ESRD PPS market basket update of 1.6 percent ($130 million), as well as the estimated changes in payments associated with several proposed changes that are expected between CY 2026 and 2027. First, as discussed in section II.B.3.b. of this proposed rule, we estimate that outlier payments in CY 2026 will be approximately 3.0 percent of total ESRD PPS payments. Accordingly, the proposed increases to the FDL and MAP amounts for CY 2027 are projected to reduce ESRD PPS payments by approximately 1.9 percent ($150 million). At the same time, we estimate that approximately $430 million will be paid through the TDAPA for DefenCath®, Vafseo®, and phosphate binders in CY 2026. The end of the TDAPA periods for these drugs is projected to result in a corresponding decrease to CY 2027 payments of $430 million (5.5 percent), which is offset by the proposed 5.3 percent increase to the ESRD PPS base rate for phosphate binders and the estimated 2.0 percent increase in payments under the post-TDAPA add-on payment adjustment in CY 2027. The net difference between estimated CY 2026 TDAPA payments and estimated CY 2027 payments through the post-TDAPA add-on payment adjustment and the ESRD PPS base rate, including the incorporation of phosphate binders, is a 1.5 percent increase in payments to ESRD facilities. For CY 2027, we estimate total payments associated with the post-TDAPA add-on payment adjustment would be approximately $170 million.
Section 1881(b)(14)(D)(iv) of the Act provides that the ESRD PPS may include such other payment adjustments as the Secretary determines appropriate. Under this authority, CMS implemented § 413.234(c) to establish the TDAPA, a transitional drug add-on payment adjustment for certain new renal dialysis drugs and biological products; § 413.236 to establish the TPNIES, a transitional add-on payment adjustment for certain new and innovative equipment and supplies; and § 413.234(g) to establish the post-TDAPA add-on payment adjustment. The TDAPA, the TPNIES, and the post-TDAPA add-on payment adjustment are not budget neutral. As discussed in section II.D. of this proposed rule, there will be no new or continuing TPNIES payments for CY 2027. As discussed in section II.E. of this proposed rule, there are currently no continuing TDAPA payments in CY 2027.
The impact table in section VIII.C.5.c. of this proposed rule displays the estimated change in Medicare payments to ESRD facilities for renal dialysis services furnished to individuals with AKI for CY 2027 compared to estimated Medicare payments for such services in CY 2026. The overall impact of the proposed CY 2027 changes is projected to be a 6.0 percent increase in Medicare payments for individuals with AKI. Hospital-based ESRD facilities would have an estimated 5.9 percent increase in Medicare payments compared with freestanding ESRD facilities that would have an estimated 6.0 percent increase. The overall impact reflects the effects of the proposed Medicare ESRD PPS payment rate update and the proposed CY 2027 ESRD PPS wage index and proposed labor related share of 63.5 percent. We estimate that the aggregate Medicare payments made to ESRD facilities for renal dialysis services furnished to individuals with AKI, at the proposed CY 2027 ESRD PPS base rate, would increase by approximately $5 million in CY 2027 compared to CY 2026.
We estimate that, as a result of previously finalized policies and changes to the ESRD QIP that we are proposing, the overall economic impact of the PY 2029 ESRD QIP would be approximately $125.4 million. The $125.4 million estimate for PY 2029 includes $102.1 million in costs associated with the collection of information requirements and approximately $23.3 million in payment reductions across all facilities.
These RFIs do not propose any policy changes and therefore do not have a direct economic impact under Executive Order 12866.
On January 1, 2011, CMS implemented the ESRD PPS, a case-mix adjusted bundled PPS for renal dialysis services furnished by ESRD facilities, as required by section 1881(b)(14) of the Act, as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Patient Protection and Affordable Care Act (Affordable Care Act) (Pub. L. 111-148), established that beginning with CY 2012, and each subsequent year, the Secretary shall annually increase payment amounts by an ESRD market basket percentage increase reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.
Section 632 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240) included several provisions that apply to the ESRD PPS. Section 632(a) of ATRA added section 1881(b)(14)(I) to the Act, which required the Secretary, by comparing per patient utilization data from 2007 with such data from 2012, to reduce the single payment for renal dialysis services furnished on or after January 1, 2014, to reflect the Secretary's estimate of the change in the utilization of ESRD-related drugs and biologicals
Section 632(b) of ATRA prohibited the Secretary from paying for oral-only
On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93) was enacted. Section 217 of PAMA included several provisions that apply to the ESRD PPS. Specifically, sections 217(b)(1) and (2) of PAMA amended sections 1881(b)(14)(F) and (I) of the Act and replaced the drug utilization adjustment that was finalized in the CY 2014 ESRD PPS final rule (78 FR 72161 through 72170) with specific provisions that dictated the market basket update for CY 2015 (0.0 percent) and how the market basket percentage increase should be reduced in CY 2016 through CY 2018.
Section 217(a)(1) of PAMA amended section 632(b)(1) of ATRA to provide that the Secretary may not pay for oral-only ESRD-related drugs under the ESRD PPS prior to January 1, 2024. Section 217(a)(2) of PAMA further amended section 632(b)(1) of ATRA by requiring that in establishing payment for oral-only drugs under the ESRD PPS, the Secretary must use data from the most recent year available. Section 217(c) of PAMA provided that as part of the CY 2016 ESRD PPS rulemaking, the Secretary shall establish a process for (1) determining when a product is no longer an oral-only drug; and (2) including new injectable and intravenous products into the ESRD PPS bundled payment.
Section 204 of the Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295) amended section 632(b)(1) of ATRA, as amended by section 217(a)(1) of PAMA, to provide that payment for oral-only renal dialysis drugs and biological products cannot be made under the ESRD PPS bundled payment prior to January 1, 2025. Effective January 1, 2025, all oral-only renal dialysis drugs and biological products are paid for under the ESRD PPS.
Under the ESRD PPS, a single per-treatment payment is made to an ESRD facility for all the renal dialysis services defined in section 1881(b)(14)(B) of the Act and furnished to an individual for the treatment of ESRD in the ESRD facility or in a patient's home. We have codified our definition of renal dialysis services at § 413.171, which is in 42 CFR part 413, subpart H, along with other ESRD PPS payment policies.
The ESRD PPS base rate is adjusted for characteristics of both adult and pediatric patients and accounts for patient case-mix variability. The adult case-mix adjusters include five categories of age, body surface area, low body mass index, onset of dialysis, and four comorbidity categories (that is, pericarditis, gastrointestinal tract bleeding, hereditary hemolytic or sickle cell anemia, and myelodysplastic syndrome). A different set of case-mix adjusters are applied for the pediatric population. Pediatric patient-level adjusters include two age categories (under age 13, or age 13 to 17) and two dialysis modalities (that is, peritoneal dialysis (PD) or hemodialysis (HD) (§ 413.235(a) and (b)(1)).
The ESRD PPS provides four facility-level adjustments. The first payment adjustment reflects differences in area wage levels developed from core-based statistical areas (CBSAs) (§ 413.231). The second payment adjustment, the low volume payment adjustment (LVPA), accounts for ESRD facilities furnishing a low volume of dialysis treatments, with two tiers such that smaller low-volume facilities receive a higher payment adjustment (§ 413.232). The third payment adjustment accounts for ESRD facilities furnishing renal dialysis services in a rural area (§ 413.233(a)). The fourth payment adjustment, the non-contiguous areas payment adjustment (NAPA), accounts for non-labor costs for ESRD facilities in certain non-contiguous areas of the U.S. (§ 413.233(b)).
There are six additional payment adjustments under the ESRD PPS. The ESRD PPS provides adjustments, when applicable, for: (1) a training add-on for home and self-dialysis modalities (§ 413.235(c)); (2) an additional payment for high cost outliers due to unusual variations in the type or amount of medically necessary care (§ 413.237); (3) a TDAPA for certain new renal dialysis drugs and biological products (§ 413.234(c)); (4) a TPNIES for certain new and innovative renal dialysis equipment and supplies (§ 413.236(d)); (5) a transitional pediatric ESRD add-on payment adjustment (TPEAPA) of 30 percent of the per-treatment payment amount for renal dialysis services furnished to pediatric ESRD patients for CYs 2024 through 2026 (§ 413.235(b)(2));
Policy changes to the ESRD PPS are proposed and finalized annually in the
Most recently, we published a final rule, which appeared in the November 24, 2025, issue of the
In accordance with section 1881(b)(14)(F)(i) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Affordable Care Act, beginning in 2012, the ESRD PPS payment amounts are required to be annually increased by an ESRD market basket increase factor and reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The application of the productivity adjustment may result in the increase factor being less than 0.0 for a year and may result in payment rates for a year
As required under section 1881(b)(14)(F)(i) of the Act, CMS developed an all-inclusive ESRD Bundled (ESRDB) input price index using CY 2008 as the base year effective for CY 2012 (75 FR 49151 through 49162). We subsequently rebased and revised the ESRDB input price index to a base year of CY 2012 in the CY 2015 ESRD PPS final rule (79 FR 66129 through 66136), and to a base year of CY 2016 in the CY 2019 ESRD PPS final rule (83 FR 56951 through 56964). In the CY 2023 ESRD PPS final rule (87 FR 67141 through 67157), we finalized a rebased ESRDB input price index to reflect a CY 2020 base year. Effective for CY 2027, we are proposing to rebase and revise the ESRDB market basket to a 2024 base year.
The ESRDB market basket is a fixed-weight, Laspeyres-type price index. A Laspeyres-type price index measures the change in price, over time, of the same mix of goods and services purchased in the base period. Any changes in the quantity or mix of goods and services (that is, intensity) purchased over time are not measured.
The index itself is constructed in three steps. First, a base period is selected (in this proposed rule, we propose to use 2024 as the base period) and total base period costs are estimated for a set of mutually exclusive and exhaustive spending categories, with the proportion of total costs that each category represents being calculated. These proportions are called cost weights. Second, each cost category is matched to an appropriate price or wage variable, referred to as a “price proxy.” In almost every instance, these price proxies are derived from publicly available statistical series that are published on a consistent schedule (preferably at least on a quarterly basis). Finally, the cost weight for each cost category is multiplied by the level of its respective price proxy. The sum of these products (that is, the cost weights multiplied by their price index levels) for all cost categories yields the composite index level of the market basket in a given period. Repeating this step for other periods produces a series of market basket levels over time. Dividing an index level for a given period by an index level for an earlier period produces a rate of growth in the input price index over that timeframe.
As previously noted, the market basket is described as a fixed-weight index because it represents the change in price over time of a constant mix (quantity and intensity) of goods and services needed to provide renal dialysis services. The effects on total costs resulting from changes in the mix of goods and services purchased after the base period are not measured. For example, an ESRD facility hiring more staff to accommodate the needs of patients would increase the volume of goods and services purchased by the ESRD facility but would not be factored into the price change measured by a fixed-weight ESRDB market basket. Only when the index is rebased would changes in the quantity and intensity be captured, with those changes being reflected in the cost weights. Therefore, we rebase the market basket periodically so that the cost weights reflect changes between base periods in the mix of goods and services that ESRD facilities purchase to furnish ESRD treatment.
We last rebased the ESRDB market basket cost weights effective for CY 2023 (87 FR 67141 through 67157), with 2020 data used as the base period for the construction of the market basket cost weights. For this CY 2027 ESRD PPS proposed rule, we propose to rebase the ESRDB market basket to reflect the 2024 cost structure for ESRD facilities and to revise applicable cost categories and price proxies used to determine the ESRDB market basket, as discussed in this proposed rule.
We refer to the proposed market basket as a CY market basket because the base period for all price proxies and weights is set to CY 2024 (that is, the average index level for CY 2024 is equal to 100). The major source data for the proposed ESRDB market basket is the 2024 Medicare cost reports (Form CMS-265-11, OMB No. 0938-0236), supplemented with 2022 data from the United States (U.S.) Census Bureau's Services Annual Survey (SAS) inflated to 2024 levels and the Bureau of Economic Analysis's (BEA) 2017 Benchmark Input-Output (I-O) data, inflated to 2024. The 2022 SAS data and 2017 Benchmark I-O data are the most recent year of detailed cost data published by the Census Bureau and the BEA for North American Industry Classification System (NAICS) Code 6214: Outpatient Care Centers, which is the 4-digit industry code that Kidney Dialysis Centers are classified within. We also are proposing to use May 2024 OEWS data from BLS for NAICS 6214 to further disaggregate the Wages and Salaries and Employee Benefits cost weights into occupational categories. We provide more detail on our proposed methodology in section II.B.1.b. of this proposed rule.
In the following section, we provide an overview of the proposed ESRDB market basket, describe the proposed methodologies for developing the cost weights, and provide information on the proposed price proxies. Then, we present the proposed CY 2027 market basket update and labor-related share based on the proposed 2024-based ESRDB market basket.
The terms “rebasing” and “revising,” while often used interchangeably, denote different activities. “Rebasing” means moving the base year for the structure of costs of an input price index (for example, in this proposed rule, we propose to shift the base year cost structure from 2020 to 2024). “Revising” means changing data sources or price proxies used in the input price index. For CY 2027, we are proposing to rebase the ESRDB market basket to reflect the 2024 cost structure of ESRD facilities and to revise the index, that is, make changes to cost categories or price proxies used in the index.
We invite public comments on our proposed methodology for deriving the proposed 2024-based ESRDB market basket discussed in this section of the proposed rule.
The major source of cost data for developing the proposed rebased and revised ESRDB market basket cost weights is the 2024 Medicare cost reports. The 2024 Medicare cost reports are for those freestanding ESRD facilities whose cost reporting period began on or after October 1, 2023, and before October 1, 2024 (approximately 95 percent of freestanding ESRD facilities had a begin date on January 1, 2024, approximately 4 percent had a begin date prior to January 1, 2024, and approximately 1 percent had a begin date after January 1, 2024). Using this methodology allowed our sample to include ESRD facilities with varying cost report years including, but not limited to, the federal fiscal year (FY) or CY. We propose to use 2024 as the base year because we believe that the 2024 Medicare cost reports represent the most recent, complete set of Medicare cost report data available to develop cost weights for ESRD facilities at the time of rulemaking. We are proposing to maintain our policy of using data from freestanding ESRD facilities (which
The current set of instructions and associated forms for the Medicare cost reports for ESRD facilities (Form 265-11, OMB No. 0938-0236) can be found in Chapter 42 of the Provider Reimbursement Manual at the following website (
The major types of costs underlying the proposed 2024-based ESRDB market basket are derived from the Medicare cost reports (Form 265-11, OMB No. 0938-0236). Specifically, we propose to use the Medicare cost reports for eleven specific types of costs: Wages and Salaries; Employee Benefits; Pharmaceuticals (both Erythropoiesis Stimulating Agents (ESAs) and All Other Drugs in the ESRDB PPS bundled payment); Supplies; Laboratories; Housekeeping; Operations & Maintenance; Capital-related: Buildings and Fixtures; Capital-related: Moveable Equipment; Professional Liability Insurance; and Administrative & Other. Total Costs are defined as the sum of the eleven cost categories and associated costs identified previously.
To create a market basket that is representative of ESRDB facilities and to help ensure the major cost weights accurately reflect the percentage of total costs for furnishing ESRD treatment, we propose to apply edits to remove reporting errors and outliers. Specifically, edits were applied to include only Medicare cost reports that had total costs greater than zero. Total costs as reported on the Medicare cost report include those costs reimbursable under the ESRD PPS. For example, we excluded costs related to vaccines from total expenditures since these are not paid for under the ESRD PPS. Next, to reduce potential distortions from outliers in the calculation of the individual cost weights for the major expenditure categories for each cost category, values less than the 5th percentile or greater than the 95th percentile were excluded from the major cost weight computations. The resulting 2024 data set, after removing cost reports with total costs equal to or less than zero and excluding outliers, included information from approximately 6,514 independent ESRD facilities' cost reports from an available pool of 7,297 cost reports (roughly 89 percent of the universe). This sample of ESRD facilities is representative of the national universe of providers by ownership-type (proprietary, nonprofit, and government) and by urban/rural status.
Since each cost weight is determined independently, that is, the 5 percent trim is applied to each cost category, the resulting weights may not sum to 100.0. We propose normalizing the results proportionally so that the sum of each of the cost category weights will equal 100.0. A similar methodology was used to derive the major cost weights in the 2020-based ESRDB market basket.
We note that for the 2024 Medicare cost reports, a discrepancy was found with most Medicare cost reports submitted by a major large dialysis organization (LDO) where the Medicare cost report field designating the facility as a chain was completed incorrectly. Worksheet S, Part II, column 1, line 19 states “Are you part of a chain organization? Enter “Y” for yes or “N” for no. If yes, complete lines 20 through 22.” Many of these facilities entered “N”; however, they provided the location of the chain organization in lines Worksheet S, Part II, lines 20 through 22, indicating that the correct response to line 19 should have been “Y”. (We note that these facilities had also indicated being part of a chain organization in their prior year's cost report.) This led to reporting of Administrative & Other net expenses that was inconsistent with the chain designation. Worksheet A-3 provides for the computation of any needed adjustments to costs applicable to services, facilities, and supplies furnished to the facility by a related organization (by common ownership or control). This worksheet is potentially completed when a facility answers `Y' to Worksheet S, Part II. These adjustments to costs are transferred to Worksheet A, column 7 (to be reflected in Worksheet A, column 8) and, therefore, would then be reflected in the Administrative & Other net expenses.
To correct this misreporting, we first checked if the value reported on Worksheet A-3, Part B, column 1, line 1 was missing or 0, and whether the value reported on Worksheet A-3, Part B, column 6, line 1 was greater than zero. If these conditions were satisfied, we added the dollar ($) value of the related organization adjustment (Worksheet A-3, Part B, column 6, line 1) to the Administrative & Other cost center net expenses reported on Worksheet B, column 9, line 8.01. For any facility that didn't have a discrepancy, no adjustment was required to the Administrative & Other net expenses.
We propose to determine Wages and Salaries costs as the sum of (1) direct patient care wages and salaries costs and (2) non-direct patient care wages and salaries costs. Direct patient care wages and salaries for 2024 are equal to the sum of costs from Worksheet B, column 4.01 (salaries for dialysis equipment technicians) and column 5 (direct patient care salaries), lines 8.01 through 17.03 (reimbursable cost centers) of the Medicare cost reports. Non-direct patient care wages and salaries are equal to the sum of all other wages and salaries costs for non-health workers, which we are proposing to derive using the following steps:
We propose to determine the Employee Benefits costs as the sum of direct patient care EH&W benefits (which we will refer to as direct patient care employee benefit costs) and estimated non-direct patient care employee benefit costs. Direct patient care employee benefit costs are reported on Worksheet B, column 6, lines 8.01 through 17.03 of the Medicare cost reports. Non-direct patient care employee benefit costs are not reported separately but are included in Worksheet A, column 3 (“Other”). We propose to derive the non-direct patient care benefit costs using the following steps:
We note that this proposed methodology for deriving total employee benefits costs from the Medicare cost report differs from the methodology we have used in prior ESRDB market baskets. Previously, we derived the Employee Benefits cost weight from Medicare cost report data for direct patient care employee benefits and supplemented with data from the 2012 U.S. Census Bureau's Services Annual Survey (SAS) for NAICS 621492, Kidney Dialysis Centers, which were inflated to the applicable base year (for example 2020) to account for non-direct patient care employee benefits. The U.S. Census Bureau discontinued publication of the SAS data for NAICS 621492 beginning in 2012 and discontinued publication of the SAS effective after the 2022 data release. For years between 2012 and 2022, the SAS data was only available at the four-digit NAICS level of detail, and we therefore continued to rely on the inflated 2012 data. We believe the proposed methodology is a technical improvement to the prior methodology used to derive the non-direct patient care employee benefits because it relies on more recent Medicare cost report data that are specific to ESRD facilities.
The proposed 2024-based ESRDB market basket includes expenditures for all drugs, including formerly separately billable drugs and all other renal dialysis drugs that were covered under Medicare Part D before the ESRD PPS was implemented. We propose to determine the pharmaceuticals costs using data reported on Worksheet B; specifically, the sum of lines 8.01 through 17.03, for the following columns: column 11, “Drugs Included in Composite Rate,” column 12, “Erythropoiesis stimulating agents (ESAs)”; and column 13, “ESRD-Related and AKI -Related Drugs.” We did not include the drug costs for Non- ESRD Related Drugs, Supplies, and Labs as reported on line 5, column 10 or the AKI Non-Renal Related Drugs, Supplies, & Lab as reported on line 5.01 column 10 as these costs are not included in the ESRD PPS bundled payment amount. Section 1842(o)(1)(A)(iv) of the Act requires that influenza, pneumococcal, COVID-19, and hepatitis B vaccines described in paragraph (A) or (B) of section 1861(s)(10) of the Act be paid based on 95 percent of average wholesale price (AWP) of the drug. Since these vaccines are not paid for under the ESRD PPS, we did not include costs reported on Worksheet B, column 9, line 7 in the proposed 2024-based ESRDB market basket. Finally, to avoid double-counting, the pharmaceuticals costs are reduced by the estimated share of non-direct patient care wages and salaries associated with the applicable drug cost centers referenced previously. This resulted in a proposed 2024-based ESRDB market basket cost weight for Pharmaceuticals of 5.3 percent, with ESA costs accounting for 3.0 percentage points and All Other Drugs accounting for the remaining 2.3 percentage points.
We calculated the proposed Supplies costs using the costs reported in the Supplies cost center (Worksheet B, column 7, lines 8.01 through 17.03) of the Medicare cost report. To avoid double-counting, the Supplies costs were reduced to exclude the estimated share of non-direct patient care wages and salaries associated with this cost center.
We calculated the proposed Laboratory costs using the costs reported in the Laboratory cost center (Worksheet B, column 8, lines 8.01 through 17.03) of the Medicare cost report. To avoid double-counting, the Laboratory costs were reduced to exclude the estimated share of non- direct patient care wages and salaries associated with this cost center.
The Medicare cost report data include reported costs for Housekeeping, Operations & Maintenance, Capital-related: Buildings and Fixtures, and Capital-related: Moveable Equipment in a single cost center. We estimated the net costs for each of these four categories using the following steps.
• The Housekeeping share is determined based on the total costs for Housekeeping reported on Worksheet A, column 4, line 4 divided by the total costs for all four subcategories reported on Worksheet A, column 4, line 5.
• The Operations & Maintenance share is determined based on the total costs for Operations & Maintenance costs reported on Worksheet A, column 4, line 3 divided by the total costs for all four subcategories reported on Worksheet A, column 4, line 5.
•
•
The proposed Housekeeping costs are estimated by multiplying the housekeeping share determined in step 2 by the total net costs calculated in step 1. To avoid double-counting, the costs for the Housekeeping category were reduced to exclude the estimated share of non-direct patient care wages and salaries associated with this cost center.
The proposed Operations & Maintenance costs are estimated by multiplying the operations & maintenance share determined in step 2 by the total net costs calculated in step 1. The operations & maintenance costs include the direct costs incurred in the operation and maintenance of the plant and equipment such as heat, light, water (excluding water treatment for dialysis purposes), air conditioning, and air treatment; the maintenance and repair of buildings, parking facilities, and equipment; painting; elevator maintenance; performance of minor renovation of buildings and equipment; and protecting employees, visitors, and facility property. To avoid double counting, the costs for the Operations & Maintenance category were reduced to exclude the estimated share of non-direct patient care wages and salaries associated with this cost center.
The proposed Capital-related: Buildings and Fixtures costs are estimated by multiplying the capital-related buildings and fixtures share from step 2 by the total net costs calculated in step 1. The capital-related buildings and fixture costs include depreciation and lease costs for buildings and fixtures, property taxes, insurance costs, and capital improvements.
The proposed Capital-related: Moveable Equipment costs are estimated by multiplying the capital-related moveable equipment share from step 2 by the total net costs calculated in step 1. The capital-related moveable equipment costs include depreciation and lease costs for moveable equipment, property taxes, insurance costs, and capital improvements. Next, we sum the costs for capital-related moveable equipment to the Capital-related Renal Dialysis Equipment costs (Worksheet B, column 4, lines 8.01 through 17.03). We reasoned this delineation was particularly important given the critical role played by dialysis machines. Likewise, because price changes associated with buildings and fixtures could move differently than those associated with moveable equipment, we continue to believe that two capital-related cost categories are appropriate.
We propose for the 2024-based ESRDB market basket to have a separate category for professional liability insurance (PLI) costs (often referred to as malpractice costs). The PLI costs are equal to the sum of premiums, paid losses, and self-insurance costs reported on Worksheet S, Part II, column 1, lines 15 through 17. For the 2020-based ESRDB market basket we did not create a separate cost category and the PLI costs were included with the Administrative & Other costs.
We computed the proportion of total Administrative & Other costs using the Administrative & Other cost center data from Worksheet B, the sum of column 9, lines 8.01 through 17.03, less PLI costs and other costs reported in this cost center but paid separately from the ESRDB PPS, which include Non-ESRD Related Drugs, Supplies, & Lab (line 5); AKI Non-renal Related Drugs, Supplies, & Labs (line 5.01); Whole Blood and Packed Red Blood cells (line 6); and Vaccines (line 7). To avoid double-counting, the costs for the Administrative & Other category were also reduced to exclude the estimated share of non-direct patient care wages and salaries associated with this cost center and the estimated non-direct patient care employee benefits costs.
After we derived costs for the major cost categories for each provider using the Medicare cost report data as previously described, we propose to address data outliers using the following steps.
First, for each of the major cost weights, we propose to trim the data to remove outliers (a standard statistical process) by: (step 1) requiring that major costs (such as Wages and Salaries costs) and total costs be greater than zero; (step 2) dividing the costs for each of the eleven categories (calculated as previously described in this section) by total costs to obtain cost weights for each ESRD facility; and (step 3) excluding the top and bottom five percent of the major cost weight (for example, Wages and Salaries costs as a percent of total costs). We note that missing values are assumed to be zero consistent with the methodology for how missing values were treated in the 2020-based ESRDB market basket.
After the outliers have been removed, we sum the costs for each category across all remaining providers. We then divide this by the sum of total costs across all remaining providers to obtain a cost weight for the proposed 2024-based ESRDB market basket for the given category. This is the same methodology used for the 2020-based ESRDB market basket.
The trimming process is done individually for each cost category so that facilities excluded from one cost weight calculation are not automatically excluded from another cost weight calculation. We note that these proposed trimming methods are the same types of edits performed for the 2020-based ESRDB market basket, as well as other PPS market baskets (including but not limited to Inpatient Prospective Payment System (IPPS) operating market basket, Skilled Nursing Facility (SNF) market basket, and home health market basket). We note that for each of the cost weights we evaluated the distribution of providers and costs by ownership-type, and by urban/rural status. For all cost weights, the trimmed sample was nationally representative.
Table 2 presents the proposed 2024-based ESRDB market basket major cost weights as derived directly from the Medicare cost report data compared to the 2020-based ESRDB market basket major costs weights derived directly from the Medicare cost report data.
From 2020 to 2024, the Wages and Salaries and Employee Benefits cost weights increased by 2.9 percentage points and 3.6 percentage points, respectively. The increase in the proposed 2024-based Wages and Salaries and Employee Benefits cost weights is the result of faster growth in labor costs compared to costs associated with the other market basket cost weights (such as Pharmaceutical costs). This faster growth is consistent with comments received during prior ESRD PPS rulemaking. The Pharmaceuticals cost weight as calculated directly from the Medicare cost reports decreased by 4.8 percentage points, which continues the downward trend in the Pharmaceuticals cost weight observed since the implementation of the ESRD PPS in 2011. We believe this falling Pharmaceuticals cost weight is attributable to three main inter-related factors: (1) reduced utilization per treatment of certain high-cost drug classes (such as ESAs), (2) a shift to more price‐competitive products, including generic drugs or biosimilars, and (3) facility‐level cost management and efficiency.
There are three instances where the proposed ESRDB market basket costs weights are further adjusted using secondary data sources. The first adjustment is to estimate contract labor costs, which would be reflected in the Administrative & Other cost weight of 16.8 percent shown in Table 2 derived from the Medicare cost report data. We propose to estimate the contract labor share of costs and reallocate those from Administrative & Other to Wages and Salaries and Employee Benefits. The second adjustment further disaggregates the Wages and Salaries and Employee Benefits weight, inclusive of contract labor costs, into occupational subcategories. The third adjustment is to further disaggregate the remaining Administrative & Other cost weight (less the contract labor cost weight) into further detail using data from the Bureau of Economic Analysis Benchmark Input-Output data.
Contract labor costs are reported in the Medicare cost report; however, they are embedded in the Other Costs from the trial balance reported on Worksheet A, Column 3 and cannot be disaggregated. We propose the following methodology to derive the contract labor cost weight. Similar to the methodology used in the 2020-based ESRDB market basket, we are proposing to use data from the U.S. Census Bureau's Services Annual Survey (SAS) to estimate these costs for the 2024-based ESRDB market basket. We propose to use data from the 2022 SAS for NAICS 6214, Outpatient Care Centers, inflated to 2024 to estimate the contract labor weight for the 2024-based ESRDB market basket. Previously, we used the 2012 SAS data for NAICS 621492, Kidney Dialysis Centers inflated to the applicable base year. Since 2012 the SAS data is no longer available from the Census Bureau at the 6-digit NAICS level of detail, we believe that proposing to use the data for NAICS 6214 is a technically appropriate alternative as ESRD facilities would be included within this NAICS category and the data reflects the more recent experience of this industry's contract labor usage.
We propose to use the share of the total costs for NAICS 6214 expenses for Temporary staff and leased employee expense from the 2022 SAS. Using this data, the proposed 2024-based ESRDB Contract Labor cost weight is 2.1
As we did for the 2020-based ESRDB market basket (87 FR 67143), we propose to allocate contract labor costs to the Wages and Salaries and Employee Benefits cost weights based on their relative proportions for employed labor under the assumption that contract labor costs are comprised of both wages and salaries and employee benefits. The contract labor allocation proportion for wages and salaries is equal to the Wages and Salaries cost weight as a percent of the sum of the Wages and Salaries cost weight and the Employee Benefits cost weight. Using the 2024 Medicare cost report data, this percentage is 77 percent. Therefore, we propose to allocate 77 percent of the Contract Labor cost weight to the Wages and Salaries cost weight and 23 percent to the Employee Benefits cost weight. The 2020-based ESRDB market basket allocated 80 percent of the Contract Labor cost weight to the Wages and Salaries cost weight and 20 percent to the Employee Benefits cost weight.
Table 3 shows the Wages and Salaries and Employee Benefits cost weights after contract labor allocation for the 2020-based ESRDB market basket and the proposed 2024-based ESRDB market basket. In aggregate, the Compensation cost weight (calculated using more detailed decimal places) increased from 45.9 percent to 50.9 percent, or 5.0 percentage points.
To further disaggregate the “Wages and Salaries” and “Employee Benefits” cost weights into four occupational subgroups (Health-Related, Management, Administrative, and Service), we propose to use the number of full time equivalents (FTEs) reported on Worksheet S-1, column 3, lines 22 through 35 of the Medicare cost reports and annual mean wages for the occupations within each group from the May 2024 BLS OEWS for NAICS 6214, Outpatient Care Centers.
The ESRD Medicare cost report FTE categories assigned to the Health-Related subgroup include “Physicians,” “Registered Nurses,” “Licensed Practical Nurses,” “Nurses Aides,” “Technicians,” and “Dieticians”; assigned to the Management subgroup is “Management”; assigned to the Administrative subgroup is “Administrative”; and assigned to the Services subgroup are “Social Workers” and “Other”. For each FTE category, we estimate the mean annual wage from the May 2024 BLS OEWS data. We multiply the number of ESRD FTEs in each subgroup by the estimated mean annual wage. Table 4 shows the share of each FTE group's compensation (number of FTEs multiplied by the mean annual wage) to total compensation for the proposed 2024-based ESRD market basket and the 2020-based ESRDB market basket. Table 5 shows the Wages and Salaries and Employee Benefits occupational mix for the proposed 2024-based ESRDB market basket compared to the 2020-based occupational mix. The proposed 2024 occupational distribution shows a shift to more health-related FTEs and fewer Management and Administrative Support Occupation FTEs.
We propose to multiply the proposed occupational mix weights by the Wages and Salaries proposed cost weight and the Employee Benefits proposed cost weight (both inclusive of contract labor) to determine the occupational subgroups' weights for Wages and Salaries and Employee Benefits as shown in Table 6. This is similar to the methodology used in the 2020-based ESRDB market basket to derive these occupational subgroup weights.
To further divide the “Administrative & Other” residual cost weight estimated from the 2024 Medicare cost report data into more detailed cost categories, we propose to use the 2017 Benchmark I-O “The Use Table (Supply-Use Framework)” for NAICS 621400, Outpatient care Centers, published by the Bureau of Economic Analysis (BEA). These data are publicly available at the following website:
Using this methodology, we propose to derive 12 detailed cost categories from the proposed 2024-based ESRDB market basket Administrative & Other cost weight of 14.7 percent. These categories are: (1) Electricity; (2) Natural Gas; (3) Rubber & Plastics; (4) Paper & Printing; (5) Miscellaneous Products; (6) Telephone and internet Service; (7) Administrative Services; (8) Financial Services; (9) Professional Fees: Labor-related; (10) Professional Fees: Nonlabor-related; (11) All Other
We note that the proposed cost category for Professional Fees: Labor-related reflects the proportion of ESRD facilities' professional fees expenses that we believe vary with local labor market. We conducted a survey of ESRD facilities in 2008 to better understand the proportion of contracted professional services that ESRD facilities typically purchase outside of their local labor market. These purchased professional services include functions such as accounting and auditing, management consulting, engineering, and legal services. Based on the survey results, we determined that, on average, 87 percent of professional services are purchased from local firms, and 13 percent are purchased from businesses located outside of the ESRD's local labor market. Thus, to derive the Professional Fees: Labor-related weight we allocate 87 percent of the expenses for Professional Fees for these selected services as labor-related; we note that 87 percent is the same percentage as used in prior years.
This proposed methodology allows for seven additional detailed cost categories than used in the 2020-based ESRDB market basket because the Benchmark I-O data is more comprehensive than the SAS data. The 2020-based ESRDB market basket included categories for Electricity, Natural Gas, Telephone, Professional Fees, and All Other Goods and Services.
Table 6 sets forth the proposed 2024-based ESRDB market basket, including the cost categories and their respective cost weights. For comparison purposes, the corresponding 2020-based ESRDB market basket cost weights also are listed.
We invite public comments on our proposed methodology for deriving the proposed 2024-based ESRDB cost categories and weights.
After computing the proposed 2024-based cost weights for the ESRDB market basket, it was necessary to select appropriate wage and price proxies to reflect the rate of price change for each expenditure category. Except for the proxy for professional liability insurance (PLI), all proposed price proxies are based on BLS data and are grouped into one of the following BLS categories:
• Producer Price Indexes—Producer Price Indexes (PPIs) measure the average change over time in the selling prices received by domestic producers for their output. The prices included in the PPI are from the first commercial transaction for many products and some services (
• Consumer Price Indexes—Consumer Price Indexes (CPIs) measure the average change over time in the prices paid by urban consumers for a market basket of consumer goods and services (
• Employment Cost Indexes—Employment Cost Indexes (ECIs) measure the rate of change in employee wage rates and employer costs for employee benefits per hour worked. These indexes are fixed-weight indexes and strictly measure the change in wage rates and employee benefits per hour. ECIs are superior to Average Hourly Earnings (AHE) as price proxies for input price indexes because they are not affected by shifts in occupation or industry mix, and because they measure pure price change and are available by both occupational group and by industry. The industry ECIs are based on the NAICS and the occupational ECIs are based on the Standard Occupational Classification System (SOC).
We evaluated the price proxies using the criteria of reliability, timeliness, availability, and relevance:
• Reliability. Reliability indicates that the index is based on valid statistical methods and has low sampling variability. Widely accepted statistical methods ensure that the data were collected and aggregated in a way that can be replicated. Low sampling variability is desirable because it indicates that the sample reflects the typical members of the population. (Sampling variability is variation that occurs by chance because only a sample was surveyed rather than the entire population.)
• Timeliness. Timeliness implies that the proxy is published regularly, preferably at least once a quarter. The market basket levels are updated quarterly, and therefore, it is important for the underlying price proxies to be up-to-date, reflecting the most recent data available. We believe that using proxies that are published regularly (at least quarterly, whenever possible) helps to ensure that we are using the most recent data available to update the market basket. We strive to use publications that are disseminated frequently, because we believe that this is an optimal way to stay abreast of the most current data available.
• Availability. Availability means that the proxy is publicly available. We prefer that our proxies are publicly available because this would help ensure that our market basket updates are as transparent to the public as possible. In addition, this enables the public to be able to obtain the price proxy data on a regular basis.
• Relevance. Relevance means that the proxy is applicable and representative of the cost category weight to which it is applied.
We believe the proposed PPIs, CPIs, and ECIs selected meet these criteria. Therefore, we believe that they continue to be the best proxy of price changes for the cost categories to which they would be applied.
In this proposed rule, we present a detailed explanation of the price proxies that we propose for each cost category weight.
We propose to use the ECI for Wages and Salaries for All Civilian Workers in Hospitals (BLS series code #CIU1026220000000I) as the price proxy for health-related occupations. Of the two health-related ECIs that we considered (Hospitals and Health Care and Social Assistance), the wage distribution within the Hospital NAICS sector (622) is more closely related to the wage distribution of ESRD facilities than it is to the wage distribution of the Health Care and Social Assistance NAICS sector (62). This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the ECI for Wages and Salaries for Private Industry Workers in Management, Business, and Financial (BLS series code #CIU2020000110000I). We believe this ECI is the most appropriate price proxy to measure the wages and salaries price growth of management personnel at ESRD facilities. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the ECI for Wages and Salaries for Private Industry Workers in Office and Administrative Support (BLS series code #CIU2020000220000I). We believe this ECI is the most appropriate price proxy to measure the wages and salaries price growth of administrative support personnel at ESRD facilities. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the ECI for Wages and Salaries for Private Industry Workers in Service Occupations (BLS series code #CIU2020000300000I). We believe this ECI is the most appropriate price proxy to measure the wages and salaries price growth of all other non-health related, non-management, and non-administrative service support personnel at ESRD facilities.
BLS does not publish ECI for Benefits price proxies for each wages and salaries ECI; however, where these series are not published, they can be derived by using the ECI for Total Compensation and the relative importance of wages and salaries with total compensation as published by BLS for each detailed ECI occupational index. Therefore, we propose to use these derived ECI benefit price proxies for each of the respective occupational benefit cost categories.
We propose to use the ECI for Benefits for All Civilian Workers in Hospitals to measure price growth of this subcategory. This is calculated using the ECI for Total Compensation for All Civilian Workers in Hospitals (BLS series code #CIU1016220000000I) and the relative importance of Wages and Salaries within Total Compensation as published by BLS. We believe this constructed ECI series is technically appropriate for the reasons stated in the Wages and Salaries price proxy section. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the ECI for Benefits for Private Industry Workers in Management, Business, and Financial to measure price growth of this subcategory. This ECI is calculated using the ECI for Total Compensation for Private Industry Workers in Management, Business, and Financial (BLS series code #CIU2010000110000I) and the relative importance of wages
We propose to use the ECI for Benefits for Private Industry Workers in Office and Administrative Support to measure price growth of this subcategory. This ECI is calculated using the ECI for Total Compensation for Private Industry Workers in Office and Administrative Support (BLS series code #CIU2010000220000I) and the relative importance of Wages and Salaries within Total Compensation. We believe this constructed ECI series is technically appropriate for the reasons stated in the wages and salaries price proxy section. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the ECI for Total Benefits for Private Industry Workers in Service Occupations (BLS series code #CIU2030000300000I) to measure price growth of this subcategory. We believe this ECI series is technically appropriate for the reasons stated in the Wages and Salaries price proxy section. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the PPI Commodity for Commercial Electric Power (BLS series code #WPU0542) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the PPI Commodity for Commercial Natural Gas (BLS series code #WPU0552) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the PPI Commodity for Biological Products, Excluding Diagnostic, for Human Use (which we will abbreviate as PPI-BPHU) (BLS series code #WPU063719) as the price proxy for the ESA drugs in the market basket. The PPI-BPHU measures the price change of prescription biologics, and ESAs would be captured within this index, if they are included in the PPI sample. Since the PPI relies on confidentiality with respect to the companies and drugs/biologicals included in the sample, we do not know if these drugs are indeed reflected in this price index. However, we believe the PPI-BPHU is an appropriate proxy to use because although ESAs may be a small part of the fuller category of biological products, we can examine whether the price increases for the ESA drugs are similar to the drugs included in the PPI- BPHU. We did this by comparing the historical price changes in the PPI- BPHU and the average sales price (ASP) for ESAs and found the cumulative growth to be consistent over the 2020 to 2024 timeframe. We will continue to monitor the trends in the prices for ESA drugs as measured by other price data sources to ensure that the PPI-BPHU is still an appropriate price proxy.
For all other drugs included in the ESRD PPS bundled payment other than ESAs, we propose to use a blend of 47 percent of the PPI Commodity for Vitamin, Nutrient, and Hematinic Preparations (which we will abbreviate as PPI-VNHP) (BLS series code #WPU063807), and 53 percent of the PPI Commodity for Pharmaceuticals for Human Use, Prescription (which we will abbreviate as PPI-Pharmaceuticals) (BLS series code #WPUSI07003). We continue to believe that the PPI-VNHP is an appropriate price proxy for the iron supplements commonly used in the treatment of ESRD, and an analysis of claims data indicate that iron supplement costs and Vitamin D analogs account for about 47 percent of the All Other Drugs costs. For the remaining drugs represented in the All Other Drugs category we propose to use the PPI Commodity for Pharmaceuticals for Human Use, Prescription, which captures the inflationary price pressures for all types of prescription drugs rather than a single therapeutic category of drugs. Though this PPI measure includes a wide variety of prescription drugs, we believe it is technically appropriate to use a broad indicator of prescription drug price trends for three key reasons: (1) the more detailed PPI measure where we believe these types of non-ESA drugs would be captured would more likely reflect price trends not faced by ESRD facilities, such as cancer drugs, (2) there have been notable changes to the types and mix of drugs paid for under the ESRD PPS bundled payment since 2016, such as the inclusion of formerly oral-only drugs and the addition of AKI-related drugs, and (3) the potential for future changes to the types and mix of drugs that may be paid for under the ESRD PPS bundled payment. For these reasons, we believe that a broader drug index representing a larger mix of prescription drugs is technically appropriate to the proposed price proxy for this cost category. We will continue to monitor the relative share of costs for iron supplements and other types of drugs for this cost category to determine if the proposed 47/53 PPI blend warrants an adjustment, and if so, we would propose such an adjustment in future rulemaking. This is similar to the price proxy used in the 2020-based ESRDB market basket, but the composite weight was 50/50.
We propose to use the PPI Commodity for Surgical and Medical Instruments (BLS series code #WPU1562) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket.
We believe this is a technically appropriate price proxy for this cost category. The Medicare cost report form instructions state that Supplies include the direct cost of total dialysis supplies used in furnishing dialysis services—for example, crit-lines, low volume lines and dialyzers, catheter kits, fistula needles and tape, saline flushes, bandages, chlorhexidine, tego caps for catheters, biopatch for catheter dressing, oxygen, suction, emergency supplies, monitors for vitals, and blood pressure cuffs. We are requesting comments on other price indexes that could be applicable to the costs reported in this category, as the instructions may not contain the exhaustive list of supply costs that ESRD facilities include in this category. Examples of potential other price proxies would include, but are not limited to, the PPI Commodity for Medical and surgical appliances and supplies (BLS series code WPU1563) and the PPI Commodity for Miscellaneous products, Personal safety equipment and clothing (BLS series code WPU1571).
We propose to use the PPI Industry for Medical Laboratories (BLS series code #PCU621511621511) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use a 25/75 blend of the PPI Commodity for Publications Printed Matter and Printing Material (BLS Series Code WPU094) and the PPI Commodity for Converted Paper and Paperboard Products (BLS series code WPU0915) to proxy the price growth of this cost category. The 2017 Benchmark I-O data shows that 25 percent of paper
We propose to use the PPI Commodity for Rubber and Plastic Products (BLS series code WPU07) to proxy the price growth of this cost category. The 2020-based ESRDB market basket did not have a separate cost category for Rubber & Plastics. These costs would have been included in the All Other Goods and Services cost category and proxied by the PPI—Final demand—Finished goods less foods and energy.
We propose to use the PPI Commodity for Finished Goods Less Food and Energy (BLS series code WPUFD4131) to proxy the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket as these costs were included in the All Other Goods and Services cost category.
We propose to use the CPI U.S. city average for Telephone Services (BLS series code #CUUR0000SEED) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the PPI Commodity for Cleaning and Building Maintenance Services (BLS series code #WPU49) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the ECI for Total compensation for All Civilian workers in Installation, Maintenance, and Repair (BLS series code CIU1010000430000I) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket.
We propose to use the ECI for Total Compensation for Private Industry Workers in Office and Administrative Support (BLS series code CIU2010000220000I) to proxy the price growth of this category. The 2020-based ESRDB market basket did not have a separate cost category for Administrative Services. These costs would have been included in the All Other Goods and Services cost category and proxied by the PPI—Final demand—Finished goods less foods and energy.
We propose to use the ECI for Total Compensation for Private Industry Workers in Financial Activities (BLS series code CIU201520A000000I) to proxy the price growth of this cost category. The 2020-based ESRDB market basket did not have a separate cost category for Financial Services. These costs would have been included in the All Other Goods and Services cost category and proxied by the PPI—Final demand—Finished goods less foods and energy.
We propose to use the ECI for Total Compensation for Private Industry Workers in Professional and Related (BLS series code CIU2010000120000I) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket; however, the 2012 SAS data did not provide enough detailed information to split the Professional Fees category between labor-related and nonlabor-related services.
We propose to use the ECI for Total Compensation for Private Industry Workers in Professional and Related (BLS series code CIU2010000120000I) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket; however, the 2012 SAS data did not provide enough detailed information to split the professional fees category between labor-related and nonlabor-related services.
We propose to use the ECI for Total Compensation for Private Industry Workers in Service Occupations (BLS series code CIU2010000300000I) to proxy the price growth of this cost category. The 2020-based ESRDB market basket did not have a separate cost category for All Other Services: Labor-related. These costs would have been included in the All Other Goods and Services cost category and proxied by the PPI—Final demand—Finished goods less food and energy.
We propose to use the CPI for All Items Less Food and Energy (BLS series code CUUR0000SA0L1E) to proxy the price growth of this cost category. We believe that using the CPI for All Items Less Food and Energy avoids double counting of changes in food and energy prices as they are not included in the ESRD PPS (food) or are already captured elsewhere in the market basket (energy). This is the same price proxy used in other CMS market baskets, such as the IPPS, SNF, Long-term Care Hospital (LTCH), Inpatient Rehabilitation Facility (IRF), and Inpatient Psychiatric Facility (IPF), to proxy the growth in the remaining “All Other Services” cost category. The 2020-based ESRDB market basket did not have a separate cost category for All Other Services: Nonlabor-related, these costs would have been included in the All Other Goods and Services cost category and proxied by the PPI—Final demand—Finished goods less food and energy.
Unlike the other price proxies that are based on publicly available price indexes from BLS and other public sources, the proxy for PLI is based on data collected directly by CMS from a sample of commercial insurance carriers. We propose to use the CMS Physician PLI index to measure the price growth of this cost category in the proposed 2024-based ESRDB market basket. This is the same proxy used in the Medicare Economic Index (MEI) and the Home Health market basket. As detailed in the CY 2014 Physician Fee Schedule (PFS) final rule (78 FR 74271), a 2012 MEI Technical Panel expressed that the current index appropriately reflects the price changes in premiums throughout the industry.
We propose to use the PPI for Lessors of Nonresidential Buildings (BLS series code PCU531120531120) to measure the price growth of this cost category in the proposed 2024-based ESRDB market basket. This is the same proxy used in the 2020-based ESRDB market basket.
We propose to use the PPI Commodity for Electrical Machinery and Equipment (BLS series code #WPU117) to measure the price growth of this cost category. This is the same price proxy used in the 2020-based ESRDB market basket.
Table 7 shows all the proposed price proxies for the proposed 2024-based ESRDB Market Basket as well as
We invite public comments on our proposed price proxies for the proposed 2024-based ESRDB market basket.
A comparison of the yearly differences of increase factors from CY 2021 to CY 2030 for the 2020-based ESRDB market basket and the proposed 2024-based ESRDB market basket is shown in Table 8. The proposed CY 2027 ESRDB market basket increase factor would be the same if we continued to use the 2020-based ESRDB market basket.
Over the CY 2021 through CY 2025 timeframe, the average percent change of the proposed 2024-based ESRDB market basket is 3.7 percent, the same as the average percent change of the 2020-based ESRDB market basket. For CY 2027, the proposed 2024-based ESRDB market basket is projected to increase 2.6 percent, which is the same projected increase as the CY 2027 projected increase of the 2020-based ESRDB market basket. For the forecast period, CY 2026 through CY 2030, the proposed 2024-based ESRDB market basket percentage increase is on average the same 5-year average projected increase as the 2020-based ESRDB market basket.
We define the labor-related share (LRS) as those expenses that are labor-intensive and vary with, or are influenced by, the local labor market. The labor-related share of a market basket is determined by identifying the national average proportion of operating costs that are related to, influenced by, or vary with the local labor market.
We propose to use the proposed 2024-based ESRDB market basket cost weights to determine the proposed labor-related share for ESRD facilities. Therefore, effective for CY 2027, we are proposing a labor-related share of 63.5 percent, compared to the current 55.2 percent that was based on the 2020-based ESRDB market basket cost weights, as shown in Table 9. These figures represent the sum of Wages and Salaries, Employee Benefits, Housekeeping, Operations & Maintenance, Administrative Services, Professional Fees: Labor-related, All Other Services: Labor-related and 46 percent of the weight for Capital-related: Buildings and Fixtures (details discussed later in this section). We used a similar methodology to calculate the 2020-based ESRDB market basket labor-related share.
The proposed labor-related share for capital-related expenses reflects the proportion of ESRD facilities' capital-related expenses that we believe varies with local labor market wages (46 percent of ESRD facilities' Capital-related: Buildings and Fixtures expenses). Capital-related expenses are affected in some proportion by variations in local labor market costs (such as construction worker wages) that are reflected in the price of the capital asset. However, many other inputs that determine capital costs are not related to local labor market costs, such as interest rates. The 46-percent figure is based on regressions run for the inpatient hospital capital PPS in 1991 (56 FR 43375). We use a similar methodology to calculate capital-related expenses for the labor-related shares for rehabilitation facilities (70 FR 30233), psychiatric facilities, long-term care facilities, and skilled nursing facilities (66 FR 39585).
We invite public comments on our proposed labor-related share based on the proposed 2024-based ESRDB cost weights.
Under section 1881(b)(14)(F)(i) of the Act, beginning in CY 2012, the ESRD PPS payment amounts are required to be annually increased by an ESRD market basket percentage increase factor and reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. We propose to use the proposed 2024-based ESRDB market basket as described in section II.B.1.b. of this proposed rule to compute the CY 2027 ESRDB market basket percentage increase based on the best available data. Consistent with historical practice, we propose to estimate the ESRDB market basket percentage increase based on IHS Global Inc.'s (IGI) forecast using the most recently available data at the time of rulemaking. IGI is a nationally recognized economic and financial forecasting firm with which CMS contracts to forecast the components of the market baskets. As discussed in section II.B.1.d.(3) of this proposed rule, we are calculating the proposed ESRDB market basket update for CY 2027 based on the proposed ESRDB market basket percentage increase and the proposed productivity adjustment, following our longstanding methodology.
Using this methodology and IGI's first quarter of 2026 forecast of the proposed 2024-based ESRDB market basket (with historical data through the fourth quarter of 2025), and consistent with our historical practice of estimating market basket increases based on the best available data, the proposed CY 2027 ESRDB market basket increase factor is 2.6 percent. We also propose that if more recent data becomes available after the publication of the proposed rule and before the publication of the final rule (for example, a more recent estimate of the market basket percentage increase), we would use such data to determine the CY 2027 ESRDB market basket percentage increase in the final rule, provided such data is appropriate (meaning methodologically consistent with the proposed approach, sufficiently complete, and available in time to be reasonably evaluated for the final rule).
Under section 1881(b)(14)(F)(i) of the Act, as amended by section 3401(h) of the Affordable Care Act, for CY 2012 and each subsequent year, the ESRDB market basket percentage increase shall be reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The statute defines the productivity adjustment to be equal to the 10-year moving average of changes in annual economy-wide, private nonfarm business multifactor productivity (as projected by the Secretary for the 10-year period ending with the applicable fiscal year (FY), year, cost reporting period, or other annual period), hereafter referred to as the “productivity adjustment”.
BLS publishes the official measures of productivity for the United States economy. The productivity measure referenced in section 1886(b)(3)(B)(xi)(II) of the Act is published by BLS as private nonfarm business total factor productivity ((TFP) previously referred to as multifactor productivity).
Based on IGI's first quarter 2026 forecast, the proposed productivity adjustment for CY 2027 (the 10-year moving average growth of TFP for the period ending CY 2027) is 1.0 percentage point. Furthermore, we propose that if more recent data becomes available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the productivity adjustment), we would use such data, if appropriate, to determine the CY 2027 productivity adjustment in the final rule.
In accordance with section 1881(b)(14)(F)(i) of the Act, we propose to base the CY 2027 ESRDB market basket percentage increase on IGI's first quarter 2026 forecast of the proposed 2024-based ESRDB market basket. We propose to then reduce the ESRDB market basket percentage increase by the proposed productivity adjustment for CY 2027 based on IGI's first quarter 2026 forecast. Therefore, the proposed CY 2027 ESRDB market basket update is equal to 1.6 percent (proposed 2.6 percent ESRDB market basket percentage increase reduced by a proposed 1.0 percentage point productivity adjustment). Furthermore, as noted previously, we propose that if more recent data becomes available after the publication of this proposed rule and before the publication of the final rule (for example, a more recent estimate of the market basket percentage increase or productivity adjustment), we would use such data, if appropriate, to determine the CY 2027 ESRD market basket percentage increase and productivity adjustment in the final rule.
We invite public comment on our proposals for the CY 2027 ESRDB market basket percentage increase and productivity adjustment.
Section 1881(b)(14)(D)(iv)(II) of the Act provides that the ESRD PPS may include a geographic wage index payment adjustment, such as the index referred to in section 1881(b)(12)(D) of the Act, as the Secretary determines to be appropriate. In the CY 2011 ESRD PPS final rule (75 FR 49200), we finalized an adjustment for wages at § 413.231. Specifically, we established a policy to adjust the labor-related portion of the ESRD PPS base rate to account for geographic differences in the area wage levels using an appropriate wage index, which reflects the relative level of hospital wages and wage-related costs in the geographic area in which the ESRD facility is located. As discussed in detail later in this section, we later implemented an ESRD PPS specific wage index methodology in the CY 2025 ESRD PPS final rule (89 FR 89108 through 89117). Under current policy, we use OMB's CBSA-based geographic area designations to define urban and rural areas and their corresponding wage index values (75 FR 49117).
Under § 413.231(d), a wage index floor value of 0.6000 is applied under the ESRD PPS as a substitute wage index for areas with very low wage index values, as finalized in the CY 2023 ESRD PPS final rule (87 FR 67161). Currently, all areas with wage index values that fall below the floor are located in Puerto Rico and the U.S. Virgin Islands. However, the wage index floor value is applicable for any area that may fall below the floor. A further description of the history of the wage index floor under the ESRD PPS can be found in the CY 2019 ESRD PPS final rule (83 FR 56964 through 56967) and the CY 2023 ESRD PPS final rule (87 FR 67161).
An ESRD facility's wage index is applied to the LRS of the ESRD PPS base rate. In the CY 2023 ESRD PPS final rule (87 FR 67153), we finalized the use of a LRS of 55.2 percent. In the CY 2021 ESRD PPS final rule (85 FR 71436), we finalized a temporary policy which applied a 5 percent cap on any decrease in an ESRD facility's wage index from the ESRD facility's wage index from the prior CY. The transition would be phased in over 2 years, such that the reduction in an ESRD facility's wage index would be capped at 5 percent in CY 2021, and no cap would be applied to the reduction in the wage index for the second year, CY 2022. In the CY 2023 ESRD PPS final rule (87 FR
In the CY 2011 ESRD PPS final rule (75 FR 49116) and the CY 2011 final rule on Payment Policies Under the Physician Fee Schedule (PFS) and Other Revisions to Part B (75 FR 73486) we established an ESRD PPS wage index methodology to use the most recent pre-floor, pre-reclassified hospital wage data collected annually under the hospital inpatient prospective payment system (IPPS). Historically, the ESRD PPS wage index values have been calculated without regard to geographic reclassifications authorized for acute care hospitals under sections 1886(d)(8) and (d)(10) of the Act and utilized pre-floor hospital data that are not adjusted for occupational mix. In the CY 2025 ESRD PPS final rule (89 FR 89116) we finalized a new ESRD PPS wage index methodology which uses mean hourly wage data from the BLS OEWS. This wage data is then weighted by a national ESRD facility occupational mix (NEFOM) which is derived from FTE data from freestanding ESRD facility cost report data. Treatment data from ESRD facility cost reports is also used to weigh the mean hourly wage data when aggregating the wage data at a CBSA level. As set forth in § 413.196(d)(2), we update the ESRD PPS wage index using the most current wage data for occupations related to the furnishing of renal dialysis services from BLS and occupational mix data from the most recent full CY of Medicare cost reports submitted in accordance with § 413.198(b).
For a detailed explanation of the current ESRD PPS wage index methodology, see the discussion in the CY 2025 ESRD PPS final rule (89 FR 89108 through 89117), and for a detailed explanation of the steps we use to calculate the ESRD PPS wage index according to this methodology see Addendum C of the CY 2025 ESRD PPS proposed rule available at
Table 10 presents the NEFOM alongside the BLS occupation titles and codes for the occupations related to the furnishing of renal dialysis services. In this proposed rule we present the NEFOM to aid interested parties in their reconstruction of the proposed ESRD PPS wage index, but the actual ESRD PPS wage index uses the total FTEs for each occupation as described in the calculation in Addendum C of the CY 2025 ESRD PPS proposed rule rather than the rounded percentages presented in Table 10. The data in Table 10 is based on data from CY 2024 freestanding ESRD facility cost reports.
For CY 2027, we propose to update the wage indices to account for updated wage levels in areas in which ESRD facilities are located using the ESRD PPS wage index methodology established in the CY 2025 ESRD PPS final rule (89 FR 89098 through 89107) and specified in § 413.196(d)(2). The ESRD PPS wage index is specific for ESRD facilities as it uses specific wage data weighted by an ESRD facility occupational mix; this differentiates the ESRD PPS wage index from other Medicare PPSs, several of which utilize the pre-floor, pre-reclassification IPPS wage index. We propose to use the most recent available BLS OEWS mean hourly wage data for various occupations related to the furnishing of renal dialysis services weighted by FTE data from CY 2024 freestanding ESRD facility cost reports. The ESRD PPS wage index values are calculated without regard to geographic reclassifications authorized under sections 1886(d)(8) and (d)(10) of the Act. For CY 2027, the updated wage data used in the analysis for this proposed rule are from the May 2026 release of the BLS OEWS, which represents data from six semiannual surveys spanning November 2022 through May 2025.
For CY 2027, we propose to update the ESRD PPS wage index to use the most recent available BLS OEWS wage data. We are proposing that if more recent data becomes available after the analysis performed for the publication of this proposed rule and before the publication of the final rule (for example, an update to the May 2025 BLS OEWS mean hourly wage data or more complete CY 2024 cost report data), we would use such data, if appropriate, to determine the CY 2027 ESRD PPS wage index in the final rule.
The proposed CY 2027 ESRD PPS wage index is set forth in Addendum A and provides a crosswalk between the final CY 2026 wage index and the proposed CY 2027 wage index. Addendum B provides an ESRD facility level impact analysis. Both Addendum A and Addendum B are available on the CMS website at
Section 1881(b)(14)(D)(ii) of the Act requires that the ESRD PPS include a payment adjustment for high-cost outliers due to unusual variations in the type or amount of medically necessary care, including variability in the amount of ESAs necessary for anemia management. Some examples of the patient conditions that may be reflective of higher facility costs when furnishing dialysis care are frailty and obesity. A patient's specific medical condition, such as secondary hyperparathyroidism, may result in higher per treatment costs. The ESRD PPS recognizes that some patients require high-cost care, and we have codified the outlier policy and our methodology for calculating outlier payments at § 413.237.
Section 413.237(a)(1) enumerates the following items and services that are eligible for outlier payments as ESRD outlier services:
• Renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B.
• Renal dialysis laboratory tests that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B.
• Renal dialysis medical/surgical supplies, including syringes, used to administer renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B.
• Renal dialysis drugs and biological products that were or would have been, prior to January 1, 2011, covered under Medicare Part D, including renal dialysis oral-only drugs effective January 1, 2025.
• Renal dialysis equipment and supplies, except for capital-related assets that are home dialysis machines (as defined in § 413.236(a)(2)), that receive the transitional add-on payment adjustment as specified in § 413.236 after the payment period has ended.
• Renal dialysis drugs and biological products that are Composite Rate Services as defined in § 413.171.
In the CY 2011 ESRD PPS final rule (75 FR 49142), CMS stated that for purposes of determining whether an ESRD facility would be eligible for an outlier payment, it would be necessary for the ESRD facility to identify the actual ESRD outlier services furnished to the patient by line item (that is, date of service) on the monthly claim. Renal dialysis drugs, laboratory tests, and medical/surgical supplies that are recognized as ESRD outlier services were specified in Transmittal 2134, dated January 14, 2011.
Under § 413.237, an ESRD facility is eligible for an outlier payment if its imputed (that is, calculated) MAP amount per treatment for ESRD outlier services exceeds a threshold. In past years, the MAP amount has reflected the average estimated expenditure per treatment for services that were or would have been considered separately billable services prior to January 1, 2011. The threshold is equal to the ESRD facility's predicted MAP per treatment plus the fixed dollar loss (FDL) amount. As described in the following paragraphs, the ESRD facility's predicted MAP amount is the national adjusted average ESRD outlier services MAP amount per treatment, further adjusted for case-mix and facility characteristics applicable to the claim. We use the term “national adjusted average” in this section of this proposed rule to more clearly distinguish the calculation of the average ESRD outlier services MAP amount per treatment from the calculation of the predicted MAP amount for a claim. The average ESRD outlier services MAP amount per treatment is based on utilization from all ESRD facilities, whereas the calculation of the predicted MAP amount for a claim is based on the individual ESRD facility and patient characteristics of the monthly claim. In accordance with § 413.237(c), ESRD facilities are paid 80 percent of the per treatment amount by which the imputed MAP amount for outlier services (that is, the actual incurred amount) exceeds this threshold. ESRD facilities are eligible to receive outlier payments for treating both adult and pediatric dialysis patients.
In the CY 2011 ESRD PPS final rule and codified in § 413.220(b)(4), using 2007 data, we established the outlier percentage—which is used to reduce the per treatment ESRD PPS base rate to account for the proportion of the estimated total Medicare payments under the ESRD PPS that are outlier payments—at 1.0 percent of total payments (75 FR 49142 through 49143). We also established the FDL amounts that are added to the predicted outlier services MAP amounts. The outlier services MAP amounts and FDL amounts are different for adult and pediatric patients due to differences in the utilization of separately billable services among adult and pediatric patients (75 FR 49140). As we explained in the CY 2011 ESRD PPS final rule (75 FR 49138 through 49139), the predicted outlier services MAP amounts for a patient are determined by multiplying the adjusted average outlier services MAP amount by the product of the patient-specific case-mix adjusters applicable using the outlier services payment multipliers developed from the regression analysis used to compute the payment adjustments.
In the CY 2023 ESRD PPS final rule, we finalized an update to the outlier methodology to better target 1.0 percent of total Medicare payments (87 FR
Lastly, in the CY 2025 ESRD PPS final rule we finalized several methodological and policy changes to the ESRD PPS outlier policy to address concerns that interested parties have raised in recent years. First, we finalized an expansion of the definition of ESRD outlier services in § 413.237(a)(1) to include drugs and biological products that are Composite Rate Services as defined in § 413.171 (89 FR 89126). Second, we finalized a policy to include the case-mix adjusted post-TDAPA add-on payment adjustment amount in the calculation of the predicted MAP amounts when applicable (89 FR89127). Lastly, we finalized changes to the inflation factors for outlier eligible drugs and biological products, laboratory tests, and supplies. For ESRD outlier drugs and biological products, we use the projected inflation factor for ESRD outlier services that are drugs and biological products derived from the historical trend in average sales price (ASP) prices and utilization for ESRD outlier drugs (89 FR 89127 through 89130). For ESRD outlier laboratory tests and supplies, we use the growth in the Producer Price Index (PPI) Industry for Medical and Diagnostic Laboratories and the PPI Commodity for Surgical and Medical Instruments, respectively (89 FR 89129 through 89130).
For CY 2027, we propose to update the MAP amounts for adult and pediatric patients using the latest available CY 2025 claims data. We propose to update the ESRD outlier services FDL amount for pediatric patients using the latest available CY 2025 claims data, and to update the ESRD outlier services FDL amount for adult patients using the latest available claims data from CY 2023, CY 2024, and CY 2025, in accordance with the methodology finalized in the CY 2023 ESRD PPS final rule (87 FR 67170 through 67174) and the changes finalized in the CY 2025 ESRD PPS final rule (89 FR 89108 through 89130). The latest available CY 2025 claims data show that outlier payments represented approximately 0.9 percent of total Medicare payments. We propose to update these values with the latest available data, if appropriate, in the final rule.
As demonstrated in Table 11, the proposed FDL amount per treatment that determines the CY 2027 outlier threshold amount for adults (column II; $114.98) is significantly higher than that used for the CY 2026 outlier policy (column I; $14.80). The higher threshold amount is accompanied by an increase in the adjusted average MAP amount for outlier services from $23.68 to $41.28. These increases are primarily attributable to the projected utilization of drugs currently paid for through the TDAPA in CY 2025, which will be ESRD outlier services in CYs 2026 and 2027. Specifically, we project that payments under the outlier adjustment would be approximately 3.0 percent of total ESRD PPS payments in CY 2026 based on utilization from the latest available CY 2025 claims. As a result, we are proposing to increase the MAP and FDL amounts to better achieve the 1.0 percent outlier target in CY 2027. Although the proposed CY 2027 adult FDL amount is higher than the CY 2026 adult FDL amount, we note that the retrospective FDL methodology that we finalized in the CY 2023 ESRD PPS final rule accounts for the introduction of these new ESRD outlier services by calculating a retrospective trend line based on prior years' TDAPA or TPNIES utilization (87 FR 67174). The retrospective FDL calculations for CYs 2023, 2024, and 2025 are $134.81, $132.36, and $124.44, respectively. Following the methodology we finalized in the CY 2023 ESRD PPS final rule (87 FR 67170 through 67174), we use these retrospective FDL amounts to project a downward trend in the FDL amount for CY 2027, resulting in the proposed adult FDL amount of $114.98.
For pediatric patients, there is also a proposed increase in the FDL amount from $162.43 to $206.43. There is a corresponding proposed increase in the adjusted average MAP amount for outlier services among pediatric patients, from $50.19 to $60.86. We note that, as discussed in section II.B.7. of this proposed rule, we are proposing to include phosphate binders in the ESRD PPS base rate. Accordingly, phosphate binders would be eligible as ESRD outlier services for CY 2027, and we have included them in our calculations.
We estimate that the percentage of patient months qualifying for outlier payments in CY 2027 would be 6.42 percent for adult patients and 8.91 percent for pediatric patients, based on the 2025 claims data.
In the CY 2011 ESRD PPS final rule (75 FR 49081) and under § 413.220(b)(4), we reduced the per treatment base rate by 1.0 percent to account for the proportion of the estimated total payments under the ESRD PPS that are outlier payments as described in § 413.237. In the CY 2023 ESRD PPS final rule, we finalized a change to the outlier methodology to better achieve this 1.0 percent target (87 FR 67170 through 67174). Based on the CY 2025 claims available for this proposed rule, outlier payments represented approximately 0.9 percent of total payments, which is slightly below the 1.0 percent target.
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), CMS established the methodology for calculating the ESRD PPS per-treatment base rate, that is, the ESRD PPS base rate, and calculating the per-treatment payment amount, which are codified at §§ 413.220 and 413.230. The CY 2011 ESRD PPS final rule also included a detailed discussion of the methodology used to calculate the ESRD PPS base rate and the computation of factors used to adjust the ESRD PPS base rate for projected outlier payments and budget neutrality in accordance with sections 1881(b)(14)(D)(ii) and 1881(b)(14)(A)(ii) of the Act, respectively. Specifically, the ESRD PPS base rate was developed from CY 2007 claims (that is, the lowest per patient utilization year as required by section 1881(b)(14)(A)(ii) of the Act), updated to CY 2011, and represented the average per treatment MAP for composite rate and separately billable services. In accordance with section 1881(b)(14)(D) of the Act and our regulation at § 413.230, the per-treatment payment amount is the sum of the ESRD PPS base rate, adjusted for the patient specific case-mix adjustments, applicable facility-level adjustments, geographic differences in area wage levels using an area wage index, and any applicable outlier payment, training adjustment add-on, the TDAPA, the TPNIES, the post-TDAPA add-on payment adjustment, and the TPEAPA for CYs 2024, 2025 and 2026.
We propose an ESRD PPS base rate for CY 2027 of $299.55, which is approximately a 6.3 percent increase from the CY 2026 ESRD PPS base rate of $281.71. As outlined in section II.B.1.d. of this proposed rule, we are proposing that if more recent data becomes available after the publication of the proposed rule and before the publication of the final rule (for example, a more recent estimate of the market basket percentage increase or productivity adjustment), we would use such data, if appropriate, to determine the CY 2027 ESRDB market basket update in the final rule. The proposed CY 2027 ESRD PPS base rate is calculated as follows:
We note that the proposed CY 2027 wage index budget neutrality factor does not include any impacts associated with the TPEAPA, as was the case with the 2024 combined wage index-TPEAPA budget neutrality finalized factor for CY 2024. Although CY 2026 is the final year of the TPEAPA, as discussed in section II.B.9. of this proposed rule, we are proposing budget neutral changes to the payment adjustments that apply for pediatric ESRD patients. Rather than calculating a combined TPEAPA-wage index budget neutrality factor, we are including the effect of the end of TPEAPA in the proposed budget neutrality factor for those pediatric proposals. This is more consistent with what we have done in past years where there were multiple budget neutral policy changes outside the wage index in a given year, such as in the CY 2016 ESRD PPS final rule (80 FR 69011). This proposed budget neutrality factor does not incorporate the budget neutrality impact of the end of the TPEAPA effective January 1, 2027. That budget neutrality impact is included in the proposed budget neutrality factor for the payment adjustments described in this proposal.
In the CY 2021 ESRD PPS final rule (85 FR 71427), we expanded eligibility for the TPNIES under § 413.236 to include certain capital-related assets that are home dialysis machines when used in the home for a single patient. To establish the TPNIES basis of payment for these items, we finalized the additional steps that the Medicare Administrative Contractors (MACs) must follow to calculate a pre-adjusted per treatment amount, using the prices they establish under § 413.236(e) for a capital-related asset that is a home dialysis machine, as well as the methodology that CMS uses to calculate the average per treatment offset amount for home dialysis machines that is used in the MACs' calculation, to account for the cost of the home dialysis machine that is already in the ESRD PPS base rate. For purposes of this proposed rule, we refer to this as the “TPNIES offset amount.”
The methodology for calculating the TPNIES offset amount is set forth in § 413.236(f)(3). Section 413.236(f)(3)(v) states that effective January 1, 2022, CMS annually updates the amount determined in § 413.236(f)(3)(iv) by the ESRDB market basket update. The TPNIES for capital-related assets that are home dialysis machines is based on 65 percent of the MAC-determined pre-adjusted per treatment amount, reduced by the TPNIES offset amount, and is paid for two CYs.
There are currently no capital-related assets that are home dialysis machines set to receive the TPNIES for CY 2027, as the TPNIES payment period for the Tablo® System ended on December 31, 2023, and there are no TPNIES applications for CY 2027. However, as required by § 413.236(f)(3)(v), we propose to update the TPNIES offset amount annually according to the methodology described previously.
We propose a CY 2027 TPNIES offset amount for capital-related assets that are home dialysis machines of $10.60, based on the application of the proposed CY 2027 ESRDB market basket update of 1.6 percent (proposed 2.6 percent ESRDB market basket percentage increase reduced by the proposed 1.0 percentage point productivity adjustment) to the CY 2026 TPNIES offset amount of $10.43. We request public comments on our proposal to update the TPNIES offset amount for capital-related assets for CY 2027.
In the CY 2024 ESRD PPS final rule we finalized an add-on payment adjustment for certain new renal dialysis drugs and biological products, which would be applied for 3 years after the end of the TDAPA period (88 FR 76388 through 76397). This adjustment, known as the post-TDAPA add-on payment adjustment, is adjusted by the patient-level case-mix adjusters and is applied to every ESRD PPS claim. In the CY 2024 ESRD PPS final rule we also clarified that for each year of the post-TDAPA period we would update the post-TDAPA add-on payment adjustment amounts based on utilization and ASP of the drug or biological product. The post-TDAPA add-on payment adjustment amounts
For CY 2026 there is one drug, Korsuva® (difelikefalin), included in the calculation of the post-TDAPA add-on payment adjustment for each of the four calendar quarters and one drug, DefenCath®, included in the calculation for only the third and fourth calendar quarters. In the CY 2026 ESRD PPS final rule (90 FR 53091 through 53092), we finalized that the post-TDAPA add-on payment adjustment amount for Korsuva® would be $0.1131 for CY 2026 and we finalized a post-TDAPA add-on payment adjustment amount for DefenCath® of $2.3710 for the third and fourth quarter of 2026.
For CY 2027, there will be four drugs in the 3-year period following the end of their TDAPA period that are potentially eligible to be included in the calculation of the post-TDAPA add-on payment adjustment. Section 413.234(c)(3) states that, should CMS not receive the latest full calendar quarter of ASP data for a drug or biological product during the TDAPA or post-TDAPA add-on payment adjustment period, we will not pay any post-TDAPA add-on payment adjustment for such product in any future year. We refer to this policy at § 413.234(c)(3) as the conditional ASP policy, which was finalized in the CY 2024 ESRD PPS final rule (88 FR 76388 through 76396) and is modeled off the conditional ASP policy for the TDAPA which was finalized in the CY 2019 ESRD PPS final rule (84 FR 60677 through 60681). The intention of these policies is to ensure that the TDAPA and post-TDAPA add-on payment adjustment are always based on the best available data, which we consider to be ASP (when ASP is available). The third quarter of 2026 reflecting the first quarter of 2026 sales would be the latest quarter of ASP data at the time of rulemaking for the proposed rule.
The post-TDAPA add-on payment adjustment period for one of these drugs, Korsuva®, began on April 1, 2024, so Korsuva® would be included in the calculation for the post-TDAPA add-on payment adjustment for only the first quarter of CY 2027, conditional on the continued receipt of ASP data. DefenCath® began its TDAPA period on July 1, 2024, so its post-TDAPA add-on payment adjustment period will begin July 1, 2026. Vafseo® began its TDAPA period January 1, 2025, so its post-TDAPA period would begin January 1, 2027, conditional on the continued receipt of ASP data. Both drugs would be included in the post-TDAPA add-on payment adjustment calculation for each quarter of CY 2027, conditional on the continued receipt of ASP data.
We are presenting the proposed post-TDAPA add-on payment adjustment amounts for each of these drugs based on the most recently available full year of utilization data at this time. Utilization for this proposed rule is from January 2025 to December 2025. The estimated post-TDAPA add-on payment adjustment amount for Korsuva® is $0.1068, the estimated post-TDAPA add-on payment adjustment amount for DefenCath® is $5.5951, and the estimated post-TDAPA add-on payment adjustment for Vafseo® is $0.9437. The cumulative estimated post-TDAPA add-on payment adjustment amount for each quarter is presented in Table 12. Consistent with the methodology finalized in the CY 2024 ESRD PPS final rule (88 FR 76388 through 76389), we intend to update these calculations with the most recent available utilization and pricing data in the final rule. If the proposal in section II.B.6.b. is finalized, we would update the post-TDAPA add-on payment adjustment amounts quarterly via change requests (CRs). We invite public comments on the estimated CY 2027 post-TDAPA add-on payment adjustment amounts presented in Table 12.
As discussed in the CY 2024 ESRD PPS final rule (88 FR 76393) and codified at 42 CFR 413.234(g), we have finalized a post-TDAPA add-on payment adjustment which is based on the most recent year of utilization data and is calculated annually in each rulemaking cycle. Under § 413.234(g)(1), CMS bases the post-TDAPA add-on payment adjustment calculation on the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of ASP data.
In the CY 2025 ESRD PPS final rule, we established a policy that, when there is less than a full year's utilization data at the time of rulemaking, we would publish the post-TDAPA add-on payment adjustment amount via Change Request (CR) once we have a full 12 months of data (89 FR 89135). Under this policy, we would still include an estimated post-TDAPA add-on payment adjustment amount in the proposed rule and update that estimated amount in the final rule, but we would note that the estimated amount presented in the final rule is subject to change. In the CY 2025 ESRD PPS final rule, we reiterated that we believe it is important to have a full year's utilization data when determining the post-TDAPA add-on payment adjustment amount so that the post-TDAPA add-on payment adjustment appropriately captures the utilization of the drug or biological product as required by § 413.234(g)(1) (89 FR 89135 through 89136). However, in that final rule, we did not finalize other circumstances where we would update the post-TDAPA add-on payment adjustment amount for a drug or biological product. Specifically, we stated that we did not intend to routinely update the post-TDAPA add-on payment adjustment amount quarterly, as we believed this would make it more difficult for ESRD facilities to estimate payments (89 FR 89136).
In response to the proposed post-TDAPA add-on payment amount published in the CY 2026 ESRD PPS proposed rule, we received a comment requesting we finalize a policy to publish the post-TDAPA add-on payment adjustment for DefenCath® after the publication of the final rule (90 FR 53091). This commenter stated that publishing the post-TDAPA add-on payment adjustment amount for that drug later, such that data from the third and fourth quarter of 2025 could be included in the calculation, would be more appropriate as it would reflect more recent data that shows increased utilization compared to the third and fourth quarter of 2024. Specifically, they noted that they believed 2024 utilization for DefenCath® was depressed by several factors, which they stated would result in an undervaluing of the drug for the post-TDAPA add-on payment adjustment. The commenter highlighted that the 2024 data would be two years old by the time the post-TDAPA add-on payment adjustment would begin in quarter 3 2026. While we did not finalize any such changes in the CY 2026 ESRD PPS final rule, we noted that we would evaluate whether additional flexibilities may be warranted in the post-TDAPA add-on payment adjustment calculation.
Since the publication of the CY 2026 ESRD PPS final rule, stakeholders have repeated their concerns with our established post-TDAPA add-on payment adjustment methodology and stated a belief that it undervalued new drugs and biological products. We understand the concerns raised by stakeholders regarding the time delay of the post-TDAPA add-on payment adjustment calculation inherent in calculating the adjustment once per year during rulemaking and we have reevaluated our policy. Although it is important for ESRD facilities to be able to accurately plan for payments, we recognize that rapid changes in price or utilization might not be fully captured by the current methodology.
We propose to modify the post-TDAPA add-on payment adjustment methodology to routinely calculate the post-TDAPA add-on payment adjustment amounts each quarter. This proposed modification would not change the steps for the calculation of the post-TDAPA add-on payment adjustment, insofar as we would still be using the most recent quarter of ASP data and the most recently available full year of utilization data. We are only proposing to perform the calculation more frequently and publish the amounts in CRs quarterly. We acknowledge that, in the past, we have stated that setting the post-TDAPA add-on payment amount once annually would improve ESRD facilities' ability to estimate payments. However, after further consideration, we believe that setting the post-TDAPA add-on payment amount more frequently would better align the post-TDAPA add-on payment amounts with the actual utilizations and prices of the renal dialysis drugs and biological products. This would allow for the payment amount to consistently be based on the most recently available data, which we believe would address concerns which stakeholders have raised that the post-TDAPA add-on payment adjustment amount was often based on outdated data. Under this proposal, we would still publish the first quarter post-TDAPA add-on payment adjustment amounts annually in the rule. We expect that generally the post-TDAPA add-on payment adjustment amounts would not change drastically throughout the year, which would allow ESRD facilities to
As we are proposing to calculate the post-TDAPA add-on payment adjustment quarterly, we are also proposing to modify the conditional ASP policy such that the post-TDAPA add-on payment adjustment would stop the next quarter after a non-submission of ASP data. This is a change from current policy, in which we would wait until the next rulemaking year to discontinue the post-TDAPA add-on payment adjustment for a drug which failed to report ASP. We note that the amount of time for processing a CR can vary and there are occasionally other factors which create additional lag in the use of claims data, so the time periods utilized in a given quarter could change from year to year. However, we intend to generally aim to include data from two quarters prior. For example, for the third quarter post-TDAPA add-on payment adjustment, which begins July 1 of a year, we would generally include data through December of the prior year, but depending on the year December data may not be available at the time of processing. Under this proposed policy, if an update to the post-TDAPA add-on payment adjustment amount for a given quarter is not operationally feasible for some currently unforeseen reason, the post-TDAPA add-on payment adjustment amount for the prior quarter would continue until such a time when updating it is operationally feasible. CMS intends to include the months from which the post-TDAPA adjustment was calculated, as well as the quarter of ASP we used for the calculation in the CR. We would also note any discontinuations of the post-TDAPA add-on payment adjustment due to failure to submit ASP data.
We are proposing changes to § 413.234(c)(3) to state that the post-TDAPA add-on payment adjustment would be calculated quarterly and that if we stopped receiving ASP data, we would not calculate the post-TDAPA add-on payment adjustment for any subsequent quarter (rather than any subsequent year, as it currently reads). We are also proposing changes to § 413.234(g) to state that we would calculate the post-TDAPA add-on payment adjustment quarterly.
Section 1881(b)(14)(A)(i) of the Act requires the Secretary to implement a payment system under which a single payment is made to a provider of services or a renal dialysis facility for renal dialysis services in lieu of any other payment. Section 1881(b)(14)(B) of the Act defines renal dialysis services, and clause (iii) of such section states that these services include other drugs and biologicals that are furnished to individuals for the treatment of ESRD and for which payment was made separately under this title, and any oral equivalent form of such drug or biological.
As we explained in the CY 2011 ESRD PPS final rule (75 FR 49044), we interpret this provision as including not only injectable drugs and biological products used for the treatment of ESRD (other than ESAs) and any oral form of ESAs, which are included under clause (ii) of section 1881(b)(14)(B) of the Act, but also all oral drugs and biological products used for the treatment of ESRD and furnished under Title XVIII of the Act. We also concluded that, to the extent oral-only drugs or biological products used for the treatment of ESRD do not fall within clause (iii) of section 1881(b)(14)(B) of the Act, such drugs or biological products would fall under clause (iv) of such section, and constitute other items and services used for the treatment of ESRD that are not described in clause (i) of section 1881(b)(14)(B) of the Act.
We finalized and promulgated the payment policies for oral-only renal dialysis service drugs and biological products in the CY 2011 ESRD PPS final rule (75 FR 49038 through 49053), where we defined renal dialysis services at § 413.171 to include other drugs and biological products furnished to individuals for the treatment of ESRD and for which payment was made separately prior to January 1, 2011 under Title XVIII of the Act, including oral-only drugs (75 FR 49044). We further described oral-only drugs as those that have no injectable equivalent or other form of administration (75 FR 49038 through 49039). Although we included oral-only renal dialysis service drugs and biological products in the definition of renal dialysis services in the CY 2011 ESRD PPS final rule (75 FR 49044), we also finalized a policy to delay payment for oral-only renal dialysis service drugs and biological products under the ESRD PPS until January 1, 2014, and codified this delay at § 413.174(f)(6) (75 FR 49042). In the CY 2011 ESRD PPS proposed and final rules (74 FR 49929 and 75 FR 49038, respectively), we noted that the oral-only drugs and biological products that we identified were limited to phosphate binders and calcimimetics, which fall into the bone and mineral metabolism ESRD PPS functional category. We stated that there were certain advantages to delaying the implementation of payment for oral-only drugs and biological products, including allowing ESRD facilities additional time to make operational changes and logistical arrangements to furnish oral-only renal dialysis drugs and biological products to their patients. Accordingly, we codified the delay in payment for oral-only renal dialysis drugs and biological products at § 413.174(f)(6) and specified that payment to an ESRD facility for renal dialysis drugs and biological products with only an oral form will be incorporated into the ESRD PPS payment rate on January 1, 2014. Since oral-only drugs were generally not covered under Medicare Part B at this time, the delay of payment under the ESRD PPS allowed these drugs to continue being paid for under Medicare Part D until inclusion in the ESRD PPS, consistent with CMS's discussion at 75 FR 49052 through 49053.
On January 3, 2013, the American Taxpayer Relief Act of 2012 (ATRA) was enacted. Section 632(b) of ATRA precluded the Secretary from implementing the policy under § 413.174(f)(6) relating to oral-only renal dialysis service drugs and biological products prior to January 1, 2016. Accordingly, in the CY 2014 ESRD PPS final rule (78 FR 72185 through 72186), we delayed payment for oral-only renal dialysis service drugs and biological products under the ESRD PPS until January 1, 2016. We implemented this statutory change through revisions of the effective date at § 413.174(f)(6) from January 1, 2014, to January 1, 2016, as discussed in the applicable final rule. In addition, we changed the date when oral-only renal dialysis service drugs and biological products would be eligible for outlier services under the outlier policy described in § 413.237(a)(1)(iv) from January 1, 2014, to January 1, 2016.
On April 1, 2014, the Protecting Access to Medicare Act of 2014 (PAMA) was enacted. Section 217(a)(1) of PAMA amended section 632(b)(1) of ATRA and precluded the Secretary from implementing the policy under § 413.174(f)(6) relating to oral-only renal dialysis service drugs and biological products prior to January 1, 2024. We implemented this statutory change in the CY 2015 ESRD PPS final rule (79 FR 66262) through revisions by modifying the effective date for providing payment for oral-only renal dialysis service drugs and biological products under the ESRD PPS at § 413.174(f)(6) from January 1, 2016, to January 1, 2024. We also
On December 19, 2014, the Achieving a Better Life Experience Act of 2014 (ABLE) was enacted. Section 204 of ABLE amended section 632(b)(1) of ATRA, as amended by section 217(a)(1) of PAMA, and precluded the Secretary from implementing the policy under § 413.174(f)(6) relating to oral-only renal dialysis service drugs and biological products prior to January 1, 2025. We implemented this statutory change in the CY 2016 ESRD PPS final rule (80 FR 69027 through 69028) by modifying the effective date for providing payment for oral-only renal dialysis service drugs and biological products under the ESRD PPS through revisions at § 413.174(f)(6) from January 1, 2024, to January 1, 2025. We also changed the date in § 413.237(a)(1)(iv) regarding outlier payments for oral-only renal dialysis service drugs made under the ESRD PPS from January 1, 2024, to January 1, 2025.
In addition to delaying implementation of the policy for oral-only renal dialysis service drugs and biological products under the ESRD PPS, discussed previously in this proposed rule, PAMA included section 217(c), which provided that as part of CY 2016 ESRD PPS rulemaking, the Secretary shall establish a process for (1) determining when a product is no longer an oral-only drug; and (2) including new injectable and intravenous products into the ESRD PPS bundled payment. Therefore, in the CY 2016 ESRD PPS final rule (80 FR 69013 through 69027), we finalized a process that allows us to recognize when an oral-only renal dialysis service drug or biological product is no longer oral-only, and a process to include new injectable and intravenous (IV) products into the ESRD PPS bundled payment, and when appropriate, modify the ESRD PPS payment amount to reflect the costs of furnishing that product.
In accordance with section 217(c)(1) of PAMA, we established § 413.234(d), which provides that an oral-only drug is no longer considered oral-only if an injectable or other form of administration of the oral-only drug is approved by FDA (80 FR 69024 through 69027). We defined an oral-only drug at § 413.234(a) to mean a drug or biological with no injectable equivalent or other form of administration other than an oral form.
Additionally, in accordance with section 217(c)(2) of PAMA, we codified the drug designation process at § 413.234(b). In the CY 2016 ESRD PPS final rule (80 FR 69024), we finalized that the drug designation process is dependent upon the ESRD PPS functional categories, consistent with our policy since the implementation of the ESRD PPS in 2011, which we discussed in detail in the CY 2011 ESRD PPS final rule (80 FR 69013 through 69015). We explained that, in the CY 2011 ESRD PPS final rule (75 FR 49044 through 49053), in order to identify drugs and biological products that are used for the treatment of ESRD and therefore meet the definition of renal dialysis services (defined at § 413.171) that would be included in the ESRD PPS base rate, we performed an extensive analysis of Medicare payments for Part B drugs and biological products billed on ESRD claims and evaluated each drug and biological product to identify its category by indication or mode of action. We stated in the CY 2011 ESRD PPS final rule that categorizing drugs and biological products on the basis of drug action allows us to determine which categories (and therefore, the drugs and biological products within the categories) would be considered used for the treatment of ESRD (75 FR 49047).
In the CY 2016 ESRD PPS final rule, we also explained that, in CY 2011 ESRD PPS rulemaking, we grouped the injectable and IV drugs and biological products into ESRD PPS functional categories based on their action (80 FR 69014). This was done for the purpose of adding new drugs or biological products with the same functions to the ESRD PPS bundled payment as expeditiously as possible after the drugs become commercially available so that beneficiaries have access to them. In the CY 2016 ESRD PPS final rule, we finalized the definition of an ESRD PPS functional category at § 413.234(a) as a distinct grouping of drugs or biologicals, as determined by CMS, whose end action effect is the treatment or management of a condition or conditions associated with ESRD (80 FR 69077).
We finalized a policy in the CY 2016 ESRD PPS final rule (80 FR 69017 through 69022) that, effective January 1, 2016, if a new injectable or IV product is used to treat or manage a condition for which there is an ESRD PPS functional category, the new injectable or IV product is considered included in the ESRD PPS bundled payment and no separate payment is available. We stated that the new injectable or IV product qualifies as an outlier service. We further explained that the ESRDB market basket updates the ESRD PPS base rate annually and accounts for price changes of the drugs and biological products reflected in the bundled payment.
We established at § 413.234(b)(2) that, if the new injectable or IV product is used to treat or manage a condition for which there is not an existing ESRD PPS functional category, the new injectable or IV product is not considered included in the ESRD PPS bundled payment and the following steps occur. First, an existing ESRD PPS functional category is revised or a new ESRD PPS functional category is added for the condition that the new injectable or IV product is used to treat or manage. Next, the new injectable or IV product is paid for using the transitional drug add-on payment adjustment (TDAPA) described at § 413.234(c). Finally, the new injectable or IV product is added to the ESRD PPS base rate following payment of the TDAPA.
The TDAPA is a payment adjustment under the ESRD PPS for certain new renal dialysis drugs and biological products, as codified at § 413.234(c). As discussed in the CY 2019 and CY 2020 ESRD PPS final rules, for new renal dialysis drugs and biological products that fall into an existing ESRD PPS functional category, the TDAPA helps ESRD facilities to incorporate new drugs and biological products and make appropriate changes in their businesses to adopt such products. Furthermore, the TDAPA provides additional payments for such associated costs and promotes competition among the products within the ESRD PPS functional categories, while also focusing Medicare resources on products that are innovative (83 FR 56935 and 84 FR 60654, respectively). For new renal dialysis drugs and biological products that do not fall within an existing ESRD PPS functional category, the TDAPA is a pathway toward a potential base rate modification (83 FR 56935).
In the CY 2016 ESRD PPS final rule, we finalized a policy at § 413.234(c) to base the TDAPA on pricing methodologies under section 1847A of the Act and pay the TDAPA until sufficient claims data for rate setting analysis for the new injectable or IV product are available, but not for less
In the CY 2016 ESRD PPS final rule (80 FR 69024 through 69027), CMS also established an exception to the drug designation process for calcimimetics and phosphate binders. We noted that in the CY 2011 ESRD PPS proposed and final rules (74 FR 49929 and 75 FR 49038, respectively), the only oral-only drugs and biological products we identified were phosphate binders and calcimimetics, which fall into the bone and mineral metabolism ESRD PPS functional category. We stated that we defined these oral-only drugs as renal dialysis services in our regulations at § 413.171 (75 FR 49044), delayed the Medicare Part B payment for these oral-only drugs until CY 2014 at § 413.174(f)(6), and continued to pay for them under Medicare Part D. We explained in the CY 2016 ESRD PPS final rule that, under § 413.234(b)(1), if injectable or IV forms of phosphate binders or calcimimetics are approved by FDA, these drugs would be considered reflected in the ESRD PPS bundled payment because these drugs are included in an existing functional category. Therefore, CMS does not make additional payment to ESRD facilities for these drugs.
However, we recognized the uniqueness of these drugs and stated that we will not apply this process to injectable or IV forms of phosphate binders and calcimimetics when they are approved because payment for the oral forms of these drugs was delayed and payment was never included in the ESRD PPS base rate to account for these drugs (80 FR 69025 through 69027). Instead, we finalized a policy that once the injectable or IV phosphate binder or calcimimetic is FDA approved and has a Healthcare Common Procedure Coding System (HCPCS) code, we would issue a CR to pay for all forms of the phosphate binder or calcimimetic using the TDAPA based on the payment methodologies under section 1847A of the Act, which could include average sales price (ASP) + 6 percent (ASP + 6), for a period of at least two years. In the CY 2016 ESRD PPS final rule, we explained that this would allow us to collect data reflecting current utilization of both the oral and injectable or IV forms of the drugs, as well as payment patterns and beneficiary co-insurance, before we add these drugs to the ESRD PPS bundled payment. We stated that during this period we would not pay outlier payments for these drugs. We further stated that at the end of the two or more years, we would adopt the methodology for including the phosphate binders and calcimimetics into the ESRD PPS bundled payment through notice-and-comment rulemaking (80 FR 69025).
In the CY 2019 and 2020 ESRD PPS final rules (83 FR 56927 through 56949 and 84 FR 60653 through 60677, respectively), we revised the drug designation process regulations at § 413.234(a), (b), and (c) to reflect that the process applies to all new renal dialysis drugs and biological products that are FDA approved regardless of the form or route of administration (83 FR 56932). In addition, we revised § 413.234(b) and (c) to expand the TDAPA to all new renal dialysis drugs and biological products, not just those in new ESRD PPS functional categories (83 FR 56942 through 56943). Finally, we revised § 413.234(c) to reflect that the TDAPA would be based on 100 percent of ASP instead of the pricing methodologies available under section 1847A of the Act, which includes ASP + 6. We explained that historically, the six percent add-on to ASP was used to cover administrative and overhead costs. However, the ESRD PPS base rate includes dollars for administrative complexities and overhead costs for drugs and biological products, so we stated that we believe ASP, without + 6, was a reasonable basis for the TDAPA under the ESRD PPS (83 FR 56943 through 56944). In the CY 2020 ESRD PPS final rule, we revised the eligibility criteria for the TDAPA, including defining specific New Drug Application (NDA) categories that are excluded from the TDAPA (84 FR 60659 through 60673).
In 2017, FDA approved an injectable calcimimetic. In accordance with the policy finalized in the CY 2016 ESRD PPS final rule, we issued a CR to implement payment under the ESRD PPS for both the oral and injectable forms of calcimimetics using the TDAPA. CR 10065, Transmittal 1889, issued August 4, 2017, replaced by Transmittal 1999, issued January 10, 2018, implemented the TDAPA for calcimimetics effective January 1, 2018. The TDAPA for calcimimetics was paid at ASP + 6 for the first two years of the TDAPA period (83 FR 56944) and was paid ASP for the third year of the TDAPA period (84 FR 60676). In the CY 2020 ESRD PPS final rule we stated that after the first two years, sufficient time had passed for ESRD facilities to address any administrative complexities and overhead costs that may have arisen related to furnishing calcimimetics (84 FR 60673). We then went through notice-and-comment rulemaking to incorporate calcimimetics into the ESRD PPS base rate beginning January 1, 2021, after the TDAPA payment period ended on December 31, 2020, using the methodology codified at § 413.234(f) (85 FR 71404 through 71410).
In the CY 2025 ESRD PPS final rule, CMS finalized payment for oral phosphate binders under the ESRD PPS using the TDAPA, consistent with § 413.234(c), with incorporation into the ESRD PPS base rate to occur through future rulemaking after sufficient data collection (89 FR 89136 through 89153). This implementation fulfilled existing regulations at § 413.174(f)(6) that required oral-only drugs to be paid for under the ESRD PPS beginning in CY 2025, after multiple legislative delays (ATRA, PAMA, and ABLE) dating back to the original CY 2014 implementation date, as discussed in section II.B.7.a.(1) of this proposed rule.
Since January 1, 2025, oral phosphate binders have been paid under the ESRD PPS through the TDAPA, which is payable under our current regulations for a period of at least two years until sufficient claims data for rate setting analysis for the new renal dialysis drug or biological product is available. The TDAPA amount for phosphate binders currently includes 100 percent of ASP plus a flat rate increase of $36.41 for monthly ESRD PPS claims to cover the operational costs associated with supplying phosphate binders to ESRD facilities. This $36.41 figure was based on 6 percent of per-patient phosphate binder spending based on Part D cost and utilization data from before the beginning of the TDAPA period (89 FR 89148). CMS has stated that we would increase the ESRD PPS base rate to account for the average per-treatment phosphate binder spending, consistent with past policy for similar drugs (calcimimetics), after the end of the TDAPA period for phosphate binders (89 FR 89148).
As we discussed previously, oral phosphate binders have been paid under the ESRD PPS using the TDAPA since January 1, 2025. In the CY 2016 ESRD PPS final rule, CMS discussed that phosphate binders fall into the bone and mineral metabolism ESRD PPS functional category but are not accounted for in the base rate. We stated that we will utilize the TDAPA to collect utilization data before incorporating these drugs into the ESRD PPS base rate (80 FR 69025). We explained that this would allow CMS to collect data reflecting current utilization of oral phosphate binders, as well as payment patterns and beneficiary co-insurance, and after a period of at least two years, we would adopt the methodology for including these drugs in the ESRD PPS bundled payment through notice-and-comment rulemaking. This would be consistent with section 217(a)(2) of PAMA, which requires the Secretary to use data from the most recent year available when establishing payment for oral-only drugs under the ESRD PPS.
We have collected sufficient claims data to conduct a rate-setting analysis for phosphate binders. Specifically, we have collected robust claims data since January 1, 2025, and analyzed the utilization of various oral phosphate binders, including sevelamer carbonate, sevelamer hydrochloride, sucroferric oxyhydroxide, lanthanum carbonate, ferric citrate, and calcium acetate. We monitored the ASP data available during the specific utilization periods. Our overall analysis of ESRD claims data for CYs 2025 and 2026 indicated utilization patterns across the various phosphate binder formulations, with variations in ASP reflecting the different product types and market dynamics within this therapeutic class.
Therefore, we believe that we are at the step of the ESRD PPS drug designation process (outlined at § 413.234) where we propose the methodology for modifying the ESRD PPS base rate to account for phosphate binders in the ESRD PPS bundled payment for CY 2027. CMS believes that a base rate increase is warranted in the case of phosphate binders because, as discussed in the CY 2011 ESRD PPS final rule, oral-only drugs, which included phosphate binders, were not included in the ESRD PPS at the inception of the bundled payment system (CY 75 FR 49043 through 49044) and currently remain unaccounted for within the ESRD PPS base rate. We propose to add a per-treatment amount to the ESRD PPS base rate to include phosphate binders in the ESRD PPS bundled payment amount for dates of service on or after January 1, 2027.
In developing the proposed methodology for including phosphate binders into the ESRD PPS base rate, we considered the methodology that we used when we incorporated calcimimetics into the ESRD PPS base rate beginning for CY 2021, as well as the methodology we used when we included Part B drugs and biological products in the ESRD PPS base rate as part of our initial implementation of the ESRD PPS. In the CY 2021 ESRD PPS final rule (85 FR 71404 through 71410), we discussed how we established the methodology for incorporating calcimimetics into the ESRD PPS base rate using utilization data from Medicare claims and applying ASP to establish the price for each drug form.
In addition, as discussed in the CY 2011 ESRD PPS final rule (75 FR 49064), we established a dialysis treatment as the unit of payment. Consistent with the approach we used to include calcimimetics in the ESRD PPS base rate and the ESRD PPS unit of payment, we are proposing a similar methodology in this rule to calculate a one-time modification to the ESRD PPS base rate on a per-treatment basis to account for phosphate binders. The proposed methodology is similar to the calcimimetics approach because we would determine utilization of the drugs, in this case, phosphate binders, along with the payment amounts associated with each phosphate binder product based on ASP, consistent with our established TDAPA pricing policy.
The following sections discuss each element of our proposed methodology in detail. As an overview, we propose to calculate a per-treatment amount for phosphate binders that would be added to the ESRD PPS base rate. We would apply 100 percent of the ASP value from the most recent calendar quarter ASP calculations to the utilization data for phosphate binders between April 1, 2025, and December 31, 2025, based on Medicare ESRD claims data. This would provide the phosphate binder expenditure amount. We would then multiply the phosphate binder expenditure amount by 1.06, consistent with the methodology that we used to calculate the flat rate add-on per-monthly claim amount of $36.41 during the TDAPA period, to yield the adjusted phosphate binder expenditure amount. Next, we would divide the adjusted phosphate binder expenditure amount by the total number of hemodialysis-equivalent dialysis treatments paid between April 1, 2025, and December 31, 2025, under the ESRD PPS. We would reduce this average per-treatment amount by one percent to account for the outlier policy, since phosphate binders would be ESRD outlier services eligible for outlier payments beginning January 1, 2027, under this proposal. We propose to add the resulting amount to the ESRD PPS base rate, as discussed in section II.B.4. of this proposed rule. We note that this amount would stay in the base rate and be subject to the annual updates (ESRDB market basket update and application of wage index budget neutrality adjustment factor). Under this proposal, CMS would stop paying for these drugs using the TDAPA for dates of service on or after January 1, 2027.
If finalized, this proposal would complete the implementation of § 413.174(f)(6), which provides that oral-only renal dialysis drugs are paid under the ESRD PPS beginning January 1, 2025, and that separate payment for oral-only phosphate binders is no longer provided beginning January 1, 2025. This proposal, if finalized, would establish the methodology for incorporating phosphate binders into the ESRD PPS base rate following the TDAPA period. We propose revising our drug designation regulation at § 413.234 by adding paragraph (h) to set forth the methodology for modifying the ESRD PPS base rate to account for the costs of phosphate binders. This proposed paragraph (h) would include the data sources and the steps we would take to calculate a per-treatment amount. We propose that, for dates of service on or after January 1, 2027, oral phosphate binders would no longer be paid for under the ESRD PPS using the TDAPA (§ 413.234(c)) and would be paid for through the ESRD PPS base rate and be eligible for outlier payments as ESRD outlier services under § 413.237.
We note that the methodology proposed in this rule is only for modifying the ESRD PPS base rate to include phosphate binder drugs. This is consistent with our established policy for renal dialysis drugs and biological products that are not considered to be included in the ESRD PPS base rate, and as outlined at § 413.234(c) and (d). This policy states that we would propose and adopt the methodology for modifying the ESRD PPS base rate, if appropriate, to account for the products through notice-and-comment rulemaking after sufficient claims data collection through the TDAPA process.
For use in the proposed calculation, we analyzed the utilization of phosphate binders reported on the ESRD facility claims for CY 2025. ESRD facilities report this information to CMS on Medicare ESRD facility claims, that is, the 837-institutional form with bill type 072X. The various phosphate binders are reported using their respective HCPCS codes, including but not limited to codes for sevelamer carbonate, sevelamer hydrochloride, sucroferric oxyhydroxide, lanthanum carbonate, ferric citrate, and calcium acetate. For purposes of this rate-setting analysis, we considered utilization of phosphate binders as the units of the products furnished to an ESRD beneficiary.
For purposes of calculating the proposed addition to the ESRD PPS base rate, we propose to use the latest available claims data with dates of service from April 1, 2025, through December 31, 2025, rather than beginning January 1, 2025. We believe this approach is appropriate because the first quarter of CY 2025 (January 1, 2025, through March 31, 2025) reflects a transitional period during which oral phosphate binders moved from coverage under Medicare Part D to payment under the ESRD PPS as TDAPA-eligible renal dialysis drugs. Utilization patterns during this initial transition period may not be representative of stable, ongoing utilization under the ESRD PPS, as ESRD facilities were in the process of establishing billing, dispensing, and operational workflows for these products. To ensure that our base rate calculation reflects a more accurate and representative picture of phosphate binder utilization and costs under the ESRD PPS, we propose to exclude first quarter 2025 data and begin our reference period on April 1, 2025. We believe this approach would produce a more reliable estimate of the costs that should be incorporated into the ESRD PPS base rate beginning January 1, 2027. We note that claims which have been received, processed, paid, and passed to the National Claims History (NCH)
For the CY 2027 ESRD PPS final rule, we propose to update this calculation with the most recent available claims data, which we anticipate to be claims with dates of service from April 1, 2025 through July 31, 2026 (that is, claims that were received, processed, paid, and passed to the NCH File as of July 2026).
We are soliciting comments on the proposed use of claims data with dates of service from April 1, 2025, through December 31, 2025 to determine the utilization of phosphate binders and our proposal to omit first quarter 2025 claims data for purposes of calculating the proposed addition to the ESRD PPS base rate to account for phosphate binders at the proposed § 413.234(h).
For use in the proposed calculation, we would set the price for phosphate binders using values from the most recent calendar quarter of ASP calculations available to the public, at 100 percent of ASP. This would be consistent with § 413.234(c)(1), which provides that TDAPA payment is based on 100 percent of ASP. The ASP-based value is a CMS-derived weighted average of all National Drug Code (NDC) sales prices submitted by drug manufacturers and assigned by CMS to the existing HCPCS codes for phosphate binders. For each billing code, CMS calculates a weighted ASP using data submitted by manufacturers, which includes the following: ASP data at the 11-digit NDC level, the number of units of the 11-digit NDC sold, and the ASP for those units. This calculation methodology is consistent with the approach described in the CY 2009 Physician Fee Schedule (PFS) final rule (73 FR 69752) and authorized in section 1847A of the Act.
Consistent with the TDAPA basis of payment established for oral phosphate binders in CY 2025, we propose to use 100 percent of the weighted ASP value. As we explained in the CY 2020 ESRD PPS final rule, the ESRD PPS accounts for storage and administration costs and ESRD facilities do not have acquisition price variation issues when compared to physicians (83 FR 56946). We believe ASP is reasonable for phosphate binders because it reflects the average amount that ESRD facilities spend to obtain the phosphate binders. As we discussed earlier in this section of this proposed rule, the ESRD PPS base rate has dollars built in for administrative complexities and overhead costs for renal dialysis drugs and biological products. We are proposing an increase to the base rate to account for the newfound responsibility and substantial pill volume associated with ESRD facility dispensing of phosphate binders, which we discuss in detail later in this proposed rule.
We believe using a value based on the most recent calendar quarter ASP calculations available to the public for phosphate binders would provide an accurate representation of the price of these drugs for ESRD facilities because it uses manufacturer sales information that includes discounts (that is, rebates, volume discounts, prompt payment, and cash payment specified in section 1847A of the Act).
For this proposed rule, the values from the most recent calendar quarter of ASP calculations available to the public are from the second quarter of 2026, and due to a two-quarter data lag, these ASP calculations reflect manufacturer sales data submitted to CMS for the fourth quarter of 2025. For the CY 2027 ESRD PPS final rule, the most recent calendar quarter of ASP calculations available to the public would be the fourth quarter of 2026, which reflects manufacturer sales data submitted into CMS for the second quarter of 2026, and we propose to use that value for purposes of our final calculation.
We propose to add § 413.234(h)(2)(ii), under which CMS would use 100 percent of the values from the most recent calendar quarter ASP calculations available to the public for phosphate binders to calculate a price for each product. We are soliciting comments on the proposed use of the values from the most recent calendar quarter ASP calculations available to the public for phosphate binders for setting the price and the proposed language at § 413.234(h).
To calculate the proposed amount for phosphate binders that would be added to the ESRD PPS base rate, we applied the values from second quarter of 2026 at 100 percent of ASP. We propose to determine utilization based on the number of units billed during the TDAPA period. For each oral phosphate binder HCPCS code, the short description states what the billing unit is for that drug or biological product and is located in Table 13. Billing units are the standardized quantities used by providers and suppliers when submitting Medicare Part B claims and are specific to each HCPCS code. For example, for sevelamer carbonate billed under J0602, one billing unit equals 20 mg/tablet. We note that billing units differ from revenue units, which are a commercial data construct used to standardize drug volume across dosage strengths for market analysis purposes.
For this proposed rule, we used the values from the most recent calendar quarter ASP calculations available to the public, which is the second quarter of 2026. This information can be found on the ESRD Payment website at
Multiplying the utilization of the oral phosphate binders by their respective ASP and then adding the expenditure amount for all forms of phosphate binders together yield the total calculated phosphate binder expenditure amount. For the period of April 1, 2025 through December 31, 2025, that was evaluated for this proposed rule, CMS calculated the total phosphate binder expenditure amount to be $269,634,395.87. We propose to update this amount in the CY 2027 ESRD PPS final rule using the most recent available data.
In addition to including direct drug costs, we are proposing to incorporate an additional amount in the base rate to reflect the operational costs associated with supplying phosphate binders to ESRD facilities. During the TDAPA period, we provided a flat rate increase of $36.41 for monthly ESRD PPS claims to cover these operational costs, which include storage, distribution, staffing, and administrative expenses unique to the high-volume, multi-product nature of phosphate binder therapy. We expect that the ongoing provision of phosphate binders will continue to result in additional operational costs for ESRD facilities. Incorporating these operational costs into the base rate is consistent with our authority under section 1881(b)(14) of the Act to establish a bundled payment that reflects the costs of furnishing renal dialysis services, as CMS considers phosphate binders to be a renal dialysis service as described at § 413.171.
As discussed earlier in this proposed rule, the ESRD PPS base rate includes general overhead and administrative costs that apply broadly across renal dialysis services. Because of this, CMS did not establish a separate operational cost component for calcimimetics during the TDAPA period for calcimimetics or when calcimimetics were incorporated into the ESRD PPS base rate. However, as discussed in the CY 2025 ESRD PPS final rule, oral phosphate binders present unique, high-volume dispensing and logistical demands that are distinct from and not captured by the general overhead and administrative costs discussed previously (89 FR 89152). For example, in response to the CY 2025 ESRD PPS proposed rule, one interested party commented that phosphate binders represent an exponential increase in the volume of pills that dialysis providers need to acquire, distribute, store, and manage, and that the relative difference between managing 360 pills per year per patient for cinacalcet as compared with 3,240 pills per year per patient for calcium carbonate is 800 percent (89 FR 89141). CMS addressed this comment, among many others, in the CY 2025 ESRD PPS final rule, where we established a flat-rate TDAPA add-on of $36.41 per monthly claim to address the circumstances
Based on our analysis of claims data from April 1, 2025, through December 31, 2025, we determined that 711,875 monthly claims included phosphate binders. To account for operational costs in the base rate calculation, we considered two approaches: (1) applying the $36.41 flat rate per monthly claim that was paid during the TDAPA period, and (2) calculating an operational cost component equal to an amount approximately equivalent to 6 percent of observed ASP-based expenditures, derived from empirical TDAPA-period payment data rather than from the statutory ASP + 6 percent methodology under section 1847A of the Act. We emphasize that this proposed approach is not a methodology for pricing phosphate binders; as we discussed earlier, we propose to address the cost of phosphate binders using a weighted average of 100 percent of ASP for each phosphate binder type and dose.
As discussed in the CY 2020 ESRD PPS final rule, we continue to believe that 100 percent of ASP is an appropriate basis for pricing renal dialysis drugs within the ESRD PPS because the bundled payment already incorporates general overhead and administrative costs (83 FR 56943 through 56944). However, oral phosphate binders present unique, high-volume dispensing and logistical demands that were not fully reflected in the historical base rate given that phosphate binders were excluded from the analysis performed for the CY 2011 ESRD PPS final rule (89 FR 89152).
Accordingly, rather than adopting a pricing methodology that includes an add-on to ASP, we propose to use the TDAPA-period data to identify and incorporate a distinct, empirically observed operational cost component into the base rate. Multiplying the 711,875 monthly claims that included phosphate binders by the $36.41 flat rate yields a total operational cost amount of $25,919,368.75 for the reference period. As noted previously in this rule, the $36.41 figure was based on 6 percent of the weighted average of Medicare expenditures for phosphate binders per month under Part D, for all phosphate binders used in a month, based on estimates for CY 2025 phosphate binder utilization using utilization patterns in CY 2023 among Part D eligible beneficiaries (89 FR 89152). Alternatively, applying 6 percent to the total ASP-based drug expenditure for oral phosphate binders during the same period yields a total operational cost amount of $16,178,063.75.
We are proposing to base operational costs associated with furnishing phosphate binders on 6 percent of total ASP-based drug expenditure for oral phosphate binders during the TDAPA period. While the flat rate add-on per-monthly claim amount of $36.41 was administratively straightforward during the TDAPA period, we believe that an operational cost component that scales with drug utilization better reflects the variable, volume-driven nature of phosphate binder dispensing. An operational cost component within the base rate would also be spread across all dialysis treatments, as intended with a PPS, and would ensure that these operational costs are updated annually as part of the ESRD market basket update.
Our analysis indicates that this utilization-based approach yields an amount approximately equivalent to 6 percent of ASP-based expenditures over the reference period.
The total number of paid hemodialysis-equivalent dialysis treatments furnished to Medicare ESRD beneficiaries between April 1, 2025, and December 31, 2025, as mentioned previously, was 17,733,591. This total number of paid treatments reflects all paid dialysis treatments regardless of whether a phosphate binder was furnished.
To calculate the combined per-treatment amount, we add the direct drug expenditure amount ($269,634,395.87) multiplied by 1.06 to account for operational costs ($16,178,063.75) to get an adjusted phosphate binder expenditure amount of $285,812,459.62. Dividing this adjusted expenditure amount by the total number of paid hemodialysis-equivalent dialysis treatments (17,733,591) provides an average per-treatment payment amount of $16.12.
We propose to reduce this amount by 1 percent to account for the outlier policy, consistent with the ESRD outlier policy at § 413.237(a)(1)(iv), which provides for budget neutrality adjustments associated with outlier payments, to get a total of $15.96 ($16.12 × 0.99 = $15.96). Under our proposal, we would apply this 1 percent reduction before increasing the base rate to account for outlier payments that would be paid beginning January 1, 2027, for oral phosphate binders since they would become eligible ESRD outlier services once the TDAPA period ends.
To determine the estimated costs in CY 2027, we would inflate the outlier-adjusted average per-treatment payment amount for phosphate binders ($15.96) to 2027 using the proposed CY 2027 ESRD PPS base rate update. As discussed in section II.B.4. of this proposed rule, the proposed CY 2027 ESRD PPS base rate is $299.55. This amount reflects a proposed CY 2027 wage index budget-neutrality adjustment factor of 1.00267, a proposed budget neutrality factor of 0.98783 for the budget neutral policies proposed in sections II.B.8., II.B.9., and II.B.10. of this proposed rule, a proposed base rate addition of $15.96 to include phosphate binders (including both direct drug costs and operational expenses), and the proposed CY 2027 ESRDB payment rate update of 1.6 percent. We believe that using the annual payment rate update would effectively update the prices set for phosphate binders from CY 2026 to CY 2027 because this is consistent with how the other components of the base rate are updated for inflation each year, which includes drugs. We note that in
We propose to add a new paragraph § 413.234(h) regarding the data sources and methodology for modifying the ESRD PPS base rate to account for the costs of phosphate binders and the operational expenses associated with providing oral phosphate binders in the ESRD PPS bundled payment. This new paragraph would state that, for dates of service on or after January 1, 2027, CMS would determine the utilization of phosphate binders by aggregating total units from Medicare ESRD facility claims (837-institutional form with bill type 072X) for the second, third, and fourth quarters of calendar year 2025 and the first two quarters of calendar year 2026. CMS would price each phosphate binder at 100 percent of the most recent calendar quarter ASP calculations available to the public. CMS would then multiply the utilization of each phosphate binder by its respective price and sum the expenditure amounts across all phosphate binder products to calculate the total oral phosphate binder expenditure amount. CMS would then calculate an adjusted phosphate binder expenditure amount by multiplying the phosphate binder expenditure amount by 1.06 to account for operational expenses. CMS would divide the adjusted total expenditure amount by the total number of paid hemodialysis-equivalent dialysis treatments from Medicare ESRD facility claims during the same claims data period to calculate the average per-treatment payment amount. Finally, CMS would reduce the average per-treatment payment amount by 1 percent to account for the outlier policy under § 413.237 to determine the amount added to the ESRD PPS base rate.
Beginning January 1, 2027, phosphate binders would also be eligible ESRD outlier services under § 413.237. The fundamental principle of the ESRD PPS is that the costs of renal dialysis services, including drugs, are incorporated into the base rate and spread across all dialysis treatments rather than assigned only to those treatments for which a particular item or service is furnished (75 FR 49030). In keeping with this principle, we believe the cost of phosphate binders should be spread across all dialysis treatments rather than be directed only to the treatments for patients who are receiving phosphate binders.
We are soliciting comment on the proposed revisions to add paragraph (h) to § 413.234 to establish the data sources and methodology for modifying the ESRD PPS base rate to account for phosphate binders in the ESRD PPS bundled payment.
Section 1881(b)(14)(D)(iii) of the Act provides that the ESRD PPS shall include a payment adjustment that reflects the extent to which costs incurred by low-volume facilities (as defined by the Secretary) in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services, and for payment for renal dialysis services furnished on or after January 1, 2011, and before January 1, 2014, such payment adjustment shall not be less than 10 percent. Therefore, the ESRD PPS provides a facility-level payment adjustment to ESRD facilities that meet the definition of a low-volume facility.
Under § 413.232(b), a low-volume facility is an ESRD facility that, based on the submitted documentation: (1) furnished less than 4,000 treatments in each of the 3 cost reporting years (based on as-filed or final settled 12-consecutive month costs reports, whichever is most recent, except as specified in paragraphs (g)(4) and (5) preceding the payment year; and (2) has not opened, closed, or received a new provider number due to a change in ownership (except where the change in ownership results in a change in facility type or as specified in paragraph (g)(6)) in the 3 cost reporting years (based on as-filed or final settled 12-consecutive month cost reports, whichever is most recent) preceding the payment year.
In addition, under § 413.232(c), for purposes of determining eligibility for the LVPA, the number of treatments considered furnished by the ESRD facility equals the aggregate number of treatments furnished by the ESRD facility and the number of treatments furnished by other ESRD facilities that are both under common ownership with, and 5 road miles or less from, the ESRD facility in question. To receive the LVPA, an ESRD facility must submit a written attestation statement to its MAC confirming that it meets the requirements as specified in § 413.232 and qualifies as a low-volume ESRD facility. For purposes of determining eligibility for the LVPA, “treatments” mean total hemodialysis equivalent treatments (Medicare and non-Medicare). For PD patients, one week of PD is considered equivalent to three HD treatments (80 FR 68994). Section 413.232(e) generally imposes a yearly November 1 deadline for attestation submissions, unless extraordinary circumstances justify an exception, and specifies exceptions for certain years where the deadline is in December or January. The November 1 attestation timeframe provides 60 days for a MAC to verify that an ESRD facility meets the LVPA eligibility criteria (76 FR 70236). The ESRD facility would then receive the LVPA for all the Medicare-eligible treatments in the payment year. Once an ESRD facility is determined to be eligible for the LVPA, a payment adjustment factor is applied to the ESRD PPS base rate for all applicable treatments furnished by the ESRD facility (89 FR 89161).
In the CY 2011 ESRD PPS final rule (75 FR 49118 through 49125), we finalized the methodology used to target the appropriate population of ESRD facilities that were low-volume facilities based on a treatment threshold. After consideration of public comments, we originally established an 18.9 percent adjustment for ESRD facilities that furnish less than 4,000 treatments annually and indicated that this increase to the base rate would encourage small ESRD facilities to continue providing access to care.
In the CY 2016 ESRD PPS proposed rule (80 FR 37819), we analyzed ESRD facilities that met the definition of a low-volume facility under § 413.232(b) as part of the updated regression analysis and found that these ESRD facilities still had higher costs compared to other ESRD facilities. A regression analysis of low-volume facility claims from CYs 2012 and 2013 and cost report data indicated a multiplier of 1.239; therefore, we proposed an updated LVPA adjustment factor of 23.9 percent in the CY 2016 ESRD PPS proposed rule (80 FR 37819) and finalized this policy in the CY 2016 ESRD PPS final rule (80 FR 69001). This update was implemented budget neutrally alongside numerous other changes to the case-mix and facility-level adjusters.
In the CY 2021 ESRD PPS final rule (85 FR 71443), we finalized a policy to allow ESRD facilities flexibility for LVPA eligibility due to the COVID-19 Public Health Emergency (PHE). Under § 413.232(g)(4), for purposes of determining ESRD facilities' eligibility for payment years 2021, 2022, and 2023, we only considered total dialysis treatments for any 6 months of their cost-reporting period ending in 2020. In the CY 2024 ESRD PPS final rule (88 FR
In the CY 2025 ESRD PPS final rule (89 FR 89153 through 89162) we finalized a 2-tiered system for the LVPA. This system provided higher payment for ESRD facilities which furnished a median of fewer than 3,000 treatments over the past three years, and a lower amount for those which furnished a median treatment amount between 3,000 and 4,000 treatments. ESRD facilities in the first tier receive a 28.9 percent LVPA, and ESRD facilities in the second tier receive an 18.3 percent LVPA. We did not propose any changes to the LVPA criteria in that rule, as we stated the purpose of that policy was not to expand the LVPA to new ESRD facilities. We implemented this change budget neutrally by scaling the factors down to maintain the total level of LVPA payments at the same amount. In that rule, we noted that we believed this scheme of budget neutrality was more appropriate because it contained the changes within the LVPA (89 FR 89159). In CY 2025, 342 ESRD facilities received the LVPA.
As discussed in the CY 2025 ESRD PPS final rule, CMS received longstanding input from stakeholders, including MedPAC and the Government Accountability Office (GAO),
Additionally, at that time, CMS considered several changes to the LVPA eligibility criteria to address the concerns that interested parties, including the GAO and MedPAC, raised about targeting LVPA payments to ESRD facilities that are necessary to protect access to care and are not located near other ESRD facilities. Specifically, these interested parties requested that we take into consideration the geographic isolation of an ESRD facility within the LVPA methodology. CMS considered incorporating geographic isolation into the LVPA. However, section 1881(b)(14)(D)(iii) of the Act requires that the LVPA reflect the extent to which costs incurred by low-volume facilities (as defined by the Secretary) in furnishing renal dialysis services exceed the costs incurred by other facilities in furnishing such services. CMS analysis did not find that isolated low-volume facilities incur higher costs than other low-volume facilities. Therefore, incorporating a metric for geographic isolation, for example distance to next nearest ESRD facility or number of ESRD facilities in a geographic area, into the LVPA would not align with statutory requirements.
CMS is evaluating alternative approaches under section 1881(b)(14)(D)(iv) of the Act. Currently, we are analyzing claims and cost data regarding dialysis treatment levels and cost to inform options for potentially tailoring our methodology to meet the requirements of the statute, while simultaneously collecting additional data on geographic isolation of ESRD facilities. The ESRD PPS has separate facility-level payment adjustments for low-volume facilities, as set forth in 42 CFR 413.232, facilities in rural areas, as set forth in § 413.233(a), and facilities in certain non-contiguous areas, as set forth in § 413.233(b). To avoid overlapping with these existing facility-level adjustments, we are analyzing the impact of potentially creating a new payment adjustment and considering innovative methodological options, such as the local dialysis need methodology on which we requested information in the CY 2024 ESRD PPS proposed rule (88 FR 42441 through 42445).
Interested parties have also indicated that LVPA eligibility criteria and the attestation process may be administratively burdensome, particularly for small ESRD facilities (85 FR 71442) and believe it may discourage participation by small ESRD facilities with limited resources that would otherwise qualify for the LVPA.
As a part of our ongoing efforts to improve the LVPA, we have requested information on improvements to the LVPA in several instances.
CMS's contractor has held three Technical Expert Panels (TEPs) to discuss potential refinements to the ESRD PPS.
In the CY 2022 ESRD PPS proposed rule LVPA RFI, we sought input on alternative approaches to the LVPA methodology (86 FR 36398 through 36399). Specifically, we requested input on: (1) whether a distinction other than census tract information should be considered; and (2) what criteria should be used to determine the threshold(s) of adjusted latent demand (in treatment counts) which determine LVPA eligibility. Additionally, we explored the LVI adjustment that MedPAC recommended in its June 2020 report to Congress. Under the LVI methodology, a determination that a facility is low volume and isolated would be based on that facility's distance from the nearest facility and its total treatment volume. Regarding the LVI methodology, we requested input on the concerns for facilities that would lose the LVPA under the LVI methodology and the potential for gaming within the LVI methodology. In addition, we requested input regarding the extent that the LVI methodology captures more isolated (and most often rural) facilities, and whether a separate rural facility adjustment should be maintained. As previously discussed, our most recent analysis of cost report data does not support the claim that isolated low-volume ESRD facilities face higher costs than non-isolated ESRD facilities; therefore, the LVI methodology would not adhere to the statutory requirement for the LVPA set forth at section 1881(b)(14)(D)(iii) of the Act.
In the CY 2024 ESRD PPS proposed rule (88 FR 42430 through 42544), we issued an RFI regarding several possible modifications to the current LVPA methodology. We provided the option of maintaining a single LVPA threshold, establishing LVPA tiers, or utilizing a continuous function to commenters. Specifically, we presented four different tiered structures for the LVPA, all of which would expand the LVPA beyond the current threshold of 4,000 treatments per year. These four structures were presented as budget neutral, with two involving a reduction to the base rate and two involving “scaling” down the factors to maintain total LVPA payments.
We received 23 comments in response to the RFI, all of which had differing opinions. Most commenters expressed support for some type of a tiered LVPA, although some commenters expressed further concerns or opposition to such a policy. A coalition of dialysis organizations recommended a 2-tiered approach, while MedPAC reiterated their support for an LVI adjustment. A common theme among a handful of comments was concern about administrative burden and transparency regarding the methodology that is chosen. Most commenters believed that the issue of payment cliffs is substantial, but many did not believe any of the options presented in the RFI could successfully eliminate gaming completely. Several commenters expressed concern with LVPA changes that would impact the base rate. A full summary of responses to the RFI can be found at
Informed by the comments on the CY 2024 LVPA RFI, we proposed a simpler, 2-tier methodology in the CY 2025 ESRD PPS proposed rule (89 FR 55797 through 55804) which did not expand the LVPA beyond the current treatment volume cap of 4,000 treatments per year. One reason why we proposed that option was to maintain the impact of the budget neutrality of that proposal within the LVPA without reducing the base rate. We noted that expanding the LVPA beyond 4,000 treatments would result in the adjustment factor being notably reduced for facilities with fewer than 4,000 treatments, and particularly facilities with fewer than 3,000 treatments (89 FR 55801). When we finalized this 2-tier methodology in the CY 2025 ESRD PPS final rule, some commenters highlighted that while it would reduce the impact of payment cliffs, it would not completely remove them (89 FR 89158 through 89161).
We requested further information in the CY 2025 ESRD PPS proposed rule (89 FR 55803 through 55803) on potential further improvements to the LVPA. These questions focused on administrative processes regarding the LVPA, specifically the attestation process. We did not receive any substantive responses to many of these questions (89 FR 89162).
CMS routinely evaluates payment adequacy under the ESRD PPS. While we often use outside information, such as public comment letters and MedPAC reports, we also conduct our own analysis of ESRD facility costs and ESRD PPS payments. While the ESRD PPS is not a cost-based system, analyses of Medicare- allowable ESRD facility costs provide insight into whether payments align with resource use. Additionally, the ESRD PPS has a long history of establishing payment adjustment factors based on cost data (occasionally combined with claims data), including the current 2-tiered LVPA (89 FR 89156) and most case-mix adjustment factors, such as adult age and onset of dialysis (80 FR 68973 through 68974 and 68984 through 68994).
CMS analyzed cost report and claims data from 2022 through 2024 to evaluate the ratio of payments to average costs for ESRD facilities. We note that directly comparing ESRD PPS payments to ESRD facility costs is not a perfect analysis as it disregards other payors, including Medicare Advantage (MA) and private payors, which could be providing higher payments for specific high-cost services. Nonetheless, this analysis indicates that payments exceed costs for higher volume ESRD facilities, while lower-volume ESRD facilities, particularly those furnishing fewer than 10,000 treatments tend to have costs that exceed payments. Notably, ESRD facilities furnishing between 4,000 and 10,000 treatments exhibit costs that exceed payments, suggesting that cost differentials extend beyond the current LVPA threshold of 4,000 treatments.
Informed by this 2022-2024 cost to payment analysis, we conducted a further analysis to account for the ESRD PPS wage index methodology finalized in the CY 2025 ESRD PPS final rule (89 FR 89097 through 89116) and discussed in section II.B.2. of this proposed rule, as this policy significantly changed relative payments by geographic area. We conducted an additional analysis using available CY 2025 ESRD PPS payments instead, to capture these changes, and compared it to CY 2024 costs projected to CY 2025. We removed the TDAPA amounts from the CY 2025 payments used for this analysis as the TDAPA amounts for phosphate binders represented significant payments in CY 2025 which were not present in the CY 2024 costs to which we are comparing. To account for the fact that, due to the
We note that the previously described analysis should not be interpreted directly in the terms of payment adequacy for several reasons. First, the ESRD PPS is not a cost-based system, and we do not make payments based on costs. Consistent with section 1881(b)(14)(A) and 1881(b)(14)(F) of the Act, the ESRD PPS payment amount is based on 98 percent of what would have been paid in 2011 had the ESRD PPS not been implemented, annually updated by an ESRDB market basket update factor. Furthermore, as discussed previously, we had to make several adjustments to both costs and payments for this analysis, which makes these results less directly applicable to actual costs and payments, although we believe they are a reasonable proxy for our purposes here. Lastly, ESRD facility cost reports include costs for payors other than Original Medicare (OM), which may be higher for several reasons. We note that we are not proposing to base any changes to the LVPA on this analysis, however, this analysis has helped CMS identify ESRD facilities which may be receiving relative payments lower than their resource use and has informed the analysis presented in section II.B.8.c. of this proposed rule. Specifically, this analysis has led us to reconsider our current LVPA policy to evaluate whether expansion of the LVPA beyond 4,000 treatments would better align payment with resource use.
We have also reviewed the patterns of ESRD facility closures over the past few years and have found evidence that ESRD facilities which have closed are disproportionately small. While we believe that the LVPA tier changes finalized in the CY 2025 ESRD PPS final rule help address this issue, by scaling the factors to keep the effect of the policy within the LVPA and maintain budget neutrality, the LVPA factor for ESRD facilities which furnish fewer than 3,000 treatments is not as large as it would be if we had not scaled the factors. Our payment to cost analysis indicates that these 3,000-treatments-and-fewer ESRD facilities have costs which exceed their payments.
To estimate cost differences across treatment volumes, CMS conducted a regression analysis using facility-level cost report data from 2022 through 2024. The dependent variable was cost per treatment, and the primary independent variable was facility size. The regression analysis was conducted at the facility level and controlled for the following characteristics: year, ownership, wage index, rurality, region, Medicare percent, home dialysis percent, pediatric share, and average non-LVPA payment adjustment multiplier.
Facility size was specified using the natural logarithm for total treatments and included both linear and quadratic (squared) terms. This specification is intended to estimate cost differences while reducing the influence of extreme values and capturing non-linear effects. Cost estimations associated with size as the natural logarithm makes the scale of comparison smaller, which makes the results less subject to variance of high volume facilities, and including a quadratic term allows us to capture more than just a linear relationship, which is preferable in this instance as we think the marginal cost-per-treatment difference of an additional treatment is likely different between low and high volume facilities.
CMS then calculated the predicted costs at the upper bound of each tier using the mean values for continuous variables and composite values for categorical variables wherein the value for the categorical variable was the proportion of the overall population of ESRD facilities which belong to that category. For example, if 10 percent of ESRD facilities are in rural areas, the value used for the rural term when determining the proxy would be 0.1. This allowed us to create a proxy
The updated adjustment factors in Table 15 are derived from the regression by taking the ratio of the exponentiated outcome for the tier with the exponentiated outcome of the comparison value. That is, we calculated the proxy value for the tier and the comparison value, applied the exponential function for each, and then divided the proxy value for the tier by the comparison value. For example, the proxy per-treatment cost for a facility with 8,000 treatments in our analysis is $317.77 and the proxy per-treatment cost for a facility with the median non-LVPA treatment count of 10,332 is $302.77. We calculated the adjustment factor for the 7,000-7,999-treatment tier by dividing $317.77 by $304.77 which equals 1.050.
We note that using these factors in the LVPA would increase payments to current LVPA facilities (those furnishing fewer than 4,000 treatments for each of the past 3 cost reporting years) by approximately $17 million and increase payment to facilities not currently eligible for the LVPA by approximately $67 million. These estimated impacts include the proposed extension of the LVPA to pediatric patients discussed in section II.B.9. of this proposed rule. These proposed increased adjustment factors, if finalized, would bring relative payments under the ESRD PPS more in line with relative costs, as demonstrated by our cost-to-payment analysis discussed in the prior section. We note that we are proposing both policies as budget neutral by reducing the ESRD PPS base rate by a budget neutrality factor, as noted in section II.B.4. of this proposed rule.
Section 1881(b)(14)(D)(iii) of the Act provides that the ESRD PPS shall include a payment adjustment that reflects the extent to which costs incurred by low-volume facilities (as defined by the Secretary) exceed the costs incurred by other facilities. Under this authority, CMS proposes to revise the definition of a low-volume facility for purposes of § 413.232 to reflect updated empirical findings demonstrating higher costs among facilities furnishing fewer than 8,000 treatments annually, when controlling for various factors including geographic area, wage index, and average case-mix adjustment factor. This proposal is intended to better align ESRD PPS payments with the observed differences in resource use and support access to care.
As noted in the CY 2016 ESRD PPS final rule (80 FR 68967 through 69077), we aim to target the benefit of the LVPA to facilities that serve the access needs of patients in remote locations. CMS analysis indicates higher costs among facilities furnishing between 4,000 and 8,000 treatments per year. Proposing a revised methodology that would increase payment to these ESRD facilities would help protect access to care for ESRD services in areas served by these ESRD facilities. Additionally, we believe that additional tiers would further reduce the incentive for gaming, as the GAO described in its 2013 report.
For CY 2027 and beyond, CMS proposes to expand LVPA eligibility and implement a tiered structure based on median treatment volume over the prior three years. This expanded eligibility would apply to ESRD facilities that
We propose to apply this policy as budget neutral outside of the LVPA, and, if finalized, we would apply the previously mentioned 0.98898 factor to the ESRD PPS base rate. When we established the 2-tiered LVPA methodology in the CY 2025 ESRD PPS final rule (89 FR 89161), we did not apply a budget neutrality factor for that methodological change. In the CY 2025 ESRD PPS proposed rule, we stated that we were not proposing to apply a budget neutrality factor because we were making changes only to the LVPA and believed at that time it was most appropriate to keep the impact of the policy change contained to ESRD facilities that were receiving the LVPA (89 FR 55801). We stated that the purpose of that change was to better allocate relative payments within the LVPA and it was not our intention at that time to expand the LVPA beyond the facilities currently eligible for the LVPA (89 FR 55802). We also discussed that expanding the LVPA beyond 4,000 treatments while scaling the factors to maintain budget neutrality within the LVPA would reduce payments for the lowest volume facilities in a way which was not in alignment with the goals of the LVPA (89 FR 55801). In contrast, CMS believes applying budget neutrality to the base rate would be appropriate now because this proposal would expand LVPA eligibility beyond currently qualifying facilities (that is, to ESRD facilities that furnish more than 4,000 treatments per year). CMS believes the proposed tiered structure balances stakeholder concerns regarding payment cliffs while maintaining alignment with statutory requirements.
In constructing this proposal, we carefully considered the responses to the CY 2024 RFI on the LVPA.
In the CY 2024 RFI, we included two potential LVPA structures which both included up to 8,000 treatments per year, but these were 4-tiered and 8-tiered structures. Some respondents opposed the 8-tier LVPA presented in that RFI, with several raising concerns with the budget neutrality factor and others stating that the adjustment factors for the lower-volume tiers were too high and the factors for the higher-volume tiers were miniscule. We considered these comments when designing the 6-tier LVPA proposed in this rule. By eliminating the 1,000 and 2,000 treatment tiers, we have mitigated the overall budget neutrality impact of the proposal. Additionally, this reduces concerns related to the high factors associated with these lowest-volume tiers. We disagree with those commenters that the higher-volume tiers' adjustment factors are miniscule. Our analysis indicates that a 5.0 percent increase is warranted for the 7,000 treatment count tier, and although this proposed adjustment factor is lower than others, it would still represent a substantial increase in payments to those facilities. Other commenters who supported the tiered approaches in response to that RFI indicated that higher-volume tiers with lower payment adjustments can serve to prevent facilities that are on the border with the more substantial tiers to exceed the treatment volume threshold in one year and still be eligible for the higher payment adjustment tiers in the next year. Several other commenters raised concerns with the tiered system and indicated a belief that it would not eliminate gaming completely.
We believe that our proposed 6-tier LVPA strikes a balance between appropriately providing higher payment to these higher cost ESRD facilities and addressing the concerns raised by commenters. We believe that the tiered policy finalized in the CY 2025 ESRD PPS final rule (89 FR 89161) which uses the median treatment volume from the past three years helps to effectively reduce gaming by eliminating the incentive to lower treatment volume in any single year. We believe that our proposal to have 3,000 treatments be the lowest-volume treatment tier also prevents any concerns related to the high adjustment factors associated with potential lower-volume tiers and reduces budget neutrality concerns. We believe that the higher tiers from 6,000 to 7,999 treatments serve to act as a sort of transition phase allowing facilities to exceed the lower treatment tiers, while still receiving a data-supported payment adjustment. Lastly, these proposed payment tiers are evidence-based as they are derived from the analysis described previously to more fully represent the extent to which these low-volume facilities truly face higher costs.
To effectuate this change, we are proposing modifications to our LVPA regulation at § 413.232 to update the current maximum LVPA threshold of 4,000 treatments to the proposed new threshold of 8,000 treatments. Specifically, we are proposing modifications to § 413.232(b)(1), which contains the treatment volume threshold for the LVPA, and (g)(5), which notes the exceptions to the treatment volume threshold for disasters and other emergencies finalized in the CY 2024 ESRD PPS final rule, to indicate the new treatment threshold of 8,000. We are proposing to update the threshold for the exception to the treatment volume threshold for disasters and other emergencies to ensure consistency with the threshold of § 413.232(b)(1). We note that these proposed modifications would retain the requirements that an ESRD facility be below the treatment volume threshold in each of the prior three cost reporting years, and that the median treatment volume over the past three cost reporting years would only be used for tier determination for eligible ESRD facilities.
We are proposing this policy change be effective January 1, 2027. However, we recognize that the LVPA requires an attestation process with which many ESRD facilities that furnish more than 4,000 treatments per year are likely unfamiliar. We are soliciting comments on how we can accommodate these facilities to allow them to properly attest for the LVPA for CY 2027, including delaying the effective date of this proposal or allowing attestations after the typical November 1, 2026, deadline. We note that changes to the attestation deadline would require a modification to § 413.232(e), likely in the form of adding a new paragraph. We are not proposing any of these changes, but we note that we may finalize them, or other changes to address any administrative challenges associated with this proposal in the CY 2027 ESRD PPS final rule, depending on comments we receive.
We request comments on all aspects of this proposal, including the proposed expansion of the LVPA above 4,000 treatments per year, the proposal to extend the LVPA to ESRD facilities which furnish fewer than 8,000 treatments per year, the proposed 6-tiered structure and adjustment factors presented in Table 16, the proposed budget neutrality factor, the proposed effective date of January 1, 2027, and the proposed modifications to § 413.232. Additionally, we are requesting comments on the potential administrative challenges associated with this proposed change and the potential solutions discussed previously.
Section 1881(b)(14)(D)(iv)(I) of the Act provides that the ESRD PPS may include such payment adjustments as the Secretary determines appropriate, including a payment adjustment for pediatric providers of services and renal dialysis facilities. Historically, determining an appropriate payment adjustment for pediatric ESRD patients
In the past, CMS has considered various payment adjustments for pediatric patients with ESRD, including different Medicare payments by sex or comorbidities (74 FR 49984 through 49986). However, many of these adjustments were not used as we were unable to get acceptable precision due to the small sample size of pediatric patients with ESRD.
Prior to the establishment of the ESRD PPS, payment for pediatric ESRD renal dialysis services was generally the same rate as adult ESRD renal dialysis services, unless the ESRD facility qualified for an exception to the composite rate. Section 1881(b)(7) of the Act stated that, subject to section 422(a)(2) of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (Pub. L. 106-554) (BIPA), the Secretary shall provide for exceptions as may be warranted by unusual circumstances (including the special circumstances of sole facilities located in isolated, rural areas and of pediatric facilities). During this time, CMS received many comments and concerns regarding the payment rate for renal dialysis services furnished to pediatric patients with ESRD. Section 623(b) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108-173) later amended section 422(a)(2) of BIPA to provide that any pediatric ESRD facility would be eligible for an exception to the composite rate, effective October 1, 2002. This statute defined pediatric ESRD facilities as facilities with at least 50 percent patients under the age of 18. These policies enabled pediatric ESRD facilities to receive payments recognizing the higher cost associated with furnishing renal dialysis services to pediatric ESRD patients (69 FR 47530).
We finalized a basic case-mix adjustment to the composite payment rate in the CY 2005 Physician Fee Schedule (PFS) final rule published on November 15, 2004 (69 FR 66327). This included a 62 percent pediatric ESRD payment increase (that is, an adjustment factor of 1.62) applied to the composite payment rate per treatment for any facility when furnishing outpatient renal dialysis services to pediatric patients with ESRD. This factor was derived from the average exception amounts for 20 ESRD facilities that had received exceptions for pediatric patients. This was intended to be a temporary measure, which would be eliminated once we developed the case-mix methodology that would apply for the ESRD PPS bundled payment. The use of this methodology allowed CMS to provide additional payment for the pediatric ESRD population under the composite rate in a data-driven manner to account for the higher costs pediatric ESRD patients faced (69 FR 66327).
Section 153(b) of MIPPA added section 1881(b)(14) of the Act, which required CMS to implement an ESRD
The CY 2011 ESRD PPS proposed rule then calculated an “expanded bundle” factor, which combined the composite rate factor of 1.199 and the separately billable factors for each of the eight groups (74 FR 44987). These expanded bundle factors were the proposed pediatric ESRD patient-specific case- mix adjustment factors that would be applied to the base rate under the ESRD PPS. These factors were based on a regression of costs for all renal dialysis services furnished to pediatric ESRD patients. Comments on this proposed rule indicated that many interested parties believed the expanded bundle factor was insufficient (75 FR 49128). In the CY 2011 ESRD PPS final rule, we responded to those comments by implementing the first iteration of the current four-group system for both the expanded bundle and the separately billable services. This methodology was data driven, but unlike the simple regression for composite rate costs, allowed for different Medicare payment amounts based on two sets of two characteristics: age of the patient (under 13 or 13 to 17) and modality of the treatment (HD or PD). Additionally, this methodology used the same groups for the expanded bundle and separately billable factors (75 FR 49134). We codified the pediatric ESRD patient payment adjustment in § 413.235(b), which states that CMS adjusts the per treatment base rate for pediatric ESRD patients in accordance with section 1881(b)(14)(D)(iv)(I) of the Act, to account for patient age and treatment modality. These multipliers were updated in the CY 2016 ESRD PPS final rule using the same methodology (80 FR 69001 through 69002).
As discussed in the CY 2024 ESRD PPS final rule (88 FR 76375), despite these changes intended to improve payment accuracy for renal dialysis services furnished to pediatric ESRD patients, CMS continued to receive comments and concerns from interested parties that payment amounts for renal dialysis services furnished to pediatric ESRD patients are insufficient. In addition to comments received through the annual ESRD PPS rulemaking, we also solicited comments from interested parties on several occasions. During the TEP of December 2020, we queried a panel of experts on how to improve payment for pediatric dialysis care under the ESRD PPS. Panelists generally preferred creating more refined case-mix adjusters over creating an entirely new pediatric ESRD PPS, citing the costs of creating an entirely new system both on CMS and the ESRD facilities and the need for new legislation to be able to increase payment through a separate pediatric ESRD PPS. Panelists also pointed to labor costs as a major reason for higher costs among pediatric dialysis clinics because these patients need more nursing attention and specialized pediatric nutritionists.
We explained that CMS sought to improve payment accuracy for renal dialysis services furnished to pediatric ESRD patients by better aligning payments with observed costs. Ensuring Medicare payments are appropriate and align costs for renal dialysis services furnished to pediatric ESRD patients would support more ESRD facilities in providing quality care to this vulnerable population. The main barrier to aligning payment has been the lack of sufficient data to determine the relative costs associated with furnishing renal dialysis services to pediatric ESRD patients. To improve payment rate accuracy for pediatric ESRD patients, CMS issued changes to the cost reports for hospital-based and freestanding ESRD facilities effective October 1, 2022, and January 1, 2023, respectively (87 FR 26760).
Nevertheless, accurate payment for pediatric ESRD dialysis under the ESRD PPS remains challenging due to small sample sizes and systematic differences between pediatric and adult renal dialysis services. Pediatric dialysis treatments often occur in hospitals which have lower volumes and higher costs. This complicates cost estimation. To address these challenges, we conducted an alternative analysis which used propensity score matching (PSM) to estimate costs accurately. Findings presented in the CY 2024 ESRD PPS final rule indicated facilities that only serve pediatric ESRD patients incur 40 percent higher costs per patient than those not serving pediatric patients (88 FR 76376). Medicare accounted for the current adjustments for higher pediatric costs from established case-mix adjusters, which were about 10 percent higher for pediatric dialysis than adults in 2022.
In the CY 2024 ESRD PPS final rule, CMS finalized the Transitional Pediatric ESRD Payment Adjustment (TPEAPA) which increased payments for all pediatric ESRD patients under 18 years of age (88 FR 76344). CMS finalized the budget neutral 30 percent add-on payment adjustment in the CY 2024 ESRD PPS final rule effective January 1, 2024, for CYs 2024 through 2026 (88 FR 76380). CMS finalized the TPEAPA as a time-limited payment adjustment, so we could collect more targeted pediatric data. The time-limited 3-year payment adjustment provided enough time to evaluate data from updates to cost reports specific to pediatric treatments. The TPEAPA is codified at § 413.235(b)(2). Beginning January 1, 2024, the ESRD PPS provided a per-treatment transitional add-on payment adjustment of 30 percent of the per treatment payment amount under § 413.230 for renal dialysis services furnished to Pediatric ESRD Patients, as defined in § 413.171, during calendar years 2024, 2025, and 2026. CMS continued to analyze payment and cost data throughout the implementation of TPEAPA to determine whether to extend the TPEAPA past December 31, 2026, or propose an alternative approach after additional data analysis.
As noted previously, payment accuracy historically has been difficult for pediatric ESRD dialysis because of the small sample size of pediatric ESRD patients receiving renal dialysis services under the ESRD PPS. Pediatric ESRD dialysis treatments differ from adult ESRD dialysis treatments in several crucial ways. For example, pediatric ESRD facilities
To better understand these differences, CMS analyzed cost reports from both freestanding (CMS-265-11) and hospital-based (CMS-2552) facilities for 2023 and 2024 following cost report revisions. We found relatively few freestanding facilities reported unique pediatric staff. Additionally, approximately 30 percent of children's hospitals as defined at 42 CFR 423(d) reported pediatric ESRD nursing staff and 25 percent reported pediatric ESRD staff other than registered nurses on the cost report. For non-children's hospitals these figures were 1 percent and 0.5 percent, respectively.
CMS observed increased reporting of pediatric-specific supply costs in hospital-based ESRD facilities between 2023 and 2024. In 2023, the mean pediatric supply cost per treatment in hospital-based ESRD facilities was $138.23; in 2024, it was $321.22. We note that this increase in pediatric ESRD supply cost per treatment likely reflects increased reporting, rather than increases in pediatric costs of greater than 100 percent. Prior to 2024, the hospital-based (CMS-2552) facilities cost report lacked the specificity to consistently delineate pediatric ESRD supply cost from adult ESRD supply cost. Additionally, CMS provided interested parties with additional guidance on the completion of cost reports to share with children's hospitals that provide renal dialysis services.
Despite continued limitations in pediatric-specific ESRD reporting, CMS observed statistically significant higher costs associated with the furnishing of renal dialysis services to pediatric ESRD patients. As discussed in the following section, an updated regression analysis of composite rate costs found the incremental cost impact of pediatric ESRD treatment share was approximately 33 percent. Specifically, using data from CYs 2022 and 2023, CMS estimates that the difference in total cost per treatment between facilities with no pediatric ESRD treatments and those furnishing exclusively pediatric ESRD treatments is approximately 33 percent.
In the CY 2011 ESRD PPS final rule, we established the pediatric ESRD case-mix adjustments based on two age categories (age <13, 13-17) and two dialysis modalities PD or HD. We used the resulting four case-mix categories as the basis for classifying pediatric ESRD patients (75 FR 49132). The adjustment factors for each of these case-mix categories were based on the product of two factors representing the cost of composite rate services and another representing the costs of formerly separately billable services. Specifically, the formula used the average payment differential between adults and pediatric ESRD patients (P), the average case mix multiplier for adults (C), the ratios for composite rate (W_
The pediatric multipliers were most recently recalculated using this established methodology in the CY 2016 ESRD PPS final rule (80 FR 69002). These multipliers are presented in Table 18.
We explained in the CY ESRD PPS 2011 final rule that to the extent the additional payments currently provided for pediatric ESRD patients under the basic case-mix composite payment system are likely to reflect higher costs for smaller dialysis facilities otherwise qualifying for the low-volume adjustment under the ESRD PPS, application of the low-volume payment adjustment (LVPA) for pediatric ESRD patients would be duplicative. Therefore, the LVPA was only applicable to adult ESRD patients and was not used in calculating the payment rate per treatment for pediatric dialysis patients. Facilities qualifying for the LVPA which treat both adult and pediatric ESRD patients, have only received the LVPA for adult dialysis patients (75 FR 49134).
For this CY 2027 ESRD PPS proposed rule, CMS revised its regression model to evaluate the relationship between cost per treatment and facility characteristics. CMS analyzed a logarithmic regression model using 2022 and 2023 cost report data and controlled for geographical and facility level characteristics (ownership, facility type, rurality, treatment volume, and percentage of home dialysis training treatments) to estimate cost differences based on pediatric share. These results are presented in Table 17.
As shown in Table 17
We propose to update the pediatric ESRD adjustment factors using the calculation established in the CY 2011 ESRD PPS final rule (75 FR 49133). The updated calculation formula is as follows:
As discussed in the previous section, the CY 2011 calculation utilized the estimated separately billable adjustments as well as 4 factors: average payment differential between adults and pediatric ESRD patients (P), the average case mix multiplier for adults (C), the weight for composite rate (W_CR) and the weight for separately billable services (W_SB). We are proposing to update these figures according to the most recent data, as follows. We note that instead of using the average payment differential P, we propose to use the average cost differential between adults and pediatric ESRD patients as derived from our regression model, which we refer to as D. As previously discussed, we conducted an updated regression analysis for the separately billable adjustments using data from CYs 2022 and 2023. These figures are presented in the “Proposed SB Multiplier” column in Table 18. Using the same data, we updated the weights for the CR and SB costs to 0.915 and 0.085, respectively. From CY 2023 claims data, we determined that the average case-mix adjustment factor for adult ESRD beneficiaries is 1.1045. Lastly, as discussed previously, we calculated that the average difference in pediatric to adult ESRD costs is 1.3298 (that is, 32.98 percent).
The CMS regression analysis presented previously in this section, using cost report data with fields for more accurate reporting of pediatric costs from 2022 and 2023, indicates 32.98 percent higher costs incurred in treating pediatric ESRD patients compared to adult ESRD patients. These findings suggest that the 30 percent TPEAPA, which was based on a 40 percent cost differential, is approximately the same order of magnitude with observed cost differentials. The current regression analysis verifies the need for establishing more permanent payment adjustments to account for higher pediatric costs on an ongoing treatment basis.
We propose to update the SB (outlier) and EB (case-mix) multipliers for pediatric patients according to the established methodology as presented in Table 18.
Historically, the ESRD PPS has not applied the LVPA for treatments furnished to pediatric ESRD patients. Section II.B.8. of this proposed rule provides background on the LVPA. In the CY 2011 ESRD PPS final rule, we codified the pediatric ESRD patient payment adjustment in § 413.235(b), which states that CMS adjusts the per treatment base rate for pediatric ESRD patients in accordance with section 1881(b)(14)(D)(iv)(I) of the Act, to account for patient age and treatment modality (75 FR 49134). Additionally, we finalized the elimination of several exceptions including the pediatric facility exception, which allowed for higher payment pediatric ESRD facilities to receive additional payments when costs exceeded payment amounts under the composite rate payment system. In other words, the pediatric facility exceptions terminated for ESRD treatment on or after January 1, 2014 (75 FR 49178). Finally, the LVPA was only applicable to adult ESRD patients and was not directly used in calculating the payment rate per treatment for pediatric dialysis patients. Facilities qualifying for the LVPA that treat both adult and pediatric ESRD patients have only received the LVPA for adult dialysis patients (75 FR 49134). As noted in section II.B.8. of this proposed rule, small ESRD facilities incur higher costs than larger ESRD facilities, in part because they do not benefit from the same economies of scale as many large ESRD facilities. Due to the low incidents of pediatric ESRD patients most pediatric units are small, which makes accounting for higher costs associated with facility size accurately in payments important; however, the small number of pediatric ESRD patients also makes separate analysis on the costs of treating pediatric ESRD patients difficult. As discussed previously, for the CY 2011 ESRD PPS final rule we finalized an alternative methodology which was based on the average payments for pediatric treatments under the composite rate system (75 FR 49132 through 49134), including those exceptions to the composite rate system for high-cost pediatric facilities. The LVPA was only extended to payments for adult patients in ESRD facilities because facilities that primarily treat pediatric ESRD patients are typically small, so the higher pediatric payments from which the methodology in the CY 2011 ESRD PPS final rule derived the pediatric case mix adjusters included any higher costs associated with low volume. As such, we concluded that extending the LVPA to payments for pediatric ESRD patients would be duplicative with the calculation of the pediatric case mix adjusters under the methodology used for the CY 2011 final rule (75 FR 49134). However, for this proposed rule, we included facility size as a separate characteristic in our regression model. As noted in Table 17, the pediatric share is an independent indicator of cost from the size of the facility.
As discussed previously, smaller ESRD facilities experience the greatest financial burden, and our latest analysis finds that this holds for pediatric ESRD facilities and adult ESRD facilities. As shown in Table 17, the natural logarithm of facility size (based on the total volume of treatment counts) is associated with a statistically significant reduction in cost. This means that regardless of a facility's share of pediatric patients, we observe that cost per treatment decreases as the facility's total number of treatments increases and, conversely, the cost per treatment increases as the facility's total number of treatments decreases. Based on this analysis, we believe that expanding the LVPA to include treatments furnished to pediatric ESRD patients would be appropriate.
Therefore, for CY 2027, we propose to revise § 413.232(f) to state that the LVPA is applicable for dialysis treatments furnished to all ESRD patients. As discussed in section II.B.8. of this proposed rule, we are proposing to make budget-neutral changes to the LVPA tier structure and adjustment factors, and we propose that those changes would be applicable to payments for all ESRD patients beginning in CY 2027. We estimate that this change would appropriately increase payments to ESRD facilities that treat a large share of pediatric patients, which our data demonstrates face higher costs due to low volume status in addition to the specific costs associated with treating pediatric ESRD patients. Our analysis of the distributional impacts associated with the proposed LVPA changes and the proposed expansion of the LVPA to pediatric ESRD patients can be found in section II.B.8. of this proposed rule.
Additionally, we note that although the LVPA does not currently apply to pediatric ESRD PPS claims, ESRD facilities that provide renal dialysis to pediatric ESRD beneficiaries are nevertheless permitted to attest to low-volume status and receive the LVPA for any adult ESRD beneficiaries they treat, under current regulation. Among the 32 dedicated children's hospitals furnishing ESRD treatments, two children's hospitals currently receive LVPA payments. Similarly, four of the 52 ESRD facilities that provide most of their treatments to pediatric ESRD patients are also receiving the LVPA for their adult ESRD patients. We believe
We also considered that small pediatric ESRD facilities within larger institutions could be small, high-cost centers specializing in care for pediatric ESRD patients. We recognize that in some cases, common ownership with other ESRD facilities that are located 5 road miles or less from the pediatric ESRD facility could create barriers to LVPA eligibility for some pediatric ESRD facilities. Under § 413.232(c), for purposes of determining eligibility for the LVPA, the number of treatments considered furnished by the ESRD facility equals the aggregate number of treatments furnished by the ESRD facility and the number of treatments furnished by other ESRD facilities that are both under common ownership with, and 5 road miles or less from, the ESRD facility in question. To receive the LVPA, an ESRD facility must submit a written attestation statement to its MAC confirming that it meets the requirements as specified in § 413.232 and qualifies as a low-volume ESRD facility. For purposes of determining eligibility for the LVPA, “treatments” mean total HD equivalent treatments (Medicare and non-Medicare). For PD patients, one week of PD is considered equivalent to three HD treatments (80 FR 68994).
We considered the nature of pediatric ESRD facilities, those ESRD facilities with at least a 50 percent pediatric patient mix, which are uniquely equipped to meet the specialized needs of a small subset of patients that other nearby adult-focused ESRD facilities may not be able to treat, including ESRD facilities under common ownership. We believe it would be appropriate to allow pediatric ESRD facilities to request an exemption from the aggregation of volume for ESRD facilities under common ownership. While we are not proposing a categorical exemption from these regulations, we are proposing that a pediatric ESRD facility that is seeking low-volume status could request an exception from its MAC from the aggregation of treatment volume for ESRD facilities under common ownership at § 413.232(c). To request such an exception, we propose that an ESRD facility would need to submit documentation to the MAC demonstrating that: (1) the ESRD facility is either owned and operated by a Medicare-certified children's hospital under § 412.23(d) or the ESRD facility provides at least 50 percent of its total treatments (Medicare and non-Medicare) to patients who are under the age of 18 and (2) the ESRD facility is under common ownership with an ESRD facility that does not provide at least 50 percent of its total treatments (Medicare and non-Medicare) to patients who are under the age of 18. If approved, the MAC would not consider the treatment volume of the commonly owned ESRD facility when calculating the treatment volume for the excepted ESRD facility. Once approved, the exception would continue for all future years so long as the ESRD facility continues to either be a Medicare-certified children's hospital or provide at least 50 percent of total treatments to patients who are under the age of 18.
The excepted ESRD facility would still have to meet all other requirements for the LVPA, including the treatment volume threshold described at § 413.232(b)(1). As this exception is only for the purposes of the aggregation of volume of commonly owned ESRD facilities, it is possible for an ESRD facility to receive this exception and not be eligible for the LVPA if it furnished 8,000 treatments or more (or 4,000 should the proposal in section II.B.8. of this proposed rule, not be finalized) in one of the past three cost reporting years. The aggregation of volume for ESRD facilities under common ownership would still apply for the excepted ESRD facility and any other commonly owned ESRD facilities within 5 road miles for which an exception has not been approved. An ESRD facility could receive exceptions for multiple commonly owned ESRD facilities, should the requirements for the exception be met for each of them. We are proposing the addition of paragraph § 413.232(g)(7) to effectuate this proposed exception and detail the process for requesting the exception.
We solicit comments on our proposed expansion to apply the LVPA to payments for pediatric patients. We also solicit comments on the proposed exception to the aggregation of volume for ESRD facilities under common ownership, the administrative process required to request such an exception, and whether such an exception is needed. We believe that extending the LVPA to these facilities could alleviate financial pressures. The LVPA is designed to offset the disproportionate costs encountered by low-volume facilities. Expanding its application would help ensure that pediatric ESRD facilities, which typically operate at lower volumes due to the specialized nature of their patient populations, receive essential financial support not fully addressed by current payment adjustments under the ESRD PPS.
As discussed, we are proposing to create an exception process for ESRD facilities that are Medicare-certified children's hospitals or that furnish more than 50 percent of treatments to pediatric ESRD patients. In the proposed new paragraph § 413.232(g)(7), we specify a timeline based on “calendar days,” rather than “days.” We believe that specifying “calendar days” avoids confusion between calendar days, working days, business days, or any other type of day. When we finalized the exceptions for disasters or other emergencies in the CY 2024 ESRD PPS final rule (88 FR 76344), we similarly created a timeline but did not specify the type of “days” despite our intention being calendar days. We are proposing edits to § 413.232(g)(5) and (6) to specify that the timeline for the exceptions is based on calendar days, consistent with the proposed language of § 413.232(g)(7). We are also proposing an edit to § 413.232(g)(6)(iv) to add the word “of” to the first sentence following “30 calendar days,” which was omitted in a typographical error. We solicit comments on these proposed changes, including whether we should finalize such changes even if the exception detailed at the proposed new paragraph (g)(7) is not finalized. We also solicit comments on whether another basis for the timeline, for example business days, would be better for ESRD facilities requesting any of these exceptions.
Under the ESRD PPS, there are three components to payment for home and self-dialysis training: (1) the base rate, (2) a wage-adjusted home and self-dialysis
CMS makes the same training add-on for both HD and PD. We recognize that the costs for home and self-dialysis training for HD and PD are likely not identical, as supported by our analysis of ESRD facility cost report data discussed later in this section. However, the ESRD PPS is a prospective payment system under section 1881(b)(14)(A)(i) of the Act. As such, payments are not intended to reflect the exact costs incurred by individual facilities, but to provide standardized payments that promote efficiency and access.
When the ESRD PPS was implemented in 2011, we proposed that the cost for all home dialysis services would be included in the bundled payment (74 FR 49930), and therefore, the computation of the base rate included home dialysis training add-on payments made to ESRD facilities as well as all composite rate payments, which account for facility costs associated with equipment, supplies, and staffing. In response to public comments, in the CY 2011 ESRD PPS final rule, we noted that although we were continuing to include training payments in computing the ESRD PPS base rate, we agreed with commenters that we should treat training as an adjustment under the ESRD PPS. Accordingly, we finalized the training add-on amount of $33.44 per treatment as an additional payment made under the ESRD PPS when one-on-one home dialysis training is furnished by a nurse for either HD or PD training or retraining (75 FR 49063), updated from the previous adjustment amount of $20. This updated amount of $33.44 per treatment was based on the national average hourly wage for Registered Nurses (RN) as published by the Occupational Employment Statistics (OES) data compiled by BLS data updated to 2011 (75 FR 49063), and reflected 1 hour of training time by a RN for both HD and PD. This average hourly wage was then inflated to 2011 by the ESRD wages and salaries proxy used in the 2008-based ESRD bundled market basket. In addition, we continued the policy of paying the home dialysis training add-on payment for 15 training treatments for PD and 25 training treatments for HD.
Section 494.100(a)(2) of the Conditions for Coverage for ESRD Facilities stipulates that the RN must conduct the home or self-dialysis training, and CMS has clarified through interpretive guidance (ESRD Program Interpretive Guidance published October 3, 2008 (
In the CY 2014 ESRD PPS final rule (78 FR 72185), CMS increased this amount from $33.44 to $50.16 to reflect 1.5 hours of training time by an RN in response to stakeholder concerns regarding payment adequacy. The $50.16 training add-on amount was consistent with average costs based on an analysis of pre-PPS cost report data.
In the CY 2017 ESRD PPS final rule (81 FR 77856), CMS further updated the home and self-dialysis training add-on to $95.60 based on 2.66 hours of RN time using BLS wage data.
In 2025, Medicare paid approximately $7 million in home and self-dialysis training add-on payment adjustment amounts, which remained relatively stable compared to prior years. This relatively flat trend, in conjunction with stakeholder feedback, may indicate that home dialysis and self-dialysis modalities remain underutilized and that payment adequacy for training may be a contributing factor.
When we last updated the training add-on amount in the CY 2017 ESRD PPS final rule (81 FR 77848 through 77856), we stated that we made changes to the freestanding ESRD facility cost reports to allow for better collection of training data, and that we would evaluate improved cost report data once available. We stated that we intended to compare the average cost per home dialysis training treatment for PD and HD to the proxy value, and to assess the extent to which the training add-on reflects ESRD facility costs for home dialysis training on average.
For this proposed rule, we analyzed the data collected on Worksheets B and C on the average home dialysis training cost per training treatment for freestanding ESRD facilities. Specifically, the following analysis is from Worksheets B and C from the freestanding ESRD facility cost report (CMS-265-11) and Worksheets I-2 and I-4 from the hospital-based ESRD facility cost report (CMS-2552-10).
We analyzed CY 2024 ESRD cost report data from freestanding and hospital-based ESRD facilities. The median cost-per-training session was approximately $712 overall, $381 for HD, and $797 for PD. The median labor cost-per-training session was approximately $283 overall, $164 for HD, and $314 for PD. CMS believes that these reported ESRD facility costs include resources associated with routine renal dialysis services in addition to training-specific activities. On average, payment per dialysis treatment was approximately $300 in 2024. As discussed in section II.B.1. of this proposed rule, the total compensation in the proposed 2024-based ESRDB market basket is 50.9 percent as presented in Table 3. Applying this to the rough per-treatment payment amount of $300 gives us a payment amount of approximately $153. To appropriately determine the extent to which training for home dialysis results in increased labor costs, we can subtract this $153 amount from the median per-training-treatment labor cost of $283. This results in a per-treatment labor net cost of about $130 per training treatment above that which is included in the per-treatment payment.
Because the ESRD PPS is not a cost-based system, and cost report data may not reliably isolate the marginal cost of training, CMS does not believe it is appropriate to base the training add-on directly on these data. As discussed in further detail in the next section, CMS
We propose to increase the training add-on according to the most recently available BLS OEWS, using the same methodology finalized in the CY 2017 ESRD PPS final rule (81 FR 77856), based on 2.66 hours of RN time and updated wage data. CMS is proposing to maintain the 2.66-hour basis as cost report data has indicated it is an appropriate basis for the training payment and is administratively simple to calculate. As discussed in the prior section, cost report data shows a net labor cost of approximately $130 per training treatment for 2024. While we are not proposing to base the training amount on this cost report data, we note that it lines up with the result from our established methodology closely. Specifically, applying this 2.66-hour basis to the estimate of RN wages from the May 2024 BLS OEWS, $47.32, would give us a training adjustment of $125.87 for 2024, before the application of any wage index. This demonstrates that our longstanding methodology generally accounts for the net labor costs associated with home dialysis training.
This proposed approach would maintain consistency with prior policy while accounting for wage growth over time and aligning with the prospective principles upon which the ESRD PPS was established.
Under the ESRD PPS, and in accordance with section 1881(b)(14)(A)(i) of the Act, CMS implemented a single base rate that applies to all dialysis treatment modalities. CMS is not proposing to differentiate payment amounts between PD and HD training. Although cost report data suggest differences, maintaining a single rate is consistent with the ESRD PPS structure as HD and PD are paid the same for adult beneficiaries, and avoids creating financial incentives that could influence modality selection.
We calculated the updated payment amount using the mean hourly wage for RNs (SOC 29-1141) from the May 2025 BLS OEWS (
This proposal would provide for an increase of $42.62 per training treatment (that is, $138.22−$95.60 = $42.62). This approach would provide a significant increase in payment for home and self-dialysis training for CY 2027 while maintaining consistent payment for both PD and HD modalities. After evaluating the cost report data presented previously in this section of the proposed rule, we believe that this amount is an appropriate proxy for the costs of home dialysis training. We propose to update this training add-on amount with additional data, for example an update in the growth in the proposed 2024-based ESRDB market basket Wages and Salaries price proxy in the final rule, if appropriate.
CMS proposes to implement this increase for the training add-on in a budget neutral manner through an adjustment to the ESRD PPS base rate. We believe implementing this budget neutral change, similar to the budget neutral training add-on in the CY 2017 ESRD PPS final rule (81 FR 77856), is appropriate because the ESRD PPS base rate includes certain training costs. For more information on the history of training add-on changes, we refer readers to a discussion in response to comments in the CY 2017 ESRD PPS final rule (81 FR 77853 through 77854). CMS will estimate aggregate impacts for this proposal using claims and cost report data.
In the CY 2011 ESRD PPS final rule we finalized a payment adjustment for ESRD patients in their first 4 months on dialysis (75 FR 49090 through 49094), which we refer to as the onset adjustment. We stated that as home dialysis training costs represent one-on-one staff time to train a patient for home dialysis, we believed we captured staffing costs for training in the onset adjustment. Since we already accounted for training salary costs in the onset adjustment, we believed that applying the training add-on adjustment in addition to the onset adjustment would have the effect of compounding the composite rate costs and would result in an overpayment of nursing staff costs associated with training dialysis patients for home dialysis. Therefore, the rule finalized that ESRD facilities would not receive the training add-on adjustment for patients who are receiving the onset adjustment. In the CY 2011 final rule we stated that we would continue to study the relationship between costs related to the onset of dialysis and home dialysis training for future refinements of the ESRD PPS (75 FR 49094).
At that time, we stated that we believed that the onset adjustment captured additional labor costs for home dialysis training sessions that occur during the onset period, which is the first four months a patient is on dialysis (75 FR 49063). The CY 2011 onset adjustment factor was finalized at 1.510 (75 FR 49094). As the training add-on was $33.44, the onset adjustment factor was generally much larger than the training add-on for any single patient, so it was reasonable to believe that notable additional labor costs associated with home dialysis training were captured by the analysis from which the onset adjustment was derived.
The current onset adjustment factor is 1.327, as finalized in the CY 2016 ESRD PPS final rule (80 FR 68992 through 68993). The current CY 2026 ESRD PPS base rate is $281.71 so a 1.327 adjustment factor would be an increase of approximately $92, which is lower than the current training add-on adjustment. As the onset adjustment is intended to account for more than just home dialysis training, the lower multiplicative onset adjustment factor, combined with the relatively low utilization of home dialysis training during the onset period, led us to reevaluate our longstanding policy of not applying the dialysis training add-on during the onset period.
We propose to allow ESRD facilities to receive the home and self-dialysis training add-on payment adjustment during the onset period. Analysis of 2024 claims data indicates that approximately 7.7 percent of onset claims include training. While this is an improvement from the inception of the ESRD PPS, we believe that patient choice would be improved by increased access to home and self-dialysis training during the onset period. Currently, approximately 44 percent of training sessions occurred during the onset period, which demonstrates that most patients which receive training are not in the onset period. CMS further believes that the training add-on reflects discrete training labor-related resources that are not fully captured by the onset adjustment and therefore would not result in duplicative payment. Home dialysis was included in the data upon which the ESRD PPS base rate was constructed in the 2011 ESRD PPS final rule (75 FR 49084). However, in that rule, we discussed how the ESRD PPS base payment alone does not address home dialysis training costs, so an additional adjustment was warranted (75 FR 49062). In the regression analysis performed for that rule, we stated that we believed the higher costs associated with the onset period were, in part, due to some training labor costs (75 FR 49063). However, based on our analysis of the training labor cost and the onset adjustment for this proposed rule, we no longer believe this is the case. There are training costs, primarily equipment supply costs, included in the ESRD PPS base rate (75 FR 49062) which are likely higher during training which would be captured by the analysis from which the onset adjustment was derived. But, as discussed previously in this section of the proposed rule, the ESRD PPS base rate does not contain significant monies for labor related to home dialysis training, so we do not believe that allowing both adjustments would be duplicative now, in large part because the onset adjustment factor has decreased since 2011 (which could have reflected some shifting utilization). Similar to how the training add-on accounts for the extra costs not accounted for by the ESRD PPS base rate, we believe that most costs associated with home dialysis training are not reflected in the current onset adjustment. Furthermore, our proposal to implement this policy budget neutrally further mitigates the risk of potential duplicative payment. We propose to base the budget neutrality of this change on the current utilization of home dialysis training during the onset period.
The proposed increase to the training add-on and the proposed allowance of the training add-on for ESRD PPS claims during the onset period would result in a budget neutrality adjustment of 0.99884. We are soliciting comments on these proposed modifications to the home and self-dialysis training adjustment, as well as the proposed budget neutrality of these proposals and the proposed budget neutrality adjustment factor of 0.99884. Additionally, we are soliciting comments on other ways in which we could improve both home dialysis and self-dialysis utilization. We are also soliciting comments on the proposal to continue to use the calculation established in the CY 2017 ESRD PPS final rule (81 FR 77856), basing the training add-on on 2.66 hours of RN time. As noted previously, we did not propose to base the training add-on on Medicare cost report data, nor did we propose to set different training payment rates for HD and PD but based on comments received in response to this proposed rule, we may finalize a different policy, if warranted. Such a policy could involve using cost reports to determine the number of hours of nursing time required for home dialysis training or modifying the training add-on for a modality based on the relative cost of that modality reported on cost reports, and we solicit comments on these potential alternative methodologies. We are also soliciting comments on alternative ways we could budget neutralize this proposal, and specifically whether it would be more appropriate to make the proposal to allow the training add-on during the onset period budget neutral by reducing the onset adjustment factor.
In the CY 2020 ESRD PPS final rule, we finalized a conditional policy for TDAPA payment based on the availability of ASP data (84 FR 60679). In that final rule, we explained that if drug manufacturers were to stop submitting full quarters of ASP data for products that are eligible for the TDAPA, and we had to revert to basing the TDAPA on the wholesale acquisition cost (WAC) or invoice pricing, we believed we would be overpaying for the TDAPA for those products. We stated that we would no longer apply the TDAPA for a new renal dialysis drug or biological product if CMS does not receive a full calendar quarter of ASP data within 30 days after the last day of the 3rd calendar quarter after the TDAPA is initiated for the product, or if CMS stops receiving the latest full calendar quarter of ASP data during the applicable TDAPA period specified in § 413.234(c)(1) or (2). We explained that once we determine that the latest full calendar quarter of ASP is not available, we would stop applying the TDAPA for the new renal dialysis drug or biological product within the next 2-calendar quarters. We adopted this conditional policy to avoid overpaying for the TDAPA on an ongoing basis and to ensure that TDAPA payment is based on the most appropriate data, that is, ASP.
In the CY 2024 ESRD PPS final rule we finalized the post-TDAPA add-on payment adjustment (88 FR 76388 through 76397). When we finalized this payment adjustment, we also finalized a similar conditional ASP policy where if CMS stopped receiving ASP data for a particular drug or biological product, we would no longer apply a post-TDAPA add-on payment adjustment for that drug or biological product.
The CY 2024 ESRD PPS proposed rule (88 FR 42472) discussed that our regulation at § 413.234(c) did not address the application of the TDAPA conditional policy in situations where the manufacturer of the new renal dialysis drug or biological product submitted zero or negative sales ASP data to CMS. Zero or negative sales may occur for a variety of reasons, including no sales, recalls of a product, or repurchases of sold products. In the CY 2012 Physician Fee Schedule (PFS) final rule (76 FR 73296), CMS clarified that zero or negative values are valid for ASP, ASP units, and WAC. Therefore, when such a scenario occurs for separately payable Medicare Part B
In the CY 2024 ESRD PPS final rule (88 FR 76410) we clarified that for purposes of the TDAPA conditional policy, in circumstances where a manufacturer submitted zero or negative sales ASP data during the TDAPA period, we consider CMS to have received the latest full calendar quarter of ASP data, and we will not discontinue TDAPA payment under the conditional policy in § 413.234(c). We further indicated that, consistent with the pricing methodologies for separately payable Medicare Part B drugs, in such circumstances, we will set the TDAPA payment amount based on WAC or, if WAC is not available, invoice pricing, for the quarter in which zero or negative sales were reported. Likewise, we finalized that we would also consider ASP reflecting zero or negative sales during the post-TDAPA period as CMS having received the latest full calendar quarter of ASP data and would not discontinue the post-TDAPA payment. We finalized that we would use WAC or, if WAC is not available, invoice pricing, for the post-TDAPA add-on payment adjustment calculation (88 FR 76396).
In the CY 2025 PFS final rule (89 FR 97981 through 97982), we specified that for the purposes of calculating a payment limit for Part B drugs, we will consider positive manufacturer's ASP data “available” and negative or zero manufacturer's ASP data “not available.” We further specified that the use of the most recent positive ASP data available for a billing and payment code for a drug is most consistent with the payment limit calculations described in section 1847A(b) and (c) of the Act, including section 1847A(c)(5)(B) of the Act. In the CY 2026 PFS final rule (90 FR 49737) we noted that the published payment limit for a drug with negative or zero ASP data reported after January 1, 2025, could be based on a positive amount that is carried forward from a previous quarter in accordance with § 414.904(i).
We propose modifications to align the TDAPA and post-TDAPA add-on payment adjustment methodologies with pricing methodologies applicable to separately payable Medicare Part B drugs under section 1847A of the Act, including the use of the most recent available positive ASP data. This proposed modification would not change the TDAPA payment for a new renal dialysis drug or biological product that is in the first three quarters of the TDAPA payment period for which ASP data has not been reported. Specifically, for any such product, TDAPA payment would continue to be based on 100 percent of WAC and, if WAC is not available, based on the drug manufacturer's invoice price. Consistent with our policy, if CMS does not receive a full calendar quarter of ASP data within 30 days of the last day of the 3rd calendar quarter following the initiation of the TDAPA, CMS will discontinue the TDAPA for that product beginning no later than 2-calendar quarters after CMS determines that such ASP data is not available. We note that, for purposes of this policy, the submission of zero or negative sales ASP data satisfies the manufacturer's ASP reporting requirement under sections 1927(b)(3)(A)(iii) and 1847A(f) of the Act.
Under this proposal, when ASP data are reported as negative or zero for a renal dialysis drug or biological product and CMS has received positive ASP data for the product in a prior calendar quarter, we would no longer base the TDAPA payment amount on WAC or, if WAC is not available, invoice pricing for that quarter. Instead, consistent with the approach adopted for separately payable Part B drugs in § 414.904(i), we would base the TDAPA payment amount on the most recent prior calendar quarter, with positive ASP data, which we consider the most recent available ASP for purposes of section 1847A of the Act. We propose to apply a similar modification to the post-TDAPA add-on payment adjustment methodology. Specifically, when the most recent full calendar quarter of ASP data reflects negative or zero sales, and CMS has received positive ASP data for the product in a prior calendar quarter, we would not base the post-TDAPA add-on payment adjustment on WAC, or invoice pricing. Instead, we would base the post-TDAPA add-on payment adjustment on the most recent prior calendar quarter with positive ASP data.
As under current policy, in circumstances where a manufacturer submits ASP data reflecting zero or negative sales, CMS considers the manufacturer to have satisfied its ASP reporting obligation, and such submissions do not trigger the discontinuation of the TDAPA under § 413.234(c). However, if a manufacturer ceases submitting ASP data, and CMS determines that the latest full calendar quarter of ASP data is not available, CMS will discontinue the TDAPA for the product within 2 calendar quarters, consistent with § 413.234(c). For purposes of the TDAPA and post-TDAPA add-on payment adjustment, zero or negative ASP data are treated as not usable for purposes of determining the payment amount but are treated as submitted for purposes of the ASP reporting requirement.
We believe this proposed approach is consistent with section 1847A of the Act because it relies on the most recent available positive ASP data when current quarter ASP data is not usable for purposes of determining a payment amount. We further believe this proposed policy would improve payment accuracy and consistency across Medicare payment systems by avoiding reliance on WAC or invoice pricing when more representative ASP data are available. This is appropriate for the ESRD PPS as it aligns payment with resource use and promotes efficiency, consistent with the principles of the ESRD PPS.
We propose modifications to § 413.234(c) and § 413.234(g)(1) to effectuate this change by amending language to state that when the most recently available quarter of ASP data is not usable because it is zero or negative, we would instead use the most recently available quarter of positive ASP data, and that we would only resort to WAC or invoice pricing if a prior quarter of positive ASP data is not available.
In the CY 2020 ESRD PPS final rule (84 FR 60681 through 60698), we established the transitional add-on payment adjustment for new and innovative equipment and supplies (TPNIES) under the ESRD PPS, pursuant to the authority of section 1881(b)(14)(D)(iv) of the Act, to support ESRD facility use and beneficiary access to these new items.
We added § 413.236 to establish the eligibility criteria and payment policies for the TPNIES. Under current § 413.236(b), CMS provides for a TPNIES to an ESRD facility for furnishing a covered equipment or supply only if the item: (1) has been designated by CMS as a renal dialysis service under § 413.171; (2) is new, meaning a complete application has been submitted to CMS under § 413.236(c) within 3 years of the date of the FDA marketing authorization; (3) is commercially available by January 1 of the particular CY, meaning the year in which the payment adjustment would take effect; (4) has a complete HCPCS Level II code application submitted, in accordance with the HCPCS Level II coding procedures on the CMS website, by the HCPCS Level
As indicated in § 413.236(c) CMS includes the summary of each TPNIES application and our analysis of the eligibility criteria for each application in the annual ESRD PPS proposed rule and announces the results in the annual ESRD PPS final rule. Because we did not receive any applications for the TPNIES for CY 2027, we did not include any TPNIES application summaries, CMS analyses, or results in this proposed rule.
In this section of the proposed rule, we identify any items previously approved for the TPNIES and for which payment is continuing for CY 2027. Because no new items were approved for the TPNIES for CY 2026 (90 FR 53102), there are no payments continuing in CY 2027.
In this section of the proposed rule, we identify any items previously approved for the TDAPA for which payment is continuing for CY 2027. Under § 413.234(c)(1), a new renal dialysis drug or biological product that is considered included in the ESRD PPS base rate is paid the TDAPA for 2 years. As described in the CY 2026 ESRD PPS final rule, no new renal dialysis drugs or biological products items were approved for the TDAPA for CY 2026 (90 FR 53102 through 53103). The 2-year TDAPA period for each new renal dialysis drug or biological product previously approved for the TDAPA will conclude on December 31, 2026. As such, there are no items previously approved for the TDAPA for which payment is continuing in CY 2027.
The Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27) was enacted on June 29, 2015, and amended the Act to provide coverage and payment for dialysis furnished by an ESRD facility to an individual with AKI. Specifically, section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) of the Act to an individual with AKI. Section 808(b) of the TPEA amended section 1834 of the Act by adding a subsection (r) to provide payment, beginning January 1, 2017, for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) of the Act to individuals with AKI at the ESRD PPS base rate, as adjusted by any applicable geographic adjustment applied under section 1881(b)(14)(D)(iv)(II) of the Act and adjusted (on a budget neutral basis for payments under section 1834(r) of the Act) by any other adjustment factor under section 1881(b)(14)(D) of the Act that the Secretary elects.
In the CY 2017 ESRD PPS final rule, we finalized several coverage and payment policies to implement subsection (r) of section 1834 of the Act and the amendments to section 1861(s)(2)(F) of the Act, including the payment rate for AKI dialysis furnished by ESRD facilities (81 FR 77866 through 77872 and 77965). We interpret section 1834(r)(1) of the Act as requiring the amount of payment for AKI dialysis services to be the base rate for renal dialysis services determined for a year under the ESRD PPS as set forth in § 413.220, updated by the ESRDB market basket percentage increase factor reduced by a productivity adjustment as set forth in § 413.196(d)(1), adjusted for wages as set forth in § 413.231, and adjusted by any other amounts deemed appropriate by the Secretary under § 413.373. We codified this policy in § 413.372 (81 FR 77965). In the CY 2025 ESRD PPS final rule, we finalized a policy to allow payment for home dialysis for beneficiaries with AKI. Additionally, we extended the payment adjustment for home and self-dialysis training to AKI dialysis payments in a budget neutral manner and calculated a reduction to the AKI dialysis payment rate which rounded to $0.00 (89 FR 89170).
The payment rate for AKI dialysis, as set forth in section 1834(r)(1) of the Act, is the ESRD PPS base rate determined for a year under section 1881(b)(14) of the Act, which is the finalized ESRD PPS base rate, including the applicable annual market basket update, geographic wage adjustments, and any other amounts deemed appropriate by the Secretary pursuant to section 1881(b)(14)(D) of the Act, for such year. We note that ESRD facilities could bill Medicare for non-renal dialysis items and services and receive separate payment in addition to the payment rate for AKI dialysis. Accordingly, we propose that the CY 2027 AKI dialysis payment rate would be equal to the proposed CY 2027 ESRD PPS base rate of $299.55 (($281.71 + $15.96) × 1.00267 × 0.98783) × 1.016 = $299.55), as discussed in section II.B.4. of this proposed rule. Additionally, we propose that if more recent data becomes available after the publication of this proposed rule and before the publication of the final rule, we would use such data, if appropriate, to determine the final CY 2027 ESRD PPS base rate. As discussed in section II.B.1.b. of this proposed rule, we are proposing to rebase and revise the ESRDB market basket to reflect a 2024 base year. This proposal would impact the ESRDB market basket update, which would impact the CY 2027 ESRD PPS base rate and therefore the AKI dialysis payment rate.
Under section 1834(r)(1) of the Act and regulations at § 413.372, the amount of payment for AKI dialysis services is the base rate for renal dialysis services determined for a year under section 1881(b)(14) of the Act (updated by the ESRDB market basket percentage increase and reduced by the productivity adjustment), as adjusted by any applicable geographic adjustment factor applied under section 1881(b)(14)(D)(iv)(II) of the Act. Accordingly, we propose to apply the same wage index under § 413.231 that is used under the ESRD PPS. As discussed in section II.B.2.a. of this proposed rule, the ESRD PPS wage index is based on mean hourly wage data from the BLS OEWS weighted by FTE data from freestanding ESRD facility cost reports. We finalized the methodology for determining the wage index value for an ESRD facility in the CY 2025 ESRD PPS final rule (89 FR 89097 through 89116),
Section 1834(r)(1) of the Act also provides that the payment rate for AKI dialysis may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r)) by any other adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act. As discussed in the CY 2025 ESRD PPS final rule, we extended the home and self-dialysis training add-on payment adjustment under the ESRD PPS to AKI dialysis payments in a budget neutral way (89 FR 89170). Under § 413.373(a), CMS applies the wage-adjusted add-on per treatment adjustment for home and self-dialysis training as set forth at § 413.235(c) to payments for AKI dialysis claims that include such training. Section 413.235(c) provides for a training add-on payment adjustment for home and self-dialysis modalities, which is wage-adjusted and paid on a per-treatment basis. Therefore, we are proposing that any revisions to the ESRD PPS training add-on payment adjustment would be reflected in payments for AKI dialysis. That is, the proposed ESRD PPS training add-on amount of $138.22 would be applicable to AKI beneficiaries during the training period. AKI beneficiaries do not receive the onset payment adjustment, so they would not be impacted by the proposal to allow training during the onset period. However, we note that for AKI beneficiaries that progress to ESRD the proposal to allow training payments during the onset period would allow for continued access to the training add-on during the onset period for ESRD. Currently there are no other adjustments that apply to AKI dialysis payments.
For a detailed discussion of the ESRD QIP's background and history, including a description of the Program's authorizing statute and the policies that we have adopted in previous final rules, we refer readers to the citations provided at IV.A. of the CY 2024 ESRD PPS final rule (88 FR 76433). We have also codified many of our policies for the ESRD QIP at 42 CFR 413.177 and 413.178.
We propose to replace the Hypercalcemia reporting measure with the Facility-Level Percentage of Chronic Hyperphosphatemia in Dialysis Patients clinical measure, update the National Healthcare Safety Network Bloodstream Infection clinical measure, and remove both the Medication Reconciliation reporting measure and the COVID-19 Vaccination Coverage Among Healthcare Personnel reporting measure beginning with the PY 2029 measure set. Table 19 summarizes the previously finalized measures, proposed new measures, and proposed updated measures that we would include in the PY 2029 ESRD QIP measure set. The technical specifications for current measures that would remain in the measure set for PY 2029 can be found in the CMS ESRD Measures Manual for the 2026 Performance Period.
Abnormalities of mineral and bone metabolism are exceedingly common and contribute significantly to morbidity and mortality in patients with advanced chronic kidney disease (CKD). Studies have associated disorders of mineral and bone metabolism with mortality, fractures, cardiovascular disease, and other morbidities.
Beginning with the PY 2029 ESRD QIP, we are proposing to remove the Hypercalcemia reporting measure under measure removal factor 5, a measure that is more strongly associated with desired patient outcomes for the particular topic becomes available (§ 413.178(c)(5)(i)(E)), and replace it with the Facility-Level Percentage of Chronic Hyperphosphatemia in Dialysis Patients (Hyperphosphatemia) clinical measure. Both calcium and phosphorus are important in mineral and bone metabolism. The Hypercalcemia reporting measure only requires reporting of the calcium value
The Hyperphosphatemia clinical measure is an outcome measure developed by CMS to assess long-term phosphorus control across the dialysis population by measuring the percentage of adult dialysis patients with a 6-month rolling average serum phosphorus value greater than or equal to 6.5 mg/dL.
For more information about the testing, feasibility, scientific acceptability, meaningfulness, and validity of the Hyperphosphatemia clinical measure, we refer readers to
The numerator of this measure includes patient reporting months with a six-month rolling average phosphorus value of 6.5 mg/dL or greater. The
We refer readers to the Partnership for Quality Measurement for details on the Pre-rulemaking Measure Review process convened by the CBE, including the voting procedures used to reach consensus on measure recommendations.
The voting results of the Recommendation Group for the proposed inclusion of the Hyperphosphatemia clinical measure in the ESRD QIP were: 16 members (76 percent) recommended adopting the measure into the ESRD QIP and 5 members (24 percent) voted not to recommend the measure for adoption.
Regarding concerns about the sufficiency of the evidence base supporting use of the Hyperphosphatemia clinical measure, we note that studies have demonstrated a consistent association between chronic hyperphosphatemia and adverse outcomes, including cardiovascular complications, bone fractures, and increased mortality.
Regarding concerns about the need for additional measure development, we note that the Hyperphosphatemia clinical measure was developed and refined with input from a technical expert panel (TEP) and underwent extensive feasibility, reliability, and validity testing. The TEP consisted of interested parties, experts, and consumer advocates who contributed their input through the Hyperphosphatemia clinical measure design process.
Regarding concerns about the potential for unintended adverse outcomes associated with dietary protein restrictions, we note the measure includes exclusions intended to mitigate potential unintended consequences, including patients with indicators of poor nutritional status, such as a 6-month rolling average albumin of less than 3.5 g/dL and a BMI under 18.5. We also note that as part of
Regarding concerns that phosphorus control is influenced by multiple clinical and patient-level factors not fully captured by the measure, we note that phosphorus management is addressed through the interdisciplinary care team of a facility, including the prescribing physician and dietitian, who work together with ESRD patients through clinical care, dietary counseling, and treatment decisions. The Hyperphosphatemia clinical measure would capture the extent to which facilities are able to address these multi-layered factors.
We refer readers to the Partnership for Quality Measurement website for details on the measure endorsement and maintenance process, including the measure evaluation procedures the Endorsement and Maintenance Committees use to evaluate measures and whether they meet endorsement criteria.
We are proposing to require facilities to submit data needed to calculate the Hyperphosphatemia clinical measure using EQRS beginning with the performance period for PY 2029. Facilities would report the required data through EQRS in accordance with the existing monthly data submission processes used for other ESRD QIP clinical measures. Because the measure uses a 6-month rolling average of serum phosphorus values, we are proposing that facilities would need to submit phosphorus data for the five months preceding the start of the performance period to allow calculation of rolling averages for the first months of the performance year. For example, the rolling average for January 2027 would be calculated using phosphorus values from August 2026 through January 2027. We are proposing that data used to calculate the Hyperphosphatemia clinical measure would be based on a 12-month performance period, with data submission consistent with current reporting deadlines for other ESRD QIP measures. For example, for PY 2029, facilities would report the required data through EQRS on a monthly basis during CY 2027, with final data submission due by the end of the December 2027 data reporting month.
As described in Table 19 of this proposed rule, we are proposing performance standards for the Hyperphosphatemia clinical measure. Facilities would be required to follow the existing submission and reporting requirements for web-based measures under the ESRD QIP, as described on the QualityNet website at
We welcome public comment on our proposals to remove the Hypercalcemia reporting measure and adopt the Hyperphosphatemia clinical measure beginning with PY 2029.
In the CY 2014 ESRD PPS final rule, we adopted the National Healthcare Safety Network (NHSN) Bloodstream Infection (BSI) in Hemodialysis Patients (hereafter referred to as the NHSN BSI) clinical measure into the ESRD QIP to assess BSIs among patients receiving hemodialysis at outpatient hemodialysis centers (78 FR 72204 through 72207). The NHSN BSI clinical measure is based on infection surveillance data reported by facilities to the Centers for Disease Control and Prevention (CDC) through the NHSN Dialysis Event surveillance system.
We are proposing to update the baseline and risk adjustment used to calculate the SIR for the NHSN BSI clinical measure beginning with PY 2029 to ensure that national benchmarks better reflect current healthcare practices, surveillance protocols, and infection prevention efforts. To estimate the expected number of BSIs, we are proposing to update the national baseline from 2014 data to 2023 data and revise the risk adjustment model to incorporate additional facility-level characteristics, including patient access type, facility hospital affiliation, and number of dialysis stations, which were identified as significant predictors of BSI risk among the data reported to NHSN. Additionally, these factors identified are not modifiable by the facility and are outside a facility's direct control. The predicted number of BSIs would be estimated using a regression model developed from the 2023 national baseline data. This model uses parameter estimates associated with the identified risk factors to calculate predicted BSIs for each facility-access type combination and then multiplies these estimates by facility patient-months to determine the predicted number of BSIs. Additionally, this updated risk adjustment model would better account for differences in facility characteristics associated with BSI risk and cannot be modified by the facility. The proposed 2023 national baseline updates would not change the underlying SIR calculation formula but would instead be used to calculate revised denominators for the SIR by estimating the number of predicted BSIs for a given facility based on the 2023 national baseline data and facility characteristics.
The proposed 2023 national baseline updates would allow facilities to compare their performance to more recent national data, improve the accuracy and fairness of external benchmark comparisons, and serve as a new national reference point for measuring progress in BSI prevention. Because the updated 2023 national baseline reflects more recent national data, facilities may observe changes in their SIR values calculated in comparison with their SIR values
For additional information on the 2023 BSI national baseline process, please refer to the CDC NHSN website at
We welcome public comment on our proposal to update the NHSN BSI clinical measure beginning with PY 2029.
We have undertaken efforts to review the existing ESRD QIP measure set to ensure continued clinical impact and effectiveness of the measures on facility performance. Based on that analysis and our evaluation of the ESRD QIP measure set, we are proposing to remove the Medication Reconciliation reporting measure and the COVID-19 Vaccination Coverage Among Healthcare Personnel reporting measure, beginning with PY 2029.
To ensure continued impact and effectiveness of our measure set on facility performance, we are proposing to remove the Medication Reconciliation (MedRec) reporting measure beginning with PY 2029. When we first adopted the MedRec reporting measure in the CY 2019 ESRD PPS final rule (83 FR 57008 through 57010), we stated that inclusion of the measure in the ESRD QIP measure set would align with national goals for patient safety and the reduction of harm caused by care delivery. The MedRec reporting measure assesses whether a facility has appropriately evaluated a patient's medications, an important safety concern for the ESRD patient population because those patients typically see multiple providers and may require numerous medications.
Our proposal to remove the MedRec reporting measure is consistent with evolving the ESRD QIP to focus on a measure set of high-value, impactful measures that have been developed to drive care improvements for a broader set of ESRD patients. As such, we are proposing to remove this measure from the ESRD QIP measure set under measure removal factor 8, the costs associated with the measure outweigh the benefit of its continued use in the program (§ 413.178(c)(5)(i)(H)).
Although recent annual measure analyses have indicated that the MedRec reporting measure may not be fully topped out based on the statistical criteria that we adopted in the CY 2015 ESRD PPS final rule (79 FR 66171 through 66174), available data show consistently high performance and limited variation across facilities. For example, the mean MedRec reporting measure performance in CY 2024 was 97.3 percent and the median MedRec reporting measure score was 10 points, which indicates more than 50 percent of providers achieved perfect scores for the measure. These results suggest that the programmatic benefit of retaining the measure is limited.
One of the goals of the ESRD QIP is to advance the program in the least burdensome manner possible, while maintaining a parsimonious set of the most meaningful quality measures and continuing to incentivize improvement in the quality of care provided to patients. Our priority is a continued focus on measurable clinical outcomes to incentivize the improvement of dialysis care quality and health outcomes for all patients through measurement and transparency. In light of consistently high performance on the MedRec reporting measure, leaving limited opportunity for further distinctions or improvements in facility performance, and the burden facilities incur in collecting, documenting, and reporting data for the measure, the costs associated with the measure outweigh the benefit of its continued use in the ESRD QIP. Our proposal to remove the MedRec reporting measure from the ESRD QIP is consistent with these priorities.
We welcome public comment on our proposal to remove the MedRec reporting measure from the ESRD QIP measure set, beginning with PY 2029.
We refer readers to the CY 2023 ESRD PPS final rule where we adopted the COVID-19 Vaccination Coverage Among Healthcare Personnel (HCP) measure (hereafter referred to as COVID-19 HCP Vaccination measure) into the ESRD QIP (87 FR 67244 through 67248) and the CY 2024 ESRD PPS final rule where we modified the COVID-19 HCP Vaccination measure to account for updated COVID-19 vaccine guidance (88 FR 76446 through 76451). The COVID-19 HCP Vaccination measure requires dialysis facilities to report the COVID-19 vaccination status of HCP through the CDC NHSN. Facilities must collect current vaccination status for all employees, licensed independent practitioners, adult trainees, students, and volunteers, as well as certain contract personnel one week out of each month and report these data on a quarterly basis (88 FR 76448 through 76449).
We propose to remove the COVID-19 HCP Vaccination measure beginning with the PY 2029 ESRD QIP under removal factor 3, a measure no longer aligns with current clinical guidelines or practice (§ 413.178(c)(5)(i)(C)). When we originally adopted this measure, the United States was in the midst of a Public Health Emergency (PHE) with millions of COVID-19 cases and over 965,000 COVID-19 deaths (87 FR 67244). In April 2023, the last full month of the PHE, the weekly number of deaths due to COVID-19 averaged around 1,300.
With the end of the PHE, the continued costs and burden to providers of reporting on this measure outweighed the benefit of continued information collection on COVID-19 HCP Vaccination in several settings. We likewise removed this measure from several program measure sets: the Hospital Inpatient Quality Reporting Program (90 FR 37010 through 37012), the Inpatient Psychiatric Facility Quality Reporting Program (90 FR 37657 through 37658), the Inpatient Rehabilitation Facility Quality Reporting Program (90 FR 37701 through 37702), the Ambulatory
Since the end of the PHE, the CDC's clinical recommendations for COVID-19 vaccination have changed. In December 2020, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended that HCP should receive a complete vaccination course.
However, these parameters no longer apply, due to evolving circumstances. The latest CDC COVID-19 vaccination recommendations for the 2025 through 2026 season are now based on shared clinical decision-making.
On this basis, we propose removing the measure from the ESRD QIP measure set under removal factor 3, a measure does not align with current clinical guidelines or practice.
If finalized, facilities would not be required to report COVID-19 HCP Vaccination reporting measure data beginning with the performance period for PY 2029. Any COVID-19 HCP vaccination data received by CMS beginning with the performance period for PY 2029 would not be used for ESRD QIP public reporting.
We welcome public comment on our proposal to remove the COVID-19 Vaccination Coverage Among Healthcare Personnel measure from the ESRD QIP beginning with PY 2029.
In the CY 2019 ESRD PPS final rule (83 FR 56991 through 56992), we finalized revisions to the ESRD QIP measure domains. Specifically, in that rule we eliminated the Reporting Domain and reorganized the Clinical Domain into three distinct domains: Patient & Family Engagement Domain, Care Coordination Domain, and Clinical Care Domain. We finalized our proposal to eliminate the Reporting Measure Domain from the ESRD QIP measure set, beginning in PY 2021, because there would no longer be any measures in that domain.
In the CY 2023 ESRD PPS final rule, we finalized our proposal to create a new Reporting Measure Domain (87 FR 67251 through 67254), which would include the six individual reporting measures in the ESRD QIP measure set at that time. In the CY 2023 ESRD PPS final rule, we stated that a separate Reporting Measure Domain was necessary to increase incentives for improving performance by increasing the weights on measures where there is the most room for improvement, especially on patient clinical outcomes.
Currently, ESRD QIP measures are weighted and distributed across five measure domains: Patient & Family Engagement, Care Coordination, Clinical Care, Safety, and Reporting. As discussed in section IV.B.2. of this proposed rule, we are proposing to replace the Hypercalcemia reporting measure with the Hyperphosphatemia clinical measure beginning with the PY 2029 ESRD QIP. In sections IV.B.4.a. and IV.B.4.b. of this proposed rule, we also propose to remove the COVID-19 Vaccination Coverage among HCP reporting measure and the MedRec reporting measure from the ESRD QIP measure set beginning with the PY 2029 ESRD QIP. If these proposals are finalized as proposed, the ESRD QIP measure set would not include any measures under the Reporting Measure Domain. Therefore, we are proposing to remove the Reporting Measure Domain and to update the domain weights and individual measure weights in the Care Coordination Domain and the Clinical Care Domain accordingly to reflect the proposed updates to the ESRD QIP measure set. As the ESRD QIP measure set has evolved over the years, we believe that removing the Reporting Measure Domain and updating the Care Coordination Domain and the Clinical Care Domain, both of which contain multiple measures, would help to address concerns regarding the impact of individual measure performance on a facility's Total Performance Score (TPS), while also further incentivizing improvement on clinical measures. Although we are proposing to remove the Reporting Measure Domain beginning with PY 2029 because the ESRD QIP measure set would no longer include any reporting measures, we note that in future rulemaking, reporting measures may be proposed for inclusion in the ESRD QIP measure set under the remaining measure domains. For a comparison of current and proposed measure domains and weighting, see Table 20 and Table 21.
We welcome public comment on our proposal to remove the Reporting Measure Domain and to update the existing domains and measure weights used to calculate the TPS, beginning with PY 2029.
Section 1881(h)(4)(A) of the Act requires the Secretary to establish performance standards with respect to the measures selected for the ESRD QIP for a performance period with respect to a year. The performance standards must include levels of achievement and improvement, as determined appropriate by the Secretary, and must be established prior to the beginning of the performance period for the year involved, as required by sections 1881(h)(4)(B) and (C) of the Act. We
We continue to believe that our current policy of 12-month performance and baseline periods provide us sufficiently reliable quality measure data for the ESRD QIP. Under this policy, we would adopt CY 2027 as the performance period and CY 2025 as the baseline period for the PY 2029 ESRD QIP. In the proposed rule, we are estimating the performance standards for the PY 2029 clinical measures in Table 22 using data from CY 2024, which were the most recent data available. We intend to update these performance standards for all measures, using CY 2025 data, in the CY 2027 ESRD PPS final rule.
In this proposed rule, we are proposing to update eligibility requirements as part of our proposal to replace the Hypercalcemia reporting measure with the Hyperphosphatemia clinical measure beginning with PY 2029. Our previously finalized and proposed new minimum eligibility requirements are described in Table 23.
Under our current policy, a facility does not receive a payment reduction for a payment year in connection with its performance under the ESRD QIP if it achieves a TPS that is at or above the minimum TPS (mTPS) that we establish for the payment year. We have defined the mTPS in our regulations at § 413.178(a)(8).
Under § 413.177(a), we implement the payment reductions on a sliding scale using ranges that reflect payment
We are seeking feedback related to the potential inclusion of the Dialysis Facility Discussion of Patient Life Goals (D-PaLS) Patient-reported Outcome Performance Measure (PRO-PM) in the ESRD QIP. For people on chronic dialysis, regular discussion of patient life goals with their dialysis facility care team can lead to better understanding by facilities and providers of those life goals, and how patients' goals can be considered as part of initial and ongoing treatment planning and decision-making.
Discussions of patient life goals are consistent with the patient plan of care requirements under § 494.90 and with clinical practice guidelines that emphasize integrating patient life goals into kidney replacement therapy decision-making and care planning as established under the ESRD Conditions for Coverage finalized in 2008 (73 FR 20370).
The D-PaLS PRO-PM assesses patients' satisfaction with whether and how their care team discusses life goals as part of treatment planning.
The population for this measure is patients on chronic dialysis in the U.S. who are at least 18 years old at the time of the survey and includes all payer types. The survey tool is available to dialysis patients in both U.S. English and in Spanish. Scoring for the D-PaLS PRO-PM is based on responses to the six individual Likert-type items that are used to generate a patient-level t-score. Response options for each item are scored from 1 to 5, with higher scores indicating greater patient agreement that the dialysis care team engages in discussions about the patient's life goals and treatment planning. For each patient at a given facility, the t-score represents a patient's perceptions of their satisfaction with their dialysis care team discussions about life goals, with t-scores greater than 40 indicating average or above average satisfaction with those discussions. The overall D-PaLS PRO-PM is calculated as the percentage of patients at a facility with a t-score greater than 40 (the facility level quality score).
The D-PaLS PRO-PM is not designed to evaluate individual life goals or whether patients achieve those goals; rather, the measure reflects the percentage of patients at a facility who report at least average satisfaction with discussions about life goals with their dialysis care team and the incorporation of those discussions into treatment planning. The intent of the D-PaLS PRO-PM is for the survey tool to be offered to patients for self-administration, with de-identified results and feedback provided to dialysis facilities. For additional details on the measure specifications, please refer to
We are seeking public comment on the proposed inclusion of the D-PaLS PRO-PM in the ESRD QIP and on the following considerations:
• Would inclusion of the D-PaLS PRO-PM provide valuable information on the extent to which facilities are asking about life goals and incorporating those discussions into treatment planning?
• What concrete approaches could dialysis facilities use to operationalize life-goal discussions on a regular basis into care planning, addressing barriers to care, modality selection including kidney transplantation, vascular access decisions, and other ESRD treatment decisions?
• To what extent can survey burden be minimized for patients while maintaining meaningful patient-reported outcomes around patient life goals discussions?
• What factors may affect patient participation or survey completion rates, and what strategies could CMS consider to encourage meaningful participation and high response rates across patients?
• What strategies could mitigate potential barriers to regular discussions of patient life goals (such as resource constraints, workflow integration, patient engagement and education) and support meaningful integration of these discussions into treatment planning?
• In addition to electronic delivery via email/text directly to patients, are there additional methods of delivery CMS should consider, for example for patients who may not access a computer or cell phone?
• What strategies could CMS use to capture information on patients who may be cognitively impaired or need a proxy to complete the survey?
On July 10, 2019, President Trump issued Executive Order (E.O.) 13879,
The ESRD PPS, implemented on January 1, 2011, established a bundled per-treatment payment for outpatient renal dialysis services furnished by ESRD facilities. While this system has served as the foundation of Medicare's ESRD payment framework for over a decade, the landscape of ESRD care delivery has evolved considerably. Advances in clinical practice, such as home dialysis technology, increased attention to the needs of beneficiaries approaching end-of-life, and growing clinical evidence supporting more flexible dialysis schedules, create opportunities to consider fundamental changes to Medicare's payment and coverage frameworks for ESRD and AKI care that could better support high-quality, patient-centered care across all dialysis modalities, settings, and patient populations.
In this section, we solicit public comment on several interrelated areas where potential payment and coverage policy changes could better align the ESRD PPS and AKI payment frameworks with the goals of E.O. 13879 and the evolving needs of ESRD beneficiaries. Specifically, we seek input on the following: (1) policies to promote greater use of home dialysis among Medicare beneficiaries; (2) approaches to strengthen care continuity and expand beneficiary choice of renal dialysis services that could be considered palliative in nature for beneficiaries approaching end-of-life; and (3) changes to the ESRD PPS to support greater flexibility for patients and nephrologists to use alternative dialysis schedules.
We note that these RFIs are intended solely to gather information and are not proposals for specific regulatory changes. Information received in response to these RFIs will be considered as CMS develops future rulemaking and policy initiatives in furtherance of E.O. 13879 and CMS's broader strategic priorities of aligning payment with value and advancing patient-centered care for Medicare beneficiaries with kidney disease. We note that the proposals in other sections of this proposed rule are not final policy and responders should not consider them as such when responding to the RFIs in this section.
CMS has statutory authority under section 1881(b)(14) of the Social Security Act (the Act) to implement a PPS for renal dialysis services furnished to individuals with ESRD. Under this authority, CMS established the ESRD PPS, which provides a bundled, per-treatment payment to ESRD facilities for renal dialysis services, as defined at § 413.171, furnished in outpatient settings.
The ESRD PPS base rate is adjusted to account for patient-level characteristics through case-mix adjustments, as well as for geographic differences in area wage levels through the wage index. The payment system also includes additional adjustments and policies, such as outlier payments for high-cost cases and a training add-on payment under § 413.235(c) for home dialysis modalities. CMS's implementing regulations for the ESRD PPS are codified at 42 CFR part 413, subpart H.
Home dialysis modalities, including PD and home HD, furnish clinically appropriate beneficiaries with the opportunity to receive renal replacement therapy in the home setting. The ESRD Conditions for Coverage at 42 CFR part 494 include requirements related to modality education and patient rights.
According to the most recent United States Renal Data System (USRDS) Annual Data Report, approximately 14 to 15 percent of prevalent (all people currently on dialysis in the U.S., not just new starters) dialysis patients nationally are treated with home modalities, with PD accounting for most home treatments and home HD comprising a smaller proportion. CMS ESRD PPS claims and dashboard data for Medicare Fee-For-Service (FFS) beneficiaries reflect similar utilization rates among the FFS population.
Although home dialysis utilization increased between 2019 and 2021, more recent data indicate that growth has moderated. Technique failure, modality switching, workforce constraints, geographic variation, and beneficiary-level factors (lack of education, limited caregiver support, fear of treatment complexity, housing constraints, and insufficient transitional support following hospitalization) may contribute to the observed plateau in prevalence rates. Based on recent Medicare FFS data, approximately 14.5 percent of prevalent FFS dialysis beneficiaries receive dialysis via home modalities. Interested parties have emphasized that increasing home dialysis requires more than provider-facing financial incentives and must address patient experience, education, support systems, operational barriers and infrastructure. They have stated that absent additional policy changes, current growth trends would not significantly increase.
Accordingly, we are soliciting comment on potential approaches, consistent with our statutory authority under section 1881 of the Act and implementing regulations at 42 CFR part 413, subpart H, that could increase home dialysis utilization among Medicare FFS beneficiaries. We are seeking public comment on policy, payment, operational, and regulatory changes within the ESRD PPS, and in coordination with other Medicare payment systems, when relevant, that could increase the percentage of incident, non-pediatric, non-MA ESRD beneficiaries initiating dialysis on a home modality and remaining on that modality. For purposes of this RFI, we use the term “incident ESRD beneficiaries” to refer to OM beneficiaries who newly initiate maintenance dialysis for ESRD during a given period, consistent with CMS ESRD PPS and United States Renal Data System (USRDS) conventions.
For purposes of this RFI, we are considering measuring home dialysis uptake among Medicare FFS ESRD beneficiaries defined as those initiating home dialysis and remaining on that modality for at least 60 days, excluding pediatric ESRD patients, as defined in § 413.171. This continuation threshold is intended to ensure sustained modality selection and prevent short-term initiation from inflating performance measurements.
We note that increasing overall home dialysis prevalence depends largely on influencing modality selection at initiation. Therefore, we are particularly interested in policies that would affect modality choice at or before the start of dialysis.
We are not proposing a specific numeric benchmark for the share of Medicare FFS ESRD beneficiaries who receive home dialysis. Instead, we seek comment on actionable policy changes that could measurably increase the number of incidences ESRD PPS beneficiaries select and sustain home dialysis. Commenters may wish to address how incremental increases in initiation rates would translate into additional incident beneficiaries selecting home modalities annually.
CMS emphasizes that modality selection must remain clinically appropriate and consistent with patient choice protections under § 494.70.
For purposes of informing public comment, CMS provides the following illustrative Medicare FFS baseline:
Approximately 220,000 chronic ESRD patients captured under the ESRD PPS
We seek comment on the feasibility of achieving a significant increase in utilization of the home dialysis modality for ESRD PPS patients.
Interested parties have identified multiple patient-level barriers affecting home dialysis initiation and retention, including limited education, fear of treatment complexity, inadequate in-home support, insufficient space for equipment and supplies, caregiver burden, and financial strain related to utilities and home modifications.
We seek comment on the following:
• What patient-level barriers directly prevent incident ESRD beneficiaries from selecting home dialysis?
• What payment or regulatory mechanisms would effectively mitigate these patient-level barriers within existing authority?
• What temporary or ongoing support would effectively enable beneficiaries to initiate and sustain home dialysis?
• How can CMS structure payment under the ESRD PPS to support beneficiaries who lack adequate care partner support?
• What policies could mitigate caregiver burnout and improve retention of home modalities?
• What approaches could reduce patients' fear of abandonment or lack of real-time support in the home setting?
• What approaches, including dialysis in a home setting, would improve ESRD beneficiaries' abilities to meet their life goals, as discussed in section IV.D. of this proposed rule?
Multiple interested parties have emphasized the importance of early and comprehensive modality education in increasing home dialysis selection.
We seek comment on the following:
• How can CMS improve access to and utilization of Kidney Disease Education (KDE) services prior to dialysis initiation?
• Whether CMS should consider revisions to payment amounts for HCPCS codes G0420 and G0421 to better support comprehensive modality education.
• Whether ESRD facilities should be permitted to furnish and bill for KDE services with appropriate safeguards.
• What policies would encourage earlier nephrology referral and shared decision-making prior to ESRD onset?
• What approaches can CMS use to ensure that beneficiaries who initiate dialysis emergently receive timely modality education and an opportunity to transition to home dialysis when clinically appropriate?
• To what extent should CMS consider if IPPS or Outpatient Prospective Payment System (OPPS) payment adjustments could incentivize urgent start PD programs?
Current home dialysis training payments have not been substantively updated for years. Interested parties have identified payment limitations and workforce constraints as barriers to expansion. While CMS is proposing to update the home and self-dialysis training add-on amount in section II.B.10. of this proposed rule, CMS seeks further comment on opportunities to expand access to home dialysis training while maintaining patient safety and quality of care. Specifically:
• Whether CMS should revise payments outside of the ESRD PPS to promote home dialysis, such as for CPT ® codes 90989 and 90993 to reflect current training intensity and costs.
• Whether CMS should redefine a completed course of home dialysis training to reflect demonstrated independent treatment over a defined period.
• Whether any ESRD CfCs related to patient training (for example, requirements for individualized training or staff competencies) may inadvertently limit the ability of facilities to scale home dialysis training capacity; and if so, what modifications, if any, CMS should consider.
• Whether aspects of the ESRD PPS payment structure for home dialysis training (including payment tied to individual training sessions) create incentives or operational constraints that limit the use of alternative training models (such as group-based or hybrid approaches).
• What safeguards and best practices would be necessary to ensure that alternative training approaches (
• What, if any, workforce development strategies would increase availability of trained home dialysis nurses, particularly in rural and underserved areas?
• To what extent can the patient education requirements regarding patient treatment modalities and setting (§ 494.70) be revised to ensure patients receive quality information through a process that is active, individualized, and iterative over time rather than a passive delivery of education materials?
• How frequently should this information (that is, regarding patient treatment modalities and setting) be offered to the patient? Should CMS specify format and delivery methods?
• How should education delivery and patient response be monitored and documented? What information should be captured and recorded? How should this be incorporated into the patient assessment and plan of care to address barriers to home dialysis to ensure it is acted upon?
• Should CMS revise minimum staff qualification requirements for those who may deliver home dialysis education? What education, qualification, and experience would be most appropriate?
Interested parties have proposed other approaches for using payment policy to directly encourage home dialysis, for example temporary staff-assisted home dialysis to support beneficiaries during initiation, following hospitalization, or during periods of caregiver strain.
We seek comment on the following:
• Whether CMS should create new payment mechanisms to promote home dialysis and what timing or clinical considerations would be relevant?
• Whether patients returning home following in-patient hospitalization, outpatient surgery, or serious injury should be eligible for temporary staff assistance to prevent modality failure. Modality failure, commonly used in nephrology, refers to the transition from a chosen dialysis treatment (such as PD) to another form (such as HD) due to technical problems, complications, or inadequate clearance. It signifies the failure of a specific treatment method to sustain a patient's health.
• Whether CMS should permit limited annual respite support to mitigate caregiver burnout?
• What eligibility criteria, staffing qualifications, and supervision requirements should be present within the CfCs for staff-assisted home dialysis to ensure patient safety and high-quality care? What clinical safeguards should be in place?
• What clinical, behavioral, or medical characteristics would make staff-assisted home dialysis inappropriate or unsafe?
• What safeguards should CMS consider to mitigate risks of overutilization or inappropriate use of staff-assisted home dialysis services, while preserving appropriate access for beneficiaries?
• How should such staff-assisted dialysis payments be structured within the ESRD PPS to support initiation and retention?
Interested parties have identified structural payment issues that may unintentionally favor in-center dialysis, including capital investment requirements and differential procedure reimbursement.
We seek comment on whether the following policies, if implemented, would meaningfully increase home dialysis utilization:
• Whether CMS should consider adjustments to the ESRD PPS base rate or related payment components under § 413.220 to better recognize infrastructure and support costs associated with home dialysis programs.
• Whether CMS should consider a redistribution within the ESRD PPS base rate structure under § 413.220 to facilitate home dialysis uptake.
• Whether CMS should consider a refinement of case-mix adjustments under § 413.235 to facilitate home dialysis uptake.
• Whether CMS should consider establishing a temporary add-on payment adjustment for beneficiaries initiating home dialysis, such as during the first 90 or 120 days of treatment, and how such a payment should be structured to ensure clinical appropriateness.
• Whether CMS should consider restructuring the ESRD PPS onset add-on payment adjustment under § 413.236(a)(2) to incorporate an education component tied to successful home dialysis initiation.
• Whether CMS should consider additional payment for supportive services, such as remote monitoring or enhanced clinical oversight, consistent with statutory authority.
• What costs for ESRD facilities are higher for home dialysis which are not currently accounted for by ESRD PPS payment mechanisms?
• What costs for ESRD beneficiaries are higher for home dialysis compared to in-center modalities?
• Whether CMS should revise the home dialysis training add-on payment adjustment under § 413.235(c) to reflect actual hours required for training.
• Whether modifications to the home dialysis training add-on payment adjustment under § 413.178(b) would materially affect uptake.
• Whether payment for CPT® code 90989 should be updated to reflect current inflation and training intensity.
• Whether CMS should redefine a “completed course” of training to reflect a patient's ability to complete a full month of home dialysis treatments independently, with the date of service defined as the last treatment date of the first full month of independent home dialysis.
• Whether CMS should increase payment for CPT® code 90993 to better reflect the resources associated with partial or interrupted training.
• Whether revised training payments would influence incident home dialysis uptake within the first 60 days of treatment.
• Whether CMS should consider restructuring the ESRD PPS onset add-on payment adjustment under § 413.236(a)(2) to incorporate a modality education component.
• Whether CMS should consider if the onset add-on payment should be divided into a care portion and an education portion.
• Whether CMS should consider if a potential education portion of the onset adjustment should be paid in a later month contingent upon successful home dialysis utilization for at least one month without assistance.
• Whether CMS should consider if restructuring the onset add-on adjustment could increase incident home dialysis selection and retention beyond 60 days.
• Whether CMS should consider enhanced public reporting of facility-level home dialysis rates prior to any modifications to QIP scoring methodologies to emphasize home dialysis utilization or improvement.
• Whether CMS should consider a home dialysis performance-based payment adjustment under the ESRD Quality Incentive Program (QIP) established under section 1881(h) of the Act.
• Whether CMS should consider clarifications to CfC requirements related to modality education under § 494.70. What specific changes would be needed to better clarify the information related to treatment modality, treatment setting, and services not offered by the facility that would support increased use of home dialysis?
• Whether factors such as current payment policy, operational practices, or other considerations may limit the use of alternative home dialysis training approaches (for example, group-based or hybrid models), and whether CMS should consider changes to support greater flexibility while maintaining individualized, patient-centered training and ensuring patient safety.
• Whether CMS should consider technical skills and patient evaluation to expand the types of licensed dialysis staff eligible to conduct training while maintaining patient safety.
• To what extent are workforce shortages limiting incident home dialysis uptake?
• What additional ESRD PPS modifications would most directly influence incident modality selection?
• Whether CMS should CMS encourages submission of quantitative analyses, actuarial estimates, and operational assessments.
• What modifications should CMS consider making to the CfCs to align with currently permissible certification action or determination by creating within the CfCs a designation of a “home-only” ESRD facility which would not provide any in-center dialysis? Is there evidence and data that under the current certification action that such a designation requires less physical infrastructure to provide care?
• What would be the impact of updating the CfCs to create a designation of a “self-dialysis-only” ESRD facility which would not provide any in-center dialysis other than self-dialysis (patients perform dialysis on themselves in-center)? Would such a designation require less staffing to provide care? What other CfC requirements would be necessary or need to be modified for this type of facility to ensure patient health and safety?
• Consideration as to whether modifications to the ESRD freestanding and hospital-based cost reports to capture more granular home dialysis costs will assist in aligning payment with value and encourage ESRD facilities to promote home dialysis modalities.
• Whether CMS should consider collecting separate data on travel costs
• Whether CMS should consider collecting more precise data on nursing hours per home training session.
• Whether CMS should collect data on hidden costs such as internet connectivity, equipment installation, shipping, and remote monitoring devices.
• Whether the advantages of collecting additional data on the ESRD cost reports would outweigh the administrative burdensome.
• CMS recognizes that certain Medicare FFS beneficiaries with advanced chronic kidney disease (CKD) or ESRD may be aligned with Accountable Care Organizations (ACOs) under the Medicare Shared Savings Program (Shared Savings Program) or CMS Innovation Center models, like the Kidney Care Choices (KCC) Model, that incorporate accountability for Medicare Parts A and B spending and quality. We seek comments to inform potential future rulemakings on whether care coordination structures, data sharing practices, or operational alignment between ESRD facilities and ACO participants could support clinically appropriate modality education around home dialysis and treatment planning at or prior to dialysis initiation, while preserving patient choice and avoiding duplicative or conflicting incentives across programs.
We are interested in whether changes in home dialysis technology since implementation of the ESRD PPS in 2011 have affected equipment installation requirements, as well as issues related to the delivery and storage of supplies.
We seek comment on the following:
• Has installation of home dialysis machines since 2011 changed significantly?
• Does the cost of any of the post-2011 required additional small home modifications affect patient's willingness to initiate home dialysis?
• Whether CMS should consider engaging with the home dialysis industry to improve supply ordering and delivery processes.
• Do excess supply delivery and storage requirements deter patients from selecting home dialysis?
• Whether CMS should consider providing time-limited additional payments to ESRD facilities that establish and implement in-center self-dialysis training and support programs, including patient education, supervised self-cannulation, and progressive independence in treatment tasks, designed to prepare beneficiaries to independently perform dialysis and transition to home dialysis modalities.
This includes consideration of whether temporary payment adjustments could support ESRD facilities developing in-center self-dialysis programs as transitional pathways to home dialysis.
We seek comment on the following:
• Whether CMS should consider, to the extent permitted under section 1881 of the Act and existing ESRD PPS authority, providing time-limited additional payments to ESRD facilities that establish and implement in-center self-dialysis training and support programs designed to prepare beneficiaries to independently perform dialysis and transition to home dialysis modalities.
• Whether an in-center self-dialysis program would measurably increase transition to home dialysis among incident beneficiaries.
• What staff qualifications and supervision should be required within the in-center facility during this time of transitional dialysis when the patient is progressing toward self-dialysis?
• How should CfC requirements be structured to better support patients in successfully transitioning to home dialysis? What requirements could be implemented to assist patients in reaching this goal?
Approximately half of ESRD facilities offer home dialysis programs.
We seek comment on the following:
• What levers CMS can employ to encourage additional facilities to establish home dialysis programs?
• To what extent CMS should consider infrastructure payments or time-limited adjustments to potentially increase geographic access.
• Are there changes that could be made to the requirements for home dialysis monitoring and/or support services that would reduce burden on dialysis facilities without negatively impacting patient health and safety?
This includes consideration of collaborative efforts within the PFS and OPPS to revise payment structures to recognize physician time and effort associated with referral to home dialysis and participation in home dialysis training.
We seek comment on the following:
• Whether CMS should test equalizing payments between PD catheter placement and vascular access placement to remove potential financial disincentives and whether demonstration authority should be used to test such alignment.
• Whether CMS should establish an additional payment recognizing the time physicians spend referring patients to home dialysis and coordinating training.
• Whether payment should be provided to physicians who actively participate in home dialysis training and care planning.
• Whether CMS should provide payment recognition for physicians supporting in-center self-dialysis programs that may serve as a transition pathway to home dialysis.
Consideration of collaborative efforts within the PFS to revise the MCP payment structure for physicians treating home dialysis patients.
We seek comment on the following:
• Whether CMS should consider payment variations for home dialysis patients under the MCP framework. Should we establish additional coding and payment for home dialysis MCP services for different numbers of visits?
• Whether MCP payment amounts for home dialysis patients should be higher than in-center MCP payments to reflect increased care coordination and oversight demands.
• Acknowledging that section 1881(b)(3)(B)(ii)(I) of the Act requires that patients receiving home dialysis have face-to-face (without the use of telehealth) clinical assessments with the physician at least monthly during the initial 3 months, how would greater telehealth flexibility for home dialysis patients improve retention and quality of care, including infection rates, within the first 60 days?
Patients often discontinue home dialysis following hospitalization or skilled nursing facility (SNF) admission.
We seek comment on the following:
• What policies would encourage continued use of PD in SNFs when clinically appropriate?
• Whether CMS should consider payment adjustments or demonstrations to incentivize SNFs to support home dialysis modalities.
• What additional health and safety requirements should be considered for ESRD facilities or nursing facilities to support continuity of modalities and ensure the safe delivery of home dialysis in this setting?
• What recommendations would improve the transition of dialysis patients between different care settings (hospital, institutional, and home)?
• Are ESRD facilities receiving electronic admission, transfer, and discharge notices as patients transition through hospitals so that they can monitor and track their patients? If not, why?
As noted previously, we are considering whether to focus on incident home dialysis initiation with a minimum duration threshold.
We seek comment on the following:
• Is a 60-day continuation threshold appropriate to ensure sustained initiation?
• To what extent CMS should consider a longer duration threshold for quality measurement purposes.
• How should CMS account for clinical contraindications or patient choice in assessing uptake?
Section 1881 of the Act establishes Medicare coverage and payment for renal dialysis services furnished to individuals with ESRD. CMS implemented the ESRD PPS beginning January 1, 2011 (75 FR 49030), which provides a bundled, per-treatment payment for renal dialysis services, including certain drugs, biologicals, laboratory services, and supplies.
The hospice benefit, established under section 1814(i) of the Act, provides a per diem payment to hospice providers for all items and services related to the palliation and management of the terminal illness and related conditions. Under current policy, services related to the terminal condition are not separately payable outside the hospice benefit.
Under the ESRD PPS, Medicare pays a single bundled amount for dialysis treatments furnished in-center or at home. This payment is intended to cover all renal dialysis services as defined in regulation at § 413.171.
Dialysis is life-sustaining but not curative. While it may be furnished consistent with palliative goals of care, current Medicare policy does not distinguish between maintenance dialysis and dialysis furnished in a comfort-focused context. As a result, payment policy does not explicitly account for palliative care objectives within ESRD treatment.
When ESRD is the terminal condition, hospice providers are responsible for furnishing dialysis services within the hospice per diem payment. Because dialysis is a high-cost service, it is rarely furnished under the hospice benefit in practice.
MedPAC reported relatively low rates of hospice utilization among ESRD beneficiaries and noted that dialysis costs may represent a substantial share of hospice payments if furnished within the hospice benefit.
Current policy requires that home dialysis be performed independently by the beneficiary or with the assistance of an unpaid caregiver. Medicare does not routinely pay for ongoing staff assistance in the home for dialysis treatments. This may create access barriers for beneficiaries with functional impairments, frailty, or lack of caregiver support.
These barriers may be particularly relevant for beneficiaries with palliative care goals who may benefit from receiving dialysis in a home-based, lower-burden setting.
In prior ESRD PPS rulemaking (see, for example, 84 FR 60648 through 60652), CMS emphasized goals of promoting home dialysis, improving patient experience, and supporting high-quality, patient-centered care. CMS also sought to maintain the integrity of prospective payment systems and avoid duplicative payment.
Consistent with these goals, CMS is exploring whether refinements to payment policy could improve access to palliative dialysis while maintaining the following: ESRD PPS bundled payment integrity; Hospice per diem integrity; and appropriate safeguards against duplicative payment and program integrity risks.
We are soliciting public comment on the following topics:
• How should CMS define “palliative dialysis” for purposes of Medicare policy?
• What clinical characteristics distinguish palliative dialysis from maintenance dialysis?
• Are there specific modalities or treatment patterns that are more consistent with palliative care?
• What objective and auditable criteria should be used to identify beneficiaries appropriate for palliative dialysis?
• Should eligibility be limited based on indicators such as serious illness, frailty, functional impairment, or limited prognosis?
• What role should existing constructs (for example, homebound status or hospice eligibility) play in defining the target population?
• Should CMS consider hybrid eligibility approaches that combine functional and prognostic criteria?
• What are the primary barriers to delivering palliative dialysis in home or community-based settings?
• Could access to staff-assisted home dialysis improve beneficiary experience for those receiving palliative dialysis?
• What services are necessary to support safe and effective home-based dialysis (for example, equipment setup, cannulation assistance, and monitoring)?
• How should CMS delineate responsibilities across ESRD facilities, home health agencies, and hospice providers? CMS also seeks comment on
• To what extent do current Medicare coverage and payment policies affect the ability of beneficiaries to receive home health and hospice services concurrently for different conditions, and how might these policies impact access to and coordination of dialysis services, including in the home setting?
• What operational or payment-related challenges do providers face in coordinating services across ESRD facilities, hospice providers, and home health agencies, and are there opportunities to improve alignment while maintaining program integrity and patient protections? CMS also seeks comment on the coordination of renal dialysis services with hospice care, including in the context of palliative dialysis:
• What are the operational, clinical, and financial barriers to coordination between ESRD facilities and hospice providers in furnishing palliative dialysis?
• What factors affect the feasibility of integrating hospice and dialysis services, including care planning, payment, and provider roles?
• Are there aspects of the ESRD CfCs or Hospice Conditions of Participation (CoPs) that may create challenges for coordination or alignment of patient goals for care?
• What best practices or models exist for integrating dialysis and hospice services while supporting patient-centered, goal-concordant care?
• What considerations should CMS take regarding staff training, care planning, and interdisciplinary coordination when dialysis is furnished in conjunction with hospice services?
• To what extent are palliative renal dialysis services currently encompassed within the ESRD PPS bundled payment?
• Are there services or supports that are not adequately reflected in current payment?
• What approaches could support palliative dialysis without creating duplicative payment across the ESRD PPS, Hospice PPS, and Home Health PPS?
• Should CMS consider time-limited or narrowly targeted payment adjustments?
• What safeguards are necessary to ensure appropriate targeting and prevent overutilization?
• How should CMS ensure that any policy remains focused on comfort-oriented care?
• What documentation, certification, or care planning requirements would be appropriate?
We are interested in feedback on potential approaches, including the following: Targeted refinements within the ESRD PPS; time-limited supports for home-based dialysis; Models testing staff-assisted home dialysis for narrowly defined populations; approaches to improve coordination between ESRD care and hospice services while preserving hospice bundle integrity; and model testing under section 1115A of the Act (CMS Innovation Center), including demonstrations designed to assess quality improvement and cost impacts.
Section 1881(b)(14)(C) of the Social Security Act (the Act) authorizes payment under the ESRD PPS based on renal dialysis services furnished during a week, or month, or such other appropriate unit of payment as the Secretary specifies. When we implemented the ESRD PPS beginning January 1, 2011, we established payment on a per-treatment basis (75 FR 49064). In developing that policy, we considered other units of payment, including a monthly ESRD PPS, which would provide ESRD facilities more flexibility in alternative treatment requirements, such as increased frequency nocturnal dialysis, home HD using compact portable dialysis machines, and shorter but more frequent dialysis services. However, given the difficulties of implementing a monthly ESRD PPS during the transition period in which a per-treatment methodology applied, we chose to continue the per-treatment payment methodology that had been in effect under the composite rate system prior to the ESRD PPS (75 FR 49064). That transition period concluded on December 31, 2013.
In the CY 2011 ESRD PPS final rule, we noted that MedPAC recommended that we reconsider the unit of payment once a strengthened dialysis quality monitoring system is implemented, to ensure that quality of care does not decline (75 FR 49064). In its comments on the CY 2011 ESRD PPS proposed rule, MedPAC noted that a larger unit of payment would be consistent with several aspects of dialysis care, pointing out that a weekly unit of payment corresponds to the typical weekly interval for PD. MedPAC also noted that Medicare pays nephrologists a monthly capitated payment for caring for dialysis beneficiaries (75 FR 49064). Since that time, the ESRD Quality Incentive Program (QIP) and the Five-Star Quality Rating System for dialysis facilities have been established and are well-functioning, addressing the quality monitoring concern MedPAC identified.
Although the ESRD PPS unit of payment is a treatment, renal dialysis services are billed monthly. In addition, the ESRD PPS currently makes a daily rate payment, which is effectively a prorated monthly payment, for certain renal dialysis services. Specifically, home Continuous Ambulatory PD (CAPD) and Continuous Cycling PD (CCPD) are paid daily for the number of PD days billed in the month, following the payment approach for this modality that has been in place since the inception of the composite rate payment system in 1983. For home patients undergoing PD, the number of days of PD, regardless of the number of dialysate exchanges performed each day, is converted to home HD-equivalent sessions by dividing the number of days of PD by 7 and multiplying the result by 3 (see Medicare Benefit Policy Manual, Chapter 11). For example, a patient receiving 30 days of home CAPD would be paid an amount equal to 12.857 home HD-equivalent treatments (30 ÷ 7 × 3 = 12.857). This approach creates a per-treatment amount that is paid for each day of PD treatment and that complies with the monthly treatment payment limit of 13 treatments in a 30-day month and 14 treatments in a 31-day month (81 FR 42809).
This existing methodology demonstrates that a daily rate structure is operationally feasible within the current ESRD PPS framework and has been successfully administered by MACs for over four decades. When thinking about alternative units of payment for the ESRD PPS, a daily payment rate is effectively the same as a prorated monthly payment rate, which functions identically to a monthly payment rate in the case that an ESRD facility bills for a full month, but also offers additional flexibility. Importantly, the daily rate payment allows for more flexible payment for renal dialysis services during service interruptions such as hospitalizations. A daily rate payment could also provide flexibility when a patient temporarily receives
In recent public comments, interested parties have further noted that some renal dialysis services do not directly correspond to a dialysis treatment. For example, oral phosphate binders, which were incorporated into the ESRD PPS bundled payment beginning January 1, 2025, through the TDAPA, and which we are proposing to incorporate into the ESRD PPS base rate beginning in CY 2027, are typically taken daily with meals and often follow irregular dosing schedules. Other oral drugs, as well as clinical interventions such as patient education, access management, and nutrition management, may occur outside the boundaries of a dialysis session. Furthermore, alternative treatment options—such as in-center self-dialysis, nocturnal dialysis, and more frequent home HD, or more conservative approaches for renal care which may not focus on dialysis—may involve treatment schedules that align more naturally with a monthly unit of payment than with the current per-treatment payment structure.
These considerations lead us to examine whether a change to the unit of payment for the ESRD PPS could more appropriately recognize patient-specific needs and better align payment with overall resource use, while continuing to advance the principles of prospective payment and the goals of Executive Order 13879,
Beyond administrative simplification, a daily rate structure could better support patient-centered care by reducing financial disincentives associated with alternative dialysis schedules. Under the current per-treatment payment structure, the ESRD PPS was designed around a conventional thrice-weekly home HD schedule. As noted in the CY 2011 ESRD PPS final rule, CMS recognized that a monthly unit of payment would provide ESRD facilities with more flexibility in alternative treatment requirements, such as increased frequency nocturnal dialysis, home HD using compact portable dialysis machines, and shorter but more frequent dialysis services (75 FR 49064). A daily rate structure could reduce the rigidity of the current payment framework and better support individualized treatment plans developed collaboratively by patients and their nephrologists, without creating financial incentives to adhere to a fixed treatment schedule when a patient's clinical needs call for a different approach. For patients who would benefit from more frequent dialysis—such as those with fluid management challenges, cardiovascular comorbidities, or a preference for shorter, more frequent sessions—a daily payment structure could remove a structural barrier to accessing those options.
At the same time, we recognize that such a change would represent a significant operational shift for ESRD facilities, MACs, and CMS systems, and would require careful consideration of how to maintain budget neutrality, preserve payment equity across modalities, protect beneficiary access to care, and ensure that payment incentives continue to support high-quality, appropriate care. We are mindful that any change to the unit of payment must be designed to ensure that patients receive all medically necessary services and that providers are not inadvertently incentivized to reduce the frequency or intensity of care. We seek public input on how a daily payment structure could be designed and monitored to achieve these goals.
We are soliciting public comment on the potential advantages, challenges, and operational considerations associated with changing the ESRD PPS unit of payment from a per-treatment to a monthly (daily rate) structure. We are not proposing any specific changes; rather, we are seeking information to inform potential future rulemaking. Specifically, we request comments on the following questions:
• Would it be appropriate for the ESRD PPS to adopt a daily payment rate following the methodology currently applied for home CAPD and CCPD (that is, a daily rate equal to three-sevenths (3/7) of the per-treatment base rate)? What are the advantages and disadvantages of this approach compared to the current per-treatment payment structure?
• Should a daily rate apply to all dialysis modalities, or are there specific modalities or circumstances for which we should consider a hybrid approach? If we should consider a hybrid approach, please explain why and describe how such an approach should be structured.
• What specific administrative burden associated with the current per-treatment payment structure would be reduced or eliminated under a daily rate? Conversely, what new administrative requirements might a daily rate introduce, and how could those be minimized? We are particularly interested in the perspectives of smaller, independent ESRD facilities.
• To what extent would a daily payment rate reduce barriers to alternative dialysis schedules, such as nocturnal dialysis, short daily home HD, or more frequent home HD? Are there specific treatment modalities or patient populations for which a daily rate would most meaningfully expand access to individualized care?
• How would a daily payment structure affect patients who receive care at multiple facilities or experience interruptions in service during a month? What billing and claims processing safeguards would be needed to prevent duplicate payment and ensure accurate reimbursement when a patient transfers between facilities?
• How should the daily rate be calibrated to maintain budget neutrality while accounting for differences in resource intensity between home HD and PD? Are there specific cost components or patient populations that would require special consideration in establishing a budget-neutral daily rate?
• Should CMS consider changes to the patient-level adjustment factors under the ESRD PPS to account for conditions associated with differences in the number of medically necessary treatments each month? If so, which patient conditions are the primary drivers of patient-level cost variation, and how should those conditions be reflected in a daily payment framework?
• What processes or frameworks could CMS consider to appropriately recognize changes in patient-level cost variation that may occur over time due to developments in clinical practice such as the introduction of new drugs, technologies, or other therapies that would be considered renal dialysis services?
• What, if any changes should CMS consider making to the ESRD PPS outlier policy to account for unusual variations in the type or amount of medically necessary care in the context of a monthly or daily payment rate? How should the outlier threshold and payment cap be structured under a daily payment system? We note that under the current payment system for CAPD and CCPD, we calculate outlier spending per home HD-equivalent treatment, which is compared to the standard outlier threshold values to determine the applicable outlier amount. We note that we could apply a similar methodology for daily rate outlier calculations in the future, or we could consider changes to our methodology.
• How should CMS design quality monitoring and oversight mechanisms to ensure that a shift to a daily payment rate would not create incentives for providers to reduce the frequency, duration, or intensity of dialysis services below what is clinically appropriate for individual patients? What quality measures, data reporting requirements, or audit mechanisms would be most effective in detecting and deterring underutilization of care under a daily payment structure? We seek comment on whether the current quality monitoring infrastructure, including the ESRD QIP and the Five-Star Quality Rating System, is sufficient to support a transition to a daily payment rate, and whether any enhancements to those programs would be needed.
• What steps could CMS take toward advancing value-based purchasing in ESRD and AKI care? How does the provision of high-quality ESRD and AKI care for Medicare beneficiaries impact costs for ESRD facilities providing renal dialysis services and how does it impact beneficiaries' total cost of care across settings?
• Which patient populations would be best served by a daily payment rate? Would any patient populations—such as pediatric patients, patients with AKI, or patients receiving palliative dialysis—be better served by maintaining a per-treatment payment amount? If so, please explain why and describe how CMS should structure payment for those populations.
• What necessary changes, if any, would ESRD facilities need to make to their billing systems, internal tracking processes, and operational workflows to accommodate a change to the unit of payment? How long do ESRD facilities anticipate they would need to implement these changes? Are there specific MAC system changes or claims processing edits that would be required?
• How does the current ESRD PPS unit of payment, and conversely how would a daily unit of payment, compare to payment structures that other payors use to pay for renal dialysis services?
Under the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501-3520, we are required to provide notice in the
• The need for the information collection and its usefulness in carrying out the proper functions of our agency.
• The accuracy of our estimate of the information collection burden.
• The quality, utility, and clarity of the information to be collected.
• Recommendations to minimize the information collection burden on the affected public, including automated collection techniques.
We are soliciting public comment on each of these issues for the following sections of this document that contain information collection requirements (ICRs):
We refer readers to the CY 2026 ESRD PPS final rule for information regarding previously used wage estimates and resulting information collection burden calculations used in this proposed rule (90 FR 53121 through 53122). To derive wage estimates, we used data from the United States Bureau of Labor Statistics' May 2025 National Occupational Employment and Wage Estimates for Medical Records Specialists, who are responsible for organizing and managing health information data, are the individuals tasked with submitting measure data to the ESRD Quality Reporting System (EQRS) (formerly, CROWNWeb) and the Centers for Disease Control and Prevention's (CDC's) NHSN, as well as compiling and submitting patient records for the purpose of data validation. When this analysis was conducted, the most recently available median hourly wage of a Medical Records Specialist (SOC 29-2072) was $24.59 per hour.
We used this wage estimate, along with updated facility and patient counts, to update our estimates for the total information collection burden in the ESRD QIP for PY 2029. We will update the information collection burden to reflect updated facility and patient counts in the CY 2027 ESRD PPS final rule.
We refer readers to the CY 2026 ESRD PPS final rule for information regarding the estimated burden associated with data validation requirements for PY 2028 (90 FR 53122).
In this proposed rule, using the most recently available data, we estimate that the aggregate cost of the EQRS data validation for PY 2029 will be approximately $36,885 (750 hours × $49.18), or an annual total of approximately $122.95 ($36,885/300 facilities) per facility in the sample. We will update the aggregate cost of EQRS data validation to reflect updated wage estimates in the CY 2027 ESRD PPS final rule. The burden cost increase associated with these requirements will be submitted to OMB in the revised information collection request (OMB control number 0938-1340).
In this proposed rule, we estimate that the aggregate cost of the NHSN data validation for PY 2029 will be approximately $73,770 (1,500 hours × $49.18), or a total of approximately $245.90 ($73,770/300 facilities) per facility in the sample. We will update the aggregate cost of NHSN data validation to reflect updated wage estimates in the CY 2027 ESRD PPS final rule. While the burden hours estimate will not change, the burden cost updates associated with these requirements will be submitted to OMB as a revision of the information collection request currently approved under OMB control number 0938-1340.
To estimate the burden associated with the EQRS reporting requirements (previously known as the CROWNWeb reporting requirements), we look at the total number of patients nationally, the number of data elements per patient-year that the facility will be required to submit to EQRS for each measure, the amount of time required for data entry, the estimated wage plus benefits applicable to the individuals within facilities who are most likely to be entering data into EQRS, and the number of facilities submitting data to EQRS. In the CY 2026 ESRD PPS final rule, we estimated that the burden associated with EQRS reporting requirements for the PY 2028 ESRD QIP was approximately $125 million for approximately 2,588,770 total burden hours (90 FR 53122).
We are proposing measure updates in this proposed rule that would affect the burden associated with EQRS reporting requirements beginning with PY 2029. We are proposing two measure removals and one measure adoption that would affect the burden associated with EQRS reporting requirements beginning with PY 2029. We provide the burden estimate for PY 2029 in this proposed rule to reflect the impact of these proposals if finalized and will update the information collection burden to reflect updated facility and patient counts in the CY 2027 ESRD PPS final rule. In this proposed rule, we estimated that the amount of time required to submit measure data to EQRS would be 2.5 minutes per element and did not use a rounded estimate of the time needed to complete data entry for EQRS reporting. There are 109 data elements for 513,475 patients across 7,582 facilities, for a total of 55,968,775 elements across all patients (109 data elements × 513,475 patients). If the two measure removals and one measure adoption are finalized as proposed, the total number of data elements would decrease to 49,807,075 data elements based on current patient and facility counts. At 2.5 minutes per element, the changes would yield approximately 274 hours per facility. Therefore, the PY 2029 burden would be 2,075,295 hours (approximately 274 hours × 7,582 facilities). Using the Medical Records Specialist wage estimates available at this time, we estimate that the PY 2029 total burden cost will be approximately $102.1 million (2,075,295 hours × $49.18). The estimated reduction in burden associated with the measure updates is described in Table 25.
The information collection request currently approved under the OMB control number 0938-1340 will be revised and submitted to OMB for approval.
If you comment on these information collections, that is, reporting, recordkeeping, or third-party disclosure requirements, please submit your comments electronically as specified in the
Comments must be received by the date and time specified in the
Because of the large number of public comments we normally receive on
On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled PPS for renal dialysis services furnished by ESRD facilities as required by section 1881(b)(14) of the Act, as added by section 153(b) of MIPPA (Pub. L. 110-275). Section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA, and amended by section 3401(h) of the Affordable Care Act (Pub. L. 111-148), established that beginning CY 2012, and each subsequent year, the Secretary shall annually increase payment amounts by an ESRDB market basket percentage increase, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. This rule proposes routine updates to the payment rate for renal dialysis services furnished by ESRD facilities and proposes to rebase and revise the ESRDB market basket and labor-related share. This rule also proposes policy changes to the ESRD PPS for CY 2027, including updates to our ESRD PPS wage index, outlier threshold, TPNIES offset amount, and post-TDAPA add-on payment adjustment amounts to reflect the latest available data for Korsuva®, DefenCath®, and Vafseo®. We are also
This rule proposes updates to the payment rate for renal dialysis services furnished by ESRD facilities to individuals with AKI. Failure to publish this proposed rule would result in ESRD facilities not receiving appropriate payments in CY 2027 for renal dialysis services furnished to patients with AKI in accordance with section 1834(r) of the Act.
Section 1881(h)(1) of the Act requires CMS to reduce the payments otherwise made to a facility under the ESRD PPS for a year by up to 2 percent if the facility does not satisfy the requirements of the ESRD QIP for that year. This rule proposes updates for the ESRD QIP, which would replace the Hypercalcemia reporting measure with the Facility Level Percentage of Chronic Hyperphosphatemia clinical measure. This rule also proposes updates to the NHSN BSI clinical measure. Additionally, this rule proposes to remove the MedRec reporting measure and the COVID-19 Vaccination Coverage Among HCP reporting measure from the ESRD QIP measure set beginning with PY 2029.
This proposed rule includes several RFIs related to potential policies to (1) increase home dialysis utilization among incident ESRD PPS beneficiaries, (2) improve access to palliative care for ESRD beneficiaries, and (3) promoting efficiency in dialysis service delivery by reevaluating the unit of payment under the ESRD PPS and AKI dialysis payment system. This section constitutes RFIs only. CMS is not proposing specific policy changes related to the RFIs at this time.
We have examined the impacts of this rule as required by Executive Order 12866, “Regulatory Planning and Review”; Executive Order 13132, “Federalism”; Executive Order 13563, “Improving Regulation and Regulatory Review”; Executive Order 14192, “Unleashing Prosperity Through Deregulation”; the Regulatory Flexibility Act (RFA) (Pub. L. 96-354); section 1102(b) of the Social Security Act; and section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
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 Executive Order 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.
A regulatory impact analysis (RIA) must be prepared for a regulatory action that is significant under section 3(f)(1) of Executive Order 12866. Based on our analysis, OMB's Office of Information and Regulatory Affairs (OIRA) has determined this rulemaking is significant pursuant to section 3(f)(1) of Executive Order 12866. Accordingly, we have prepared a Regulatory Impact Analysis that presents, to the best of our ability, the estimated costs and benefits associated with this rulemaking.
We estimate that the proposed revisions to the ESRD PPS would result in an increase of approximately $90 million in ESRD PPS payments to ESRD facilities in CY 2027. This includes the estimated impact of the proposed ESRD PPS market basket update of 1.6 percent ($130 million), as well as the estimated changes in payments associated with several changes that are expected between CYs 2026 and 2027. The net effect of the offsetting increases and decreases to payments, as discussed in the following paragraph, results in the estimated $90 million overall increase in ESRD PPS payments to ESRD facilities in CY 2027.
First, as discussed in section II.B.3.b. of this proposed rule, we estimate that outlier payments in CY 2026 will be approximately 3.0 percent of total ESRD PPS payments. Accordingly, the proposed increases to the FDL and MAP amounts for CY 2027 are projected to reduce ESRD PPS payments by approximately 1.9 percent ($150 million). At the same time, we estimate that approximately $430 million will be paid through the TDAPA for DefenCath®, Vafseo®, and phosphate binders in CY 2026. The end of the TDAPA periods for these drugs is projected to result in a corresponding decrease to CY 2027 payments of $430 million (5.5 percent), which is offset by the proposed 5.3 percent increase to the ESRD PPS base rate for phosphate binders and the estimated 2.0 percent increase in payments under the post-TDAPA add-on payment adjustment in CY 2027. The net difference between estimated CY 2026 TDAPA payments and estimated CY 2027 payments under the post-TDAPA add-on payment adjustment and the ESRD PPS base rate, including the proposed incorporation of phosphate binders, is a 1.5 percent increase in payments to ESRD facilities. In addition, this amount includes, but is not impacted by, any budget neutral proposals for CY 2027 such as the routine updates to the ESRD PPS wage index, labor-related share, and the changes to the LVPA. In addition, for public awareness, we estimate that the updated CY 2027 post-TDAPA add-on payment adjustments will total approximately $170 million, an increase from around $34 million in CY 2026. These amounts are included in the estimated $90 million overall increase in ESRD PPS payments for CY 2027, because as we previously noted the net effect of the offsetting increases and decreases to payments, as discussed in the prior paragraph, results in the estimated $90 million overall increase in ESRD PPS payments to ESRD facilities in CY 2027.
We estimate that the proposed updates to the AKI dialysis payment rate would result in an increase of approximately $5 million in Medicare payments to ESRD facilities in CY 2027.
We estimate that, as a result of our previously finalized policies and the policies we are proposing in this proposed rule, the updated ESRD QIP will result in $23.3 million in estimated
These RFIs solicit comments on increasing home dialysis uptake, improving palliative care under the ESRD PPS, and promoting efficiency in dialysis service delivery. These RFIs do not propose any policy changes and therefore do not have a direct economic impact under Executive Order 12866.
We estimate that the combined impact of the policies proposed in this rule on payments for CY 2027 is approximately $90 million based on the combined estimates of the updated ESRD PPS and the AKI dialysis payment rates.
In this section, we discuss the anticipated benefits, costs, and transfers associated with the changes in this proposed rule. Additionally, we estimate the total regulatory review costs associated with reading and interpreting this proposed rule.
Under the proposed CY 2027 ESRD PPS and AKI dialysis payment, ESRD facilities would continue to receive payment for renal dialysis services furnished to Medicare beneficiaries under a case-mix adjusted PPS. We continue to expect that making prospective Medicare payments to ESRD facilities will enhance the efficiency of the Medicare program. Additionally, we expect that updating the Medicare ESRD PPS base rate and rate for AKI dialysis treatments furnished by ESRD facilities by 6.3 percent based on the proposed CY 2027 ESRDB market basket percentage increase of 2.6 percent reduced by the proposed CY 2027 productivity adjustment of 1.0 percentage point, as well as the proposed increase to the ESRD PPS base rate from the inclusion of phosphate binders into the base rate, would improve or maintain beneficiary access to high quality care by ensuring that payment rates reflect the best available data on the resources involved in delivering renal dialysis services. We estimate that overall payments under the ESRD PPS would increase by 1.1 percent and payments under the AKI payment system would increase by 6.0 percent because of the proposed policies in this rule.
We do not anticipate the provisions of this proposed rule regarding ESRD PPS and AKI rates-setting will create additional cost or burden to ESRD facilities.
We have made no changes to our methodology for calculating the annual burden associated with the information collection requirements for EQRS data validation (previously known as the CROWNWeb validation study) or NHSN data validation. Although we do not anticipate that the proposals in this proposed rule regarding ESRD QIP will create additional cost or burden to ESRD facilities for PY 2029, we intend to update the estimated costs associated with the information collection requirements under the ESRD QIP in the CY 2027 ESRD PPS final rule, with updated estimates of the total number of ESRD facilities, the total number of patients nationally, and a refined estimate of the number of hours needed to complete data entry for EQRS reporting.
We estimate that the proposed updates to the ESRD PPS and AKI dialysis payment rates would result in a total increase of approximately $90 million in Medicare payments to ESRD facilities in CY 2027, which includes the amount associated with the proposed inclusion of phosphate binders to the base rate, the proposed updates to the outlier threshold amounts, and proposed updates to the ESRD wage index. This estimate includes an increase of approximately $5 million in Medicare payments to ESRD facilities in CY 2027 due to the proposed updates to the AKI dialysis payment rate, of which approximately 20 percent is increased beneficiary coinsurance payments. We estimate approximately $70 million in transfers from the Federal Government to ESRD facilities due to increased Medicare program payments and approximately $20 million in transfers from beneficiaries to ESRD facilities due to increased beneficiary coinsurance payments because of this proposed rule.
If regulations impose administrative costs on private entities, such as the time needed to read and interpret this ESRD PPS proposed rule, we should estimate the cost associated with regulatory review. Due to the uncertainty involved with accurately quantifying the number of entities that will review the ESRD PPS proposed rule, we assume that the total number of unique commenters on last year's ESRD PPS proposed rule, which was 208 for the CY 2026 ESRD PPS proposed rule, is equal to the number of individual reviewers of this proposed rule. We acknowledge that this assumption may understate or overstate the costs of reviewing this proposed rule. It is possible that not all commenters reviewed last year's proposed rule in detail, and it is also possible that some reviewers chose not to comment on the CY 2026 ESRD PPS proposed rule. For these reasons, we determined that the number of past commenters would be a fair estimate of the number of reviewers of this proposed rule. We used a similar methodology for calculating the regulatory review costs in the CY 2026 ESRD PPS proposed and final rules. We solicit comments on this approach.
We also recognized that different types of entities are in many cases affected by mutually exclusive sections of this proposed rule, and therefore for the purposes of our estimate we assumed that each reviewer reads approximately 50 percent of this proposed rule. We seek comments on this assumption.
Using the BLS OEWS May 2025 National, cross-industry median hourly wage information for medical and health service managers (SOC 11-9111), we estimate that the cost of reviewing this rule is $119.10 ($59.55 * 2) per hour, including overhead and fringe benefits
To understand the impact of the proposed changes affecting Medicare payments to different categories of ESRD facilities, it is necessary to compare estimated payments in CY 2026 to estimated payments in CY 2027. To estimate the impact among various types of ESRD facilities, it is imperative that the estimates of Medicare payments in CY 2026 and CY 2027 contain similar inputs. Therefore, we simulated Medicare payments only for those ESRD facilities for which we can calculate both current Medicare payments and new Medicare payments.
For this proposed rule, we use CY 2025 data from the Medicare Part A and Part B Common Working Files as of February 13, 2026, as a basis for Medicare dialysis treatments and payments under the ESRD PPS. We updated the 2025 claims to 2026 and 2027 using various updates. The proposed updates to the ESRD PPS base rate are described in section II.B.4. of this proposed rule. Table 26 shows the impact of the estimated CY 2027 ESRD PPS payments compared to estimated ESRD PPS payments to ESRD facilities in CY 2026.
Column A of the impact table indicates the number of ESRD facilities for each impact category.
Column B indicates the number of dialysis treatments (in millions).
Column C represents the change in payment to each ESRD facility type based on the changes to the outlier FDL and MAP amounts proposed in section II.B.3. of this proposed rule. As we previously discussed, we estimate a 1.9 percent reduction in ESRD PPS payments to reduce outlier payments to better align with the 1.0 percent outlier target in CY 2027. The largest projected decrease would be approximately 4.8 percent for hospital-based ESRD facilities.
Column D represents the changes in simulated payments between CY 2026 and CY 2027 due to routine changes in TDAPA eligibility for Vafseo®, which will become outlier eligible and be included in the post-TDAPA add-on payment adjustment calculation beginning January 1, 2027, at the end of its TDAPA period, and DefenCath®, which is paid for through the TDAPA until July 1, 2026 and is included in the post-TDAPA add-on payment adjustment calculation for the third and fourth quarters of CY 2026. DefenCath® will continue to be outlier eligible and included in the post-TDAPA add-on payment adjustment in CY 2027. This column also represents the difference between simulated TDAPA payments for phosphate binders in CY 2026 and simulated payments under the ESRD PPS base rate for these drugs in CY 2027.
Column E represents the impact of proposed budget neutral changes to payments for pediatric ESRD patients, including the proposed revisions to the pediatric case-mix adjusters as well as the proposed expansion of the LVPA to treatments for pediatric ESRD patients. Table 26 shows that these proposed policies would increase payments by 2.0 percent to ESRD facilities with 50 percent or more pediatric patients, while the largest decrease would be 0.3 percent for ESRD facilities with between 2 and 49 percent pediatric patients.
Column F represents the impact of proposed budget neutral changes to the LVPA. The largest estimated increase would be 6.7 percent for ESRD facilities furnishing between 4,000 and 4,999 treatments per year. Conversely, we estimate that payments to ESRD facilities furnishing more than 8,000 treatments per year would decrease approximately 1.1 percent.
Column G represents the impact of proposed budget neutral changes to the home and self-dialysis training add-on, which we estimate would have distributional impacts of 0.1 percentage point or less for nearly all categories of ESRD facilities.
Column H represents the effect of the proposed updates to the ESRD PPS wage index for CY 2027, including the continued application of the 5 percent cap on wage index decreases. This column also shows the effect of the proposal to update the LRS from 55.2 percent to 63.5 percent in CY 2027. These proposed updates would be budget neutral, so the total impact of these proposed policy changes is 0.0 percent. However, we estimate there would be distributional impacts because of these proposed updates. The largest increase would be to ESRD facilities in the Pacific region, which would receive 1.8 percent higher payments because of the updated ESRD PPS wage index and LRS. The largest decrease would be for ESRD facilities in the East South Central region, which would receive 1.5 percent lower payments because of the updated ESRD PPS wage index and LRS.
Column I reflects the overall impact of the policies discussed in this proposed rule, including the routine updates to the wage index, outlier thresholds, and post-TDAPA add-on payment adjustment amounts as well as the proposed inclusion of phosphate binders into the base rate, the proposed changes to payments for pediatric ESRD patients, the proposed LVPA changes, and the proposed changes to the home and self-dialysis training add-on. This column also reflects the proposed ESRD PPS payment rate update for CY 2027 of 1.6 percent, which reflects the proposed ESRDB market basket percentage increase for CY 2027 of 2.6 percent reduced by the proposed productivity adjustment of 1.0 percentage point. We expect that overall ESRD facilities would experience a 1.1 percent increase in estimated Medicare payments in CY 2027. The categories of types of ESRD facilities in the impact table show impacts ranging from a 5.6 percent decrease in CY 2027 estimated Medicare payments for regional chains to a 5.6 percent increase in estimated payments for independent facilities.
Under the ESRD PPS, Medicare pays ESRD facilities a single bundled payment for renal dialysis services, which may have been separately paid to other providers or suppliers (for example, laboratories, and durable medical equipment suppliers) by Medicare prior to the implementation of the ESRD PPS. Therefore, in CY 2027, we estimate that the ESRD PPS will have zero impact on these other providers.
We estimate that Medicare spending (total Medicare program payments) for
ESRD facilities in CY 2027 would be approximately $6.2 billion. This estimate considers a projected decrease in FFS Medicare ESRD beneficiary enrollment of 1.5 percent in CY 2027.
Under the ESRD PPS, beneficiaries are responsible for paying 20 percent of the ESRD PPS payment amount. As a result of the projected 1.1 percent overall increase in the CY 2027 ESRD PPS payment amounts, we estimate that there would be an increase in beneficiary coinsurance payments of 1.1 percent in CY 2027, which translates to approximately $20 million.
In section II.B.7. of this proposed rule, we discuss our proposal to incorporate phosphate binders into the ESRD PPS base rate. We considered, but did not propose, delaying the incorporation of phosphate binders and continuing TDAPA for another year. We did not propose to continue TDAPA for a third year after we evaluated utilization data during the first year of TDAPA and met with several interested parties through public meetings where they recommended incorporation this year.
We also considered alternative ways to account for operational costs when proposing the incorporation of phosphate binders. We considered basing the increased amount on the $36.41 paid during TDAPA. We also considered not including an increased amount as some operational costs associated with furnishing oral drugs is already included in the ESRD PPS base rate. As discussed in section II.B.7. of this proposed rule, we are proposing to recalculate the operational increase based on more recent utilization and price data. We believe that this proposed policy strikes the appropriate balance by capturing the operational costs not already included in the ESRD PPS base rate while accounting for the efficiency of the ESRD PPS.
We note that our proposed base rate modification would cause a relatively uniform and significant increase in payments across all provider types, including small entities. As we have previously discussed, this increase in payments is partially offset by the projected decrease in TDAPA payments from CY 2026 to CY 2027. For small entities, including independent ESRD facilities, hospital-based ESRD facilities,
As discussed in section II.B.8. of this proposed rule, we are proposing to extend the LVPA beyond the current treatment volume threshold of 4,000 treatments per year in a budget neutral manner. We considered proposing this policy non-budget neutrally but did not do so because budget neutrality for this proposal is more consistent with our well-established methodologies. We also considered alternative tier structures, for example an 8-tiered structure that includes separate tiers for facilities that furnish fewer than 1,000 and 1,000 to 2,000 treatments or a 4-tier structure that stops at 6,000 treatments. As discussed in section II.B.8. of this proposed rule, we proposed the 6-tier methodology based on our analysis of cost report data and consideration of responses to comments on our CY 2024 RFI on the LVPA. We note that this proposed policy would have a positive impact on smaller ESRD facilities that furnish fewer than 8,000 treatments per year. For the smallest ESRD facilities that furnish fewer than 3,000 treatments per year, this increase is estimated to be approximately 1.6 percent. For independent and hospital-based ESRD facilities, we estimate an impact of 0.1 percentage point or less. We believe this proposed change to the LVPA would appropriately align payment with resource use for small entities and therefore, we did not consider alternatives to minimize the impact of the proposed increases for those categories of small entities that would be significantly impacted.
As discussed in section II.B.9. of this proposed rule, we are proposing to recalculate the case-mix adjustment factors for pediatric ESRD patients. We considered, but did not propose, to extend the TPEAPA rather than establish permanently increased adjustment factors. We considered this so that we could have more time to collect and evaluate pediatric specific cost report data. However, as noted in the section, we believe that we have enough information to establish permanent adjusters for CY 2027, and our evaluation of cost report data indicates that the proposed adjusters are appropriate.
For small entities, including independent ESRD facilities, hospital-based ESRD facilities, and ESRD facilities furnishing fewer than 3,000 treatments per year, we note that the impact of these proposed policies is estimated to be 0.2 percentage point or less and therefore, we did not consider alternatives to mitigate the impact of this proposed increase on small entities.
As discussed in section II.B.10. of this proposed rule, we propose increasing the home dialysis training add-on amount based on updated wage data using the methodology established in the CY 2017 ESRD PPS final rule. We considered, but did not propose, to base this add-on amount directly on cost report data. We also considered proposing separate training add-on amounts for HD and PD. As discussed in section II.B.10. of this proposed rule, we propose the single training add-on based on the established methodology because it is most consistent with the established principles of the PPS. Basing payment directly on cost report data is not something we have historically done, and we generally maintained payment parity between HD and PD to promote efficiency.
For small entities, including independent ESRD facilities, hospital-based ESRD facilities, and ESRD facilities furnishing fewer than 3,000 treatments per year, we note that the impact of these proposed policies is estimated to be 0.1 percentage point or less and therefore, we did not consider alternatives to mitigate the impact of this proposed change on small entities.
To understand the impact of the proposed changes affecting Medicare payments to different categories of ESRD facilities for renal dialysis services furnished to individuals with AKI, it is necessary to compare estimated Medicare payments in CY 2026 to estimated Medicare payments in CY 2027. To estimate the impact among various types of ESRD facilities for renal dialysis services furnished to individuals with AKI, it is imperative that the Medicare payment estimates in CY 2026 and CY 2027 contain similar inputs. Therefore, we simulated Medicare payments only for those ESRD facilities for which we can calculate both current Medicare payments and new Medicare payments.
For this proposed rule, we used CY 2025 data from the Medicare Part A and Part B Common Working Files as of February 13, 2026, as a basis for Medicare for renal dialysis services furnished to individuals with AKI. We updated the 2025 claims to 2026 and 2027 using various updates. The proposed updates to the AKI dialysis payment amount are described in section III.C. of this proposed rule. Table 27 shows the impact of the estimated CY 2027 Medicare payments for renal dialysis services furnished to individuals with AKI compared to estimated Medicare payments for renal dialysis services furnished to individuals with AKI in CY 2026.
Column A of the impact table indicates the number of ESRD facilities for each impact category, and column B indicates the number of AKI dialysis treatments (in thousands). Column C shows the effect of the proposal to increase the ESRD PPS base rate to incorporate payment for phosphate binders, which directly increases the AKI dialysis payment rate by approximately 5.7 percent. Column D shows the combined budget neutral impact associated with the proposed pediatric adjustment and LVPA changes, which do not apply to AKI dialysis payments, but which reduce the ESRD PPS base rate and by extension the AKI dialysis payment rate by approximately 1.1 percent. The main driver of this estimated decrease is the application of the proposed budget neutrality factor of 0.98898 associated with the proposed changes to the LVPA. As we noted earlier in this rule, the proposed changes to pediatric payments result in a budget neutrality factor of 0.99999.
Column E shows the impact from the proposed changes to the home dialysis training add-on, which have a 0.1 percentage point reduction to total payments and have small distributional impacts for the small number of AKI dialysis claims that include home dialysis training sessions. Column F shows the effect of the proposed CY 2027 wage index described in section II.B.2. of this proposed rule as well as the proposed increase to the LRS for CY 2027.
Column G shows the overall impact of all policies discussed in this proposed rule, including the 1.6 percent increase to the ESRD PPS base rate, which reflects the proposed ESRDB market basket percentage increase for CY 2027 of 2.6 percent reduced by the proposed productivity adjustment of 1.0 percentage point as well as the proposed incorporation of phosphate binders into the ESRD PPS base rate. We expect that overall ESRD facilities would experience a 6.0 percent increase in estimated Medicare payments in CY 2027 for treatment of AKI beneficiaries. The categories of types of ESRD facilities in the impact table show impacts ranging from an increase of 1.8 percent for the Puerto Rico and the US Virgin Islands to an increase of 8.5 percent for the Pacific region in CY 2027 estimated Medicare payments for renal dialysis services provided by ESRD facilities to individuals with AKI.
Under section 1834(r) of the Act, as added by section 808(b) of TPEA, we are proposing updates to the payment rate for renal dialysis services furnished by ESRD facilities to beneficiaries with AKI. The only two Medicare providers and suppliers authorized to provide these outpatient renal dialysis services are hospital outpatient departments and ESRD facilities. The patient and his or her physician make the decision about where the renal dialysis services are furnished. Therefore, this proposed change will have zero impact on other Medicare providers.
We estimate that approximately $90 million in total payments would be paid to ESRD facilities in CY 2027 because of patients with AKI receiving renal dialysis services in an ESRD facility at the lower ESRD PPS base rate versus receiving those services only in the hospital outpatient setting and paid under the outpatient prospective payment system, where services were required to be administered prior to the TPEA.
Currently, beneficiaries have a 20 percent coinsurance obligation when they receive AKI dialysis in the hospital outpatient setting. When these services are furnished in an ESRD facility, the patients will continue to be responsible for 20 percent coinsurance. Because the AKI dialysis payment rate paid to ESRD facilities is lower than the outpatient hospital PPS's payment amount, we expect beneficiaries to pay less coinsurance when AKI dialysis is furnished by ESRD facilities.
As we discussed in the CY 2017 ESRD PPS proposed rule (81 FR 42870), we considered adjusting the AKI dialysis payment rate by including the ESRD PPS case-mix adjustments, and other adjustments at section 1881(b)(14)(D) of the Act, as well as not paying separately for AKI specific drugs and laboratory tests. Similarly, we considered proposing applying other facility-level or case-mix adjustment factors, for
The ESRD QIP is intended to promote improvements in the quality of ESRD dialysis facility services provided to beneficiaries. The general methodology that we use to calculate a facility's Total Performance Score (TPS) is described in our regulations at § 413.178(e).
Any reductions in the ESRD PPS payments as a result of a facility's performance under the PY 2029 ESRD QIP will apply to the ESRD PPS payments made to the facility for services furnished in CY 2029, consistent with our regulations at § 413.177.
For the PY 2029 ESRD QIP, we estimate that, of the 7,582 facilities (including those not receiving a TPS) enrolled in Medicare, approximately 45.6 percent or 3,458 of the facilities that have sufficient data to calculate a TPS would receive a payment reduction for PY 2029. Among an estimated 3,458 facilities that will receive a payment reduction, approximately 53.1 percent or 1,835 facilities will receive the smallest payment reduction of 0.5 percent. Based on our proposals, the total estimated payment reductions for all the 3,458 facilities expected to receive a payment reduction in PY 2029 will be approximately $23,324,157. Facilities that do not receive a TPS do not receive a payment reduction.
Table 28 shows the overall estimated distribution of payment reductions resulting from the PY 2029 ESRD QIP.
To estimate whether a facility will receive a payment reduction for PY 2029, we scored each facility on achievement and improvement on several clinical measures for which there were available data from EQRS and Medicare claims. Payment reduction estimates were calculated using the most recent data available (specified in Table 28) in accordance with the proposals in this proposed rule. Measures used for the simulation are shown in Table 29.
For all measures except the SHR clinical measure, the SRR clinical measure, the STrR measure, and the ICH CAHPS measure, measures with less than 11 eligible patients for a facility were not included in that facility's TPS. For the SHR clinical measure and the SRR clinical measure, facilities were required to have at least 5 patient-years at risk and 11 index discharges, respectively, to be included in the facility's TPS. For the STrR clinical measure, facilities were required to have at least 10 patient-years at risk to be included in the facility's TPS. For the ICH CAHPS measure, facilities were required to have at least 30 survey-eligible patients to be included in the facility's TPS. Each facility's TPS was compared to an estimated mTPS and an estimated payment reduction table consistent with the proposed policies outlined in section IV.C. of this proposed rule. Facilities were required to have at least one measure in at least two domains to receive a TPS.
To estimate the total payment reductions in PY 2029 for each facility resulting from this proposed rule, we multiplied the total Medicare payments to the facility during the 1-year period between January 2024 and December 2024 by the facility's estimated payment reduction percentage expected under the ESRD QIP, yielding a total payment reduction amount for each facility.
Table 30 shows the estimated impact of the ESRD QIP payment reductions to all ESRD facilities for PY 2029. The table also details the distribution of ESRD facilities by size (both among facilities considered to be small entities and by number of treatments per facility), geography (both rural and urban and by region), and facility type (hospital based and freestanding facilities). Given that the performance period used for these calculations differs from the performance period we are using for the PY 2029 ESRD QIP, the actual impact of the PY 2029 ESRD QIP may vary significantly from the values provided here.
For PY 2029, we estimate that the ESRD QIP will contribute approximately $23,324,157 in Medicare savings. For comparison, Table 31 shows the payment reductions that we estimate will be applied by the ESRD QIP from PY 2018 through PY 2029.
The ESRD QIP is applicable to ESRD facilities. Since the Program's inception, there is evidence of improved performance on ESRD QIP measures. As we stated in the CY 2018 ESRD PPS final rule, one objective measure we can examine to demonstrate the improved quality of care over time is the improvement of performance standards (82 FR 50795). As the ESRD QIP has refined its measure set and as facilities have gained experience with the measures included in the Program, performance standards have generally continued to rise. We view this as evidence that facility performance (and therefore the quality of care provided to Medicare beneficiaries) is objectively improving. We continue to monitor and evaluate trends in the quality and cost of care for patients under the ESRD QIP, incorporating both existing measures and new measures as they are implemented in the Program. We will provide additional information about the impact of the ESRD QIP on beneficiaries as we learn more by examining these impacts through the analysis of available data from our existing measures.
In section IV.B.2. of this proposed rule, we are proposing to replace the Hypercalcemia reporting measure with the Facility Level Percentage of Chronic Hyperphosphatemia clinical measure beginning with PY 2029. We considered retaining the Hypercalcemia measure in the ESRD QIP. However, we believe removal is appropriate because the proposed Hyperphosphatemia clinical measure captures a related clinical concept while reducing reporting burden and improving alignment with clinical care priorities. We believe adoption of the Hyperphosphatemia measure in its place is appropriate because it addresses an important clinical outcome associated with dialysis care and aligns the ESRD QIP with current clinical priorities related to mineral and bone disease management among dialysis patients.
Consistent with OMB Circular A-4 (available at
The RFA requires agencies to evaluate alternatives that may reduce regulatory burden on small entities when a proposed rule is expected to have a significant impact on a substantial number of small entities. This section presents a detailed analysis of the anticipated effects of this proposed rule on small entities. Overall, this proposed rule includes proposed updates to the ESRD QIP, as well as proposed revisions to payment rates and policies applicable to the ESRD PPS and AKI dialysis payment. These proposed changes are expected to have a significant positive impact on small entities. The anticipated benefits are primarily attributable to projected cost savings and increases in payments, as discussed in the sections that follow.
For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. This proposed rule would likely impact ESRD facilities, which are classified under NAICS category 621492, Kidney Dialysis Centers. There could also be impacts to hospitals that operate a hospital-based ESRD facility, which would include NAICS category 622110, hospitals, and NAICS category 622310, specialty hospitals (which can include children's hospitals). We focus our analysis on Kidney Dialysis Centers (NAICS category 621492), because we generally believe that hospital-based ESRD facilities make up only a portion of a hospital's revenues and therefore payment updates proposed in this rule would not have significant impact on hospitals overall. Furthermore, as shown in Table 26, we estimate that payments to hospital-based ESRD facilities would increase by approximately 2.0 percent overall, and payments to ESRD facilities with more than 50 percent pediatric patients, which are more likely to be owned by children's hospitals, would increase by approximately 6.2 percent.
We also do not believe ESRD facilities are operated by small government entities such as counties or towns with populations of 50,000 or less, and therefore, they are not enumerated or included in this estimated RFA analysis. Individuals and States are not included in the definition of a small entity. Therefore, the number of small entities estimated in this RFA analysis includes the number of ESRD facilities that are either considered small businesses or nonprofit organizations.
According to the Small Business Administration's (SBA) March 2023 size standards, an ESRD facility (NAICS code 621492) is classified as a small business if it has average revenues of less than $47 million across the past 5 years.
As shown in Table 33, approximately 459 ESRD facilities, at the firm level, can be considered small according to the SBA. As we stated earlier, the SBA defines small ESRD facilities (firms) as businesses having less than $47 million in total annual revenue. According to the U.S. Census, a firm is a legal entity or parent company that owns and operates the business, or ESRD facility, in this case. Therefore, Table G8 only reflects data at the firm level and not at the establishment level, where multiple establishments could be owned by a firm.
HHS uses a change in revenue of more than 3 to 5 percent as its measure of significant economic impact on small entities. The agency considers the rule to have a significant impact on a substantial number of small businesses when more than 5 percent of impacted small entities meet the significant impact threshold defined above. As shown in Table G8, the impact of the proposed QIP measure changes in this rule would result in a cost savings impact of 3.5 percent for the smallest category of ESRD facilities, which comprise approximately 7.8 percent of small firms. For all other categories the proposed changes have an impact that falls below the 3 to 5 percent threshold.
We also considered the impacts of changes in transfers due to proposed payment policy changes in this proposed rule. For the purposes of this analysis, we exclude the ESRD facilities that are owned and operated by large dialysis organizations (LDOs) and regional chains, which will have total revenues of more than $6.5 billion in any year when the total revenues for all locations are combined for each business (LDO or regional chain), and are not, therefore, considered small businesses. Because we lack data on individual ESRD facilities' receipts, we applied a different analytic framework to identify ESRD facilities that are likely small businesses and to assess the impact of payment policy changes on those entities. Accordingly, we consider the 484 ESRD facilities that are independent and 326 ESRD facilities that are hospital-based, as shown in the ownership category in Table 26, to be small businesses. These ESRD facilities represent approximately 11 percent of all ESRD facilities in our data set.
Additionally, we identified in our analytic file that there are 753 ESRD facilities that are considered nonprofit organizations, which is approximately 10 percent of all ESRD facilities in our data set. In total, accounting for the 342 nonprofit ESRD facilities that are also considered small businesses, there are 1,216 ESRD facilities that are either small businesses or nonprofit organizations, which is approximately 16 percent of all ESRD facilities in our data set.
As we noted earlier in this proposed rule, HHS's practice in interpreting the RFA is to consider effects economically “significant” on a “substantial” number of small entities only if greater than 5 percent of providers reach a threshold of 3 to 5 percent or more of total revenue or total costs. As shown in Table 26, we estimate that the overall revenue impact of this proposed rule on all ESRD facilities is a positive increase to Medicare FFS payments by approximately 1.1 percent. For the ESRD PPS updates proposed in this rule, a hospital-based ESRD facility (as defined by type of ownership, not by type of ESRD facility) is estimated to receive a 2.0 percent increase in Medicare FFS payments for CY 2027. An independent facility (as defined by ownership type) is likewise estimated to receive a 5.6 percent increase in Medicare FFS payments for CY 2027. Although not displayed in Table 26, we have found that among the 810 ESRD facilities that are small businesses, approximately 29.4 percent (238 out of 810) furnish fewer than 3,000 treatments per year. These ESRD facilities are estimated to receive a 6.7 percent increase in Medicare FFS payments. By contrast, those furnishing 3,000 or more treatments per year are estimated to receive a 4.1 percent increase in Medicare FFS payments. Additionally, among the 753 nonprofit ESRD facilities, approximately 19.1 percent (144 out of 753) furnish fewer than 3,000 treatments per year. These ESRD facilities are estimated to receive a 7.7 percent increase in Medicare FFS payments. By contrast, those furnishing 3,000 or more treatments per year are estimated to receive a 1.4 percent increase in Medicare FFS payments.
For AKI dialysis, we are unable to estimate whether patients will go to certain types of ESRD facilities, however, we have estimated there is a potential for $90 million in total CY 2027 payments for AKI dialysis treatments that could potentially be furnished in ESRD facilities that are small businesses or nonprofits.
Based on the estimated Medicare payment impacts described previously, we believe that the change in revenue threshold will be reached by some categories of small entities as a result of the policies in this proposed rule. This analysis is based on the assumptions described earlier in section VIII.C of this proposed rule, which includes a discussion of data sources, general assumptions, and alternatives considered.
For the ESRD QIP, we estimate that of the 3,458 ESRD facilities expected to receive a payment reduction as a result of their performance on the PY 2029 ESRD QIP, 410 are ESRD small entity facilities. The overall payment reduction for small entities would be approximately 0.59 percent of total ESRD payments, which is below the 3 to 5 percent threshold HHS uses to assess significant economic impact. We present these findings in Table 28 (“Estimated Distribution of PY 2029 ESRD QIP Payment Reductions”) and Table 30 (“Estimated Impact of ESRD QIP Payment Reductions to ESRD Facilities for PY 2029”). Table 28 shows the overall estimated distribution of payment reductions resulting from the PY 2029 ESRD QIP. Table 30 shows the updated estimated impact of the ESRD QIP payment reductions to all ESRD facilities for PY 2029 and also details the distribution of ESRD facilities by size, geography, and facility type.
Therefore, the Secretary has determined that the proposed policies in this rule are expected to have a significant positive economic impact on a substantial number of small entities, primarily through increased revenues associated with the proposed ESRD PPS base rate increase. In addition, the proposed updates to the ESRD QIP are expected to generate cost savings for small entities. As discussed in section VIII.C.5.a.(5) of this CY 2027 ESRD PPS proposed rule, CMS considered alternative policy approaches to minimize the impact of this proposed rule on small entities. However, CMS did not propose these alternatives, because the proposed policies are expected to more appropriately align payments with resource utilization in CY 2027. This RFA section, together with the RIA, constitutes our Initial Regulatory Flexibility Analysis.
In addition, section 1102(b) of the Act requires the preparation of a regulatory impact analysis for any rule that may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We do not anticipate that this proposed rule will have a significant adverse impact on a substantial number of small rural hospitals, as the majority of dialysis facilities operate as freestanding entities. Although there are 111 rural hospital-based ESRD facilities, we do not have sufficient information to determine how many of these ESRD facilities are affiliated with hospitals that have fewer than 100 beds. Nevertheless the 111 rural hospital-based ESRD facilities are projected to experience an average payment increase of 3.7 percent under this proposed rule. Accordingly, the Secretary has determined that the proposed rule is expected to have a significant positive impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2026, that threshold is approximately $193 million. We do not interpret Medicare payment rules as being unfunded mandates but simply as conditions for the receipt of payments from the Federal Government for providing services that meet Federal standards. This interpretation applies whether the facilities or providers are private, State, local, or Tribal. Therefore, this proposed rule does not mandate any requirements for State, local, or Tribal governments, or for the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. We have reviewed this proposed rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it will not have substantial direct effects on the rights, roles, and responsibilities of State, local, or Tribal government.
Executive Order 14192, entitled “Unleashing Prosperity Through Deregulation” was issued on January 31, 2025, and requires that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.” This proposed rule, if finalized as proposed, is expected to be an Executive Order 14192 regulatory action, generating annualized costs of approximately $0.1 billion.
The Addenda for the annual ESRD PPS proposed and final rule will no
Mehmet Oz, Administrator of the Centers for Medicare & Medicaid Services, approved this document on June 5, 2026.
Diseases, Health facilities, Medicare, Puerto Rico, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR part 413 as set forth below:
42 U.S.C. 1302, 1395d(d), 1395f(b), 1395g, 1395l(a), (i), and (n), 1395m, 1395x(v), 1395x(kkk), 1395hh, 1395rr, 1395tt, and 1395ww.
The revisions and addition read as follows:
(b) * * *
(1) Furnished fewer than 8,000 total treatments in each of the 3 cost reporting years (based on as-filed or final settled 12-consecutive month cost reports, whichever is most recent, except as specified in paragraphs (g)(4) and (5) of this section) preceding the payment year; and
(c) For the purpose of determining the number of treatments under paragraph (b)(1) of this section, except as specified at paragraph (g)(7) of this section, the number of treatments considered furnished by the ESRD facility shall equal the aggregate number of treatments furnished by the ESRD facility and the number of treatments furnished by other ESRD facilities that are both:
(f) The low-volume adjustment applies for dialysis treatments provided to all ESRD patients.
(g) * * *
(5) For payment year 2024 and subsequent payment years, an ESRD facility may attest in the attestation specified in paragraph (e) of this section that it would have met the requirements of paragraph (b)(1) of this section, except that for one or more of the most recent 3 cost reporting years the facility furnished 8,000 or more treatments because of temporary patient-shifting as a result of the closure or operational disruption of another ESRD facility due to a disaster or other emergency. For the purposes of the exception in this paragraph (g)(5), temporary patient-shifting is defined as providing renal dialysis services to one or more displaced patient(s) at any time through the end of the CY following the 12-month period beginning when an ESRD facility first begins providing renal dialysis services to one or more displaced patients. For any facility that so attests—
(i) The facility must also attest that it furnished treatments equal to or in excess of 8,000 in the cost reporting year due to temporary patient-shifting as a result of the closure or operational disruption of an ESRD facility resulting from a disaster or other emergency;
(ii) The facility must request an exception under this paragraph (g)(5) from CMS, in the form and manner specified by CMS, no later than the attestation deadline specified in paragraph (e) of this section or 30 calendar days after the end of the cost reporting year, whichever is later, for each cost reporting year that the facility furnishes treatments equal to or in excess of 8,000 due to temporary patient-shifting as a result of the closure or operational disruption of an ESRD facility resulting from a disaster or other emergency;
(iii) Within 30 calendar days of CMS's receipt of the facility's request, CMS will review the request and either approve the request based on a determination that the ESRD facility furnished treatments equal to or in excess of 8,000 in the cost reporting year due to temporary patient-shifting as a result of the closure or operational disruption of an ESRD facility resulting from a disaster or other emergency, or deny the request, and will notify the facility and the MAC of its decision;
(iv) If CMS approves the request, the ESRD facility is paid the low-volume adjustment on claims for Medicare beneficiaries, on the basis of the exception in this paragraph (g)(5), during the payment year in which the temporary patient-shifting occurred, so long as all other requirements for the low-volume adjustment are met. For any future payment year, the ESRD facility would not be prevented from receiving the low-volume adjustment if the ESRD facility meets or exceeds the 8,000 treatment threshold in a cost reporting year due to temporary patient-shifting as a result of the disaster or other emergency that resulted in another ESRD facility's closure or operational disruption, so long as all other requirements for the low-volume adjustment are met; and
(v) The facility must maintain documentation of the number of displaced patients treated and information about the ESRD facility or facilities that closed or experienced operational disruptions due to a disaster or other emergency and previously treated those patients, and must provide such supporting documentation to CMS and the MAC upon request.
(6) * * *
(i) The ESRD facility would need to request such an exception from CMS, in the form and manner specified by CMS, within 60 calendar days of the facility's closure, and the ESRD facility must inform the MAC of this request in writing;
(ii) Within 30 calendar days of CMS's receipt of the facility's request, CMS will review the request and either approve the request based on a determination that the ESRD facility closed due to a disaster or other emergency, or deny the request, and will inform both the facility and the MAC of its decision; and
(iv) The ESRD facility that attests under this paragraph (g)(6) to have closed due to a disaster or other emergency would need to notify CMS and the MAC, in the form and manner specified by CMS, within 30 calendar days of reopening and providing renal dialysis services. Within 30 calendar days of CMS's receipt of the facility's
(7) ESRD facilities that are children's hospitals, as defined at § 412.23(d), or that furnish more than 50 percent of treatments (Medicare and non-Medicare) to Pediatric ESRD Patients may request an exception to the aggregation of number of treatments in paragraph (c) of this section.
(i) The ESRD facility must attest that it is either owned and operated by a Medicare-certified children's hospital, as defined at § 412.23(d), or the ESRD facility provides at least 50 percent of its total treatments (Medicare and non-Medicare) to Pediatric ESRD Patients and that it is under common ownership, as defined in paragraph (d) of this section, with one or more ESRD facilities that do not furnish at least 50 percent of its total treatments to Pediatric ESRD Patients;
(ii) The facility must request an exception under this paragraph (g)(7) from CMS, in the form and manner specified by CMS, no later than the attestation deadline specified in paragraph (e) of this section or 30 calendar days after the end of the cost reporting year, whichever is later;
(iii) Within 60 calendar days of CMS's receipt of the facility's request, CMS will review the request and either approve or deny the request based on a determination of whether the ESRD facility meets the requirements of paragraph (g)(7)(i) of this section, and will notify the facility and the MAC of its decision;
(iv) If CMS approves the request, the ESRD facility's number of treatments, for the purposes of the low-volume adjustment, would not be aggregated with the number of treatments of the commonly-owned facility for which the exception has been granted, on the basis of the exception in this paragraph (g)(7), for all future payment years, so long as the ESRD facility remains a children's hospital or furnishes more than 50 percent of treatments to Pediatric ESRD Patients. To receive the low-volume adjustment the ESRD facility must continue to satisfy all other requirements. Approval of an exception under this paragraph (g)(7) applies only to the ESRD facility for which the exception is granted and does not affect the aggregation of treatment volume for any other commonly-owned ESRD facility; and
(v) The facility must maintain documentation of the number of total treatments and pediatric treatments which it provides and must provide such supporting documentation to CMS and the MAC upon request.
The revisions and addition read as follows:
(c)
(3) For any new renal dialysis drug or biological product that is eligible for payment using the transitional drug add-on payment adjustment described in paragraphs (b)(1)(iii) and (c)(1) of this section, CMS applies a post-TDAPA add-on payment adjustment to all ESRD PPS claims that is calculated using the methodology set forth in paragraph (g) of this section. CMS will apply the post-TDAPA add-on payment adjustment beginning 8 calendar quarters after the first calendar quarter in which the transitional drug add-on payment adjustment is paid for the applicable product and ending 12 calendar quarters after the end of the last calendar quarter in which the transitional drug add-on payment adjustment is paid for the applicable product. If CMS stops receiving the latest full calendar quarter of ASP data for the applicable renal dialysis drug or biological product during the applicable time period specified in paragraph (c)(1) of this section or during the 3-year period following such applicable time period, CMS will not pay any post-TDAPA add-on payment adjustment for such product in any future quarter.
(g) * * *
(1) CMS bases the calculation on the most recent 12-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of ASP data. If the most recent full calendar quarter of ASP data reflects zero or negative sales, then the calculation is based on 100 percent of the most recent positive ASP amount from a previous quarter; if there is no previous quarter of positive ASP data, then the calculation is based on 100 percent of WAC; and, if WAC is not available, the payment is based on the drug manufacturer's invoice.
(2) CMS calculates the post-TDAPA add-on payment adjustment quarterly as the expenditure for the new renal dialysis drug or biological product divided by the total number of ESRD PPS treatments during the same period.
(h)
(1) The methodology specified in paragraph (h)(2) of this section for determining the average per treatment payment amount for phosphate binders that is added to the ESRD PPS base rate uses the following data sources:
(i) Total units of phosphate binders and total number of paid hemodialysis-equivalent dialysis treatments furnished, as derived from Medicare ESRD facility claims (the 837-institutional form with bill type 072X) for the second, third, and fourth quarters of calendar year 2025 and for the first and second quarters of calendar year 2026.
(ii) The weighted average ASP based on the most recent determinations by CMS.
(2) CMS uses the following methodology to calculate the average per treatment payment amount for phosphate binders that is added to the ESRD PPS base rate:
(i) Determines utilization of each phosphate binder by aggregating the total units of phosphate binders from the claims data described in paragraph (h)(1)(i) of this section.
(ii) Determines a price for each phosphate binder by calculating 100 percent of the value from the most recent calendar quarter ASP calculations available to the public for each HCPCS code describing phosphate binders.
(iii) Calculates the total phosphate binder expenditure amount by multiplying the utilization of each phosphate binder determined in paragraph (h)(2)(i) of this section by their respective prices determined in paragraph (h)(2)(ii) of this section and summing the expenditure amounts across all phosphate binder products.
(iv) Calculates an adjusted phosphate binder expenditure amount that accounts for operational cost expenditures associated with furnishing phosphate binders, based on the additional amount added to the transitional drug add-on payment adjustment amount for phosphate binders under paragraph (c)(4) of this section.
(v) Calculates the average per treatment payment amount by dividing the adjusted phosphate binder expenditure amount determined in paragraph (h)(2)(iv) of this section by the total number of paid hemodialysis-equivalent dialysis treatments during the same period described in paragraph (h)(1)(i) of this section.
(vi) Calculates the amount added to the ESRD PPS base rate by reducing the average per treatment payment amount determined in paragraph (h)(2)(v) of this section by 1 percent to account for the outlier policy under § 413.237.
(3) Phosphate binders will be eligible ESRD outlier services under § 413.237 beginning January 1, 2027.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
FAA proposes to amend various airworthiness regulations to modernize certain certification standards for transport category airplanes and propulsion systems. This rule would be both deregulatory and relieving by reducing the number of exemptions, special conditions, and equivalent level of safety findings required during the certification process. FAA expects that this proposal would reduce certification costs and time to certify new and changed products for both industry and FAA while maintaining or increasing the level of safety provided by the current regulations. FAA proposes to remove Special Federal Aviation Regulation (SFAR) No. 109 from part 25 and relocate certain of its requirements. Finally, this action would address industry and National Transportation Safety Board recommendations while also harmonizing FAA's regulations with international standards.
Send comments on or before August 25, 2026.
Send comments identified by docket number FAA-2026-0430 using any of the following methods:
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James Wilborn, AIR-62A, Product Policy Management: Transport Airplanes & Engines Section, Policy and Standards Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, WA 98198; (206) 231-3237;
FAA proposes to amend various airworthiness regulations in title 14, Code of Federal Regulations (14 CFR) to modernize certain certification standards for transport category airplanes and propulsion systems. By codifying frequently issued exemptions and special conditions (SC or SCs) and reducing the need for equivalent level of safety (ELOS) findings, this proposal would reduce certification costs and time to certify new and changed products
Part 25 prescribes airworthiness standards for type certification of transport category airplanes. Some of these airworthiness standards may not adequately address a current certification project for many reasons, including prior safety-related incidents, new technology, and evolving industry needs. When such a gap is identified during the certification process, FAA addresses it by using a variety of design-specific tools, including, exemptions, SCs, and ELOS findings. FAA uses these tools to set requirements for a safe design for the product. However, these tools are labor intensive and costly for both the applicant seeking type certification
As defined in § 11.15, a “petition for exemption” is a request to FAA by an individual or entity asking for relief from the requirements of a current regulation. After receiving the petition, FAA publishes a summary of it in the
As defined in § 11.19, an SC is a rule that applies to a particular proposed design. Per § 21.16, FAA issues SCs if the airworthiness regulations do not contain adequate or appropriate safety standards for an aircraft, aircraft engine, or propeller because of a novel or unusual design feature. The phrase “novel or unusual” applies to design features of the product to be certificated when compared to the current airworthiness standards.
FAA uses the issue paper (IP) process described in FAA Order 8110.112A, “Standardized Procedures for Usage of Issue Papers and Development of Equivalent Levels of Safety Memorandums,” dated October 3, 2014, to develop the SCs.
FAA makes an ELOS finding when literal compliance with an airworthiness standard cannot be shown and, per § 21.21(b)(1), compensating factors can be shown to provide a level of safety equivalent to that established by the airworthiness standards. An ELOS finding may document compliance criteria different from what is stated in the rule, but is judged as acceptable by FAA.
A difference between SCs and ELOS findings is SCs focus on direct compliance with specific requirements for new and novel designs, while ELOS findings allow a non-compliant design to meet the same level of safety as existing airworthiness standards due to compensating factors. SCs are only used for aircraft with novel or unusual design features.
Unlike exemptions and SCs, an ELOS finding is not developed through a
FAA posts online an ELOS memorandum for each ELOS finding, to communicate the rationale to the public. The ELOS memorandum is a publicly releasable document that is a part of the project's certification basis. The ELOS memorandum explains the basis for FAA's finding that the applicant's proposal provides an ELOS to the airworthiness standards and documents those critical aspects of the ELOS finding that must be maintained for continued airworthiness.
When Executive Order (E.O.) 13777, “Enforcing the Regulatory Reform Agenda,” was signed on February 24, 2017, it required each Federal agency to establish a Regulatory Reform Task Force (RRTF) to evaluate current regulations and make recommendations for their repeal, replacement, or modification. As part of this process, the E.O. required the RRTF to seek input and assistance from entities significantly affected by its regulations. Because the ARAC's membership represents a broad spectrum of entities significantly affected by FAA's regulations, DOT, through FAA, tasked ARAC to consider (1) recommendations on existing regulations that are good candidates for repeal, replacement, or modification; and (2) recommendations on regulatory action identified in FAA's regulatory agenda.
Section 312 of FAA Reauthorization Act of 2024 titled “Transport airplane and propulsion certification modernization” requires FAA to publish a draft rule on this subject. The agency added this item to its regulatory agenda in 2022.
The NTSB is an independent U.S. government agency that investigates civil transportation accidents and makes recommendations to prevent future accidents. This proposed rule would address certain NTSB Safety Recommendations issued following accidents involving turboprop-powered transport category airplanes.
In response to ARAC and NTSB recommendations, FAA is proposing the following ten deregulatory actions to reduce certification costs and the time to certify new products for both industry and FAA, while maintaining or increasing the level of safety compared to the existing regulations:
1. Remove Special Federal Aviation Regulation (SFAR) No. 109 from part 25 and relocate certain parts or portions of its requirements to new §§ 25.821, 25.823, 25.825, 25.827, 25.829, and 25.830 to harmonize with the corresponding EASA airworthiness standards. FAA would also incorporate definitions of “low occupancy” and “non-commercially operated” airplanes in new § 25.4(d) to reduce the need for exemptions and ELOS findings for cabin interior designs of transport category airplanes operated for private use. For details, see the discussion under section III.A of this NPRM.
2. Revise § 25.251(b) to allow use of an acceptable means, other than flight test, for speeds above V
3. Revise § 25.349(a) to prescribe the design rolling maneuver requirement in terms of flightdeck roll control movement, rather than aileron deflection, to ensure that the rolling maneuver loads used in the structural design of the airplane are adequate. This would eliminate the need for SCs. For details, see the discussion under section III.C of this NPRM.
4. Revise § 25.809(a) to remove the requirement to be able to view the evacuee landing point from flightcrew and overwing exits because the structure of the wing under the overwing exits and curvature of the fuselage under the flightcrew exit obstructs the view of the evacuee landing point. This would eliminate the need for exemptions and would harmonize with EASA CS 25.809(a). For details, see the discussion under section III.D of this NPRM.
5. Revise §§ 25.811 and 25.812 to permit alternative exit sign configurations. This would eliminate the need for ELOS findings and harmonize with the corresponding EASA airworthiness standards within CS 25.811 and CS 25.812. For details, see the discussion under sections III.A.2.k and III.E of this NPRM.
6. Revise § 25.853(g) to replace the requirement to have self-contained removable ashtrays installed in lavatories with a requirement lavatories have a means to safely dispose of lit combustible material. This would provide operators with more design options and potentially eliminate excessive maintenance. For details, see the discussion under section III.F of this NPRM.
7. Revise § 25.1155 to require a means to prevent the flightcrew on propeller-powered airplanes from inadvertently or intentionally placing the power lever below flight idle while in flight, unless the airplane has been certified for that type of operation, and to require a similar provision for turbojet-powered airplanes with thrust reverser systems intended for use only on the ground. This would address NTSB safety recommendations and harmonize with EASA CS 25.1155. For details, see the discussion under section III.G of this NPRM.
8. Revise § 25.1193(e)(3) to maintain the existing fireproof requirement for cowling and nacelle skin for in-flight operations while providing an alternative requirement for ground operation. This would eliminate the need for ELOS findings and harmonize with EASA CS 25.1193(e)(3). For details, see the discussion under section III.H of this NPRM.
9. Revise § 25.1549 to allow manufacturers flexibility to (1) provide awareness of only those powerplant and auxiliary power unit (APU) operating conditions that require flightcrew action necessary to maintain continued safe operation, (2) use colors other than green to denote normal operating conditions, and (3) provide any additional information needed by maintenance personnel when following the instructions for continued airworthiness. This would eliminate the need for ELOS findings. For details, see the discussion under section III.I of this NPRM.
10. Revise § 25.1555(d)(1) to require each emergency control either be colored red or illuminate red when a condition necessitates its use, and have appropriate safeguards to allow its intended use while preventing unintentional actuation and not restricting its use when needed. This would eliminate the need for ELOS findings. For details, see the discussion under section III.J of this NPRM.
FAA reviewed its certification process to find other areas not identified by ARAC or NTSB where the certification standards for transport category airplanes and propulsion systems could be modernized. FAA identified several exemptions, SCs, and ELOS findings FAA frequently grants or issues during the certification process. Based on this review, FAA identified fourteen additional deregulatory actions to reduce certification costs and the time to certify new products for both industry and FAA, while maintaining or improving the level of safety in the existing regulations.
1. Add new § 25.797 for carriage of authorized persons,
2. Revise §§ 25.5 and 25.981 and appendix N to part 25 to require a new Fuel Tank Flammability Assessment Method (FTFAM). This would eliminate the need for applicants to submit additional paperwork requesting use of the new FTFAM. For details, see the discussion under section III.L of this NPRM.
3. Revise § 25.773(a)(2) to allow use of ground tests in lieu of night flight tests to show the flightdeck is free of glare and reflection. The proposed allowance for ground tests would eliminate the need for ELOS findings. For details, see the discussion under section III.M of this NPRM.
4. Revise § 25.773(b)(1) to require the means to maintain a clear portion of the windshield function in light precipitation conditions at speeds normally encountered during ground operations. Proposed § 25.773(b)(1) would eliminate SCs commonly granted for use of hydrophobic coatings in lieu of windshield wipers. For details, see the discussion under section III.M of this NPRM.
5. Revise § 25.785(b) to except berths intended for carriage of medical patients (
6. Add new § 25.788 to require safety standards for installation of showers, large display panels, and large, nonstructural glass panels. The proposed requirements for shower and large display panels would harmonize with the corresponding EASA airworthiness standards in EASA CS 25.788. The proposed requirements for large, nonstructural glass panels would eliminate the need for commonly issued SCs. For details, see the discussion under section III.O of this NPRM.
7. Revise § 25.801(a) to change the citation referenced from § 25.807(e) to § 25.807(i). This would correct an error introduced with amendment 25-88 when FAA moved its “ditching emergency exits for passengers” requirements from paragraph (e) to (i). It also would harmonize with EASA CS 25.801(a). For details, see the discussion under section III.P of this NPRM.
8. Revise § 25.810(a)(1)(ii) to provide an option allowing 10 seconds to automatically erect assisting means from the time the opening means of the exit is actuated for non-Type C exits. This would harmonize the proposed requirement with the corresponding EASA CS 25.810(a)(1)(ii). For details, see the discussion under section III.Q of this NPRM.
9. Revise § 25.813 to incorporate improvements for Type III and IV emergency exit access and ease of operation. This would harmonize the proposed requirements with the corresponding EASA airworthiness standards in CS 25.813. For details, see the discussion under section III.R of this NPRM.
10. Revise § 25.841(a) regarding the exposure of occupants to certain cabin pressure altitudes due to cabin decompression caused by structural, system, or engine failures. This would eliminate the need for commonly granted exemptions. In addition, revise § 25.841(d)(1) regarding the cabin pressure high altitude warning alert during high elevation airport operations. This would correct the current description. For details, see the discussion under section III.S of this NPRM.
11. Revise § 25.854 to add cabin length to the applicability of lavatory fire protection. This would harmonize the proposed requirements with the corresponding EASA airworthiness standards. For details, see the discussion under section III.T of this NPRM.
12. Move the requirements for operation without normal electrical power for airplanes that use mechanical flight controls from § 25.1351(d) into new § 25.1352 and add similar requirements for airplanes that use electrical and electronic systems to perform critical functions. In addition, revise § 25.1705 to reference the § 25.1352 requirements. This would eliminate the need for commonly issued SCs. For details, see the discussion under section III.U of this NPRM.
13. Revise § 25.1365(b) to require that installations of galleys and cooking appliances minimize the hazards, such as burns and spilled liquids, to the airplane, passengers, and crew. This would harmonize the proposed requirements with the corresponding EASA airworthiness standards. For details, see the discussion under section III.A.2(l) of this NPRM.
14. Add § 25.1447(c)(6) to require sufficient oxygen outlets in areas of the cabin, other than those addressed by § 25.1447(c)(1), that may be occupied by passengers or crew. This would harmonize proposed § 25.1447(c)(6) with EASA CS 25.1447(c)(3). For details, see the discussion under section III.V of this NPRM.
EASA CS-25 prescribes the airworthiness standards corresponding to 14 CFR part 25 for products certified by the European Union. Applicants for FAA type certification of transport category airplanes also seek EASA validation of the type certificate, for which the applicant must show compliance with EASA CS-25. Though part 25 and CS-25 are similar, they differ in several respects. Where part 25 and CS-25 differ, an applicant must meet both airworthiness standards to obtain a U.S. type certificate and validation of the type certificate by EASA, or obtain exemptions, SCs, or ELOS findings or the foreign authority's equivalent to those, as necessary to meet one standard in lieu of the other.
FAA is not aware of any aircraft manufacturers who sell only to the U.S. market. As such, these manufacturers design their aircraft to meet both FAA and EASA regulations. Therefore, any proposal below to match EASA regulations would result in no new requirements for applicants.
FAA's draft guidance material associated with this proposed rule would also provide harmonized compliance approaches with EASA's Acceptable Means of Compliance (AMC) in CS-25 amendment 28.
FAA expects modernization of airworthiness standards for type certification of transport category airplanes would reduce time to certify and certification costs for manufacturers, modifiers, and FAA while maintaining or increasing safety. FAA expects this reduction in costs and time to certify would also promote innovation by reducing (1) the time and costs for manufacturers and modifiers to obtain type certification for new or changed products and (2) disincentives to design changes and improvements.
This proposed rule would also eliminate certain differences between U.S. and European airworthiness standards. Because U.S. manufacturers and modifiers of transport category airplanes typically sell their products domestically and internationally, harmonizing FAA's requirements with those of EASA would reduce the cost and complexity of certification by eliminating the necessity of establishing the aircraft design meets different requirements.
FAA's authority to issue rules on 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 FAA's authority.
This rulemaking is issued under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General Requirements.” Under that section, FAA is charged with prescribing regulations that promote safe flight of civil aircraft in air commerce by prescribing regulations and minimum standards for the design and performance of aircraft the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority as it prescribes new safety standards for the design and performance of transport category airplanes.
In addition, Section 312, “Transport airplane and propulsion certification modernization,” of the FAA Reauthorization Act of 2024 (Pub. L. 118-63) requires FAA to publish a notice of proposed rulemaking on this subject.
FAA issued SFAR No. 109 on May 8, 2009 (74 FR 21533). SFAR No. 109 amended the airworthiness standards for transport category airplanes by adding new cabin interior criteria for operators of private use, not for hire, not for common carriage airplanes. The standards in SFAR No. 109 provide alternative criteria for transport category airplanes that are operated for private use while continuing to provide an acceptable level of safety for those operations. The applicability of SFAR No. 109 is limited to airplanes with 60 or fewer passengers (SFAR No. 109 paragraph 2(a)).
Currently, proposed designs for transport category airplanes must comply with the standards of part 25 to be eligible for a type certificate in this category, with exceptions provided in SFAR No. 109 for airplanes meeting the applicability of that SFAR. Because most transport category airplanes are used by airlines, the requirements of part 25 are largely developed for cabin interiors equipped for the commercial carriage of relatively high numbers of passengers. Part 25, therefore, is not fully adapted to cabin interiors of executive interiors,
Furthermore, ARAC recommended that FAA repeal SFAR No. 109 and harmonize several related regulations with the corresponding airworthiness standards in EASA CS-25, amendment 19.
Three limitations of SFAR No. 109 that continue to drive applicants to choose not to use it are (1) it is limited to only private use airplanes, so it provides no relief for chartered jets operated under part 135; (2) applicants must limit occupancy to 60 passengers; and (3) applicants must meet all applicable provisions of SFAR No. 109 if seeking certification under its provisions and thus cannot choose to use alternative standards for any part of the interior. The capacity of some proposed larger airplanes with executive interiors has exceeded 60 passengers, and FAA has granted exemptions for these configurations with the same limitations as SFAR No. 109. FAA has also granted exemptions for certain executive interior features, such as interior doors, in chartered jets operated under part 135.
EASA initiated a rulemaking committee in 2012
Subsequently, EASA issued NPA 2017-12 on July 24, 2017, followed by amendment 21 on March 27, 2018, to amend appendix S of CS-25 by creating
FAA proposes to remove SFAR No. 109 and add many of its requirements into new §§ 25.4(d), 25.821, 25.823, 25.825, 25.827, 25.829, and 25.830. Though some of the proposals linked to this change would reduce the need for exemptions and ELOS findings in the future, other changes would harmonize requirements applicable to low occupancy airplanes and non-commercially operated airplanes with the corresponding sections of EASA CS to the extent consistent with FAA's statutory safety mission. This would serve to eliminate the costs and resource allocation required for an applicant to meet two differing certification standards.
EASA incorporated requirements for low occupancy airplanes and non-commercially operated airplanes in the form of an appendix to CS-25. The U.S. regulatory structure does not permit issuance of requirements in the form of appendices;
These EASA appendix S regulations are applicable only to low occupancy airplanes or non-commercially operated airplanes, as specified in each regulation. EASA also incorporated certain provisions, historically addressed by FAA using SFAR No. 109, exemptions and ELOS findings, into CS 25.812(e)(3), 25.812(l)(1), and 25.1365 to make them applicable to any transport category airplane, as discussed below in this preamble. FAA is also proposing to add new § 25.1583(j) to ensure non-commercially operated airplanes have the appropriate limitations in their airplane flight manuals (AFM).
FAA proposes to incorporate definitions of “low occupancy airplanes” and “non-commercially operated airplanes” in new § 25.4(d), in order to clarify the application of this proposed rule and expand the applicability of relief from certain part 25 regulations beyond that provided currently by SFAR No. 109. These proposed definitions align with the definitions in CS 25, appendix S.1(a).
SFAR No. 109 applies to airplanes not “offered for common carriage or operated for hire” for which passenger capacity may not exceed 60 (SFAR No. 109 paragraph 2(a) and (d)). In addition, paragraph 7(c) of SFAR No. 109, for airplanes with more than one exit pair (which is required for passenger seating configurations of 20 or more per § 25.807(g)) in which an exit is deactivated to result in an exit distance greater than 60 feet, limits the total number of passenger seats in the airplane to 33 percent of the maximum seating capacity for the airplane model using the exit ratings listed in § 25.807(g) for the original certified exits or the maximum allowable after modification when exits are deactivated, whichever is less. The proposed definition for “non-commercially operated” airplanes would align with CS-25 appendix S.1 and change the upper limit on the total number of passenger seats, for passenger seating configurations of 20 or more, to 50 percent of the maximum passenger seating capacity on the type certificate data sheet (TCDS). The proposed definition would also apply an upper limit of 150 passengers per deck or one-half of the maximum passenger seating capacity for that deck as indicated in the airplane TCDS, whichever is less.
As part of its certification of transport category airplanes proposed to be configured with executive interiors and operated under part 135, the SFAR 109 final rule has a table identifying which paragraphs could also be accepted in part 135 operation, and FAA has granted exemptions
Based on the committee analysis, EASA incorporated a new definition of “low occupancy” airplane that encompasses those airplanes that have a passenger seating capacity limited to 19 (per the TCDS), as well as larger airplanes configured for operating with no more than one-third of the approved passenger seating capacity on the TCDS (both in total capacity and per zone),
FAA has carefully reviewed the EASA committee analysis and rationale and
As discussed, FAA applies different design standards to commercially operated airplanes as compared to non-commercially operated airplanes. The proposed § 25.1583(j) would require applicants to include limitations in the limitations section of the airplane flight manual for proposed airplane designs that would incorporate interior features permitted only in non-commercially operated airplanes. This limitation would ensure those airplanes are not offered for hire or common carriage.
SFAR No. 109 paragraph 10 provides requirements applicable to the proposed installation of interior doors between passenger seats and exits on non-commercially operated airplanes in lieu of the requirements of § 25.813(e), which prohibits such doors. Prior to SFAR 109, FAA had granted several exemptions from § 25.813(e) for installation of interior doors; these exemptions included conditions and limitations consistent with SFAR No. 109 paragraph 10. EASA's amendment 19 to CS-25 expanded the allowance for installation of interior doors to commercially operated airplanes having a passenger seating configuration of 19 or less, but with additional safety requirements as compared to non-commercially operated airplanes. After EASA issued amendment 19 to CS-25, FAA reviewed the EASA rule, analysis, and rationale and has determined additional analysis or studies are not required, and as such began issuing exemptions
SFAR No. 109 paragraph 13 provides requirements for fire detection in isolated compartments for airplanes with a type certificated passenger capacity of 20 or more. EASA S25.10(c) aligns with these requirements, but adds applicability to airplanes with a cabin length of more than 60 feet, to ensure an adequate level of safety for airplanes of that size configured with low occupancy. EASA S25.10(c) also includes an option for a visual indication or audible warning in the passenger cabin that would be readily detected by a cabin crew member instead of the SFAR 109 requirement to signal the flightcrew. This paragraph provides a further option: if it can be demonstrated that a fire would be directly and quickly detected because the compartment is likely to be occupied for the majority of the flight time, a smoke detection system is not required. These options are not in SFAR No. 109 paragraph 13; however, FAA proposes to add these options because if the compartment is occupied for the majority of the flight time it would not be considered isolated (smoke would be detected by the occupants making the need for a detection system unnecessary) and the system can warn the cabin crew directly of the threat instead of waiting for the flightcrew to communicate the warning to the cabin crew. Therefore, FAA proposes to adopt the requirements of CS-25 section S25.10(c) as new § 25.821(c).
SFAR No. 109 paragraph 7 allows the deactivation of exits to create a distance of greater than 60 feet between exits and provides conditions a proposed design must meet if the distance between emergency exits exceeds that required by § 25.807(f)(4). EASA provided conditions in CS S25.10(d) and (e) similar to those of SFAR No. 109 paragraph 7, but with certain differences described below.
SFAR No. 109 paragraph 7(a) requires each passenger seat be located within 30 feet of the nearest exit on each side of the fuselage. EASA incorporated this condition as CS S25.10(d)(3) but used performance-based language in the requirement and provided an AMC to CS 25.10 different from SFAR No. 109 paragraph 7(a). EASA CS S25.10(d)(3) states the distance from each passenger seat to at least one remaining emergency exit, on each side of the fuselage, remains “compatible with easy egress” from the airplane. EASA's AMC to CS 25.10 provides a method of compliance for “compatible with easy egress” as meeting two conditions: (1) within 30 feet from the nearest emergency exit on one side of the fuselage on the same deck and within 45 feet from the nearest emergency exit on the other side of the fuselage on the same deck, and (2) the occupant of the seat has the possibility to move to an emergency exit, on the left side or the right side of the fuselage, while at all points along the way remaining within 30 feet of an emergency exit on one side of the fuselage on the same deck and within 45 feet of an emergency exit on the other side of the fuselage on the same deck. FAA has evaluated this difference and determined it fulfills the same intent as SFAR No. 109 paragraph 7(a) while providing applicants with flexibility in how compliance is shown for non-commercially operated airplanes only because passengers on commercial low occupancy airplanes would not have the familiarity of the cabin configuration as those passengers carried in private operations. FAA proposes to adopt the requirements of CS-25 section S25.10(d)(3) as new § 25.821(e)(3).
SFAR No. 109 paragraph 7(b) limits the number of passenger seats in passenger zones.
SFAR No. 109 paragraph 7(c) provides the condition that the total number of passenger seats in the airplane may not exceed 33 percent of the maximum seating capacity for the airplane model using the exit ratings listed in § 25.807(g) for the original certified exits or the maximum allowable after modification when exits are deactivated, whichever is less. This requirement is no longer limited to exit deactivation and is instead replaced by the seating capacity limitations in the definitions of non-commercially operated airplanes and low occupancy airplanes as adopted from EASA CS S25.1(a) and now defined in § 25.4(d) as discussed above. Passenger seating limits are further limited when exits are deactivated through adoption of EASA CS 25.10(d)(1) and (d)(2) as new § 25.821(e)(1) and (e)(2).
SFAR No. 109 paragraph 7(d) provides the condition that a distance of more than 60 feet between adjacent passenger emergency exits on the same side of the same deck of the fuselage is allowed only once on each side of the fuselage. EASA incorporated this condition as CS S25.10(e)(2). FAA proposes to move the requirements of SFAR No. 109 paragraph 7(d) to new § 25.821(e)(4).
Paragraph CS-25 S25.10(d), “Deactivation of existing emergency exits,” specifies that deactivation of one or more emergency exits that results in non-compliance with CS 25.807(e)
Paragraph CS-25 S25.10(e) permits deactivation of emergency exits that results in non-compliance with CS 25.807(f)(4) on non-commercially operated airplanes only, provided the requirements of S25.10(d)(1) through S25.10(d)(3) are met. CS 25.807(f)(4) requires passenger seats be no more than 60 feet from the adjacent emergency exit on the same side of the fuselage. FAA concurs with EASA that these restrictions are necessary where an applicant's proposed design would not comply with § 25.807(f)(4), and allowing such a noncompliance is only appropriate, from a safety perspective, for non-commercially operated airplanes. FAA proposes to adopt the substance of CS-25 sections S25.10(d)(1) through S25.10(d)(3) as § 25.821(e)(1) through § 25.821(e)(3), and S25.10(e)(2) as § 25.821(e)(4) as discussed previously.
SFAR No. 109 paragraph 12, Materials for Compartment Interiors, provides a condition under which an applicant need not demonstrate its proposed design's compliance with certain flammability requirements of § 25.853 if it can be shown the maximum time for evacuation of the occupants does not exceed 45 seconds. Also, in the course of approving the designs of non-SFAR 109 transport category airplanes, FAA granted several exemptions
In addition, EASA provided a condition under which mattresses of permanent bed installations located in compartments isolated from the main passenger cabin by doors or equivalent means that would normally be closed during taxiing, takeoff, and landing need not meet the seat cushion flammability requirements of CS 25.853(c).
FAA has issued ELOS findings to § 25.813(c)(2)
FAA does not adopt the terms of this provision (EASA S25.20(b)(2)) for this proposed rule. FAA considers EASA S25.20(b)(2) insufficient for two main reasons. First, the conditions for a demonstration are necessarily non-hazardous. Under actual emergency conditions (such as smoke in the cabin, adverse airplane attitude, or fuselage disruption), unobstructed access can be much more important than in a demonstration. Second, the Type IV exit is only permitted for airplanes with 9 or fewer passengers.
SFAR No. 109 paragraph 11, Width of Aisle, allows aisle width to be reduced to zero inches between passenger seats in-flight if:
• The applicant demonstrates that all areas of the cabin are easily accessible by a crew member in the event of an emergency.
• Instructions are provided at each passenger seat for restoring the aisle width required by § 25.815.
• Procedures are established and documented in the AFM to ensure the required aisle widths are provided during taxiing, takeoff, and landing.
EASA incorporated the same allowance and conditions in CS S25.30(a).
SFAR No. 109 paragraph 4(a) provides an alternate requirement to the handhold requirement of § 25.785(j) to allow a means to enable persons to steady themselves in moderately rough air. EASA incorporated the same alternate requirement in CS S25.30(b) adding language that the means must be an “acceptable means.”
FAA proposes to adopt the requirements of CS-25 section S25.30 as new § 25.825 with the “acceptable means” language. An acceptable means of compliance with this section has been defined in a proposed Change 2 to AC 25-17A, “Transport Airplane Cabin Interiors Crashworthiness Handbook,” which is available in the docket. The AC refers to the conditions for compliance for firm handholds in EASA AMC to appendix S, S25.30(b) amendment 28.
SFAR No. 109 paragraph 6, Passenger Information Signs, provides, in lieu of the “no smoking” placard requirements of § 25.791(a),
FAA proposes to adopt the requirements of CS-25 section S25.40(a) as new § 25.827(a), with one substantive difference. Paragraph CS-25 S25.40(a) permits relief from CS 25.791(a), CS 25.791(d), and CS 25.853(g) for both low occupancy and non-commercially operated airplanes. FAA finds such relief appropriate for non-commercially operated airplanes, but not for commercially operated, low occupancy airplanes. FAA is proposing alternate, more performance-based language for § 25.853(g), as discussed in section III.F of this preamble. The reasons FAA is maintaining requirements for disposal means for lit cigarettes in § 25.853(g) are discussed in that section. FAA has provided exclusions to this requirement for non-commercially operated airplanes because persons flying on non-commercially operated airplanes typically have more knowledge and familiarity in doing so. FAA is not aware of a persuasive reason to expand this exclusion to commercially operated airplanes of any size or occupancy. FAA proposes to apply the corresponding § 25.827(a) only to airplanes operated non-commercially.
CS-25 S25.40(b) provides an allowance for non-commercially operated airplanes to reduce the number of markings and placards required by CS 25.1541 by providing briefing cards that are part of the type design, referenced in the limitations section of the AFM, and are easily accessible from each passenger seat. Owners of non-commercially operated airplanes typically prefer, for aesthetic reasons, fewer placards on interior furnishings; however, FAA has not previously granted relief from § 25.1541. The proposed requirements will allow the briefing card to replace multiple placards throughout the cabin because the briefing cards would convey the necessary information. FAA agrees with EASA that providing briefing cards under the conditions stipulated in CS-25 S25.40(b) (that the cards are referenced in the limitations section of the AFM and are easily accessible from each passenger seat) provides an acceptable level of safety for non-commercially operated airplanes. FAA proposes to adopt the requirements of CS-25 S25.40(b) as § 25.827(b).
SFAR No. 109 paragraph 2(a)(1) requires each seat not suitable for occupancy during taxiing, takeoff, and landing be marked as such. EASA incorporated this requirement as S25.40(c)(2), with the additional constraint the placard be legible to the seated occupant. SFAR No. 109 paragraph 2(a)(2) requires, if more than 60 passenger seats (the passenger capacity limit of SFAR No. 109) are installed, the AFM and a placard adjacent to each passenger boarding door state the maximum passenger capacity. EASA incorporated this requirement as paragraph CS-25 S25.40(c)(1), except the upper limit is the approved passenger seating configuration rather than a limit of 60 passengers. Paragraph CS-25 S25.40(c)(1) defines “seats in excess” as the difference between the total number of seats approved for occupancy during taxiing, takeoff, and landing and the approved passenger seating configuration.
Though EASA defines the “approved passenger seating configuration” as the maximum number of passengers that may be carried on the airplane, FAA finds this could create some confusion and proposes to clarify the issue. FAA considers the approved passenger seating configuration to be the type design definition of the seat installation (which includes the seats in excess);
SFAR No. 109 paragraph 5, Direct View, provides an alternative requirement to § 25.785(h)(2) for non-commercially operated airplanes that a majority of the installed crew member seats must face the passenger cabin. EASA incorporated the same alternative requirement in S25.50(a) for non-commercially operated airplanes. In S25.50(b), EASA restated the content of CS 25.785(h)(2) as applicable to low occupancy airplanes. Because there is no difference between S25.50(b) and § 25.785(h)(2), a separate requirement to address cabin attendant direct view for low occupancy airplanes is not needed. FAA clarifies the AMC material referenced in EASA S25.50(b) is not an acceptable means of compliance to § 25.785(h)(2) as FAA and EASA have a long-standing difference in interpretation regarding what needs to be viewed when it comes to showing compliance with the direct view requirement. Existing FAA accepted means of compliance to § 25.785(h)(2)
SFAR No. 109 paragraph 16, Security, states the requirements of § 25.795 are not applicable to airplanes approved in accordance with SFAR 109. In the NPRM that proposed § 25.795,
FAA specifically sought input on this subject in the NPRM, but FAA received no comments. Because FAA did not receive further input on this topic and EASA harmonized with SFAR No. 109 in CS-25 section S25.60 at amendment 21, FAA proposes to incorporate this language as § 25.830, with applicability to airplanes operated non-commercially.
SFAR No. 109, paragraph 4(b) provides injury criteria for multiple-occupancy side-facing seats. This proposed rule would remove SFAR No. 109 but not replace its injury criteria for multiple-occupancy side-facing seats in the proposed updates to part 25. FAA issued Policy Statement PS-ANM-25-03-R1, “Technical Criteria for Approving Side-Facing Seats,” dated November 5, 2012,
Section 25.811(d)(1) contains requirements for emergency exit locator signs, and § 25.811(d)(2) contains requirements for emergency exit marking signs. SFAR No. 109, paragraph 8 provides conditions under which a single sign can be installed at each exit to serve both the marking and locator sign function. FAA also provides guidance in AC 25-17A, applicable to all proposed transport category airplanes, to permit a single sign to serve both the locator and marker sign functions of paragraphs (d)(1) and (d)(2). Therefore, because the use of a single sign to serve both functions is already allowed under part 25, FAA has determined retaining paragraph 8 of SFAR 109 would be superfluous and thus proposes to not carry it over into this rulemaking.
SFAR No. 109 paragraph 9(a) provides alternate size and brightness requirements for emergency exit signs in lieu of the requirements of § 25.812(b)(1). FAA is incorporating these alternate requirements into § 25.812(b)(2), along with other updates to incorporate the terms of commonly issued ELOS findings as discussed in section III.E. of this NPRM.
SFAR No. 109 paragraph 9(b) provides alternate requirements for floor proximity escape path markings in lieu of the requirements of § 25.812(e)(1). For cabin seating compartments that do not have the main cabin aisle entering and exiting the compartment, paragraph 9(b) requires markings and visual features not more than 4 feet above the cabin floor in lieu of the requirements of § 25.812(e)(1) to guide occupants to the exit. EASA incorporated this requirement as CS 25.812(e)(3), which is applicable to all airplanes, not just those that are non-commercially operated. FAA agrees with EASA that, for compartments that do not have the main cabin aisle incorporated in the compartment, this is an appropriate requirement regardless of type of operation. FAA proposes to incorporate the language in SFAR No. 109 paragraph 9(b) as new § 25.812(e)(3), which would also harmonize this requirement with CS 25.812(e)(3).
SFAR No. 109 paragraph 9(c) provides alternate requirements to § 25.812(l) for emergency lights in the event of a transverse separation of the fuselage. Paragraph 9(c)(1) allows, for airplanes with a maximum passenger seating capacity of 9 or less, that not more than 50 percent of all electrically illuminated emergency lights required by § 25.812 may be rendered inoperative in addition to the lights directly damaged by the separation. Paragraph 9(c)(2) allows, for airplanes with a maximum passenger seating capacity of 10 to 19, that not more than 33 percent of all electrically illuminated emergency lights required by § 25.812 may be rendered inoperative in addition to the lights directly damaged by the separation. EASA incorporated these provisions into CS 25.812(l)(1), which is applicable to all airplanes proposed for EASA's approval, not just those that would be non-commercially operated. FAA agrees with EASA that this allowance for remaining lights following a transverse
Currently, § 25.1365(b) requires overheat or fire protection for installations of galleys and cooking appliances but does not address hazards to occupants other than overheat and fire. SFAR No. 109, paragraph 14 includes requirements for installation of cooktops that are prescriptive rather than performance-based, such as specifying several design details about the cookware restraint system. These prescriptive requirements in SFAR No. 109 address hazards to occupants and the aircraft, but with this rulemaking FAA is proposing to remove SFAR No. 109 in its entirety. FAA proposes to add a performance-based requirement to proposed § 25.1365 to require the design minimize the risk of overheat, fire, smoke, burns, or spilled liquids to occupants and to the airplane due to any cooking appliance. The proposed performance-based requirement would provide increased flexibility for applicants and encourage innovation because performance-based requirements focus on achieving a desired outcome without prescribing a specific approach an applicant must use to achieve that outcome. The prescriptive design details of SFAR No. 109, paragraph 14 would remain available as one acceptable means of compliance and are incorporated in the draft of Change 2 to AC 25-17A, as discussed below. Proposed § 25.1365 would apply to commercial airplanes as well as low occupancy and non-commercial airplanes because the safety requirements for the installation of a cooktop should be the same for all transport category airplanes.
Furthermore, this proposed rule would harmonize with EASA CS 25.1365(b), with the following difference. Where CS 25.1365(b) lists “overheat, fire, burns, or spilled liquids,” proposed § 25.1365(b) lists “overheat, fire, smoke, burns, or spilled liquids.” This proposed list would explicitly include both fire and smoke to address existing SFAR No. 109 requirements related to fire detection, fire suppression, material flammability, and ventilation; however, there is no difference in the intent of the rule due to this difference. The EASA CS-25 AMC 25.1365(b) includes guidance on fire detection, fire suppression, material flammability, and ventilation that is consistent with the existing SFAR No. 109 requirements to address those hazards.
EASA CS-25 AMC 25.1365(b) guidance incorporates the design standards currently required by SFAR No. 109 paragraph 14 as acceptable means of compliance to the performance-based requirement in CS 25.1365(b). FAA would consider EASA CS-25 AMC 25.1365(b) amendment 28
SFAR No. 109, paragraph 15 requires, for airplanes that were originally type certificated with more than 60 passengers, the number of hand-held fire extinguishers to be the greater of that provided in accordance with the requirements of § 25.851 or a number equal to the number of originally type certificated exit pairs. FAA has not included this requirement as a condition for recent exemptions for non-commercially operated airplanes of this size.
FAA considers the majority of the sections in EASA CS-25 AMC to appendix S amendment 28
Currently, paragraph (b) of § 25.251, “Vibration and buffeting,” at amendment 25-77, requires that an applicant show, by flight test, that each part of the airplane is free from excessive vibration under any appropriate speed and power conditions up to V
FAA has issued several ELOS findings
When an applicant proposes an external modification to an existing type design, it must address compliance with § 25.251(b), which requires, in summary, that each part of the airplane be demonstrated in flight to be free from excessive vibration. As part of previous airplane certification programs, FAA has granted ELOS findings if an applicant can show that the airplane is free from excessive vibration and buffeting through an acceptable means other than flight testing. FAA considers the extent of the external airplane modification, particularly the size, shape, and location of the modification with respect to the unmodified airplane, may cause significant changes in the aerodynamic flow field around the
Until recently, there were no valid analytical methods to substantiate there is no excessive vibration at V
After FAA acceptance of both the validated CFD and the results of the aerodynamic analysis, the applicant would not be required to perform a flight test to V
ARAC recommended FAA modify § 25.251(a) and (b) by removing the words “demonstrated in flight to be” from each paragraph.
FAA has proposed Change 2 to AC 25-7D, “Flight Test Guide for Certification of Transport Category Airplanes,” to describe acceptable means, but not the only means, of showing compliance with proposed § 25.251(b). In order to assess whether the external modification could be reliably evaluated, proposed AC 25-7D Change 2 would provide for any suitable combination of using information from similar approved designs, flight test, and an aerodynamic analysis. This document is available in the docket. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Currently, § 25.349, “Rolling conditions,” at amendment 25-94, specifies various rolling maneuver load conditions for which the airplane must be designed and prescribes the rolling maneuvers in terms of aileron deflection.
FAA proposes to revise § 25.349(a) to prescribe the design rolling maneuver requirement in terms of flightdeck roll control movement, rather than aileron deflection. This would ensure the rolling maneuver loads used in the structural design of the airplane are adequate. FAA is also proposing other related changes described under paragraph III.C.2.
By prescribing the rolling maneuvers in terms of aileron deflection only, § 25.349 does not consider the potential effects of airplane systems. Most modern transport category airplanes are equipped with electronic flight control systems, which can affect the behavior of the airplane during a rolling maneuver. Section 25.349 also assumes just a single aileron is deflected on each wing. In fact, most modern airplanes are equipped with multiple control surfaces (such as flaperons or spoilers) that may be used in performing the rolling maneuver.
To ensure the effects of the electronic flight control system and the appropriate deflection of any flight control surface are considered, proposed § 25.349(a) would prescribe the rolling maneuvers in terms of flightdeck roll control movement, rather than aileron deflection.
In addition to this change, FAA proposes the following related changes. For the rolling conditions specified by § 25.349(a)(2) and § 25.349(a)(3), at airspeeds V
Currently, § 25.349(a)(1) specifies the applicant investigate angular acceleration for airplanes with proposed engines or other weight concentrations outboard of the fuselage. FAA proposes to remove this qualification and require applicants to investigate angular acceleration on all proposed transport category airplanes, regardless of their configuration, to ensure the design rolling maneuver loads are adequate. ARAC recommended this change to § 25.349(a)(1).
Currently, § 25.349(a) specifies the prescribed rolling maneuvers be combined with two separate airplane load factor conditions: load factors of zero and two-thirds of the positive maneuvering load factor used in the design. FAA proposes to revise § 25.349(a) to require applicants to evaluate additional load factors between these two load factor values. Though ARAC did not recommend this change, requiring applicants to evaluate a range of load factors would address potentially higher loads that could occur at load factors between zero and two-thirds. This would also harmonize with CS 25.349(a) requirements for
In June 2013, EASA revised CS 25.349(a) at amendment 13
EASA CS 25.349 requires applicants to investigate the specified rolling maneuvers without any corrective yaw control action to maximize sideslip (evaluated as a failure condition), and, as a separate condition, with corrective yaw control action to reduce sideslip as far as possible. The proposed FAA rule would require only that applicants investigate the rolling maneuvers assuming rational or conservative yaw control input. This is consistent with past FAA certification practice. That is, current § 25.349 and related SCs do not require applicants to investigate rolling maneuvers assuming no corrective yaw control action or that this be evaluated as a failure condition.
EASA provides the following advisory material in CS-25 AMC 25.349(a): “The physical limitations of the aircraft from the cockpit roll control device to the control surface deflection, such as control stops position, maximum power and displacement rate of the servo controls, and control law limiters, may be taken into account.”
FAA does not plan to issue an AC in conjunction with proposed § 25.349. However, FAA agrees with the EASA AMC. FAA agrees applicants would be able to use CS-25 AMC 25.349(a) amendment 28
Currently, § 25.809(a), at amendment 25-116, requires, for all exits, the ability to view likely areas of evacuee ground contact from inside the airplane with the exit closed. Some applicants have been unable to meet this requirement for flightcrew and overwing exits when it is not possible to see the ground contact point from inside the airplane due to the curvature of the fuselage, the distance to the ground contact point, or the wing itself blocking the view. As a result, these applicants have petitioned for an exemption from § 25.809(a). FAA has found it in the public interest to grant exemptions from the requirements of this rule for flightdeck and overwing exits when compliance with the rule is not practical.
As outlined in the overview section above, currently § 25.809(a) at amendment 25-116 requires, for all exits, (1) the ability to view likely areas of evacuee ground contact from inside the airplane with the exit closed and (2) the likely areas of evacuee ground contact be viewable during all lighting conditions with the landing gear extended as well as in all conditions of landing gear collapse. When FAA wrote the NPRM and final rule for amendment 25-116,
Flightcrew exits are used generally when the passenger exits are not available to the crew, or the situation demands more rapid egress than is possible by leaving the flightdeck and moving to a passenger exit. In those cases, outside viewing of the specific ground-contact point is largely moot because there is no alternative to using the flightcrew exit(s). Flightcrew should have a means to see outside the airplane to assess conditions generally, even if the specific point of ground contact is not visible. Flightdeck windows typically satisfy this need.
On many overwing exits, the location where the evacuee makes first contact on the ground is a considerable distance from the point from which they exit the passenger cabin. The distance the evacuee moves either forward or aft on the wing upper surface, and then down to the ground—by escape slide, jumping off of the wing, or sliding down the leading or trailing edge of the wing—makes it impossible to see the ground-contact point from inside the airplane because of the distance from the viewing point inside the airplane to the ground, given fuselage curvature or the wing itself blocking the view.
FAA and EASA collaborated to improve the CS-25 rule language based on experience applying this rule. EASA incorporated the improved language in CS-25 at amendment 12, dated July 13, 2012, to allow situations where viewing the ground contact point was not practical and to update the requirement for all emergency exits to have means to permit viewing of the conditions outside the exit when the exit is closed, in all ambient lighting conditions with the landing gears extended or in any condition of collapse. Emergency evacuations are sometimes combined with a hazard, such as a fire outside the airplane. As the hazard may pose an immediate threat, it is often necessary to avoid opening certain emergency exits in order to prevent injuries to evacuees. Thus, requiring a means to permit viewing the conditions outside the exit, such as a viewing window, allows the crew and passengers to assess the outside conditions generally and determine whether it is safe for evacuees to use a particular exit. In addition, all ambient lighting conditions must be considered because evacuations can take place during the day or night. This CS 25.809(a) requirement is consistent with the conditions imposed by FAA when granting exemptions from the ground contact point viewing requirement of § 25.809(a).
In addition, ARAC recommended FAA harmonize § 25.809(a) with EASA CS 25.809(a) at amendment 12.
FAA considers the provisions of amendment 28 of EASA CS-25 AMC 25.809(a) and AMC 25.809(a)(3)
Currently, § 25.811(e) requires operating handles for Type I and larger passenger emergency exits to be self-illuminated and, for Type II and larger, requires passenger emergency exits have red arrows with prescriptive dimensions. Sections 25.811(g) and 25.812(b) currently require passenger emergency exit signs use letters only. In addition, §§ 25.811(g) and 25.812(b) do not allow the universal exit symbol of the green running man through a door opening that is found worldwide in buildings and in various other forms of transportation.
FAA has made ELOS findings in several applications to permit proposed variations in size of exit signs and allow the use of FAA-approved universal symbols rather than the word “exit.” Previous ELOS findings allowed the installation of smaller exit signs for specific airplanes based on their passenger cabin aisle lengths and fuselage diameters. The reduced sized signs were found acceptable for specific airplanes based on their small passenger cabin, aisle length, and fuselage diameters. FAA determined reduced size exit signs provide an acceptable level of safety for a cabin of this size.
In the findings for allowance of a symbol, FAA intended “universal” to mean it is understandable by any non-English speaker as applicants' designs have incorporated pictorial representations rather than language. As discussed below, this proposal would replace prescriptive requirements with performance-based requirements, respond to ARAC recommendations, and harmonize §§ 25.811(e) and (g) and 25.812(b) with EASA CS-25 25.811(e) and (g) and 25.812(b) to permit alternate emergency exit sign markings and lighting configurations.
Currently, §§ 25.811(e) and (g) and 25.812(b) contain prescriptive requirements for emergency exit marking and lighting and are not harmonized with EASA CS 25.811(e) and (g) and 25.812(b). FAA has made ELOS findings to permit variations in size of exit signs and to allow the use of FAA-approved universal symbols, rather than the word “exit.”
Proposed § 25.811(e)(2) would require each Type A, Type B, Type C, or Type I passenger emergency exit operating handles, and the cover removal instructions if the operating handle is covered, to be self-illuminated, and proposed § 25.811(e)(4) would replace prescriptive arrow requirements with more flexible language. The proposed § 25.811(g) would allow the use of an FAA-approved universal symbolic exit sign and require the design of exit signs be chosen to provide a consistent set throughout the cabin. This change would harmonize the rule language with EASA for FAA-approved universal symbol acceptance but would add requirements for AFM operating limitations that passenger information cards and special emphasis briefings be given by the cabin crew before takeoff and landing to advise passengers the meaning of the symbol is for an emergency exit. The special emphasis briefing and information cards have been conditions of FAA's ELOS findings permitting use of FAA-approved universal symbolic exit signs because the U.S. public is generally accustomed to text-based exit signs rather than symbolic exit signs. FAA expects these measures will educate the flying public on the proposed FAA-approved universal symbolic exit signs over time. FAA intends to reevaluate the need for these additional measures when symbolic exit signs become more prevalent in the U.S.
Proposed § 25.812(b) includes performance-based size, brightness, and contrast requirements for letter-based emergency exit signs and universal symbolic exit signs and harmonizes the language with EASA for sign brightness and contrast.
FAA considers amendment 28 of EASA AMC 25.811(e)(4) and AMC 25.812(b)(1) and AMC 25.812(b)(2)
FAA has drafted Change 2 to AC 25-17A to refer to the EASA AMC and include additional guidance on these differences in expectations between FAA and EASA. The EASA AMC and draft AC are available in the docket. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Currently, § 25.853(g) requires self-contained, removable ashtrays on or near the entry side of lavatory doors. ARAC and industry recommended FAA repeal § 25.853(g) due to the prescriptive nature of the rule, the prohibition of smoking in lavatories (§ 91.519), the ban on smoking on air carrier flights (part 252), and the requirement for smoke detectors and built-in fire extinguishers in lavatories (§ 25.854).
FAA does not agree that a repeal of the rule would be in the public interest. However, proposed § 25.853(g) would replace the prescriptive requirement for self-contained removable ashtrays with a performance-based requirement that lavatories must have an approved means to dispose of lit combustible material safely located conspicuously on or near the entry side of each lavatory door, except that one means may serve more than one lavatory door if the means can be seen readily from the cabin side of each lavatory served.
After multiple fires in the 1970s started in lavatory waste receptacles, FAA issued Airworthiness Directive (AD) 74-08-09
In 1980, FAA revised the design requirements for placarding and installation of ashtrays outside of lavatories, with amendment 25-51
ARAC recommended FAA repeal § 25.853(g), which requires self-contained, removable ashtrays on or near the entry side of lavatory doors.
FAA does not agree that a repeal of the rule would be in the public interest. Smoking is prohibited onboard airplanes operated under part 121 and is prohibited in all lavatories. Data shows, however, that despite the placards and pre-flight briefings, passengers still light cigarettes in lavatories and in the passenger cabin. FAA records show that FAA initiated at least 345 enforcement actions during a 5-year period (2019 to 2024) for violations of the smoking prohibitions onboard U.S.-based carriers.
The requirement for waste receptacles to be fire resistant and contain fires has existed since 1964,
The justification proposed by ARAC regarding the need for a requirement for smoke detectors in lavatories did not account for the fact detectors are not installed to detect cigarette smoke, though this is a common misconception. Detection might not occur until paper is smoldering or a fire is developing.
The ARAC proposal to remove the requirements for ashtrays entirely would result in manufacturing and maintenance cost savings but could result in fires leading to incidents and accidents because there would be no method of safe disposal of lit cigarettes. There are potential cost savings if industry develops safe methods of lit cigarette disposal that are easier to maintain than removable ashtrays and less likely to be missing or stolen.
Proposed § 25.853(g) would replace the prescriptive requirement for self-contained removable ashtrays with a performance-based requirement that lavatories must have an approved means to dispose of lit combustible material safely located conspicuously on or near the entry side of each lavatory door, except that one means may serve more than one lavatory door if the means can be seen readily from the cabin side of each lavatory served.
FAA has drafted Change 2 to AC 25-17A to include guidance that a self-contained removable ashtray is an approved means of compliance to § 25.853(g). This document is available in the docket. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Currently, § 25.1155, “Reverse thrust and propeller pitch settings below the flight regime,” at amendment 25-11 requires each control for reverse thrust and for propeller pitch settings below the flight regime to have a means to prevent inadvertent operation. These means include a positive lock or stop at the flight idle position and require a separate and distinct operation by the flightcrew to displace the control out of the flight regime for propeller-powered airplanes, or out of forward thrust regime for turbojet-powered airplanes. Certificated designs to meet § 25.1155 have included latches intended to prevent inadvertent movement of the power levers below the flight idle stop and a mechanical detent, which requires a significant increase in force to lift and pull the power levers below flight idle. Other certificated designs included the “piggyback” type, with dual engine throttle and dual thrust reverser levers that are linked and provide a hard stop for the engine throttle lever at forward idle. Mechanical interlock systems prevent the flightcrew from moving the engine throttles past the reverse idle position until thrust reversers are deployed.
However, § 25.1155 does not contain adequate requirements to prevent selection or activation (whether intentional or inadvertent) of propeller pitch settings below the flight regime, or reverse thrust regime for turbojet-powered airplanes, when the airplane is outside of the approved in-flight operating envelope for that function.
FAA proposes to revise § 25.1155 to require a means to prevent the flightcrew on propeller-powered airplanes from inadvertently or intentionally placing the power lever below flight idle while in flight unless the airplane has been certified for that type of operation. FAA also proposes to include a similar requirement for turbojet-powered airplanes with thrust reverser systems intended for use only on the ground.
Proposed § 25.1155 stems from ARAC recommendations
A number of accidents involving turboprop-powered transport category airplanes have been caused by a movement of the power lever to a position below the flight idle regime when the airplane was in flight. Investigation of these accidents
As a result of these accidents, FAA has applied § 21.21(b)(2) to certification projects for new turboprop-powered airplane designs to incorporate a means to prevent movement of the power levers below the flight idle stop when the airplane is in flight. Section 21.21(b)(2) requires no feature or characteristic make the aircraft unsafe. In addition, FAA has issued ADs
Unfortunately, though these mitigations improved the situation, they did not prevent the recurrence of all such events. Follow-on accidents
Though the accident history associated with a pilot-initiated in-flight thrust reversal on turbojet-powered airplanes is more limited than that of turboprop-powered airplanes, turbojet-powered airplane accidents have occurred due to in-flight thrust reverser deployment.
In response to two turboprop-powered airplane accidents,
In 1998, FAA tasked ARAC
Current § 25.1155 requires a positive lock or stop at the flight idle position and a separate and distinct operation by the flightcrew whenever they displace the reverse thrust control from the forward thrust regime and the control for propeller pitch settings below the flight regime. However, for the majority of transport category airplanes, displacement of these controls during flight could lead to a hazardous or catastrophic situation.
Proposed § 25.1155 is intended to prevent (1) the loss of airplane controllability or (2) engine overspeed and consequent loss of engine power, caused by the power levers being positioned below the flight idle stop while the airplane is in flight. The proposed § 25.1155(a) would retain the intent of current § 25.1155 while making it less prescriptive by requiring a positive lock or stop, to accomplish the objective of requiring a separate and distinct operation by the flightcrew to displace the control from the flight regime. This is a difference from EASA CS 25.1155(a), which specifies only a positive lock or stop.
The proposed § 25.1155(b) would add a requirement for additional means to prevent the flightcrew on propeller-powered airplanes from inadvertently or intentionally placing the power lever below flight idle while in flight unless the airplane has been certified for that type of operation. In addition, proposed § 25.1155 would include a similar requirement for turbojet-powered airplanes with thrust reverser systems intended for use only on the ground.
The proposed § 25.1155(c) would also require the reliability of the means of preventing the flightcrew from inadvertently or intentionally placing the power lever below flight idle while in flight be high enough that loss of such means is remote. Further, proposed § 25.1155(d) would require a flightdeck alert be provided to the flightcrew if the means are lost.
Proposed § 25.1155(e) would also require a flightdeck alert be provided to the flightcrew whenever the flightdeck control for propeller pitch setting is displaced below the flight regime, or for turbojet-powered airplanes, the flightdeck control is displaced from the forward thrust regime to the reverse thrust regime and the airplane is operating outside the approved in-flight operating envelope for such settings. This alert would not need to be provided if the means to prevent the flightcrew from placing the power lever below flight idle while in flight is a means, such as a mechanical balk, that prevents movement of the control.
FAA has drafted AC 25.1155-X, “Reverse Thrust and Propeller Pitch Settings Below the Flight Regime,” to provide guidance material on one acceptable means, but not the only means, of showing compliance with proposed § 25.1155. This document is available in the docket. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Currently, paragraph (e)(1) of § 25.1193, “Cowling and nacelle skin,” requires that each airplane be designed and constructed so that no fire originating in any fire zone can enter, either through openings or by burning through external skin, any other zone or region where it would create additional hazards. Section 25.1193(e)(2) requires each airplane meet § 25.1193(e)(1) with the landing gear retracted (if applicable). Section 25.1193(e)(3) states each airplane must have fireproof skin in areas subject to flame if a fire starts in the engine power or accessory sections.
FAA proposes to revise § 25.1193(e)(3) to maintain the existing fireproof requirement for cowling and nacelle skin for in-flight operations and for ground operations where not containing the effects of a fire could result in serious hazards. Proposed § 25.1193(e)(3) would provide a less stringent requirement for ground operations where not containing the effects of a fire is found not to create any additional hazards.
The proposed revision of § 25.1193(e)(3) would eliminate the need for FAA to continue to make an ELOS finding during the certification process of a new airplane design to address this situation and would adopt ARAC recommendations
Section 25.1193(e)(3) currently requires the cowl and nacelle skin surrounding engine fire zones,
FAA has allowed, via ELOS findings,
Per FAA policy,
The proposed revision of § 25.1193(e)(3) would require cowling and nacelle skin to be fireproof in only critical areas of the airplane during ground operation. As described in AC 25.1193-X paragraph 6.3.1, a copy of which is included in the docket, critical areas would be those areas where not containing the effects of a fire could result in serious hazards to the aircraft and injuries to crew, passengers, or ground personnel. For areas of the cowling and nacelle skin that are not critical for containing the effects of a fire during ground operation, the proposed rule would allow those areas to be either fire resistant or compliant with the current requirements of § 25.1193(e)(1). The proposed rule would retain the current § 25.1193(e)(3) “fireproof” requirement for cowling and nacelle skin during in-flight operations because not containing the effects of a fire in flight could have the greatest hazard potential to the airplane or prevent continued safe flight and landing.
FAA has drafted AC 25.1193-X, “Cowling and Nacelle Skin,” to provide guidance material on one acceptable means, but not the only means, of showing compliance with proposed § 25.1193. This document is available in the docket. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Currently, § 25.1549
FAA proposes to revise § 25.1549 to provide awareness of powerplant and APU operating conditions that are within normal limits, within precautionary limits, and outside of normal limits, as applicable. The proposed § 25.1549 would allow flexibility for manufacturers to provide awareness of powerplant and APU operating conditions based on required flightcrew action necessary to maintain continued safe operation by reference to § 25.1322. Proposed § 25.1549 would also allow manufacturers flexibility to use colors other than green to denote normal operating conditions. Lastly, proposed § 25.1549 would require manufacturers to provide any additional information needed by maintenance personnel when following the instructions for continued airworthiness required by § 25.1529, “Instructions for Continued Airworthiness” and § 25.1729 “Instructions for Continued Airworthiness: EWIS.”
FAA has been accepting compensating factors through ELOS findings
The requirements of § 25.1549 were originally developed based on earlier technology using analog radial dial or linear gauge instruments to display powerplant and APU parameters on the flightdeck. Section 25.1549 currently requires certain markings on the instruments in order to provide flightcrew awareness of powerplant and APU operation. The reliance on automated control systems in modern turbine engines and APUs decreases the need for flightcrew awareness of some powerplant and APU operating conditions. For these conditions, it may not be necessary to provide the flightcrew with all of the information in the instrument marking requirements of § 25.1549. The current requirements of § 25.1549 for powerplant and APU instruments are prescriptive and do not allow airplane manufacturers flexibility to innovate powerplant and APU instrument displays. Airplane manufacturers have requested an ELOS finding under § 21.21 for modern electronic displays in designs that did not directly comply with the requirements of § 25.1549.
ARAC proposed an alternative recommendation to § 25.1549(b) that would require each normal operating range to be readily indicated to the flightcrew by use of markings, colors, color changes, or other means.
The Aerospace Industries Association (AIA) Powerplant Indications Task Team (PITT) was formed July 2001 in response to an FAA task raised at the ARAC Powerplant Installation Harmonization Working Group in October 2000 to investigate a number of concerns related to powerplant indications. The AIA PITT issued a report
FAA has received a number of industry requests for ELOS findings,
FAA proposes to revise § 25.1549 to allow applicants flexibility in design, while still providing flightcrews with the necessary awareness of powerplant and APU operating conditions. The proposal would include the considerations recommended by the AIA PITT Report to increase flexibility, align with § 25.1322, and eliminate the need for ELOS findings. The proposal would address the ARAC recommendation to eliminate the need for ELOS findings, though the proposal differs from the ARAC recommended language, as previously discussed.
This proposal maintains the original intent of § 25.1549 by requiring the airplane design to provide flightcrew awareness of any propulsion and APU operating condition with operating limits requiring flightcrew action necessary to maintain continued safe operation. This includes awareness of applicable normal operating conditions and operating outside of applicable normal limits.
Proposed § 25.1549 would allow the continued use of the color green for displaying normal operating conditions, as well as the use of other colors when the design consistently uses the same colors for displaying normal operating conditions. FAA's proposal does not specify a specific color, only that the design displays colors are consistent with colors used for normal operation for other airplane systems.
Proposed § 25.1549(b) would require the design to provide any additional information on powerplant and APU operating conditions needed for maintenance personnel to evaluate each powerplant and APU installation according to the ICA required by §§ 25.1529 and 25.1729. The removal of prescriptive powerplant and APU instrument marking requirements may make information unavailable to maintenance personnel needed to support powerplant and APU maintenance. The proposed rule is intended to ensure the design provides any information on powerplant and APU operating conditions needed by maintenance personnel when following the ICA, even if the flightcrew does not need to be aware of the same information to maintain safe flight.
The proposed rule is also intended to align powerplant and APU operating awareness with the flightcrew alerting requirements of § 25.1322. Any information the design provides to comply with § 25.1549 would also be required to meet § 25.1322.
An important difference between the existing § 25.1549 and the proposed § 25.1549 is how the requirements would be grouped. The existing § 25.1549 has marking requirements for each powerplant and APU instrument in four paragraphs: (1) each maximum and minimum safe operating limit, (2) each normal operating range, (3) each takeoff and precautionary range, and (4) each speed range that is restricted because of excessive vibration stresses. The proposed § 25.1549 for powerplant and APU operating awareness would have three paragraphs: (1) information needed for the flightcrew to identify operating limits and take necessary action, (2) any additional information needed for maintenance personnel to identify normal operation according to the ICA required by §§ 25.1529 and 25.1729, and (3) displaying flightdeck information.
The proposed § 25.1549 would maintain grouping requirements based on normal limits for each powerplant and APU installation but differ by grouping remaining requirements for all other operating conditions using the phrase “outside of normal limits.” Therefore, the current requirements of § 25.1549(c) for each takeoff and precautionary range and of § 25.1549(d) for each engine, APU, or propeller speed range that is restricted because of excessive vibration stresses would be considered outside of normal limits under the proposed § 25.1549; it is unnecessary to explicitly state these conditions in the regulation.
Furthermore, FAA considers the takeoff range separate from the normal operating range in the current § 25.1549(b) and would consider the takeoff range as outside of normal limits under the proposed § 25.1549(a)(2), (a)(3), and (c)(2), if applicable to the design. FAA considers the precautionary range separate from the normal operating range in the current § 25.1549(b) and would consider the precautionary range as outside of normal limits under the proposed § 25.1549(a)(2), (a)(3), and (c)(2), if applicable to the design. The proposed change to effectively include any applicable takeoff range, precautionary range, and each engine, APU, or propeller speed range that is restricted because of excessive vibration stresses as outside of normal operating limits would modernize the requirements of § 25.1549 and make them more consistent with the flightcrew alerting requirements of § 25.1322.
The proposed § 25.1549(c) would also allow manufacturers flexibility for the design to use colors that are consistent with colors used for normal operation of other airplane systems when operating within normal limits. The proposed § 25.1549(c) would also require the flightdeck information displayed outside of normal limits to meet § 25.1322.
In addition, proposed § 25.1549 would alleviate the need for ELOS findings to § 25.1549 for APU installations that allow unattended operation while the airplane is on the ground or limited flightcrew monitoring of APU installation parameters while in flight. The proposed APU installations where FAA has made ELOS findings related to unattended operation on the ground or limited flightcrew monitoring in flight have all incorporated features that automatically monitor APU operating conditions. These features either automatically shut down the APU when an operating parameter is exceeded or APU system fault is detected or alert the flightcrew to conditions requiring the flightcrew to shut down the APU while in flight. Because the only flightcrew actions are to shut down the APU and activate APU compartment fire extinguishing, for these designs FAA has found associated flightcrew alerting sufficient in lieu of the design providing more detailed information to the flightcrew for certain APU parameter exceedances. Proposed § 25.1549 would require the design to provide flightcrew awareness of any propulsion and APU operating
Currently, paragraph (d)(1) of § 25.1555, “Control markings,” requires for accessory, auxiliary, and emergency controls that each emergency control, including each fuel jettisoning and fluid shutoff control, be colored red. FAA proposes to revise § 25.1555(d)(1) by allowing the emergency controls to either be colored red or illuminate red when a condition necessitates its use, if it has appropriate safeguards to prevent unintentional actuation while allowing its intended use and not restricting its use when needed.
Proposed § 25.1555(d)(1) is intended to allow applicants flexibility in the design of the emergency controls consistent with the agency's flightdeck alerting philosophy and requirements and eliminate the need for FAA to make continued ELOS findings to address this topic.
Section 25.1555(d)(1) currently requires emergency controls to be colored red. The purpose of the current requirement is twofold: (1) to reinforce flightcrew awareness that actuating emergency controls may have a permanent effect on the airplane systems and (2) to denote that failure to actuate emergency controls in accordance with a prescribed emergency procedure may jeopardize continued safe flight and landing.
The § 25.1555 requirements were originally developed for traditional flightdeck designs with mechanical controls that did not present as much information to the flightcrew as a modern flightdeck. For these traditional designs, flightcrews were expected to extract, or pull, information from all indications available. As more information and automation were added to flightdecks, flightcrew capability to process information presented to them became more challenging. Flightdecks evolved to “push” information to the flightcrew, leading to the so-called “quiet and dark flightdeck” design philosophy. Under this philosophy, indications and controls in the flightdeck are subdued or consistently dark unless flightcrew awareness and subsequent action become necessary. The purpose is to provide the flightcrew with the correct balance of information necessary to appropriately manage the airplane by providing an enhanced interface through reduced workload and greater awareness.
FAA has made ELOS findings
FAA has received a number of industry requests for ELOS findings to incorporate emergency controls that illuminate red during emergency conditions, in lieu of the § 25.1555(d)(1) requirement emergency controls be colored red. FAA has determined such designs provide an ELOS to § 25.1555(d)(1) and has issued an ELOS finding for several certification projects under § 21.21(b)(1). The current regulation is inconsistent with the “quiet and dark” flightdeck design philosophy. In addition, processing repetitive ELOS findings for the same general issue involving a single regulation imposes a burden on both FAA and industry.
This proposal would maintain the original intent of § 25.1555(d)(1) by requiring the airplane design to provide flightcrew awareness of any emergency conditions requiring flightcrew action necessary to maintain continued safe operation. The proposal would also require, if the applicant chooses to incorporate emergency controls that illuminate red rather than are always colored red, the emergency controls employ an appropriate means to inhibit or prevent operation if the emergency control is unintentionally manipulated, but not completely restrict its use if needed. This condition is necessary because during the times the control is not illuminated red, the flightcrew has less obvious indication it is an emergency control. The design means to inhibit or prevent operation in non-emergency situations would prevent accidental selection or improper operation by flightcrew.
FAA has drafted AC 20-175A, “Controls for Flightdeck Systems,” to provide guidance material on one acceptable means, but not the only means, of showing compliance with proposed § 25.1555(d)(1). This document is available in the docket. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Part 25 currently has no regulations for carriage of authorized persons
In past airplane certification programs, FAA granted exemptions
Part 25 certification regulations identify occupant safety requirements for “flightcrew,” “crew,” “flight attendants,” and “passengers.”
The current requirements of § 25.857(e), amendment 25-142, permit only the carriage of cargo, and no passengers, when a Class E cargo compartment is installed on the airplane. Class E cargo compartments are separate from the flightdeck and encompass most of the interior of the airplane. In the case of a fire that might occur in a Class E cargo compartment, the primary means of control is to starve the fire of oxygen and is accomplished by shutting off ventilating airflow. Additional operational mitigations include depressurizing the airplane and maintaining an altitude that does not support combustion. Due to this emergency depressurization procedure, § 25.857(e) does not permit passengers on airplanes with Class E cargo compartments.
Section 121.583 permits the certificate holder to authorize carriage of certain persons (authorized persons) without compliance to the passenger-carrying requirements of part 121. However, § 121.583 does not address various passenger safety features absent in all-cargo airplanes. This leaves a gap between the type certification requirements of part 25 and the operational rules of part 121. In order to bridge that gap, FAA has been providing relief from various part 25 passenger safety requirements through the issuance of exemptions
Cargo operators have identified the need, at times, to carry a small number of certain authorized persons on cargo flights. Allowing the carriage of certain authorized persons aboard cargo flights enables the cargo operator to optimize the utility of its airplanes at some airports because authorized persons are familiar with specific cargo and aware of potential safety issues inherent to the carriage or the loading and off-loading of that cargo. For example, when live animals such as horses are carried as cargo, animal handlers seated forward of the Class E cargo compartment need to be able to access the Class E cargo compartment to care for the animals in-flight to maintain the animals' health and comfort. Therefore, certain authorized persons are seen by FAA and industry as a benefit to the safety and efficiency of air cargo operations.
As previously noted, FAA has granted several exemptions to the part 25 requirement for “cargo only,” to allow the carriage of a small number of authorized persons if certain conditions and limitations are followed. These conditions and limitations are intended to make it safe to carry authorized persons on all-cargo flights. These exemptions require changes to the airplane flight manual to limit the occupancy of the airplane and require specific training and briefings for authorized persons. The exemptions limit the persons carried to those persons authorized by § 121.583(a). The exemptions have typically required the airplanes to include specific emergency equipment, warning systems to alert authorized persons of hazards including in-flight fire, decompression and turbulence, an acceptable escape system such as ropes or inertia escape reels or slides, and the authorized persons to be physically able to use the escape systems.
This proposal would reduce the need for FAA to grant exemptions to permit authorized persons aboard all-cargo airplanes with Class E cargo compartments. This would provide a benefit to applicants and FAA by reducing certification project hours. Several proposed type design requirements and associated operational procedures and limitations together would provide an acceptable level of safety for authorized persons onboard all-cargo airplanes. This proposed rule would improve FAA and industry standardization and will better align FAA's certification rules with its operating rules. This proposed rule would retain the design features and operational procedures and limitations of previously issued exemptions to ensure the safety of authorized persons onboard all-cargo airplanes in the event of an emergency, such as a cargo fire or decompression.
For operation under part 121, § 121.583 provides operational requirements for carriage of persons authorized by the certificate holder without complying with certain passenger-carrying airplane requirements. Section 121.583(a) lists categories of persons that can be authorized. Section 121.583(c) requires all such authorized persons have been orally briefed before each takeoff. Section 121.583(d) requires each certificate holder operating an airplane carrying persons covered by § 121.583(a) to incorporate procedures for the safe carriage of such authorized persons into the certificate holder's operations manual. Similarly, for operations under parts 125 and 135, §§ 125.331 and 135.85 provide for carriage of authorized persons without complying with certain passenger-carrying aircraft requirements.
As mentioned in the background and discussion above, a gap currently exists between the part 25 airworthiness certification requirements and any required specific procedures, instructions, and briefings not contained in the applicable guidance pertaining to the safe carriage of authorized persons. Currently, these requirements are only found within the conditions and limitations contained within a grant of exemption. Applicable guidance for §§ 121.583, 125.331, and 135.85 is in FAA Order 8900.1 and AC 120-85, “Air Cargo Operations,” which include additional information specifically for all-cargo operational procedures, instruction, or briefings for safe carriage of non-crew persons where certain passenger-carrying airplane requirements are not met. The guidance includes items such as specifying physical capabilities, instructions, and a provision for aircraft familiarization to allow compliance with applicable part 25 airworthiness certification requirements. For example, the procedures would include providing the authorized persons instruction in the use of the emergency equipment, including evacuation assist means. These procedures would be contained in FAA-approved or accepted operators manuals required by the operating rules.
The proposed § 25.797(a) would require the applicant to specify limitations in the airplane flight manual for the type and the maximum number of authorized persons that can be
To ensure the safety of the authorized persons, the proposed text would also require the airplane flight manual to prohibit occupancy of the cargo compartment during taxiing, takeoff, and landing and include operating procedures for briefing the occupants on appropriate emergency procedures, the meaning of all required alerts, and the limitation that access to the Class E cargo compartment is prohibited during taxiing, takeoff, and landing.
Section 25.791(b), amendment 25-153, requires lighted passenger information “fasten seat belts” signs, operable by the flightcrew and visible to seated passengers, to inform seated passengers when corresponding actions are required. The seating locations for authorized persons on all-cargo airplanes are not typical passenger cabins and may not have a practical means to provide lighted “fasten seat belts” signs. The proposed § 25.797(b) would require a flightcrew-operated alert system in lieu of § 25.791(b), allowing the crew, when necessary, to inform authorized persons to return to their seats and fasten their seat belts. The authorized persons would receive instructions and briefings on these alert systems in accordance with §§ 121.583, 125.331, and 135.85.
Section 25.807(g)(1), amendment 25-114, requires at least one Type IV or larger overwing exit in each side of the fuselage or, if overwing exits are not provided, at least one exit in each side that meets the minimum dimensions of a Type III exit. In addition, § 25.807(i)(1), amendment 25-114, requires for airplanes with a passenger seating configuration of nine or fewer seats, a ditching exit meet the minimum size for a Type IV exit. Some cargo airplane configurations are equipped with a crew entry door that meets the requirement of a Type III exit on the left-hand side of the airplane. However, in many cases, the right-hand side of the all-cargo airplane does not have a Type III exit. FAA has accepted the right-hand flight deck window to serve as this right-hand emergency exit, provided the opening mechanism is modified to be openable from the outside and a demonstration is required to show the flightdeck window is a usable exit. The proposed § 25.797(c) would allow relief from § 25.807(g)(1) and (i)(1) if the flightcrew exits designated for use by authorized persons are openable from the inside and the outside, and the exits be demonstrated as a useable exit by test. If configurations are requested for more than 9 authorized persons, the applicant would be required to meet the applicable emergency exit requirements of § 25.807 or could petition for an exemption from the applicable paragraphs of § 25.807.
If an applicant requests certification of the aircraft for ditching, § 25.1411(d)(2) requires life rafts be stowed near exits through which the rafts can be launched. In some past design projects, applicants have proposed designs for life rafts that do not fit through the flightdeck window proposed as an exit. If life rafts must be installed for flights over water, they must be of a design that can be launched out any one of the exits, including the right-hand flightdeck window if proposed as an exit, to meet § 25.1411(d)(2). In the past, FAA typically has included this as a condition in grants of exemption to accommodate authorized persons, to ensure applicants appropriately have complied, even though this is a requirement of the current regulations that were not exempted. FAA is not proposing any change to the regulations as compliance with § 25.1411(d)(2) is sufficient to ensure a functional life raft design.
Section 25.809(a), amendment 25-116, requires means be provided at each emergency exit to permit viewing of the likely areas of evacuee ground contact. This requirement is intended to ensure evacuees can make good decisions about the safest exit to use, in the event of hazards on the ground, prior to evacuation. The type of assist means (
As discussed in section III.D. of this NPRM, FAA proposes to revise § 25.809(a) to remove the requirement to permit viewing of the likely areas of evacuee ground contact for flightcrew exits. For all-cargo airplanes with carriage of a small number of authorized persons, FAA has determined, in the course of its analysis of previous petitions for exemption,
Section 25.810(a)(1), amendment 25-114, requires the passenger emergency exits be equipped with a self-supporting slide or equivalent assist means. All-cargo airplanes are often designed with only one emergency exit door on the left-hand side of the airplane, and a hatch or window exit located in the flightdeck to provide egress on the right-hand side. Flightcrew exits that are hatches or windows often have ropes or inertia reels with harnesses as the egress means rather than escape slides. The carriage of non-crew persons on these airplanes means the non-crew persons must be able to use these egress means normally used only by flightcrew. In order to establish an acceptable level of safety, the proposed § 25.797(e) would require FAA-approved evacuation means to be provided for each occupant, and proposed § 25.797(c) would require the applicant demonstrate the proposed left-hand and the right-hand emergency exits provide an acceptable means to allow rapid evacuation, using the assist means proposed for authorized persons, in addition to the flightcrew. These demonstrations would include the harnesses (if used with the inertia reels) and the range of occupants intended to use the assist means.
Section 25.812(e), amendment 25-128, requires floor proximity emergency escape path marking in the passenger areas of the airplane. The purpose of § 25.812(e) is to ensure passengers can make their way to exits when visibility in the cabin above the floor is obscured, whether by smoke or loss of normal airplane lighting in the cabin. Because of the limited area of the seating area and the short distance(s) to the emergency exits, the lack of the floor proximity emergency escape path
In the proposed § 25.797(f), FAA would allow relief from § 25.812(e) and § 25.812(l) if the seats for authorized persons are near the emergency exits.
Section § 25.813(b), amendment 25-128, requires adequate space for certain exit types to allow crewmember(s) to assist in the evacuation of passengers. The proposed § 25.797(a)(4) would require authorized persons be instructed and briefed on how to operate the emergency exits and the assist means. FAA has determined that considering the small number of authorized persons, the size of the seating area for authorized persons, and the proximity of authorized persons to the emergency exits, the flightcrew can also provide instructions and some physical assistance to authorized persons, if needed, in lieu of a dedicated assist space. Therefore, in the proposed § 25.797(f)(3), in lieu of the assist space requirements of § 25.813(b), assist space requirements need not be met if all seats for authorized persons are near the emergency exits. This topic is currently captured in the exemption process
Section 25.1447(c)(1) contains several requirements for oxygen dispensing units, including automatic presentation of the oxygen dispensing units if certification for operation above 30,000 feet is requested by the applicant. For seated passengers in typical passenger airplanes, the automatic presentation of masks throughout the cabin indicates the need to don an oxygen mask. However, in seating areas for authorized persons on all-cargo airplanes, the typical features of passenger cabins are not installed, so there is often not a practical means of providing automatic presentation of masks. FAA proposes new § 25.797(g), to allow manual activation of supplemental oxygen dispensing units located within reach of the seated occupant for authorized persons, with an automatically activated aural alert, in case of a decompression, that notifies occupants of the need to don oxygen masks and initiate oxygen flow.
The proposed § 25.797(g)(1) would require the portable oxygen units be sized adequately for continuous and uninterrupted use during unpressurized flight with cabin pressure altitudes that require the use of supplemental oxygen (
To ensure adequate hypoxia protection during non-sedentary use, the proposed § 25.797(g)(2) would require portable oxygen units meet the requirements for flightcrew oxygen equipment in § 25.1443(a) or (b), or the portable oxygen units be shown to protect authorized persons from hypoxia at an activity level required to return to his or her seat following a rapid decompression to 25,000 feet cabin altitude.
Section 25.1449 states there must be a means for the crew to determine whether oxygen is being delivered to the dispensing units. However, under proposed § 25.797(g)(3), the equipment design would provide a means for authorized persons to determine that oxygen is flowing to their dispensing equipment. The design in combination with training of the authorized person would allow them to make the determination whether oxygen is being delivered to the portable oxygen dispensing equipment.
Section 25.1447(c)(1) requires an “immediately available” supply of oxygen for each person when the airplane is operating above 25,000 feet. For those designs in which persons are permitted to enter the Class E cargo compartment during flight, it is not feasible to install the typical passenger oxygen masks. Therefore, a portable oxygen unit must be available for each person. Because the portable oxygen units may also be used for protection from smoke in the event of a fire in the cargo compartment, the proposed § 25.797(i)(2) would require the portable oxygen units also meet the protective breathing equipment requirements in § 25.1439(b)(1), (2), and (4).
To provide persons with an acceptable level of safety while they are in the Class E cargo compartment, the proposed § 25.797(k)(3) would require a placard notifying authorized persons they must carry a portable oxygen unit with a full-face oxygen mask when entering the cargo compartment. A portable oxygen dispensing unit with a full-face oxygen mask also provides a reasonable level of protection from smoke inhalation.
Section 25.1447(c)(1) requires 10 percent more oxygen masks than occupant seats. The purpose is so oxygen masks are available for children sitting on passengers' laps and for flight attendants moving about the cabin.
Section 25.1423(c), amendment 25-115, requires a public address (PA) system to be intelligible at all passenger seats, lavatories, and flight attendant seats and work stations. In addition, the operating rules for commercially operated airplanes in §§ 121.319 and 135.150 require PA and crewmember interphone systems for seating capacities of more than 19 passengers. These existing certification and operational rules do not address the case of an all-cargo airplane with carriage of authorized persons because a cargo compartment is not also a passenger compartment to which those requirements apply. Section 25.797(h) of the proposed rule would require applicants to install this same PA and a two-way communication means to allow for the necessary communication between the flightcrew and the authorized persons.
The proposed § 25.797(h)(1) would require a PA system to be audible for configurations that carry authorized persons in occupied compartments such as the seating area and the Class E cargo compartment. The proposed § 25.797(h)(2) would require a two-way communication means, such as an
Two-way communication means is necessary to communicate from the flight deck to the seating area, and the PA system is necessary so the flightcrew can announce necessary safety information to any location throughout the cargo airplane including the Class E cargo compartment if access is permitted during flight. The two-way communication system would be required under this proposal to be independent of the PA system, except for handsets, headsets, microphones, selector switches, and signal devices, which can be shared. The proposed requirements within § 25.797(h) for communication means are consistent with conditions that FAA has often required in part 25 exemptions
FAA has previously granted exemptions for authorized persons to access a Class E cargo compartment in flight, provided certain conditions are met.
In order to be consistent with previously granted relief, minimize the exposure risk to authorized persons while in the Class E cargo compartment, and eliminate the need for future exemptions to address this situation, the proposed § 25.797(i)(1) would require in-flight access to the Class E cargo compartment be limited to a maximum of three authorized persons for the handling of hazardous or perishable cargo. For the care and handling of animals including additional cargo, in-flight access to the Class E cargo compartment would be limited to a maximum of one authorized person for every four animals. Currently, the upper limit of the number of authorized persons is determined by the design (provisions for occupant safety) and the quantity of animals carried and is not capped in the regulation. The intent of the proposed § 25.797(i)(1) is to limit the occupancy of authorized persons in order to minimize the risk exposure.
As discussed in section III.K.3.g of this NPRM, supplemental oxygen and protective breathing equipment, the proposed § 25.797(j)(1) would require an automatic aural decompression to alert authorized persons to don their oxygen masks and initiate oxygen flow.
To ensure authorized persons with access to the Class E cargo compartment know to leave the cargo compartment in the event smoke or fire is detected in the compartment, the proposed § 25.797(j)(2) would require the installation of a visual alert that is recognizable in the Class E cargo compartment. The alert would notify authorized persons of the smoke or fire in the compartment. The alert would indicate all personnel must don their oxygen mask (and initiate flow), return to their seats, and secure the smoke barrier (
To address hazards caused by moving about the airplane in turbulence, the proposed § 25.797(j)(3) would require a flightcrew-operated alert system in lieu of § 25.785(j). Section 25.785(j), amendment 25-88, requires handholds along each aisle, which could be seat backs, a handgrip, or a rail. The purpose of the requirement for handholds is to ensure that occupants have a means to steady themselves in moderate turbulence while traversing the aisles of typical passenger airplanes. An all-cargo airplane does not have aisles, and it is not feasible to require handholds in a cargo compartment as that would interfere with loading of cargo. The alert system required in proposed § 25.797(j)(3) would allow the crew to indicate, at the onset of turbulence, to persons not in their seats in such locations as the lavatory or in the cargo compartment that they must return to their seats.
The alert systems would be required to be recognized in the accessible areas such as the lavatory, the flight deck, any occupied compartment forward of the Class E cargo compartment, and the Class E cargo compartment. This topic is currently captured in the exemption process
Section 25.1541 requires placards be installed for the safe operation of the airplane. The proposed § 25.797(k) would require placards be installed in a conspicuous location in the seating area for the authorized persons on or adjacent to the access means to the cargo compartment. These placards would convey the safety information listed in proposed § 25.797(k) to persons onboard the airplane regarding access to the cargo compartment and appropriate safety precautions to mitigate safety hazards due to turbulence, smoke, and fire. The requirement for these placards are currently captured in the exemption process
Section 25.857(e)(4) requires, for class E cargo compartments, the design to provide means to exclude hazardous quantities of smoke, flames, or noxious gases from the flightcrew compartment. Section 25.855(h)(2) requires flight tests to show § 25.857(e)(4) is met. To address the hazard for non-crew persons, FAA would propose § 25.797(l) to extend this exclusion requirement to all seating areas, not just the flightcrew compartment. The means by which applicants typically already provide such exclusion is a smoke barrier between the Class E cargo compartment and the occupied compartments. However, if an applicant requests approval for authorized persons to enter the Class E cargo compartment, authorized persons would open this means to gain access to the compartment. To provide an appropriate level of safety, the proposed § 25.797(k)(6) would require the applicant to install a placard indicating that the smoke barrier must be secured, (
FAA is concerned about the potential for hazardous quantities of smoke, flames, and noxious gases entering the seating areas in the event of a fire on the main deck cargo compartment. The amount of smoke that would enter these areas when the smoke barrier is open while authorized persons are leaving the cargo compartment, pursuant to § 25.855, must not create a hazard to the occupants.
FAA Order 8900.1 volume 3 chapter 48, “Flight Standards Information Management System,” and AC 120-85, “Air Cargo Operations,” include guidance on the operational procedures, instruction, and briefings necessary for safe carriage of non-crew authorized persons where certain passenger-carrying airplane requirements are not met.
Currently, §§ 25.5, “Incorporations by reference,” 25.981, “Fuel tank explosion prevention,” and N25.3, “Fuel tank flammability exposure analysis,” of appendix N to part 25 in part, require applicants to use Report No. DOT/FAA/AR05/08, “Fuel Tank Flammability Assessment Method User's Manual,” dated May 2008 to conduct a fuel tank flammability exposure analysis. FAA proposes to revise §§ 25.5(b)(1) and 25.981(b)(1) and section N25.3(a), (b)(5), and (d)(5) of appendix N to part 25 to instead require the use of Report No. DOT/FAA/TC-21/3, “Fuel Tank Flammability Assessment Method User's Manual—Updated for Version 11,” dated January 2021.
The “Reduction of Fuel Tank Flammability in Transport Category Airplanes” final rule in 2008
Because FAA required applicants to use version 10 of the FTFAM, several errors have been discovered in the FTFAM computer model code, and FAA has made improvements to the code to meet specific needs of applicants to assess the flammability of unique fuel tank features. FAA included these corrections and improvements in version 11 of the FTFAM. A summary of the changes is as follows:
• The descent profile was corrected to accurately represent the descent rate that is defined in the regulation.
• The temperature lapse rate calculations were corrected to consistently utilize 3.57 degrees F/1000 feet lapse rate.
• There were additional areas in the code that were corrected or improved and had no impact on the results of the flammability analysis.
For comparative purposes, the overall effect of these changes correcting the errors over 1,000 flights, using standardized inputs, is a Flammability Evaluation Exposure Time of 55.45 percent versus 52.90 percent prior to the change.
FAA has received several requests from applicants to use version 11 of the FTFAM, the download website address
The proposed rule changes would apply to new type certification programs of transport category airplane designs and to amended or supplemental type certificate programs as determined under § 21.101, “Designation of applicable regulations.” In the future, applicants who want FAA certification of new airplanes under part 25 would need to follow the methods and procedures in Report No. DOT/FAA/TC-21/3 using version 11 of the FTFAM.
AC 25.981-2A, “Fuel Tank Flammability Reduction Means,” dated September 19, 2008, provides guidance on one acceptable means, but not the only means, of showing compliance with § 25.981, part 26 subpart D, and related airworthiness standards for transport category airplanes about limiting the time a fuel tank may be flammable or mitigation of hazards from flammable fuel air mixtures within fuel tanks. AC 25.981-2A references the FTFAM user's manual, Report No. DOT/FAA/AR05/08. The revised AC is draft AC 25.981-2B, which would change the Report No. DOT/FAA/AR05/08 reference to Report No. DOT/FAA/TC-21/3, to be consistent with this proposed rule. The draft AC is available in the docket. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Currently, § 25.773, “Pilot compartment view,” at amendment 25-144, specifies various requirements for pilot compartment (
Section 25.773(b)(1) currently requires that the airplane have a means to maintain a clear portion of the windshield during precipitation conditions, sufficient for both pilots to have a sufficiently extensive view along the flight path in normal flight attitudes. To maintain consistency with § 25.773(a)(1) and previously issued SCs that allow a hydrophobic coating in lieu of windshield wipers, FAA is proposing to revise this section to instead require a sufficiently extensive view for all operations within the operating limitations of the airplane, including taxiing, takeoff, approach, and landing.
In addition, FAA is proposing to revise § 25.773(b)(1)(ii) to require the means to maintain a clear portion of the windshield be designed to function, without continuous attention by the crew, in light precipitation conditions at speeds normally encountered during ground operations. The current requirements of § 25.773(b)(1)(ii), which prescribe pilot compartment view requirements in icing conditions, would be maintained, but moved to new § 25.773(b)(1)(iii). In addition, adopting proposed § 25.773(b)(1)(ii) would eliminate the need to develop an IP and issue SCs for use of hydrophobic coatings in lieu of windshield wipers in future airplane certification projects.
Section 25.773 applies to any installed equipment that might obstruct the pilots' view or produce glare and reflection within the flightdeck. Flightdeck glare and reflections can be introduced by a number of sources including sunlight reflecting from flightdeck displays, instruments, or even the flightcrew's clothing. At night, such sources may include airfield and other external lighting in addition to the flightdeck displays and installed equipment.
FAA has made ELOS findings for applicants seeking to do ground tests in lieu of night flight tests to show compliance with § 25.773(a)(2) for proposed designs on previously certificated airplanes. In these ELOS findings, FAA required applicants to provide a dark flightdeck equivalent to a night environment. For most changes to the flightdeck, a ground test will provide equivalent validation to a night flight to ensure the pilot compartment view meets the requirement of § 25.773(a)(2) in non-precipitation conditions. However, under proposed § 25.773(a)(2), night flight tests would still be required for newly certificated airplanes and for changes to the flight deck that may produce any appreciable effect on the pilot compartment view glare or reflection based on service history or previous flight test results. In addition, if the test pilot notes any significant glare or reflection during the proposed ground test, then further evaluation in a night flight test would be required.
Applicants seeking FAA certification of a new airplane design would be required to comply with the existing night flight tests requirement to establish a baseline for acceptability of pilot compartment vision. For changes to the flightdeck for any previously certificated airplane, the proposed rule would permit applicants to perform a ground test in lieu of a night flight test if they demonstrate, by analysis or similarity, the change has no appreciable effect on the pilot compartment view, glare, or reflection, based on service history or previous flight test results. Changes that introduce no appreciable effect may be reconfiguration or changes to internal lights, alerts or annunciations, hardware, or heads down displays. Night flight tests would still be required for changes to the flightdeck where it would be impractical or impossible to determine the acceptability of glare or reflection from a ground test. Examples of such changes could be installation of flightdeck windshields, transparent displays, external lighting modifications, exhaust signatures that have the potential to impact views, and any installation involving night vision imaging systems.
In addition, FAA has issued SCs
FAA proposes to revise § 25.773(b)(1) to make it consistent with § 25.773(a)(1) by requiring a sufficiently extensive view for all operations within the operating limitations of the airplane, including taxiing, takeoff, approach, and landing, and to add additional light precipitation conditions to § 25.773(b)(1)(ii), making it consistent with previously issued SCs. Light precipitation conditions may include mist, drizzle, and light rain. This proposed rule would eliminate the need to issue SCs for new certification projects that use a hydrophobic windshield coating instead of mechanical windshield wipers. As a result of proposed § 25.773(b)(1)(ii), FAA proposes to maintain the text, but move the requirements in current § 25.773(b)(1)(ii) and its subparagraphs, which cover consideration of various icing conditions, to § 25.773(b)(1)(iii).
FAA has drafted Policy Statement, PS-AIR-25.773-01, “Night Testing Requirements for Reflection or Glare in the Flightdeck,” to provide guidance on ground test conditions that may be used in lieu of night flight tests for certain proposed changes to the flightdeck and specify circumstances that may require further scrutiny of changes during ground tests and lead to further testing (including night flight tests) if there is ambiguity concerning the amount or effects of glare or reflection.
FAA has drafted Policy Statement PS-AIR-25-31, “Use of Hydrophobic Coating in lieu of Windshield Wipers” to provide additional guidance that may be used when hydrophobic coatings are used in lieu of windshield wipers.
These documents are available in the docket. Comments on these proposed policy documents may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Currently, § 25.785(b) requires seats and berths to meet the requirements of § 25.562, “Emergency landing dynamic conditions.” Section 25.562 specifies dynamic test conditions for assessment of occupant injury, as well as structural criteria. The reason for implementation of § 25.562 was to provide an overall increased level of passenger safety by reducing serious injuries that would affect passengers' ability to evacuate the aircraft in a survivable accident. FAA proposes to revise paragraph (b) of § 25.785, “Seats, berths, safety belts, and harnesses,” to except berths intended only for carriage of medical patients (
FAA has granted several exemptions
As mentioned above, FAA has granted several exemptions to the emergency
Currently, part 25 regulations only address the use of glass in windshields, instrument or display transparencies, and window applications.
Some proposed executive transport airplane interiors include showers. FAA's existing safety standards do not provide specific requirements or guidance for occupant safety in a shower cubicle. A shower cubicle is a completely enclosed space surrounding the area in the cabin where an occupant can take a shower. The shower cubicle must perform the basic function of retaining the water and mitigating any hazards from the water such as leakage, ventilation, and high humidity and would separate the wet area from any nearby electrical outlets. To provide shower occupants with an ELOS to the level provided by FAA design standards for other areas of the cabin, the proposed § 25.788(a) would address hazards to occupants due to turbulence and decompression and prevent shower occupancy during taxiing, takeoff, and landings. The proposed rule would require audio and visual “return to seat” indications similar to those required by § 25.791(b) and a means to steady oneself in moderately rough air. To address decompression, the proposed rule would require audio and visual indications of the need for oxygen and revise the language in § 25.1447(c)(6) to provide sufficient outlets and units of dispensing equipment in occupied areas of the cabin. This would include oxygen for shower cubicle occupants. The proposed rule would also require the design to preclude anyone from being trapped inside the shower cubicle and add a requirement for a placard to display the shower is not to be used for stowage of cargo or passenger baggage. In addition, adopting proposed § 25.788(a) would harmonize with the corresponding EASA airworthiness standard.
Manufacturers have installed display panels (
The proposed § 25.788(c) would apply the requirements of the proposed § 25.788(b) to large non-structural glass panel installations installed in certain areas. The proposed paragraph would require the glass, when fractured, to break only into small pieces with relatively dull edges (such as tempered or toughened glass does) as opposed to sharp or jagged shards (such as ordinary annealed glass does). In addition, the proposed § 25.788(c) would require the design include a means to retain glass fragments. Compliance with this requirement would be shown concurrently with the proposed requirements of § 25.788(b) by showing any glass fragments are retained under the load conditions specified in § 25.788(b). In 2016, FAA began issuing SCs that required means to retain glass fragments, and applicants to account for the hazards of loose glass fragments in the airplane cabin. For the personal safety of the airplane occupants, FAA proposes to establish a general rule requiring these installations to retain glass fragments rather than fully harmonize with the EASA AMC guidance for allowing expulsion of some glass particles as noted in the advisory material paragraph of this section below. A large non-structural glass panel installation is defined to include the glass itself, the means to retain any broken glass (
FAA would consider amendment 28 of CS-25 AMC 25.788(a) and AMC 25.1447(c)(3) as acceptable means of compliance with proposed § 25.788(a) for shower installations, and AMC 25.788(b) amendment 28 as acceptable means of compliance with proposed § 25.788(b) for installation of large display panels.
For installation of nonstructural glass panels, FAA would consider EASA CS-25 AMC 25.603(a) amendment 28,
Currently, § 25.801(a) prescribes requirements for ditching emergency
Currently, § 25.810 provides requirements for emergency egress assist means, which assist occupants in descending to the ground from an emergency exit. The requirements include time limits in which the assist means must be automatically erected. Section 25.810(a)(1)(ii) requires, for Type C exits, that the assist means be automatically erected within 10 seconds from the time the opening means of the exit is actuated; for non-Type C exits, it requires assist means be automatically erected within 6 seconds after deployment of the assist means is begun. The beginning of deployment of the assist means can occur any time between the time the opening means of the exit is actuated and the time the exit is fully open. The total time taken for the exit and assist means to become ready for egress, (
FAA proposes to revise § 25.810(a)(1)(ii) to include an option for the assist means installed at non-Type C exits to be ready to use within 10 seconds of actuating the exit opening means. The 10-second requirement would be more stringent than the current requirement for non-Type C exits for those exits where deployment of assist means begins more than 4 seconds after exit actuation; therefore, FAA would retain the current standard in the proposed rule as an option for non-Type C exits.
This proposed rule would harmonize with EASA CS 25.810
FAA considers EASA CS-25, AMC 25.810 amendment 28
Currently, § 25.813 prescribes requirements for emergency exit access. Section 25.813(c) provides access requirements for Type III and Type IV exits. FAA proposes to incorporate the terms of commonly issued ELOS findings for passageway size into § 25.813(c). FAA also proposes to harmonize the remainder of § 25.813(c) with EASA CS 25.813(c) and to remove introductory text to § 25.813 inadvertently not removed at amendment 25-88.
Compliance with § 25.813(c)(1)(i) requires, for each Type III exit, that for interior arrangements with three-seat (triple seat) rows on the exit side of the aisle, the unobstructed passageway must be at least 20 inches wide, as measured with adjacent seats adjusted to their most adverse positions (
However, tests conducted by FAA Civil Aerospace Medical Institute (CAMI) on evacuations through Type III exits have shown for interior arrangements with triple-seat rows, unobstructed passageways 13 inches wide with the centerlines of the passageways offset no more than 6.5 inches from those of the exits, provide evacuation performance essentially equivalent to that obtained with the dimensions specified in § 25.813(c)(1)(i) for triple-seat rows.
In addition, for airplanes with Type III passenger emergency exits, § 121.310(f)(3)(iii) requires airplanes type certificated after January 1, 1958, to meet the requirements of § 25.813(c), effective June 3, 1992, concerning access to those exits. However, § 121.310(f)(3)(iv) provides for the authorization of deviations, if it is determined that special circumstances would make such compliance impractical. The effect of these requirements is that for any airplane operated in part 121 for which FAA has issued an ELOS finding to § 25.813(c) for alternate passageway dimensions, FAA must approve a deviation to allow that operator to operate their airplane.
Proposed § 25.813(c) would replace the existing 20-inch passageway requirement with one of 13 inches where the passageway is bound by three-seat rows and revise the minimum offset in accordance with the CAMI evacuation testing through Type III exits noted above. This would also harmonize with current EASA CS 25.813(c). The proposed § 25.813(c) would remove the need for FAA to issue ELOS findings to § 25.813(c) and deviation letters to the operators to § 121.310(f)(3)(iii) to recognize the part 25 ELOS findings.
FAA also proposes to harmonize the remainder of the section, as well as revise the section title to “Emergency exit access and ease of operation,” with the EASA CS 25.813. This would include changing the applicability of § 25.813(c)(2) from airplanes with passenger seating configurations of 60 or more, to those with 20 or more. This proposal would also add § 25.813(c)(6) through § 25.813(c)(9). EASA added these requirements to CS-25 in amendment 9
Harmonization with CS 25.813 would also remove the introductory text to § 25.813, which requires the location of emergency exits afford an effective means of evacuation and be distributed uniformly. This text is redundant to § 25.807(e) and (f) and should have been removed at amendment 25-88 (61 FR 57945, November 8, 1996) when those paragraphs were introduced into part 25, as shown in NPRM 90-4 (
FAA considers amendment 28 of EASA CS-25 AMC 25.813, AMC 25.813(c), and AMC 25.813(e)
Paragraph (a)(2) of § 25.841, “Pressurized cabins,” at amendment 25-87, requires the airplane be designed so that occupants will not be exposed to a cabin pressure altitude that exceeds 25,000 feet for more than 2 minutes or 40,000 feet for any duration, after decompression from all failures not shown to be extremely improbable. FAA proposes to revise § 25.841(a)(2) so that these requirements apply only to failures of systems or structure. FAA proposes to revise § 25.841(a)(3) to require the airplane be designed so that, after decompression from any engine failure, occupants will not be exposed to a cabin pressure altitude that exceeds 25,000 feet for more than 3 minutes, 40,000 feet for more than 1 minute, or 45,000 feet for any duration. FAA also proposes to add new paragraph (a)(4) to require airplane manufacturers demonstrate by flight test compliance to paragraphs (a)(2) and (3), and the airplane flight manual include flightcrew procedures and limitations to ensure compliance with proposed paragraphs (a)(2) and (3).
In past airplane certification programs, FAA has granted exemptions
FAA issued amendment 25-87 (61 FR 28684) to § 25.841 to standardize certification of all transport category airplanes proposed to operate at cruise altitudes above 40,000 feet. Prior to amendment 25-87, FAA issued SCs to applicants proposing small transport category airplanes (small business jets) with aft fuselage mounted engine configurations that would be operated at cruise altitudes above 40,000 feet. In contrast, large transport category airplanes with wing-mounted engine configurations had not been able to operate above 40,000 feet due to engine thrust limitations. However, newer engine designs permitted later models to operate above 40,000 feet so FAA decided to propose to revise § 25.841 rather than continue to issue SCs. In developing amendment 25-87, FAA assumed passenger cabins of large transport category airplanes would not experience rapid decompression because of the large cabin volume, as opposed to smaller executive business jets. However, as airplane fuselages grew in size, so did engine size, and an uncontained engine failure on a large transport category airplane can result in a large hole that would cause the cabin to depressurize rapidly.
FAA tasked ARAC to review § 25.841(a) regarding airplane cabin altitudes resulting from cabin decompression and to determine if revisions were needed to ensure during certain failure conditions the cabin environment was survivable for crew and passengers.
The MSHWG also determined there is nothing distinctive about a particular altitude (
The MSHWG and FAA reviews indicate since 1959 through 2006 there have been approximately 3,000 loss-of-cabin-pressure events. The majority of these have been caused by system failures (
In response to FAA Reauthorization Act of 2018 (Pub. L. 115-254), Section 309, Call to Action Airline Engine Safety Review, FAA formed the Engine and Airframe-Engine Integration (EAEI) Review Team in September 2018.
Uncontained engine failures occurring at maximum cruise altitude of the airplane remain rare events. New engine designs provide significant improvement to the risk of uncontained engine failures by using higher quality materials and better manufacturing methods. In addition, maintenance inspections use new technologies that can detect smaller cracks or defects in fan, compressor, or turbine disks, thus further reducing the likelihood of engine failure in operation. Because these events are rare, FAA considers the risk versus benefits to be acceptable in allowing high cruise altitude operations. High altitude flight enables passengers to reach their destination more quickly, burns less fuel, and creates less pollution as shown in the ARAC MSHWG report. Though the increased cabin pressure altitude and duration of exposure include an increased level of risk, the level of risk provided by the proposed rule is consistent with exemptions FAA has granted since 2006.
The proposed changes to § 25.841(a) are based on Policy Memorandum ANM-03-112-16. A draft of this policy was reviewed by the ARAC MSHWG.
After the MSHWG issued its recommendations, CAMI conducted an extensive literature review of previous testing and created a physiological model. In addition, CAMI conducted a test as described in report titled, “Human Responses to a Simulated 35,000-Foot Rapid Decompression and the Subsequent Descent Profile Required by FAA Policy.”
The results of the CAMI normobaric
Flightcrew must be trained to ensure an immediate response to a decompression event to help optimize occupant survival (refer to § 121.417(b)(3)). Flightcrew training may be different when showing compliance to § 121.417(b)(3)(i) for commercial airplanes configured with a feature,
FAA proposes to revise § 25.841(a)(2) and (3) to accommodate certain design constraints related to engine location (
FAA also proposes to revise § 25.841(a)(3) to specify the maximum allowed cabin pressure altitude and duration of occupant exposure for all engine failures not shown to be extremely improbable resulting in decompression. These limits are based on Policy Statement ANM-03-112-16 and subsequent results of testing by CAMI.
• No exposure above a cabin pressure-altitude of 45,000 feet pressure-altitude.
• A maximum of one minute exposure above a cabin pressure-altitude of 40,000 feet pressure-altitude.
• A maximum of 3 minutes above a cabin pressure-altitude of 25,000 feet pressure-altitude.
This proposal would alleviate the need for applicants to petition FAA for an exemption for their proposed designs
The worst-case rapid decompression events creating the largest holes in the airplane fuselage have originated from uncontained engine failures. In addition, the worst-case decompression events occur very rarely (between once in 10 million and 100 million flight hours),
In proposed § 25.841(a)(2) and (a)(3), FAA would set different regulatory standards to balance public safety with economic costs. As discussed, proposed § 25.841(a)(2) would maintain the current requirements for all fuselage structure damage considered under § 25.571(b) or (e)(1), and all system failures not shown by the applicant to be extremely improbable, while proposed § 25.841(a)(3) would provide relief from the current requirement for engine failures not shown to be extremely improbable. FAA proposes the costs associated with more stringent requirements for engine failures not shown to be extremely improbable outweigh the additional safety benefits that would result from these more stringent requirements. FAA has a statutory obligation per 49 U.S.C. 44701 to impose regulations that best tend to reduce or eliminate accidents in air transportation. However, higher altitude cruise operations effectuate several benefits to passengers and society at large, including a faster cruise speed and reduction in flight time, a reduction in fuel burn, and a reduction in engine emissions, and proposed § 25.841(a)(3) would provide an acceptable level of safety commensurate with these benefits. In addition, proposed § 25.841(a) is premised on operators fulfilling the required initial and recurrent emergency training provisions in accordance with §§ 121.397, 121.417, and 121.427 for all crewmembers, including training for a rapid decompression and donning of oxygen masks. Proposed § 25.841(a) is also premised on operators and flightcrew members complying with the requirements of §§ 91.211, 121.333, or 135.157, as applicable.
FAA has drafted AC 25.841-X, “Regulatory Guidance on Compliance with § 25.841(a),” to provide guidance material on one acceptable means, but not the only means, of showing compliance with proposed § 25.841(a). It is available for review in the docket. The AC also provides details from the CAMI normobaric rapid decompression tests. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
AC 25-20, “Pressurization, Ventilation and Oxygen Systems Assessment for Subsonic Flight Including High Altitude Operation,” dated September 10, 1996, contains guidance on § 25.841 and other related regulations. FAA has determined that existing AC 25-22, “Certification of Transport Airplane Mechanical Systems,” dated March 14, 2000, provides acceptable guidance to the other regulations addressed in AC 25-20, and as a result FAA would cancel AC 25-20 concurrently with issuance of the final rule and AC 25.841-X.
Paragraph (d)(1) of § 25.841, “Pressurized cabins,” at amendment 25-151, requires the time when the airplane cabin pressure high altitude warning alert is shifted to a higher level during high elevation airport operations be minimized. However, the current requirements in § 25.841(d)(1) are overly prescriptive, and in developing them, FAA did not consider some airplane operators may perform step-climb and step-cruise after takeoff and perform step-descent and step-cruise during descent. These types of operation may result in noncompliance with § 25.841(d)(1). Therefore, FAA is proposing to revise § 25.841(d)(1) to a performance-based requirement that still meets the intent of the original requirements.
FAA issued amendment 25-151 (88 FR 44032, July 11, 2023) to § 25.841 to accommodate airplane operations into or out of airports with elevations at or above 8,000 feet above sea level. Prior to this amendment, FAA would document ELOS findings when an airplane manufacturer or modifier proposed to certify airplane cabin pressurization systems used for operations into or out of airports with elevations at or above 8,000 feet. FAA conducted this rulemaking to relieve the burden on industry and FAA resulting from project-specific ELOS requests and petitions for exemption to accommodate operations at high elevation airports for transport category airplanes.
FAA has received information from a foreign authority and one airplane manufacturer explaining some airplane operators perform step-climb and step-cruise after takeoff and perform step-descent and step-cruise during descent. In addition, some airplane models may not be able to meet § 25.841(d)(1) at amendment 25-151 because of limitations on the operation of the airplane environmental control pressurization system and physiological limits on acceptable rate of change of cabin pressure. Retaining the regulation without modification would result in airplane manufacturers preparing ELOS requests, which would result in continued burden on industry and FAA.
Therefore, FAA is proposing to revise § 25.841(d)(1) to require that the time in flight the cabin pressure high altitude warning alert is above 10,000 feet cabin pressure altitude is minimized. This revision would eliminate overly prescriptive requirements while retaining the intent of the original requirement. Proposed § 25.841(d)(1) would allow airplane manufacturers flexibility in the design of cabin pressure high altitude warning alerting systems while retaining the requirement that the time in flight where the cabin pressure high altitude warning is above 10,000 feet cabin pressure altitude is minimized.
Section 25.841(c)(2) at amendment 25-151 requires the cabin pressurization system be designed to minimize the
Currently, § 25.854 provides lavatory fire protection for airplanes with a passenger capacity of 20 or more. FAA proposes to harmonize with EASA CS 25.854 by changing the applicability of those requirements to airplanes with a cabin length of 60 feet or more to address proposed larger cabins configured for a passenger capacity of 19 or less. Proposed § 25.854 would ensure only airplanes with limited cabin length, as well as limited passenger capacity, would not be required to comply with the lavatory fire protection requirement.
FAA is proposing to add a cabin length limit to the existing passenger capacity limit in order to address proposals for larger cabins configured for passenger capacity of 19 seats or less. Lavatory fires are usually detected by cabin personnel early enough to allow prompt control and extinguishment. The smaller cabin size allows for this detection by its occupants earlier than a larger cabin with few occupants. The proposed cabin size limit is based on the survey of already certified airplanes with 19 seats or less that EASA discusses in their CS 25.854 rule change
FAA would consider EASA CS-25 AMC 25.854 amendment 28 as an acceptable means of compliance with proposed § 25.854 for cabin length measurement. FAA has drafted Change 2 to AC 25-17A to refer to the EASA AMC for guidance, and these documents are available in the docket. Comments to the proposed AC may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
Section 25.1351(d), “Operation without normal electrical power,” contains requirements for airplanes using mechanical control cables and linkages for flight control or otherwise do not rely on a continuous source of electrical power for continued operation with normal electrical power inoperative. FAA proposes to move the § 25.1351(d) requirements into new § 25.1352, “Operation without normal electrical power,” and add new requirements for airplanes using electrical and electronic systems to perform critical functions, such as flight controls. As a result of this proposed change, FAA also proposes to revise § 25.1705, “Systems and functions: EWIS,” by adding a reference to § 25.1352.
FAA has issued SCs in past airplane certification programs for airplanes requiring a continuous source of electrical power to maintain safe flight and landing,
The design of modern transport category airplanes incorporates electrical and electronic systems that perform critical functions. The loss of these functions may result in loss of flight-critical systems. Examples of electrical and electronic systems that perform critical functions include electronic displays, electronic flight control computers and control architecture (
The current requirement for operation without normal electrical power is contained in § 25.1351(d). However, this requirement does not adequately address airplane models with electrical and electronic systems that perform critical functions, the loss of which may be catastrophic to the airplane. Since § 25.1351(d) does not contain adequate or appropriate safety standards for these airplane models, FAA issues SCs for each of these models.
Section 25.1351(d) currently requires safe operation in visual flight rule (VFR) conditions for at least 5 minutes after loss of normal electrical power, excluding the battery. In developing the current rule, FAA envisaged a traditional airplane design that uses mechanical control cables and linkages for flight control. These manual controls allow the flightcrew to maintain aerodynamic control of the airplane for an indefinite period of time after loss of all electrical power. Under these conditions, a mechanical flight control system provides the flightcrew with the ability to fly the airplane while attempting to identify the cause of the electrical failure, restart the engine(s) if necessary, and attempt to reestablish some of the electrical power generation capability.
Current § 25.1351(d) does not contain adequate or appropriate safety standards that address fly-by-wire design features. Fly-by wire airplane models include novel or unusual design features that need SCs to address requirements associated with electronic flight-control systems requiring a continuous source of electrical power to maintain safe flight and landing. To maintain the level of safety envisioned by the current rule, the SCs require an airplane design with electrical and electronic systems performing critical functions must not be time-limited in its operation under all reasonably foreseeable conditions, including loss of all normal sources of engine- or APU-generated electrical power. Unless the applicant can show that the non-restorable loss of the engine and APU electrical power sources is extremely improbable, the applicant must demonstrate the airplane is capable of continued safe flight and landing, including steering and braking on the ground for airplanes using steer-
FAA proposes to codify the terms of previously issued SCs for transport airplane designs using electrical systems and electronic systems to perform critical functions and move the current requirements for transport airplane designs utilizing mechanical control cables and linkages for flight controls from § 25.1351(d) into new § 25.1352. FAA is proposing this new regulation to have one regulation that contains requirements specific to operation without normal electrical power. Proposed § 25.1352 will consolidate two different sets of requirements based on the airplane's design and clearly delineate the applicability of these requirements and their associated means of compliance.
Proposed § 25.1352(a) would define alternative electrical power sources for the purpose of compliance with the requirements of § 25.1352. This definition is derived from previous “Operation Without Normal Electrical Power” SCs,
Proposed § 25.1352(a) describes normal electrical power as power from all sources generated for use during normal operating conditions and specifies normal electrical power does not include alternative power sources. However, an applicant may use the same type of technology as the source of electrical power during normal operating conditions (
Proposed § 25.1352(b) and (c) would define the specific requirements applicable to an airplane's design based on whether the design relies on a continuous source of electrical power to maintain safe operation. The applicability language of proposed § 25.1352(b) and (c) is derived from the previously issued SCs.
Proposed § 25.1352(b) would apply to airplanes that use mechanical control cables and linkages for flight control or otherwise do not rely on a continuous source of electrical power for continued operation. These airplanes would typically comply with current § 25.1351(d) without the need for SCs. Paragraph (b) would include the same requirements as § 25.1351(d), with two minor exceptions. First, FAA has removed the title “Operation without normal electrical power,” since these requirements would be moved to proposed § 25.1352. Second, FAA has removed the parenthetical phrase “(electrical power sources excluding the battery)” because alternative electrical power sources would be defined in proposed § 25.1352(a).
Proposed § 25.1352(c) would apply to airplanes that use electrical and electronic systems to perform critical functions, the loss of which may result in loss of flight controls or other critical systems and may be catastrophic to the airplane. These airplane designs need a continuous source of electrical power to maintain safe operation. Today, these airplanes must comply with SCs in order to gain type certification. Paragraph (c)(1) through (7) of proposed § 25.1352 include the same requirements as previously issued SCs with one exception: paragraphs (c)(2)(i) and (c)(4)(ii) of proposed § 25.1352 do not specify an applicant must account for the longest or maximum diversion time, which are terms related to the duration of extended operations (ETOPS). The phrase “continued safe flight and landing,” as used throughout proposed § 25.1352(c), includes the duration of the flight, subsequent landing, and rollout; it would apply to all operations, regardless of whether the airplane is operating under an ETOPS approval.
Proposed § 25.1352(c)(1) would require the applicant to use a combination of testing and analysis to show the airplane is capable of continued safe flight and landing with all normal electrical power sources inoperative. Under § 25.1352(c)(6)(i), this must be done under the assumption the loss of normal electrical power sources occurs during night instrument meteorological conditions at the most critical phase of the flight, relative to the worst possible electrical power distribution and equipment-loads-demand condition. Under § 25.1352(c)(4)(i), when all sources of normal electrical power become inoperative, the proposal would require emergency electrical power to be immediately supplied without the need for flightcrew intervention. This is meant to ensure the airplane can maintain safe flight during the time it takes for the electrical power generation and distribution system to be reconfigured, either automatically or with flightcrew actions, so it can provide the required electrical power from its alternative electrical power sources.
The proposal would require the airplane to provide a flightcrew alert and indication when normal electrical power is not available, with corresponding non-normal procedures in the AFM, which would direct the flightcrew to take appropriate actions. Further, the AFM would also be required to include an operating limitation to direct flightcrew to take appropriate actions to activate the APU after loss of normal engine-driven generated electrical power if the APU is used to satisfy the requirements of § 25.1352(c)(1). The airplane's design must also provide for sufficient electrical power to allow for multiple (
In addition, in showing capability for continued safe flight and landing, the proposal would require the applicant to account for systems capability, effects on crew workload and operating conditions, and the physiological needs of the passengers and flightcrew when all normal electrical power sources are inoperative. Physiological needs mean those biological requirements necessary for human survival. This means the airplane must provide adequate environmental conditions such as temperature control and oxygen. It also means providing for an adequate amount of operational toilets, as well as any other system required to ensure physiological needs are adequately addressed.
FAA also proposes to revise § 25.1705 by adding new § 25.1705(b)(13) that lists § 25.1352. When § 25.1705 was adopted,
Currently, § 25.1447 prescribes equipment standards for oxygen dispensing units for occupants at their seats. FAA proposes to add a new § 25.1447(c)(6) to require sufficient oxygen outlets in other areas of the cabin which may be occupied by passengers or crew, such as galleys. This proposed rule would ensure occupants not in their seats, in the event of a decompression, have access to oxygen. The proposed rule would harmonize § 25.1447(c)(6) with EASA CS 25.1447(c)(3). Existing differences between other paragraphs of § 25.1447 and EASA CS 25.1447 are not addressed by this proposed rule.
FAA would consider EASA CS-25 AMC 25.1447(c)(3) amendment 28 as an acceptable means of compliance with proposed § 25.1447(c)(6). FAA has drafted Change 2 to AC 25-17A, “Transport Airplane Cabin Interiors Crashworthiness Handbook,” to refer to the EASA AMC for guidance, and these documents are available in the docket. Comments to the proposed AC and means of compliance may be submitted via the instructions on the “Aviation Safety Draft Documents Open for Comment” web page at
E.O. 12866 (“Regulatory Planning and Review”) and E.O. 13563 (“Improving Regulation and Regulatory Review”) require agencies to regulate in the “most cost-effective manner,” to make a “reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.” The Office of Management and Budget has determined this proposed rule is not a significant regulatory action as defined in section (3)(f)(1) of E.O. 12866.
FAA expects modernization of airworthiness standards for type certification of transport category airplanes would reduce time to certify and certification costs for manufacturers, modifiers, and FAA while maintaining or increasing safety. FAA expects this reduction in costs and time to certify would also promote innovation by reducing the time and costs for manufacturers and modifiers to obtain type certification for new or changed products.
By updating current airworthiness standards to reflect new technology and evolving industry needs, FAA anticipates the proposal would reduce the need for exemptions, SCs, and ELOS findings relative to the current regulations. As described in section I.B. of this NPRM, “Background,” each request for an exemption, SC, or ELOS finding requires applicants for type certification to incur costs to generate, analyze, and submit project-specific data and await FAA decisions to be certain of the requirements on their proposed design. For each exemption, SC, or ELOS finding request, FAA must incur costs to evaluate the submitted data and to develop and publish a decision which maintains safety. Reducing the need for these project-specific processes would reduce flow-time and cost relative to the current regulatory baseline for each type certification project for both the applicant and FAA.
This proposed rule would also eliminate certain differences between U.S. and European airworthiness standards. Because U.S. manufacturers and modifiers of transport category airplanes typically sell their products domestically and internationally, harmonizing FAA's requirements with those of EASA would reduce the cost and complexity of certification by providing them a consistent set of requirements.
Table 2 contains a summary of the expected impacts by proposed area of change. See section III of this NPRM, “Discussion of the Proposal,” for a detailed description of the proposed regulatory changes and their effects.
The Regulatory Flexibility Act (RFA) of 1980, (5 U.S.C. 601-612), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104 121, 110 Stat. 857, March 29, 1996) and the Small Business Jobs Act of 2010 (Pub. L. 111-240,), requires Federal agencies to consider the effects of the regulatory action on small business and other small entities and to minimize any significant economic impact. The term “small entities” comprises small businesses and not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000.
FAA used Hoovers Online,
The Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. Pursuant to these Acts, the establishment of standards is not considered an unnecessary obstacle to the foreign commerce of the United States, so long as the standard has a legitimate domestic objective, such as the protection of safety, and does not operate in a manner that excludes imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, they be the basis for U.S. standards.
As the proposed provisions in this rulemaking harmonize with international standards, FAA does not consider this rule as creating an unnecessary obstacle to foreign commerce.
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) governs the issuance of Federal regulations that require unfunded mandates. An unfunded mandate is a regulation that requires a State, local, or Tribal Government or the private sector to incur direct costs without the Federal Government having first provided the funds to pay those costs. FAA determined the proposed rule would not result in the expenditure of $193 million or more ($100,000,000 adjusted for inflation using the most current Implicit Price Deflator for the Gross Domestic Product) by State, local, or Tribal Governments, in the aggregate, or the private sector, in any one year.
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) requires FAA consider the impact of paperwork and other information collection burdens imposed on the public. FAA has determined there would be no new requirement for information collection associated with this proposed rule.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is FAA policy to conform to International Civil Aviation Organization (ICAO) Standards and Recommended Practices to the maximum extent practicable. FAA has reviewed the corresponding ICAO Standards and Recommended Practices and has identified no differences with these proposed regulations.
The Department has analyzed the environmental impacts of this final rule pursuant to the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321
Section 1205 of FAA Reauthorization Act of 1996 (110 Stat. 3213) requires the Administrator, when modifying 14 CFR regulations in a manner affecting intrastate aviation in Alaska, to consider the extent to which Alaska is not served by transportation modes other than aviation, and to establish appropriate regulatory distinctions. Because this proposed rule would apply to the certification of future designs of transport category airplanes and their subsequent operation, it could, if adopted, affect intrastate aviation in Alaska. FAA, therefore, specifically requests comments on whether there is justification for applying the proposed rule differently in intrastate operations in Alaska.
FAA has analyzed this proposed rule under the principles and criteria of E.O. 13132, Federalism. FAA has determined this action would not have a substantial direct effect on the States, or the relationship between the Federal Government and the States, or on the distribution of power and responsibilities among the various levels of government, and, therefore, would not have federalism implications.
Consistent with E.O. 13175, Consultation and Coordination with Indian Tribal Governments,
FAA analyzed this proposed rule under E.O. 13211, Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use (May 18, 2001). FAA has determined it would not be a “significant energy action” under the E.O. and would not be likely to have a significant adverse effect on the supply, distribution, or use of energy.
E.O. 13609, Promoting International Regulatory Cooperation, promotes international regulatory cooperation to (1) meet shared challenges involving health, safety, labor, security, environmental, and other issues and reduce, eliminate, or (2) prevent unnecessary differences in regulatory requirements. FAA has analyzed this proposed action under the policy and agency responsibilities of E.O. 13609. FAA has determined this proposed action would eliminate differences between U.S. aviation standards and those of other civil aviation authorities by harmonizing regulatory requirements to the extent practical.
This proposed rule, if finalized as proposed, is expected to be an E.O. 14192 deregulatory action.
FAA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. FAA also invites comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should submit only one time if comments are filed electronically, or commenters should send only one copy of written comments if comments are filed in writing.
FAA will file in the docket all comments it receives, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rule. Before acting on this proposal, FAA will consider all comments it receives on or before the closing date for comments. FAA will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. FAA may change this proposal in light of the comments it receives.
Confidential Business Information (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 is relevant or responsive to this NPRM, it is important you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” 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 James Wilborn, 2200 South 216th Street, Des Moines, WA 98198. Any commentary FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.
A copy of this NPRM, all comments received, any final rule, and all background material may be viewed online at
Copies may also be obtained by sending a request to the Federal Aviation Administration, Office of Rulemaking, ARM-1, 800 Independence Avenue SW, Washington, DC 20591, or by calling (202) 267-9677. Requests must identify the docket or notice number of this rulemaking.
All documents FAA considered in developing this proposed rule, including economic analyses and technical reports, may be accessed in the electronic docket for this rulemaking.
The Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104 121, 110 Stat. 857, March 29, 1996) requires FAA to comply with small entity requests for information or advice about compliance with statutes and regulations within its jurisdiction. A small entity with questions regarding this document may contact its local FAA official, or the person listed under the
FAA is incorporating by refence Report No. DOT/FAA/TC-21/3, “Fuel Tank Flammability Assessment Method User's Manual—Updated for Version 11,” dated January 2021. Report No. DOT/FAA/TC-21/3. This material serves as a user's manual for the FTFAM to assist the user in its operation and to discuss the permissible changes that may be made to this model specific to a particular fleet of aircraft. This material is available at
Aircraft, Aviation safety, Incorporation by reference, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, the Federal Aviation Administration proposes to amend chapter I of title 14, Code of Federal Regulations as follows:
49 U.S.C. 106(f), 40113, 44701, 44702 and 44704; Pub. L. 115-254, 132 Stat 3281 (49 U.S.C. 44903 note).
(d) For purposes of this part, the terms non-commercially operated and low occupancy are defined as follows:
(1) Non-commercially operated airplanes are airplanes that are not offered for common carriage and not operated for hire, with a passenger seating configuration limited in accordance with paragraphs (d)(1)(i) and (d)(1)(ii) of this section. The operators may receive remuneration to the extent consistent with parts 125 and 91, subpart F, of this chapter. The passenger seating configuration must not exceed:
(i) 19 passengers; or
(ii) One-half of the maximum passenger seating capacity of the type certified airplane as indicated in the airplane type certificate data sheet (TCDS), provided that:
(A) The total number of passengers approved for occupancy during taxiing, takeoff, or landing does not exceed 150 per deck; and
(B) The total number of passengers approved for occupancy on a deck during taxiing, takeoff, or landing does also not exceed one-half of the maximum passenger seating capacity for that deck as indicated in the airplane TCDS.
(2) A low occupancy airplane, irrespective of the type of operations (commercial or non-commercial), is an airplane that has a passenger seating configuration of:
(i) Not more than 19 passengers; or
(ii) Not more than one-third of the maximum passenger seating capacity of the type certified airplane as indicated in the airplane TCDS, provided that:
(A) The total number of passenger seats approved for occupancy during taxiing, takeoff, or landing does not exceed 100 per deck; and
(B) The total number of passenger seats approved for occupancy during taxiing, takeoff, or landing in any individual zone between pairs of emergency exits does not also exceed one-third of the sum of the passenger seat allowances for the emergency exit pairs bounding that zone, using the passenger seat allowance for each emergency exit pair as defined by the applicable certification basis of the airplane. For the purpose of determining compliance with this zonal limitation, in the case of an airplane with deactivated emergency exits, assume that all emergency exits are functional.
Certain material is incorporated by reference into this part with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by reference (IBR) material is available for inspection at the Federal Aviation Administration (FAA) and at the National Archives and Records Administration (NARA). Contact FAA at: Rules and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW, Washington, DC 20591; (202) 267-8783;
(a) National Technical Information Services (NTIS), 5301 Shawnee Road Alexandria, Virginia 22312; email:
(1) Report No. DOT/FAA/TC-21/3, “Fuel Tank Flammability Assessment Method User's Manual—Updated for Version 11,” dated January 2021, IBR approved for § 25.981 and appendix N to part 25.
(2) [Reserved]
(b) [Reserved]
(b) Each part of the airplane must be demonstrated in flight to be free from excessive vibration under any appropriate speed and power conditions up to V
(a)
(1) Conditions corresponding to steady rolling velocities must be investigated. In addition, conditions corresponding to maximum angular acceleration must be investigated. For the angular acceleration conditions, zero rolling velocity may be assumed in the absence of a rational time history investigation of the maneuver.
(2) At V
(3) At V
(4) At V
(a)
(1) Each pilot compartment must be arranged to give the pilots a sufficiently extensive, clear, and undistorted view to enable them to perform any maneuvers safely within the operating limitations of the airplane, including taxiing, takeoff, approach, and landing.
(2) Each pilot compartment must be free of glare and reflection that could interfere with the normal duties of the minimum flightcrew (established under § 25.1523). This must be shown in day and night flight tests under non-precipitation conditions. In lieu of night flight tests under the required non-precipitation conditions, ground tests may be used for changes to airplanes previously certificated where changes to the flight deck are not expected to produce any appreciable effect on the pilot compartment view glare or reflection based on service history or previous flight test results.
(b) * * *
(1) The airplane must have a means to maintain a clear portion of the windshield, during precipitation conditions, sufficient for both pilots to have a sufficiently extensive view for all operations within the operating limitations of the airplane, including taxiing, takeoff, approach, and landing. This means must be designed to function, without continuous attention on the part of the crew, in—
(i) Heavy rain at speeds up to 1.5 V
(ii) Light precipitation conditions at speeds normally encountered during ground operations, and
(iii) The icing conditions specified in appendix C to this part and the following icing conditions specified in appendix O to this part, if certification for flight in icing conditions is sought:
(A) For airplanes certificated in accordance with § 25.1420(a)(1), the icing conditions that the airplane is certified to exit safely following detection.
(B) For airplanes certificated in accordance with § 25.1420(a)(2), the icing conditions that the airplane is certified to operate safely in and the icing conditions that the airplane is certified to exit safely following detection.
(C) For airplanes certificated in accordance with § 25.1420(a)(3) and for airplanes not subject to § 25.1420, all icing conditions.
(b) Each seat, berth, safety belt, harness, and adjacent part of the airplane at each station designated as occupiable during takeoff and landing must be designed so that a person making proper use of these facilities will not suffer serious injury in an emergency landing as a result of the inertia forces specified in §§ 25.561 and 25.562. However, berths only for the carriage of medical patients (
(a)
(1) Audio and visual “return to seat” indications must be provided and readily audible and visible to a shower cubicle occupant, and activated at the same time as the signs required by § 25.791(b);
(2) Audio and visual indications about the need for oxygen use must be provided and readily audible and visible to a shower cubicle occupant, and activated in the case of cabin depressurization or deployment of the oxygen-dispensing units in the cabin;
(3) Placards must be installed to indicate that the shower cubicle must not be used for the stowage of cargo or passenger baggage;
(4) There must be means in the shower cubicle to enable persons to steady themselves in moderately rough air; and
(5) The shower cubicle must be designed in a way that precludes anyone from being trapped inside. If a locking mechanism is installed, it must be capable of being unlocked from the inside and the outside without the aid of any tool.
(b)
(1) Each relevant flight and ground load condition of subpart C of this part (including the emergency landing conditions prescribed in § 25.561);
(2) Any load to be expected in service; and
(3) A cabin depressurization.
(c)
(a) The limitations section of the airplane flight manual must:
(1) Prohibit the carriage of persons other than authorized persons identified in § 121.583;
(2) Indicate the maximum number of authorized persons;
(3) Prohibit occupancy of the cargo compartment during taxiing, takeoff, and landing; and
(4) Require a flightcrew member brief each authorized person before each flight on the following:
(i) Appropriate emergency procedures to ensure the safety of the flight,
(ii) The meaning of all alerts required by this section, and
(iii) That access to the Class E cargo compartment is prohibited during taxiing, takeoff, and landing.
(b) In lieu of the lighted sign requirements of § 25.791(b), the airplane must provide a flightcrew-operated alert system to inform the authorized persons when to fasten their seat belts.
(c) In lieu of the emergency exit size requirements of § 25.807(g)(1) and (i)(1), flightcrew exits may be designated for use by 9 or less authorized persons, provided the exit is openable from the inside and the outside. The flightcrew exits must be demonstrated as a usable exit by test.
(d) In lieu of the means to permit viewing of the likely areas of evacuee ground contact requirements of § 25.809(a), for the exits designated for use by authorized persons, a means such as a fuselage-mounted emergency egress light must be installed to light the ground contact area.
(e) In lieu of the assist means requirements of § 25.810(a)(1), for the exits designated for use by authorized persons, approved emergency means to allow rapid evacuation must be provided for each occupant.
(f) If all seats for authorized persons are near the emergency exits, then the following need not be met:
(1) The floor proximity emergency escape path marking requirements of § 25.812(e);
(2) The transverse vertical separation requirements of § 25.812(l)(1); and
(3) The assist space requirements of § 25.813(b).
(g) If an automatically-presented oxygen dispensing system required by
(1) Each such oxygen mask and oxygen supply for use while seated must be sized to provide adequate oxygen for continuous and uninterrupted use during the worst-case flight duration following decompression and meet the minimum mass flow of supplemental oxygen requirements in § 25.1443(c).
(2) If portable oxygen units are installed to allow mobility, the portable oxygen units must meet the performance requirements of:
(i) § 25.1443(a);
(ii) § 25.1443(b); or
(iii) The equipment must be shown to protect the authorized person from hypoxia at an activity level required to return to their seat following a rapid decompression to 25,000 feet cabin altitude.
(3) In lieu of crew determination if oxygen is being delivered to the dispensing units as required by § 25.1449, there must be a means to allow each authorized person to determine whether oxygen is being delivered to their portable oxygen dispensing equipment.
(4) An automatically activated aural alerting system must, in the case of a decompression, notify authorized persons when to don oxygen masks and initiate flow to the masks.
(h) There must be a means to allow authorized persons and the flight deck to communicate.
(1) A public address (PA) system meeting the requirements of § 25.1423 must be installed. The PA system must be audible throughout the occupiable compartments of the airplane and activated from either the flightdeck or from the seating area for the authorized persons.
(2) A means must be installed that provides two-way communication between the seating area for authorized persons and the flightdeck and is within reach of at least one of the authorized persons at their seat. This system must be independent of the PA system except for handsets, headsets, microphones, selector switches, and signaling devices.
(i) If certification permitting access into a Class E cargo compartment in-flight is requested, the compartment must meet the following requirements:
(1) In-flight access to the Class E cargo compartment is limited to a maximum of three authorized persons for the handling of hazardous or perishable cargo. If animals are carried as cargo, inflight access is limited to a maximum of one authorized person for every four animals. The placard required by paragraph (k)(1) of this section must state the applicable limit on in-flight access.
(2) Full-face portable oxygen equipment meeting the requirements of paragraph (g)(2) through (4) of this section and the protective breathing equipment requirements of § 25.1439(b)(1), (2), and (4) must be provided for each authorized person outside the compartment.
(j) The following alert systems must be installed, and be recognizable in all accessible areas such as the lavatory, the flight deck, any occupied compartment forward of the Class E cargo compartment, and the Class E cargo compartment at all occupant locations and orientations, during all expected operational conditions, including a rapid decompression where moisture in the air may condense:
(1) In the event of decompression, an automatically activated aural alerting system must notify authorized persons to don oxygen masks and immediately return to their seats, initiate flow to the masks, and ensure that the access provisions necessary to prevent smoke penetration into occupied areas have been secured.
(2) In the event of smoke or fire detection, a visual alerting system must notify authorized persons to don oxygen masks and immediately return to their seats and must ensure that the access provisions necessary to prevent smoke penetration into occupied areas have been secured.
(3) In the event of turbulence and prior to taxiing, takeoff, and landing, regardless of whether handholds are installed to show compliance with § 25.785(j), an alerting system must notify authorized persons to return to their seats immediately and ensure that the access provisions necessary to prevent smoke penetration into occupied areas have been secured.
(k) Placards must be installed in a conspicuous location in the seating area for the authorized persons on or adjacent to the access means to the cargo compartment and must provide the following information:
(1) The limit on the number of authorized persons permitted in-flight access to the cargo compartment.
(2) That occupancy of the cargo compartment is prohibited during taxiing, takeoff, and landing.
(3) That each authorized person must carry a portable oxygen unit with full face mask while inside the cargo compartment.
(4) The actions authorized persons must do in the event of different alerts.
(5) That smoking is not allowed within the cargo compartment.
(6) That the access provisions necessary to prevent smoke penetration into occupied areas must be secured except when entering or leaving the cargo compartment.
(7) That the cargo compartment must not be entered in case of fire or smoke being detected inside that compartment.
(8) That when authorized persons are carried, the seat position within reach of the two-way communication system required by paragraph (h)(2) of this section must be occupied for taxiing, takeoff, and landing.
(l) Flight tests must be conducted in accordance with § 25.855(h) to show compliance with the provisions of § 25.857 concerning the entry of hazardous quantities of smoke into the occupied areas. The test must account for the time to evacuate authorized persons from the main deck cargo compartment through open access provisions necessary to prevent smoke penetration into occupied areas. Occupancy of the main deck Class E cargo compartment must be limited based on the results of these tests, and identified by the placard required in paragraph (k)(1) of this section.
(a)
(1) Each emergency exit, including a flightcrew emergency exit, must be a movable door or hatch in the external walls of the fuselage, allowing unobstructed opening to the outside.
(2) Each emergency exit, including a flightcrew emergency exit, must have means to permit viewing of the conditions outside the exit when the exit is closed, in all ambient lighting conditions with the landing gears extended or in any condition of collapse. The viewing means may be on or adjacent to the exit provided no obstructions exist between the exit and the viewing means.
(3) For non-overwing passenger emergency exits, a means must also be provided to permit viewing of the likely areas of evacuee ground contact when the exit is closed with the landing gears extended or in any condition of collapse. Further, the likely areas of evacuee ground contact must be viewable with the exit closed during all
(a) * * *
(1) * * *
(ii) Except for assisting means installed at Type C exits, it must be automatically erected within 6 seconds after deployment is begun or within 10 seconds from the time the opening means of the exit is actuated. Assisting means installed at Type C exits must be automatically erected within 10 seconds from the time the opening means of the exit is actuated.
(e) * * *
(2) Each passenger emergency exit operating handle, and the cover removal instructions if the operating handle is covered, must—
(i) Be self-illuminated with an initial brightness of at least 160 microlamberts (0.51 candela/m
(ii) * * *
(3) * * *
(4) All Type II and larger passenger emergency exits with a locking mechanism released by motion of a handle must be marked to show the handle's operation by an arrow with a shaft at least 0.75 inches (19 mm) wide, adjacent to the handle, that indicates the full extent and direction of the unlocking motion required. The word “open” must be horizontally situated adjacent to the arrowhead and must be in capital letters at least 1 inch (25 mm) high. The arrow and word “open” must be located on a background that provides adequate contrast.
(g) Each sign required by paragraph (d) of this section may use the word “exit” in its legend in place of the term “emergency exit” or an approved universal symbolic exit sign. The design of exit signs must be chosen to provide a consistent set throughout the cabin. If an approved universal symbol is used, limitations in the airplane flight manual must require a special emphasis briefing be given to the passengers on the meaning of the symbolic exit signs prior to each flight and prior to each landing, and that appropriate symbolic exit sign information be incorporated into standard passenger information cards (such as those required by §§ 121.571(b), 135.117(e), and 91.1035(f)) at each passenger seat place that may be occupied for taxiing, takeoff, and landing.
(b) * * *
(1) Airplanes that have a passenger seating configuration, excluding pilot seats, of 10 seats or more must meet the following requirements:
(i) Each passenger emergency exit locator sign required by § 25.811(d)(1) and each passenger emergency exit marking sign required by § 25.811(d)(2) must have red letters on an illuminated white background or an approved universal symbolic exit sign, of adequate size. These signs must be internally electrically illuminated with the brighter area having a brightness of at least 25 foot lamberts (86 candela/m
(ii) Each passenger emergency exit sign required by § 25.811(d)(3) must have red letters on a white background or be an approved universal symbolic exit sign, of adequate size. These signs must be internally electrically illuminated or self-illuminated by other than electrical means and must have an initial brightness of at least 400 microlamberts (1.27 candela/m
(2) For airplanes that have a passenger seating configuration, excluding pilot seats, of nine seats or less, each sign required by § 25.811(d)(1), (d)(2), and (d)(3) must have red letters on a white background or an approved universal symbolic exit sign, of adequate size. These signs may be internally electrically illuminated, or self-illuminated by other than electrical means, with an initial brightness of at least 160 microlamberts (0.51 candela/m
(e) * * *
(1) After leaving the passenger seat, visually identify the emergency escape path along the cabin aisle floor to the first exits or pair of exits forward and aft of the seat;
(2) Readily identify each exit from the emergency escape path by reference only to markings and visual features not more than 4 feet above the cabin floor; and
(3) In the case of passengers seated in seats authorized for occupancy during taxiing, takeoff, and landing, in a compartment that does not incorporate any part of the main cabin aisle, in lieu of § 25.812(e)(1), egress this compartment and enter the main cabin aisle using only markings and visual features not more than 4 feet above the cabin floor, and proceed to the exits using the marking system necessary to complete the actions as described in § 25.812(e)(1) and (e)(2) above.
(l) * * *
(1) The percentage of electrically-illuminated emergency lights required by § 25.812(a) through (d) or § 25.812(e) that are rendered inoperative, in addition to the lights that are directly damaged by the separation, does not exceed the values set in table 1 to this paragraph:
(a) There must be a passageway leading from the nearest main aisle to each Type A, Type B, Type C, Type I, or Type II emergency exit and between individual passenger areas. Each passageway leading to a Type A or Type B exit must be unobstructed and at least 36 inches (91 cm) wide. Passageways between individual passenger areas and those leading to Type I, Type II, or Type C emergency exits must be unobstructed and at least 20 inches (50.8 cm) wide. Unless there are two or more main aisles, each Type A or B exit must be located so that there is passenger flow along the main aisle to that exit from both the forward and aft directions. If
(1) A cross-aisle that leads directly to each passageway between the nearest main aisle and a Type A or B exit; and
(2) A cross-aisle that leads to the immediate vicinity of each passageway between the nearest main aisle and a Type C, Type I, Type II, or Type III exit; except that when two Type III exits are located within three passenger rows of each other, a single cross-aisle may be used if it leads to the vicinity between the passageways from the nearest main aisle to each exit.
(b) * * *
(1) * * *
(2) For each Type A or Type B exit, assist space must be provided at each side of the exit regardless of whether an assist means is required by § 25.810(a).
(3) For each Type C, Type I, or Type II exit installed in an airplane with seating for more than 80 passengers, an assist space must be provided at one side of the passageway regardless of whether an assist means is required by § 25.810(a).
(4) For each Type C, Type I, or Type II exit, an assist space must be provided at one side of the passageway if an assist means is required by § 25.810(a).
(c) The following must be provided for each Type III or Type IV exit:
(1) There must be access from the nearest aisle to each exit.
(2) In addition, for each Type III exit in an airplane that has a passenger seating configuration of 20 or more and that only has seats installed immediately to the forward and aft of the access route(s)—
(i) Except as provided in paragraph (c)(2)(ii) of this section, the access must be provided by an unobstructed passageway that is at least 10 inches (25.4 cm) in width for interior arrangements in which the adjacent seat rows on the exit side of the aisle contain two seats, or 13 inches (33 cm) in width for interior arrangements in which those rows contain three seats. The width of the passageway must be measured with adjacent seats adjusted to their most adverse positions. At least 10 inches (25.4 cm) of the required passageway width must be within the required projected opening width of the exit.
(ii) In lieu of one 10- or 13-inch (25.4- or 33-cm) passageway, there may be two unobstructed passageways that must be at least 6 inches (15.2 cm) in width and lead to an unobstructed space adjacent to each exit. Adjacent exits must not share a common passageway. The width of the passageways must be measured with adjacent seats adjusted to their most adverse positions. The unobstructed space adjacent to the exit must extend vertically from the floor to the ceiling (or to the bottom of upper sidewall stowage bins), inboard from the exit for a distance not less than the width of the narrowest passenger seat installed on the airplane and from the forward edge of the forward passageway to the aft edge of the aft passageway. The exit opening must be totally within the fore and aft bounds of the unobstructed space.
(3) Each Type III exit in an airplane that has a passenger seating configuration of 20 or more and which has an access route bounded by any item(s) other than only seats (
(4) In addition to the access—
(i) For airplanes that have a passenger seating configuration of 20 or more, the projected opening of the exit provided may not be obstructed and there must be no interference in opening the exit by seats, berths, or other protrusions (including adjacent seats adjusted to their most adverse positions) for a distance from that exit not less than the width of the narrowest passenger seat installed on the airplane or 15.75 inches (40 cm), whichever is the least.
(ii) For airplanes that have a passenger seating configuration of 19 or less, there may be minor obstructions in this region if there are compensating factors to maintain the effectiveness of the exit.
(5) For each Type III and Type IV exit, there must be placards that—
(i) Are readable by all persons seated adjacent to and facing a passageway to the exit, one in their normal field of view, and one adjacent to or on the exit;
(ii) Accurately state or illustrate the proper method of opening the exit, including the correct use of controls, handles, handholds, etc.; and
(iii) If the exit is a removable hatch, state the weight of the hatch and indicate an appropriate location to place the hatch after removal.
(6) For airplanes with a passenger seating configuration of 41 or more, each Type III exit must be designed such that, when operated to the fully open position, the hatch or door is automatically disposed so that it can neither reduce the size of the exit opening, the passageway(s) leading to the exit, nor the unobstructed space specified in paragraph (c)(2)(ii) of this section, to below the required minimum dimensions. In the fully open position, it must also not obstruct egress from the exit via the escape route specified in § 25.810(c).
(7) The design of each seat, bulkhead, partition, or other feature bounding the passageway leading to each Type III or Type IV exit, must be such that—
(i) Evacuees are hindered from climbing over in the course of evacuating;
(ii) Any baggage stowage provisions (such as under-seat stowage) would prevent baggage items entering the passageway under the inertia forces of § 25.561(b)(3), unless placards are installed to indicate that no baggage shall be stowed under the seats bounding the passageway; and
(iii) No protrusions (such as coat hooks) could impede evacuation.
(8) The design and arrangement of all seats bordering and facing a passageway to each Type III or Type IV exit, both with and without the bottom cushion in place, must be free from any gap that might entrap a foot or other part of a person standing or kneeling on a seat or moving on or along the seat row.
(9) The latch design of deployable features (such as tables, video monitors, telephones, leg or foot rests) mounted on seats or bulkheads/partitions bordering and facing a passageway to a Type III or Type IV exit, must be such that inadvertent release by evacuating passengers will not occur. The latch design of deployable features must also be such that cabin crew can easily check that the items are fully latched in the stowed position. Placards indicating that each such item must be stowed for taxiing, takeoff, and landing must be installed in the normal field of view of, and be readable by each person seated in each seat bordering and facing a passageway to a Type III or Type IV exit.
(f) If it is necessary to pass through a doorway separating any crewmember seat (except those seats on the flightdeck), that is occupiable for takeoff and landing, from any emergency exit, the door must have a means to latch it in the open position. The latching means must be able to withstand the loads imposed upon it when the door is subjected to the ultimate inertia forces, relative to the surrounding structure, listed in § 25.561(b).
(a)
(1) Each door is open before the airplane enters any of the taxiing, takeoff, and landing phases;
(2) Each door remains open during taxiing, takeoff, and landing, and during and after a crash landing; and
(3) In the case of any probable failure or jamming of a door in a position other than fully open, any occupant is able, from any compartment separated by that door, to restore in an easy and simple manner a sufficient opening to access the compartment on the other side of the door.
(b)
(1) Within the compartment, there is at least one emergency exit above the waterline on each side of the fuselage that meets at least the requirements of a Type IV emergency exit for a compartment with a passenger seating configuration of 9 seats or less, or a Type III emergency exit for a compartment with a passenger seating configuration of 10 seats or more; or
(2) Within the compartment, there is at least one emergency exit above the waterline on one side of the fuselage that meets at least the requirements of a Type IV emergency exit for a compartment with a passenger seating configuration of 9 seats or less, or a Type III emergency exit for a compartment with a passenger seating configuration of 10 seats or more; and
(i) An occupant of the compartment would not need to go through more than one door to access an emergency exit above the waterline on the other side of the fuselage; and
(ii) The demonstration of compliance with the provisions of paragraph (a)(1) and (a)(2) of this section does not rely on any passenger action, nor involve any flightcrew member leaving their position in the flightdeck.
(c)
(d) [Reserved].
(e)
(1) The number of passenger seats allowed in a zone between two remaining adjacent pairs of emergency exits is limited to one-half of the combined rated capacity of the two pairs of emergency exits (rounded to the nearest whole number);
(2) The number of passenger seats allowed in a zone with only one remaining pair of emergency exits at one end is limited to one-half of the rated capacity of the pair of emergency exits (rounded to the nearest whole number);
(3) The distance from each passenger seat to at least one remaining emergency exit, on each side of the fuselage, remains compatible with easy egress from the airplane; and
(4) A distance of more than 60 feet between adjacent remaining emergency exits is created only once per side of the fuselage on each deck.
(a)
(1) Mattresses of permanent bed installations that are located in compartments isolated from the main passenger cabin by doors, or equivalent means, that would normally be closed during taxiing, takeoff, and landing need not meet the Oil Burner Test requirement of part II of appendix F to part 25, as required by § 25.853(c).
(2) On non-commercially operated airplanes only, compliance with § 25.853(d) need not be demonstrated if it can be shown by test, or a combination of test and analysis, under the conditions specified in appendix J to part 25 that the maximum time for evacuation of all occupants does not exceed 45 seconds.
(b)
(1) It is ensured that the item will be safely stowed before entering any of the taxiing, takeoff, approach, and landing phases, by means of a position monitoring and alerting system that, in a timely manner, notifies the flightcrew and compels the passengers to stow the item if it is in a position that creates an obstruction. It must be substantiated that, with the item in its most adverse position(s), the remaining exit is at least as effective as a Type IV emergency exit, unless it can be shown that following any single failure of any item creating the obstruction, an exit at least as effective as a Type IV emergency exit can be obtained by simple and obvious means.
(2) [Reserved].
(3) For airplanes required to have at least one cabin crewmember onboard, the item is intended for use only by a cabin crewmember that has direct view of the deployable item, and can confirm that it is correctly stowed and secured, while the cabin crewmember is seated during taxiing, takeoff, and landing.
(a)
(1) All areas of the cabin must be easily accessible by passengers or crew in the event of an emergency situation (
(2) Placard instructions for restoring the aisle to the taxiing, takeoff, and landing configuration must be provided at the locations where the width of the cabin aisle is reduced; and
(3) Procedures must be established and documented in the airplane flight manual for restoring the aisle width for taxiing, takeoff, and landing.
(b)
(a)
(1) A “No smoking” placard must be conspicuously located inside the passenger compartment in the immediate vicinity of every door that can be used as a passenger boarding door; each placard must be clearly legible for passengers entering the airplane; and
(2) The indication that smoking is prohibited must be the subject of a passenger briefing, and the requirement for this briefing must be included in the airplane flight manual (AFM) limitations section.
(b)
(1) The detailed minimum instructions to be included in the briefing card must be part of the type design and referred to in the limitations section of the AFM; and
(2) The briefing card must be easily accessible from each passenger seat. A dedicated stowage must be provided to stow the briefing card within easy reach of each seated passenger with their seat belts fastened.
(c)
(1) If the total number of seats approved for occupancy during taxiing, takeoff, and landing is greater than the approved maximum passenger seating capacity, then the difference between these two quantities is defined to be seats in excess. If seats in excess exist, a placard indicating the maximum passenger seating capacity must be installed adjacent to every door that can be used as a passenger boarding door. This placard must be clearly legible for passengers entering the airplane. In addition, a note must be included in the limitations section of the AFM stating that there are excess seats installed and indicating the maximum passenger seating capacity.
(2) For each seating location available for in-flight use only (including in-flight-only seats, beds, berths, and divans), a placard indicating that the location cannot be occupied during taxiing, takeoff, and landing must be installed such that the placard is legible to the seated occupant.
In lieu of the requirements of § 25.785(h)(2), to the extent practical without compromising proximity to a required floor level emergency exit, compliance with the following cabin crew direct view requirement may be shown:
(a) For non-commercially operated airplanes, at least half of the installed cabin crewmember seats must face the passenger cabin.
(b) [Reserved].
Non-commercially operated airplanes do not need to comply with the security specifications of § 25.795.
(a) * * *
(2) The airplane must be designed so that occupants will not be exposed to a cabin pressure altitude that exceeds the following after decompression from any system failure not shown to be extremely improbable, or any structural damage considered under § 25.571(b) or (e)(1):
(i) Twenty-five thousand feet for more than 2 minutes, or
(ii) Forty thousand feet for any duration.
(3) The airplane must be designed so that occupants will not be exposed to a cabin pressure altitude that exceeds the following after decompression from any engine failure not shown to be extremely improbable:
(i) Twenty-five thousand feet for more than 3 minutes,
(ii) Forty thousand feet for more than 1 minute, or
(iii) Forty-five thousand feet for any duration.
(4) Airplane manufacturers must demonstrate by flight test that the airplane can meet the conditions in § 25.841(a)(2) and (a)(3). The flightcrew procedures and associated limitations that address compliance to § 25.841(a)(2) and (a)(3) must be included in the airplane flight manual.
(d) * * *
(1) The time in flight that the cabin pressure high altitude warning alert is above 10,000 feet cabin pressure altitude is minimized;
(g) Regardless of whether smoking is allowed in any part of the airplane, lavatories must have an approved means to dispose of lit combustible material safely located conspicuously on or near the entry side of each lavatory door, except that one means may serve more than one lavatory door if the means can be seen readily from the cabin side of each lavatory served.
For airplanes with a passenger capacity of 20 or more, or with a cabin length of 60 feet (18.29 meters) or more:
(e)
(1) Authorized persons, as defined in § 121.583, are permitted to be carried in airplanes with Class E cargo compartments, provided that the requirements of § 25.797 are met.
(b) * * *
(1) Fleet Average Flammability Exposure is determined in accordance with appendix N to this part. The assessment must be done in accordance with the methods and procedures set forth in Report No. DOT/FAA/TC-21/3, “Fuel Tank Flammability Assessment Method User's Manual—Updated for Version 11,” dated January 2021 (incorporated by reference, see § 25.5).
Each control for selecting propeller pitch settings below the flight regime (reverse thrust for turbojet-powered airplanes) must have the following:
(a) A means, such as a positive lock or stop, that requires a separate and distinct operation by the flightcrew to displace the control from the flight regime (forward thrust regime for turbojet-powered airplanes), and it must only be possible to make this separate and distinct operation once the control has reached the flight idle position.
(b) A means to prevent both inadvertent and intentional selection or activation of propeller pitch settings below the flight regime, or of reverse thrust for turbojet-powered airplanes, when out of the approved in-flight operating envelope for that function. Override of this means by the flightcrew is prohibited.
(c) A level of reliability such that the loss of the means required by paragraph (b) of this section is remote.
(d) An alert for the flightcrew, in accordance with § 25.1322, when the prevention means required by paragraph (b) of this section is lost.
(e) An alert for the flightcrew, in accordance with § 25.1322, when a flightdeck control is displaced from the flight regime (forward thrust regime for turbojet-powered airplanes) into a position to select propeller pitch settings below the flight regime (reverse thrust for turbojet-powered airplanes) outside the approved in-flight operating envelope. This flightcrew alert need not be provided if the means required by paragraph (b) of this section is a mechanical balk that prevents movement of the control.
(e) * * *
(3) Have cowling and nacelle skin, in areas subject to flame if a fire starts in an engine fire zone, which comply with the following:
(i) For in-flight operations, cowling and nacelle skin must be fireproof; and
(ii) For ground operations, cowling and nacelle skin must be:
(A) Fireproof in areas where a skin burnthrough would affect critical areas of the airplane, and
(B) Fire-resistant or compliant with paragraph (e)(1) of this section in areas where a skin burnthrough would not affect critical areas of the airplane.
(a) For the purposes of this section, normal electrical power is power from all sources generated for use during normal operating conditions. It does not include alternative power sources.
(b) For an airplane design that utilizes mechanical control cables and linkages for flight control, or otherwise does not rely on a continuous source of electrical power for continued operation: The applicant must show by analysis, tests, or both that the airplane can be operated safely in Visual Flight Rules conditions, for a period of not less than 5 minutes, with the normal electrical power inoperative, with critical fuel type (from the standpoint of flameout and restart capability), and with the airplane initially at the maximum certificated altitude. Parts of the electrical system may remain on if—
(1) A single malfunction, including a wire bundle or junction box fire, cannot result in loss of both the part turned off and the part turned on; and
(2) The parts turned on are electrically and mechanically isolated from the parts turned off.
(c) An airplane design that utilizes electrical and electronic systems to perform critical functions, the loss of which may result in loss of flight controls or other critical systems and may be catastrophic to the airplane, must comply with paragraphs (c)(1) through (7) of this section.
(1) The applicant must show by test or a combination of test and analysis that the airplane is capable of continued safe flight and landing with all normal electrical power sources inoperative.
(2) In showing compliance with paragraph (c)(1) of this section, the applicant—
(i) Must account for systems capability, effects on flightcrew workload and operating conditions, and the physiological needs of the crew and passengers;
(ii) Must account for common cause failures, cascading failures, and zonal physical threats; and
(iii) May include a showing of the airplane's ability to restore operation of portions of the normal electrical power generation and distribution system if it can be shown that unrecoverable loss of those portions of the system is extremely improbable. The airplane's design must provide an alternative source of electrical power for the time required to restore the minimum electrical power generation capability required for continued safe flight and landing. The applicant's showing may exclude the unrecoverable loss of all engines.
(3) Regardless of any electrical generation and distribution system recovery capability shown under paragraph (c)(2) of this section, sufficient electrical system capability must be provided to—
(i) Allow time to descend, with all engines inoperative, at the speed that provides the best glide distance, from the maximum operating altitude to the top of the engine restart envelope; and
(ii) Subsequently allow multiple start attempts of each engine and APU. The airplane's design must provide this capability in addition to the electrical capability required by existing part 25 requirements related to operation with all engines inoperative.
(4) For compliance with paragraph (c)(1) of this section, the airplane emergency electrical power system must be designed to supply—
(i) Electrical power required for immediate safety, which must continue to operate without the need for flightcrew action following the loss of the normal electrical power, for a duration sufficient to allow reconfiguration of the electrical power system to provide a non-time-limited source of electrical power; and
(ii) Electrical power required for continued safe flight and landing.
(5) If the applicant uses APU-generated electrical power to satisfy the requirements of paragraph (c)(1) of this section, and if reaching a suitable runway for landing is beyond the capacity of the alternative power sources, then the APU must be able to be started under any foreseeable flight condition prior to the depletion of the alternative power sources or the restoration of normal electrical power, whichever occurs first. Flight test must demonstrate this capability at the most critical condition.
(i) The applicant must show that the APU will provide adequate electrical power for continued safe flight and landing.
(ii) The airplane must provide an adequate alert and indication of loss of normal electrical power to direct the flightcrew to the non-normal procedures, and the AFM must furnish non-normal procedures that will direct the pilot to take appropriate actions.
(6) As part of showing compliance with paragraphs (c)(2) through (c)(5) of this section, the tests to demonstrate loss of all normal electrical power must also consider the following—
(i) The assumption that the failure condition occurs during night instrument meteorological conditions (IMC) at the most critical phase of the
(ii) After the un-restorable loss of normal engine-driven generated electrical power the airplane engine restart capability is provided, and operations continued in IMC.
(iii) The airplane is demonstrated to be capable of continued safe flight and landing. The duration of this capability must be computed based on the maximum diversion time capability for which the airplane is being certified. The applicant must account for airspeed reductions resulting from the associated failure or failures.
(7) The airplane must provide adequate indication of loss of normal electrical power to direct the flightcrew to the non-normal procedures, and the AFM must furnish non-normal procedures that will direct the pilot to take appropriate actions.
(b) The installation of galleys and cooking appliances must be such as to minimize the risk of overheat, fire, smoke, burns, or spilled liquids, to the airplane, passengers, and crew.
(c) * * *
(6) There must be sufficient outlets and units of dispensing equipment of a type similar to that required by paragraph (c)(1) of this section in all other areas that may be occupied by passengers or flight crewmembers during flight.
(a) The powerplant and auxiliary power unit (APU) installation design must provide the flightcrew with the information needed to—
(1) Identify that each powerplant and APU installation is operating within normal limits,
(2) Identify that each powerplant and APU installation is operating outside of normal limits, if any, and
(3) Determine the appropriate actions and corresponding alerting prioritization, if needed, in accordance with the flightcrew alerting requirements of § 25.1322.
(b) The powerplant and APU installation design must provide additional information needed on powerplant and APU operating conditions, if any, for maintenance personnel to evaluate each powerplant and APU installation according to the Instructions for Continued Airworthiness required by §§ 25.1529 and 25.1729.
(c) The flightdeck information required by paragraphs (a) and (b) of this section must—
(1) Be displayed using colors that are consistent with the colors used for normal operation of the other airplane systems when operating within normal limits, and
(2) Meet the flightcrew alerting requirements of § 25.1322 when operating outside of normal limits, if any.
(d) * * *
(1) Each emergency control (including each fuel jettisoning and fluid shutoff control) must—
(i) Be colored red; or
(ii) Illuminate red when a condition necessitates its use, and have appropriate safeguards to allow its intended use while preventing unintentional actuation, and not restricting use when needed; and
(j)
(b) * * *
(13) § 25.1352 Operation without normal electrical power.
(a) A flammability exposure analysis must be conducted for the fuel tank under evaluation to determine fleet average flammability exposure for the airplane and fuel types under evaluation. For fuel tanks that are subdivided by baffles or compartments, an analysis must be performed either for each section of the tank, or for the section of the tank having the highest flammability exposure. Consideration of transport effects is not allowed in the analysis. The analysis must be done in accordance with the methods and procedures set forth in Report No. DOT/FAA/TC-21/3, “Fuel Tank Flammability Assessment Method User's Manual—Updated for Version 11,” dated January 2021 (incorporated by reference, see § 25.5). The parameters specified in sections N25.3(b) and (c) of this appendix must be used in the fuel tank flammability exposure “Monte Carlo” analysis.
(b) * * *
(5) Airplane Climb and Descent Profiles, as defined in the Report No. DOT/FAA/TC-21/3, “Fuel Tank Flammability Assessment Method User's Manual—Updated for Version 11,” dated January 2021 (incorporated by reference in § 25.5).
(d) * * *
(5) If an FRM is used that is affected by oxygen concentrations in the fuel tank, the time periods when oxygen evolution from the fuel results in the fuel tank or compartment exceeding the inert level. The applicant must include any times when oxygen evolution from the fuel in the tank or compartment under evaluation would result in a flammable fuel tank. The oxygen evolution rate that must be used is defined in Report No. DOT/FAA/TC-21/3, “Fuel Tank Flammability Assessment Method User's Manual—Updated for Version 11,” dated January 2021 (incorporated by reference in § 25.5).
Issued under authority provided by 49 U.S.C. 106(f), 44701(a), and 44704 in Washington, DC.
Nuclear Regulatory Commission.
Proposed rule and draft guidance; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is proposing to revise its regulations to modernize security and fitness-for-duty requirements to enhance efficiency, consistent with Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission.” The proposed revisions are intended to reduce regulatory burden, where appropriate, while continuing to provide reasonable assurance that safety and security will be adequately maintained at NRC-licensed facilities.
Comments must be submitted electronically using
Submit your comments, identified by Docket ID NRC-2025-1303, at
Do not include any personally identifiable information (such as name, address, or other contact information) or confidential business information that you do not want publicly disclosed. All comments are public records; they are publicly displayed exactly as received and will not be deleted, modified, or redacted. Comments may be submitted anonymously.
Follow the search instructions on
You can read a plain language description of this proposed rule at
Nicole Fields, Office of Nuclear Material Safety and Safeguards, telephone: 630-829-9570, email:
The U.S. Nuclear Regulatory Commission (NRC) is proposing to revise its regulations to modernize security and fitness-for-duty requirements to enhance efficiency, consistent with Executive Order 14300, “Ordering the Reform of the Nuclear Regulatory Commission.”
Major provisions of this proposed rule, supported by accompanying draft guidance, include the following:
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The NRC prepared a draft regulatory analysis to determine the expected quantitative costs and benefits of this proposed rule and associated draft 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 draft guidance would result
The draft regulatory analysis also considers qualitative factors, such as regulatory efficiency. These benefits would result from clarifications, administrative changes, and streamlining of processes (such as notifications), along with aligning requirements with existing Federal regulations instead of maintaining separate but similar NRC requirements.
For more information, please see the draft regulatory analysis (available in the NRC's Agencywide Documents Access and Management System (ADAMS) Accession No. ML26113A051).
Please refer to Docket ID NRC-2025-1303 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(g), which directs the NRC to “[r]evise the Reactor Oversight Process and reactor security rules and requirements to reduce unnecessary burdens and be responsive to credible risks.”
Over the decades, the NRC has developed a comprehensive regulatory framework to ensure that licensee programs at nuclear facilities provide reasonable assurance that public health and safety is adequately protected and are in accord with the common defense and security. This proposed rule seeks to modernize the NRC's regulatory framework for licensee security programs—reducing regulatory burden, where appropriate, while continuing to provide reasonable assurance of adequate safety and security. The principal regulations relevant to this
The regulations in 10 CFR part 26 govern fitness-for-duty (FFD) programs, including drug and alcohol testing and fatigue management, for personnel at nuclear power plants and certain other NRC-licensed facilities. The requirements are designed, in part, to provide reasonable assurance that individuals are trustworthy, reliable, and not under the influence of any substances, legal or illegal, or mentally or physically impaired from any cause that could adversely affect their ability to safely and competently perform their duties.
The regulations in 10 CFR part 72 set forth requirements for the licensing and operation of ISFSIs. These facilities are used to safely store spent nuclear fuel and certain other radioactive materials, both at power reactor sites and away from reactor sites. Part 72 includes both safety and security provisions, with physical protection requirements that vary depending on whether the ISFSI is operated under a general license or specific license.
The regulations in 10 CFR part 73 address the physical protection of plants and materials. Part 73 contains detailed requirements for physical security programs, access authorization, cybersecurity, and the protection of safeguards information. These requirements apply to commercial nuclear power reactors, fuel cycle facilities, and other licensees that possess special nuclear material (SNM). The regulation is structured to protect against the design basis threats of radiological sabotage and theft or diversion of SNM, and includes requirements for security organization, training, response strategies, and contingency planning.
The regulations in 10 CFR part 95 establish requirements for facility security clearances and the safeguarding of national security information and restricted data. These requirements are intended to ensure that NRC licensees and certificate holders who require access to classified information maintain appropriate security measures in accordance with the National Industrial Security Program.
The NRC recognizes the need to modernize and streamline its security and FFD regulations to reduce unnecessary regulatory burden, promote regulatory clarity, provide appropriate program flexibility, and support the deployment of innovative technologies, while also continuing to provide reasonable assurance that safety and security will be adequately maintained. This proposed rule aligns with national policy directives to facilitate the expansion of United States nuclear energy capacity, as articulated in recent Executive Orders and statutory mandates.
In addition to E.O. 14300, other recent E.O.s related to the expansion of United States nuclear energy capacity include E.O. 14156, “Declaring a National Energy Emergency” (90 FR 8433; January 29, 2025), which stressed the need for a reliable, diversified, and affordable supply of energy, and E.O. 14154, “Unleashing American Energy” (90 FR 8353; January 29, 2025), which stated that it is in the national interest to “unleash America's affordable and reliable energy and national resources.”
Recent statutory mandates related to nuclear energy capacity include the Nuclear Energy Innovation and Modernization Act (Pub. L. 115-439, 132 Stat. 5572) (NEIMA) and the Accelerating Deployment of Versatile, Advanced Nuclear for Clean Energy Act of 2024 (Pub. L. 118-67, 138 Stat. 1448) (ADVANCE Act). In response to NEIMA, the NRC recently issued a final rule establishing 10 CFR part 53, “Risk-Informed, Technology-Inclusive Regulatory Framework for Commercial Nuclear Power Plants,” which sets forth a regulatory framework for licensing and regulating advanced reactors (91 FR 15696; March 30, 2026). Part 53 is designed to accommodate a wide range of reactor technologies and business models, providing performance-based requirements that enable the use of modern safety and security approaches. As discussed in Section IV of this document, proposed changes as a part of this proposed rule would apply to licensees and applicants under 10 CFR parts 50, “Domestic Licensing of Production and Utilization Facilities”; 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants”; and 53. The proposed amendments are intended to provide enhanced regulatory flexibility for both current and future licensees, streamline administrative processes, and ensure that NRC requirements remain effective, efficient, and responsive to credible risks.
The NRC prepared an unofficial redline strikeout version of the proposed changes to regulatory text that is intended to help the reader identify the changes. The unofficial redline strikeout version of the proposed rule is publicly available and is listed in the “Availability of Documents” section. Comments on the rule text should refer to this proposed rule and not the unofficial redline strikeout version.
The discussion is organized by subject area because of the wide-ranging set of issues covered by this proposed rule. The proposed rule also includes minor editorial corrections.
The proposed rule would incorporate effectiveness and efficiency improvements into the NRC's FFD program requirements for drug and alcohol testing and fatigue management since the NRC's extensive amendments of part 26 in 2008 (73 FR 17176; March 31, 2008). These proposed effectiveness and efficiency changes would reduce unnecessary regulatory burden on licensees and other entities and address section 5(g) of E.O. 14300. This proposed rule focuses on three areas: (1) incorporating lessons learned from implementing part 26 since 2008; (2) aligning part 26 with select updates made to the U.S. Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (HHS Guidelines) and the U.S. Department of Transportation (DOT) drug testing requirements in 49 CFR part 40, “Procedures for Transportation Workplace Drug and Alcohol Testing Programs”; and (3) addressing three PRMs.
Proposed changes to the drug and alcohol testing program requirements include the following: expanding the option to collect and drug test oral fluid specimens for all conditions for testing in § 26.31(c); implementing a risk-informed reduction to the annual random testing rate in § 26.31(d)(2)(vii) that applies to most licensee employees (
From 2010 through 2012, the NRC also received three PRMs (docketed by the NRC as PRM-26-4, PRM-26-7, and PRM-26-8), which the NRC determined to be appropriate for consideration in the rulemaking process; all three of the PRMs are being considered as part of this rulemaking. To address PRM-26-4, “California Association of Marriage and Family Therapists” (75 FR 51958; August 24, 2010), the NRC is proposing to add State-licensed or State-certified marriage and family therapists to the list of acceptable credentials in § 26.187(b) that qualify individuals to serve as substance abuse experts (SAEs). The NRC also considered the issues identified for rulemaking in PRM-26-7, “Certification of Substance Abuse Experts” (76 FR 61625; October 5, 2011), related to Certified Addiction Specialists. The NRC is not proposing to add the petitioner's requested Certified Addiction Specialist that has been certified by the American Academy of Health Care Providers in the Addictive Disorders to the list of acceptable credentials to serve as an SAE under § 26.187(b), and accordingly would deny PRM-26-7.
Finally, the NRC considered the issues identified for rulemaking in PRM-26-8, “Additional Synthetic Drug Testing” (78 FR 22209; April 15, 2013). The NRC determined that the 2022 part 26 final rule (87 FR 71422; November 22, 2022), in part, addressed the issues raised in this petition by expanding the drug testing panel to include additional semi-synthetic opioids (hydrocodone, hydromorphone, oxycodone, oxymorphone), methylenedioxy-methamphetamine (MDMA), and methylenedioxyamphetamine (MDA). Under § 26.31(d)(1)(i), licensees and other entities also have the ability to consult with local law enforcement, hospitals, and drug counseling services to determine if other drugs with abuse potential are being used in the geographic locale of facilities, and to expand the drug testing panels to include any controlled substance that is listed on Schedules I through V of section 202 of the Controlled Substances Act. In addition, under § 26.77(b), a licensee or other entity must take immediate action to prevent any individual from performing covered duties if they appear impaired, which provides reasonable assurance that impairment from any cause (including the use of both scheduled and unscheduled substances) can be addressed. Accordingly, the NRC is not proposing changes related to PRM-26-8 and would deny this petition.
HHS and DOT have also updated their drug testing program requirements since the 2008 and 2022 amendments to part 26. On October 12, 2023, HHS published final revisions to the HHS Guidelines for the testing of drugs in urine and oral fluid specimens (88 FR 70768 and 88 FR 70814, respectively). DOT published two final rules amending its drug and alcohol testing programs in 49 CFR part 40. One updated DOT's urine drug testing requirements (82 FR 52229; November 13, 2017), and the other enabled oral fluid drug testing (88 FR 27596; May 2, 2023). The HHS Guidelines govern Federal employee workplace drug testing programs at more than 100 Federal agencies and Federal agency drug testing programs (
The proposed rule includes a risk-informed change that would extend the implementation milestone for when a licensee or other entity must transition from the optional subpart K to an FFD program that meets all of the requirements of part 26, except subparts K and M, “Fitness for Duty Programs for Facilities Licensed under 10 CFR part 53.” The milestone would change from the receipt of special nuclear material in the form of fuel assemblies to before initial fuel load into the reactor.
The NRC has reassessed the risks presented during the construction of nuclear power reactors and has determined that implementation of § 26.3(a) and (c) and § 26.4(e)(1) is not commensurate with current risk insights. Section 26.3(a) currently requires, in part, that licensees authorized to operate a nuclear power reactor under part 50 and holders of a combined license (COL) under part 52 after the Commission has made the finding under § 52.103(g) shall implement the FFD program under the requirements of part 26, except for subparts K and M, before the receipt of SNM in the form of fuel assemblies. Under § 26.3(c), licensees and other entities constructing a nuclear power plant must implement their FFD program no later than receipt of SNM in the form of fuel assemblies. The risk associated with unirradiated fuel, however, does not increase when the fuel arrives onsite, because its engineered safety features, storage, and configuration have not changed since the fuel was in transit. For transit and receipt onsite, the same physical protection requirements (
The proposed rule would expand the option to collect and drug test oral fluid specimens for all conditions of testing specified under § 26.31(c). This proposed change would provide an effective method to thwart attempts to subvert the drug testing process because all oral fluid specimens would be collected under direct observation. Each year, approximately 25 to 30 percent of the drug testing violations under part 26 are identified subversion attempts. In most cases, a donor attempts to provide a specimen that did not come from their body (
Currently, under § 26.83(b), licensees and other entities have the option to collect and drug test an oral fluid specimen instead of a urine specimen only when a directly observed collection is required (
Blind performance test samples (BPTSs) are formulated to verify the accuracy and reliability of each drug and validity test performed by the HHS-certified laboratory that a licensee or other entity uses to perform testing under contract. In each calendar quarter, BPTSs must be submitted to the laboratory for each drug or drug metabolite that must be tested in donor specimens and for each validity test performed to identify subversion attempts. A licensee or other entity must prepare BPTSs to appear as donor specimens to the laboratory, and BPTSs must be submitted along with donor specimens throughout the calendar quarter to evaluate laboratory performance.
Each year, operating experience demonstrates that the BPTS program identifies unsatisfactory performance at HHS-certified laboratories. Given the consolidated use of testing laboratories by industry, an identified performance issue at one laboratory generally impacts numerous licensee and other entity FFD programs. Identified performance issues, for example, have pertained to false negative test results because of laboratory certified scientists failing to adhere to laboratory testing procedures, weaknesses in laboratory standard operating procedures, improperly formulated reagents used in testing, and testing equipment maintenance issues.
The proposed rule would incorporate three effectiveness and efficiency improvements for blind performance testing programs based on industry practice and lessons learned. These improvements would reduce unnecessary regulatory burden for licensees and other entities.
The proposed rule would eliminate the increased number of BPTSs that must be submitted in the initial 90 days of a licensee or other entity initiating a contract with a new HHS-certified laboratory. Under the existing requirements in § 26.168(a), in this initial 90-day period, a minimum of 30 BPTSs must be submitted for testing, whereas in each subsequent calendar quarter, a minimum of 10 BPTSs must be submitted for testing. The increased number of BPTS submissions in the initial 90 days of testing is unnecessary. The NRC has found that the post-initial 90-day period BPTS submission number of 10 BPTSs per calendar quarter is sufficient to identify unsatisfactory laboratory performance. The blind testing program already requires that, if unsatisfactory performance is identified (
The proposed rule would revise § 26.168(a) to clarify how a licensee or other entity is to determine how many BPTSs it must submit for testing in each calendar quarter, after the initial 90-day period, to the HHS-certified laboratory that it maintains under contract to perform testing. The current BPTS submission requirements require a minimum of 10 BPTSs to be submitted per quarter, or 1 percent of the donor specimens up to a maximum of 100 BPTSs, whichever is greater. Generally, § 26.168(a) has been applied at the facility level (
The NRC is proposing to eliminate the BPTS submission requirements in § 26.168(b)(1) and (2) that require a licensee or other entity to submit at least two BPTSs positive for marijuana in each quarter and to replace the BPTS positive for PCP with an additional BPTS positive for cocaine in at least two quarters per year. These prescriptive requirements are unnecessarily restrictive to effectively challenge testing performed at HHS-certified laboratories (
The proposed rule would amend part 26 to permit licensees and other entities to escort construction workers performing activities covered under § 26.4(f) instead of requiring these workers to be subject to an FFD program. This proposed change is based on recent operating experience from implementing subpart K FFD programs at the Vogtle Electric Generating Plant Units 3 and 4. Specifically, the NRC issued an exemption to the Vogtle licensee to permit the escorting of construction workers (84 FR 27364; June 12, 2019). To permit escorting, the proposed rule would amend § 26.5, “Definitions,” to define the word “Escort”; § 26.4(e) to include a new requirement that individuals that serve as an escort must be subject to an FFD program that meets all part 26 requirements, except subparts I, “Managing Fatigue,” K, and M; § 26.4(f) to state that individuals who are escorted and constructing or directing the construction of safety- or security-related structures, systems, and components (SSCs) need not be subject to the licensee's FFD program; § 26.27(c)(5) and § 26.606(b)(7) to require the licensee or other entity to establish, implement, and maintain written procedures for escorting; and § 26.403(a) and (b) to require the licensee or other entity implementing a subpart K FFD program to establish, carry out, and maintain a procedure for escorts and those individuals under escort. These proposed changes would improve regulatory flexibility and potentially reduce costs by enabling licensees and other entities the opportunity to better plan and carry out construction activities with individuals who may be onsite for only short periods of time.
The proposed rule would revise § 26.29(c)(2) to change the FFD program refresher training interval from a nominal 12-month frequency to a nominal 24-month frequency. This proposed change would align with the refresher training interval that would apply to future part 53 licensees and other entities that implement § 26.608(b) of subpart M. The proposed rule would maintain the requirement in existing §§ 26.29(c)(2) and 26.608(b) for refresher training to be performed more frequently than the specified interval if the need is indicated, such as when an individual fails to properly implement FFD program procedures, or because of the severity of problems discovered through licensee-performed FFD program audits. This proposed change would reduce unnecessary regulatory burden by providing licensees and other entities with more flexibility on when to perform FFD program refresher training.
The proposed rule would revise § 26.31(d)(2)(vii) to reduce the annual random testing rate from 50 percent to 25 percent for most licensee employees (
The licensee employee workforce has consistently tested positive at much lower rates on pre-access and random drug and alcohol testing than the contractor/vendor workforce. The data show two to three times higher positive rates for contractor/vendors than licensee employees. In addition, FFD program performance data has consistently demonstrated that the licensee employee worker population has very low subversion rates.
The existing 50 percent annual random testing rate would continue to apply to the small subset of licensee employees that perform critical safety and security-related functions (
The proposed rule would amend § 26.31(d)(2)(vii) to incorporate a requirement—similar to that described in § 26.607(b)(2)(vi) of subpart M of 10 CFR part 26—that applies to FFD programs with small staff sizes where random testing cannot be implemented without predictability. Small staff sizes can contribute to increased predictability in random testing, due to the possibility for staff to make inferences based on patterns in testing frequency that are more easily recognizable when there is a smaller pool of employees to choose from. For FFD programs with small staff sizes, the proposed rule—under a new § 26.31(d)(2)(vii)(C)—would require the use of a consortium/third-party administrator (C/TPA) to include the workers from multiple licensees or other entities in a combined random testing pool, from which the C/TPA would make testing selections throughout the year. Use of a C/TPA would significantly improve the effectiveness of the random testing programs of potential future licensee sites that may have small worker populations, and would ensure that individuals at these facilities would not be able to predict whether random testing would be conducted in a given period of time. As discussed in the 2026 part 53 final rule, C/TPAs have been used for many years by other Federally-regulated testing programs implemented by the U.S. Department of Transportation, such as those covering independent owner-operator truck drivers. This proposed aligning change would ensure that effective random testing programs can be implemented at future nuclear power reactor sites under parts 50 and 52 that may be operated by a small number of individuals.
The proposed rule would also include a conforming revision to § 26.607(b)(2)(vi) to ensure that a C/TPA-managed random testing pool for a facility licensed under part 53 meets the same annual random testing rate as that required under § 26.607(b)(2)(v). Without this correction, a C/TPA pool would not have a specified random testing rate.
The proposed rule would eliminate the § 26.41(c)(2) requirement for licensees and other entities to annually audit the HHS-certified laboratories maintained under contract to perform testing. These audits are redundant because HHS's National Laboratory Certification Program (NLCP) uses highly trained technical experts to independently inspect each HHS-certified laboratory twice per year. The NLCP inspection process evaluates the majority of laboratory services and functions provided to licensees and other entities under part 26, and the § 26.168 performance-based blind performance testing program (
The proposed rule would revise § 26.607(c)(4), in subpart M of 10 CFR part 26, to align with the requirements of § 26.153(f) that apply to existing licensees and other entities implementing FFD programs under part 26. Paragraph § 26.607(c)(4) requires, in part, that each licensee or other entity establish and maintain a contract with the HHS-certified laboratory relied upon for testing, and that the contract must stipulate that the laboratory is subject to inspection and auditing by the licensee or other entity, and that the laboratory must provide access to records and permit copying and removal of records, if necessary. However, § 26.607(c)(4), as published in the 2026 final rule that created subpart M, did not include other important contractual requirements in § 26.153(f). The proposed rule would address these differences between the commensurate requirements by creating a new § 26.607(c)(5) that would replace the last sentence currently in § 26.607(c)(4).
Specifically, the proposed rule would add the requirements equivalent to those in the existing requirements of § 26.153(f)(1) through (6). These requirements specify that laboratories must comply with applicable provisions of any State licensor; make qualified personnel available to testify at any administrative or disciplinary proceedings against an individual based on a laboratory's test results; and provide a donor with access, upon written request, to all laboratory records associated with testing of the individual's specimen and any relevant records on laboratory certification, review, or revocation-of-certification proceedings. These requirements also include individual privacy requirements pertaining to laboratory records; conflict of interest provisions applicable to a licensee's or other entity's medical review officer (MRO); and the requirement that the NRC and any licensee or other entity using the laboratory's services must be permitted to inspect the laboratory at any time, including unannounced inspections.
Maintaining uniform contractual requirements for HHS-certified laboratories that perform testing for any licensee or other entity FFD program under part 26 would be necessary because the NRC does not regulate HHS-certified laboratories. As such, contractual requirements would ensure that the NRC and its licensees and other entities have adequate access to each laboratory facility, its personnel, and its records, as necessary to conduct quality assurance reviews. Contractual requirements would also ensure that conflicts of interest do not exist between the laboratory and MROs who may review the laboratory's test results for a licensee or other entity.
The proposed rule would remove the § 26.607(c)(4) requirement that a licensee or other entity maintain a contract with a back-up HHS-certified laboratory for each biological specimen tested. While a contract with a primary laboratory performing testing on all donor specimens for a licensee or other entity is necessary, imposing a requirement that a back-up laboratory also be maintained under contract is unnecessarily restrictive, inconsistent with industry practice, and is not required for current licensees and other entities implementing an FFD program under part 26.
A back-up HHS-certified laboratory typically conducts testing for a licensee or other entity only when a donor is determined to have violated the FFD policy based on a confirmed positive drug test result or a substituted or adulterated validity test result, and the donor requests retesting at a second laboratory to independently verify the accuracy of the initial laboratory's test result. Many current licensees and other entities implementing FFD programs under part 26 do not maintain a contractual relationship with a particular back-up laboratory and instead provide a donor with a list of all HHS-certified laboratories in the United States to choose from with respect to conducting additional testing on their specimen.
Given the limited use of back-up laboratories by existing licensees, the § 26.607(c)(4) contractual requirement would impose an unnecessary additional burden on future part 53 licensees and other entities that implement subpart M FFD programs and is inconsistent with the current HHS-certified laboratory contractual requirements that apply to part 50 and 52 licensees and other entities. The proposed change would reduce unnecessary regulatory burden and afford donors maximum flexibility in choosing the HHS-certified laboratory to perform additional testing on their specimens, in instances where follow-up testing is requested after an FFD policy violation has been determined.
The proposed rule would eliminate subpart F, “Licensee Testing Facilities.” Under subpart F, part 26 currently enables licensees to conduct initial drug and initial validity testing on urine specimens at a licensee testing facility (LTF), typically located at the power reactor site. Any specimen tested by an LTF that does not test negative or has a validity testing issue must be forwarded to an HHS-certified laboratory for additional testing.
Historically, LTF testing was the preferred option for many FFD programs because of the quick turnaround time on negative drug test results, which enabled the timely in-processing of workers during outages. Use of LTFs, however, has steadily declined over time as HHS-certified laboratories have greatly improved the turnaround times for reporting negative test results, and no licensee FFD programs currently use an LTF. Operating experience also demonstrates that future use of LTFs is unlikely given high operating costs, the increasing technical complexity of urine testing (
Eliminating the option for LTFs would improve regulatory effectiveness and efficiency by more closely aligning the part 26 drug testing program with the HHS and DOT testing programs, both of which require testing to be performed at HHS-certified laboratories. Eliminating subpart F would also simplify other part 26 requirements beyond subpart F, because numerous sections reference the use of an LTF or describe LTF-specific processes. Eliminating subpart F would also reduce the administrative burden on the NRC to maintain training programs and inspection procedures that accommodate LTF use.
On December 3, 2025 (90 FR 55621), the NRC published a direct final rule to insert a conditional sunset provision into § 26.121, “Purpose,” and certain other regulations in response to E.O. 14270, “Zero-Based Regulatory Budgeting to Unleash American Energy” (90 FR 15643; April 15, 2025). The conditional sunset provision in § 26.121 provides that subpart F of part 26 will cease to have effect on January 8, 2027, unless the NRC, after considering public input on the costs and benefits of the
The proposed rule would risk-inform the 24-hour reporting requirement in § 26.719(b)(2) to notify the NRC of significant violations of a licensee's or other entity's FFD policy by supervisory personnel. Specifically, the proposed rule would focus this notification requirement on supervisors who direct the operation or maintenance of safety- or security-related SSCs or who direct the performance of security duties as specified in § 26.4(a)(5).
The timely reporting of information to the NRC is necessary to enable prompt regulatory action, if needed. Operating experience demonstrates that 24-hour notification of FFD policy violations for supervisors directing work activity that is not safety- or security-significant is unnecessary. These violations would continue to be captured in the existing annual FFD program performance reporting requirements under §§ 26.717, “Fitness-for-duty program performance data,” and 26.417(b)(2), which ensure that the NRC receives uniform and robust information on all FFD program violations. This risk-informed change would reduce unnecessary burden on licensees, other entities, and the NRC.
The proposed rule would apply the same behavioral observation program (BOP) requirement to SAEs that already applies to MROs and MRO staff under § 26.31(b)(1)(v). The change would make SAEs subject to BOP when onsite at a licensee or other entity's facility, removing the current distinction between MROs and MRO staff, who are subject to BOP when onsite, and SAEs, who are currently subject to BOP both onsite and offsite when they are providing services to an FFD program. SAE and MRO functions are typically, although not always, performed by the same medical professional. Under the current requirements, if a medical professional is both an MRO and an SAE for the same FFD program, that professional is not subject to BOP when performing services for the licensee from an offsite location. However, if that same professional only provided SAE services to a licensee, they would be subject to BOP at whatever location they provided services to that licensee's FFD program. This BOP distinction between MROs and SAEs poses an unnecessary burden on licensees and other entities that choose to use medical professionals that only provide SAE services. SAEs also typically provide services to FFD programs from locations other than a licensee's or other entity's facility, communicating with individuals by telephone or by video teleconference methods. Therefore, this change would reduce unnecessary regulatory burden on licensees and other entities that rely on SAEs that do not also provide services as MROs.
A shy-bladder evaluation is required under current § 26.119, “Determining `shy' bladder,” if a donor is unable to provide a urine specimen of adequate quantity for drug testing within the 3 hours permitted for a urine collection. A shy-bladder evaluation must be completed within 5 business days of the unsuccessful attempt and performed by a licensed physician that is acceptable to the MRO and has expertise in the medical issues raised by the donor's inability to provide a specimen for testing. The proposed rule would revise § 26.119(a) to extend the deadline to complete a shy-bladder evaluation from 5 business days to 10 business days if a justification acceptable to the MRO is provided by the donor.
The purpose of a timely evaluation is to determine if a medical condition precluded the donor from providing a urine specimen for testing (
The proposed rule would revise paragraph (1) of § 26.167(d), “Quality control requirements for performing initial drug tests,” in three ways. It would remove “of urine” from the phrase “any initial drug test of urine performed by an HHS-certified laboratory,” to clarify that the initial drug testing requirements apply to any specimen that is tested by an HHS-certified laboratory (
Under paragraph (a) of § 26.183, “Medical review officer,” an MRO must be a physician holding either a Doctor of Medicine or Doctor of Osteopathy degree who is licensed to practice medicine by any State or Territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. The proposed rule would revise § 26.183(a) to clarify that “an equivalent foreign degree” also would be acceptable. This clarification would ensure that physicians who have received their medical degrees from
The proposed rule would address inconsistencies in the requirements that apply to the review of dilute test results to clearly define the activities that must be performed by MROs and that may be performed by MRO staff.
As currently written in § 26.183(c), one of the responsibilities of the MRO is to review and interpret dilute test results, and § 26.185(g)(2) and (4) specify how the MRO is to conduct the reviews of those results. For MRO staff, § 26.183(d)(2)(ii) limits the review of dilute test results to performing administrative functions (
The proposed rule would make changes to § 26.183(c) and (c)(1), § 26.183(d)(2)(ii) through (iv), and § 26.185(b) by replacing “dilute” with “positive and dilute.” The proposed rule would also make the conforming change of adding the term “positive and dilute” to § 26.405(g). These changes would reduce unnecessary regulatory burden by addressing internal inconsistencies in the part 26 requirements regarding the review of dilute positive and dilute negative validity test results.
The proposed rule would enable licensees to more efficiently address the misuse of controlled substances by individuals by allowing licensees to more readily address instances wherein an individual illegally uses a prescription medication that has not been prescribed to them.
Currently, under § 26.185(j)(3), if the MRO determines that a donor has used another individual's prescription medication and no clinical evidence of drug abuse is found during the required clinical examination, the MRO must report that the donor misused a prescription. However, under the current framework, this is not considered a positive test result. The MRO is to report an FFD policy violation for a confirmed positive test result only when clinical evidence of abuse also exists.
Requiring the MRO to confirm a positive test result only if clinical evidence of drug abuse exists, even when the donor admits to using another individual's prescription medication and lacks a legitimate medical explanation, is inconsistent with the HHS Guidelines and DOT requirements. Specifically, under those programs, the MRO is to report a confirmed positive drug test result if a donor admits to unauthorized use of a drug or does not provide a legitimate medical explanation for the test result (
The use of another person's prescription medication is prohibited by Federal law and is described in the HHS “Medical Review Officer Manual for Federal Workplace Drug Testing Programs (effective February 1, 2024).” Specifically, the MRO Manual states that—
Under no circumstances can prescriptions be legally transferred from a different individual to a donor in the event the donor exhausts his or her own prescription medication, even if the other individual's medication is identical and prescribed for the same medical condition (Controlled Substances Act Revised 2010, Pharmacist's Manual, Section VIII—Dispensing Requirements—Required Information for Prescription Labels). Federal Food and Drug Administration regulations [found in 21 CFR 290.5] require that the label of any drug listed as a “controlled substance” in Schedules II, III, or IV of the [Controlled Substances Act] must, when dispensed to or for a patient, contain the following warning: “CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”
The proposed rule would eliminate the requirement in § 26.185(j)(3) to determine that clinical signs of abuse exist to report a positive test result as an FFD policy violation when a donor admits to using another individual's prescription medication. This proposed rule change would align with other Federal agency testing policies, would improve public health and safety and common defense and security by allowing licensees to more efficiently address known trustworthiness and reliability concerns, and would remove unnecessary regulatory burden, as a positive test result could be reported by an MRO after a discussion with the donor (
The proposed rule would add a State-licensed or -certified marriage and family therapist (MFT) to the list of credentials that would qualify individuals to serve as an SAE under § 26.187(b). This action would address the PRM docketed as PRM-26-4.
To be a State-licensed or -certified MFT requires a master's or doctoral degree, supervised clinical experience, and successful completion of the national examination conducted by the American Association for Marriage and Family Therapy Regulatory Board. Many programs accredited by the Commission on Accreditation of Marriage and Family Therapists have “substance abuse” knowledge as part of their core curriculum requirements in their graduate studies. Potential candidates can sit for the examination only after their credentials have been examined and found to meet the education and experience requirements for licensure or certification in their respective States. In 2006, the DOT added State-licensed or -certified MFTs to its list of credentialed professionals eligible to serve as substance abuse professionals under 49 CFR 40.281(a) (71 FR 49382; August 23, 2006).
Updating the § 26.187(b) SAE credential list to include State-licensed or -certified MFTs would be consistent with the approach taken by the NRC when it established the SAE requirements in the 2008 part 26 final rule. In the 2008 part 26 final rule, the NRC stated that it had adapted many of the SAE provisions from the DOT requirements regarding substance abuse professionals under 49 CFR part 40, subpart O.
This proposed change would reduce unnecessary regulatory burden by allowing licensees and other entities to consider additional qualified individuals who may be able to provide SAE services.
The proposed rule would address a PRM (PRM-26-7) that requested that the “Certified Addiction Specialist” (CAS) certification from the American Academy of Health Care Providers in the Addictive Disorders (the Academy) be added to the list of acceptable credentials to serve as an SAE under § 26.187(b)(5). In a supplement to its petition to the NRC dated August 3, 2011 (ML11256A020), the Academy stated that it was in the process of preparing a petition to request that the DOT add the CAS certification to the substance abuse professional credentials in 49 CFR 40.281(a). As of the issuance of this proposed rule, however, the CAS credential does not appear on the DOT's approved credentials list in 49 CFR 40.281(a), and the NRC has not received any additional information to support the Academy's petition. Furthermore, the NRC evaluated publicly available information regarding the CAS credentialling process and determined that, while the training and education requirements are similar to those in place for credentials currently accepted in accordance with NRC requirements, the Academy did not provide adequate information on the examination process associated with the CAS credential. Based on this evaluation, the NRC determined that there is insufficient information available to support adding the CAS certification to the list of acceptable credentials. The proposed rule, therefore, would not incorporate the CAS certification into § 26.187(b)(5).
The proposed rule would remove the prohibition on the use of electronic means to perform face-to-face for-cause determinations of fitness under § 26.189(c), because video technology has advanced significantly since the creation of the § 26.189(c) requirement in the 2008 part 26 final rule.
Video teleconference technology is already being used by some clinicians to complete other NRC-required evaluations, such as performing psychological assessments under the personnel access authorization requirements in § 73.56(e)(4) or determinations of fitness performed under § 26.189(b) when potentially disqualifying FFD information is discovered about individuals subject to part 26.
The proposed rule would specify that if video teleconference technology is used by a professional to conduct a face-to-face determination of fitness for a for-cause drug and alcohol testing determination under § 26.31(c)(2) or a fatigue assessment performed for cause under § 26.211(a)(1), then the determination must be supported by an individual that is in the room with the person being evaluated. A supporting person would be necessary in these circumstances to ensure that the professional performing the determination of fitness is provided with contemporaneous information that can only be obtained in the location where the person is being assessed (
Eliminating the prohibition on the use of electronic communications to perform face-to-face determinations of fitness would reduce unnecessary regulatory burden and could improve the speed at which these determinations are made.
The proposed rule would make a conforming change to terminology used in § 26.405(c)(3) that applies to FFD programs implemented under subpart K of part 26. Specifically, the proposed rule would replace “post-accident” with “post-event” and “accident” with “event.” The term “post-event” is used in FFD program requirements under subpart M of part 26. The term “post-event” is also used in NRC Forms 890, “Single Positive Test Form,” and 891, “Annual Reporting Form for Drug and Alcohol Tests,” which licensees and other entities have used to submit FFD program performance data to the NRC under § 26.417(b)(2).
The proposed rule would clarify the provisions of § 26.419, “Suitability and fitness evaluations,” for individuals who direct the construction of safety- or security-related SSCs in subpart K FFD programs to ensure that licensees are able to assign duties to those individuals in accordance with FFD program requirements.
Section 26.4(f) requires that individuals constructing or directing the construction of safety- or security-related SSCs be subject to a subpart K FFD program (or an FFD program that meets all the requirements of part 26, except for subparts I, K, and M). Furthermore, in the 2008 part 26 final rule, the Commission stated that § 26.419 “requires licensees and other entities who implement FFD programs under subpart K to develop, implement, and maintain procedures for evaluating whether to assign individuals to the duties specified in § 26.4(f).” However, the rule text of § 26.419 only includes provisions for assigning duties to “individuals to construct safety- and security-related SSCs,” but does not currently include such provisions for the individuals directing those activities. As such, the NRC is proposing to include in § 26.419 individuals directing the construction of safety- or security-related SSCs to provide clarity and maintain consistency with § 26.4(f) and the intent of the 2008 part 26 final rule.
The proposed rule would make a conforming change to the terminology used in § 26.401(b), revising the term “entities” to “licensees and other entities.” This administrative revision would provide consistency in the use of the terminology across part 26, subpart K.
The NRC is proposing to add a new exception from the work hour controls in § 26.205(c) and (d) during sequestration events as an alternative to licensees needing to grant waivers. This new exception in § 26.207(e) would address sequestration events during which licensee personnel remain on-site at the facility due to unavoidable external conditions (
Under the proposed rule, during such events, licensees would be able to implement alternative fatigue management controls for up to 60 days, consistent with those authorized by the NRC during the COVID-19 public health emergency (
The NRC is proposing to eliminate the requirement in § 26.203(e) and § 26.717(b)(9) for licensees to provide annual reports of waivers and fatigue management program information to the NRC. In addition, the NRC is also proposing to eliminate the same requirement for subpart M FFD programs in § 26.202(e). Annually, the FFD performance reports have included limited instances when waivers to the work hour controls were issued, with the trends decreasing in the years since the requirements were first implemented in 2009, demonstrating the successful implementation of the work hour controls to mitigate fatigue. While no longer submitted in an annual report, the associated records would continue to be maintained by licensees in accordance with § 26.203(d) and would be available for NRC inspection or review as needed. The elimination of the reports would reduce burden on licensees and would also save NRC resources associated with the receipt and maintenance of these records.
The NRC is proposing changes to §§ 26.207(a)(1)(ii) and 26.211(b) to allow additional licensees to use electronic communications to perform face-to-face assessments to support the approval of work hour control waivers and to conduct fatigue assessments. Under the current provisions, only licensees and other entities under 10 CFR part 53, as specified in § 26.3(f), can use electronic communications for these purposes. The proposed changes would expand the option of using electronic communications to other types of NRC licensees specified in § 26.3(a), (c), and (d). The provisions would continue to indicate that supervisors may conduct such assessments from a remote location under appropriate circumstances, and that such remotely conducted assessments 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 and 26.203(c), or §§ 26.608 and 26.202(c).
The reasoning for these changes and the associated need for in-person support to augment electronic communications is addressed further in the discussion of the proposed changes to § 26.189(c) in Section IV.A.(i)(u) of this document.
The proposed rule would add two new definitions, revise five definitions, and remove four definitions in § 26.5. The additions, revisions, and removals would improve the clarity, consistency, and accuracy of the requirements under part 26. Specifically, this proposed rule would add definitions for “Escort” and “Sequestration event.” In conjunction with another proposed rule change to remove subpart F, “Licensee Testing Facilities,” this proposed rule would revise definitions for “Analytical run,” “Cancelled test,” “Cutoff level,” “Positive result,” and “Rejected for testing”; and remove definitions for “Licensee testing facility,” “Questionable validity,” “Validity screening test,” and “Validity screening test lot.”
A definition for “Escort” would be added, defining the term to mean a person who is designated by the licensee or other entity to be responsible for directly observing an individual who has been assigned to perform duties and responsibilities or maintain the type of access described in § 26.4(f) but is not subject to the requirements in part 26.
A definition for “Sequestration event” would be added, defining the term to mean a situation in which personnel remain on-site at a nuclear power reactor due to unavoidable external conditions that pose a risk to the safe, secure, and continuous operation of the facility.
An ISFSI is a complex designed for the safe storage of power reactor spent nuclear fuel and certain other radioactive materials. These installations use robust storage systems, such as dry casks, that securely contain and shield the radioactive material until it can be disposed of in the future, allowing licensees to store this material safely on site or at standalone storage locations. The security risk profile of an ISFSI is reduced from that of an operating nuclear power reactor due to the absence of a fueled reactor and the placement of all spent fuel into these robust storage systems. This configuration eliminates reactor-related target sets and significantly lowers the potential consequences of radiological sabotage.
There are two main types of ISFSIs regulated by the NRC: general license ISFSIs and specific license ISFSIs. A general license ISFSI is operated by a nuclear power plant licensee under a general license provided in NRC regulations. Section 72.210, “General license issued,” states that a general license for an ISFSI is issued to persons authorized to possess or operate nuclear power reactors under 10 CFR part 50, part 52, or part 53. A nuclear power plant licensee does not need to apply for a separate, stand-alone license for the ISFSI. In contrast, a specific license ISFSI is authorized through a separate, detailed licensing process that is independent from the nuclear power reactor license. Although both types of ISFSIs must meet NRC safety and security standards, there are differences in the licensing approach and in some of the security requirements that currently apply to each type.
The proposed requirements for ISFSI security would enhance consistency and regulatory clarity between general and specific license ISFSIs. Licensees operating general license ISFSIs that are not collocated with an operating reactor would have the option to provide physical protection under the same requirements that apply to specific license ISFSIs. These changes would provide consistency for similarly situated ISFSIs, while reducing the burden of submitting exemption and alternative measure requests.
Additionally, this proposed rule would extend the time associated with submitting ISFSI security plan changes to the NRC. The frequency required for the submission of security plan changes would be modified to reduce the licensee burden that is associated with security plan revisions.
The proposed rule would include changes addressing security requirements for ISFSIs located either outside the protected area (PA) of an operating reactor or within the PA of a decommissioning reactor for which all
Some ISFSIs are located within the same PA as an operating reactor. Other ISFSIs are located in a separate PA because either the reactor with which an ISFSI was originally collocated has gone into decommissioning or the ISFSI was constructed with a separate PA. The proposed changes to parts 72 and 73 of the NRC's regulations would allow licensees with ISFSIs in this latter category the option to implement security requirements that are designed specifically for ISFSIs. With regards to ISFSIs adjacent to decommissioning reactors, the proposed changes are consistent with those in SECY-24-0011, “Final Rule: Regulatory Improvements for Production and Utilization Facilities Transitioning to Decommissioning,” dated January 31, 2024, which is currently being considered by the Commission.
This proposed rule would revise § 72.212(b)(9) to allow general license ISFSIs the option to develop and implement their physical protection programs in accordance with § 73.51, “Requirements for the physical protection of stored spent nuclear fuel and high-level radioactive waste,” instead of § 73.55, “Requirements for physical protection of licensed activities in nuclear power reactors against radiological sabotage.” This change would align the physical protection requirements of general license ISFSIs and specific license ISFSIs for separate protected areas constructed outside the PA of an existing operating reactor, or during decommissioning, once all spent fuel at the site has been placed in dry storage. This change would be appropriate because the security requirements in § 73.51 are designed for and provide security appropriate to the reduced risk level of ISFSIs as compared to nuclear power plants, which are subject to § 73.55. This change would reduce the regulatory burden on current and future licensees by offering the increased flexibility provided under § 73.51. In particular, licensees that choose to transition to § 73.51 would no longer be required to implement protection measures against the design basis threat nor comply with the associated requirements outlined in § 73.55.
The proposed rule also includes conforming changes to §§ 72.13, “Applicability,” and 73.51 to clarify the applicability of the security requirements that are found in part 72, subpart H, “Physical Protection,” to general license ISFSIs. Currently, these licensees need to submit alternative measures or exemption requests from certain § 73.55 requirements to allow for the implementation of security requirements that are consistent with the risk profile for their facilities. The proposed change would eliminate the need to submit alternative measures or exemption requests. Licensees that elect to implement the new proposed regulatory requirements would provide a revised security plan through the process described in paragraph (p)(2) of § 50.54, “Conditions of licenses.”
ISFSIs that are within an operating reactor PA would still be required to implement § 73.55, consistent with the physical protection program for the reactor, with the specific exceptions in § 72.212(b)(9). Additionally, licensee physical protection programs would be required to continue to address the terms of any applicable security-related orders associated with either a general or specific license ISFSI.
The proposed rule would extend the time associated with the requirement to submit ISFSI security plan changes to the NRC under paragraph (e) of § 72.44, “License conditions,” and paragraph (b) of § 72.186, “Change to physical security and safeguards contingency plans.” Instead of submitting to the Commission a report containing a description of each change within two months after the change is made, licensees would have to submit the report within 12 months after the change is made. This revision would reduce the licensee burden that is associated with security plan revisions. The extension would also maintain safety and security because it would be limited to reports of changes that would not decrease the effectiveness of the plans.
Under this proposed rule, the security regulations for the physical protection of plants and materials under 10 CFR part 73, along with their associated guidance documents, would be revised to reduce unnecessary burdens and respond to credible risks—as directed in E.O. 14300, section 5(g)—to support efficiencies in licensing and oversight. Where possible, prescriptive requirements would be replaced with more performance-based requirements to streamline, clarify, and modernize the current regulations, thus increasing flexibility for current and future licensees and facilitating the increased deployment of new civilian nuclear reactor technologies, consistent with section 2(b) of E.O. 14300.
This proposal covers updates across various elements of part 73, including physical protection, security training, access authorization, and cybersecurity for power reactors; transmittal of safeguards information (SGI); special nuclear material security; records; and definitions. This proposal also incorporates changes to part 73 intended to address industry concerns from the 2023 Enhanced Weapons final rule, the consideration of law enforcement support to licensee security programs, and certain aspects of the draft final decommissioning rule in SECY-24-0011.
The proposed changes to § 73.55, as well as appendices B, “General Criteria for Security Personnel,” and C, “Licensee Safeguards Contingency Plans,” to part 73, would support the agency's mission to enable the safe and secure use and deployment of civilian nuclear energy technologies and would reduce unnecessary burden on current and future licensees.
This proposed rule would provide licensees with increased flexibility in implementing their physical protection programs by incorporating performance-based requirements and, where appropriate, allowing for specific alternatives. The proposed alternatives would most likely be available to non-light water reactor designs that incorporate security by design and engineered safety or security features.
For the existing light-water reactor fleet, the proposed revision of the security requirements would eliminate certain prescriptive requirements that are more appropriately addressed in regulatory guidance and in some instances are no longer necessary for the implementation of the physical protection program.
This proposed rule would establish a revised performance objective that applies a risk-informed approach that would continue to provide reasonable assurance that activities involving special nuclear material are not inimical to the common defense and security, and do not pose an unreasonable risk to public health and safety.
Existing licensees that are in compliance with § 73.55 as of the effective date of publication of the final rule, if this proposed change is made effective in a final rule, would also be in compliance with the proposed revisions to the regulations and would not be required to modify their current physical protection programs. However, existing licensees would be able to voluntarily adopt the proposed
This proposal builds on previous efforts to risk-inform physical security regulations by shifting from prescriptive to performance-based requirements to allow for the use of technology-neutral alternatives (
The proposed amendments would revise § 73.55 and appendices B and C to 10 CFR part 73 to enhance requirements for physical protection, power reactor security training, and contingency response. Specifically, the proposed revisions should provide increased flexibility in the implementation of security, training, and response measures. This would be accomplished by modifying the performance objective, the use of performance-based requirements, and the use of voluntary alternatives that allow for the use of technology and engineered design features.
The proposed requirements would adopt technology-inclusive approaches to provide the necessary regulatory flexibility for licensing and regulating multiple categories of nuclear reactor technologies and designs. A technology-inclusive approach to security requirements would provide greater flexibility in both the design and implementation of physical protection programs. Licensees and applicants using this approach could integrate security considerations into the safety design process, enabling the effective implementation of security measures through the use of both design-based and engineered security features. This approach could enable safety and security functions to work collaboratively in the implementation of the physical protection program. Additionally, the proposed technology-inclusive approach would allow for the increased use of technology by licensees to implement security measures for the protection of a facility, providing greater operational flexibility.
The general performance objectives throughout part 73 would be revised to reflect the Commission's decision on the concept of “high assurance” as it relates to licensee physical protection programs. In SRM-SECY-16-0073, “Staff Requirements—SECY-16-0073—Options and Recommendations for the Force-on-Force Inspection Program in Response to SRM-SECY-14-0088,” dated October 5, 2016, the Commission determined that the concept of “high assurance” in security regulations is functionally equivalent to “reasonable assurance” used in safety contexts and that security regulations should not be applied using a “zero risk” mentality. Therefore, the proposed rule would revise the regulations in §§ 73.20(a), 73.22(f)(3), 73.51(b)(1), 73.54(a), 73.55(b)(1), and 73.56(c) to use the term “reasonable assurance” in place of “high assurance.”
The performance objective in § 73.55(b)(3) would be revised from specifically protecting against significant core damage and spent fuel sabotage to a broader goal of preventing a release of radionuclides from any source that exceeds the dose reference values defined in § 50.34(a)(1)(ii)(D)(
This proposed rule would introduce a revised set of requirements in § 73.55(f), “Target sets,” that adopts a risk-informed, technology-inclusive, and graded approach through the identification of achievable target sets. Licensees that voluntarily elect to implement the revised performance objective would need to perform an analysis to identify the necessary plant equipment, operator actions, mitigative measures, detection capabilities, assessment processes, and armed response needed to identify the achievable target sets for the site's physical protection program, which must be designed to prevent a radionuclide release from exceeding the dose reference values specified in § 50.34(a)(1)(ii)(D)(
Achievable target sets would be identified through a site-specific analysis. Achievable target sets would include those that are within the capabilities of the design basis threat adversary to compromise, destroy, or render non-functional; cannot be mitigated after adversary interference is precluded and prior to a release of radionuclides exceeding the dose reference values defined in in § 50.34(a)(1)(ii)(D)(
Under this framework, licensees would determine the applicability of § 73.55 as follows:
• If a licensee could demonstrate that no achievable target sets exist, and would not credit any active measures (
• If a licensee could demonstrate that no achievable target sets exist, and would credit active measures in making that demonstration, then the licensee would be required to implement the applicable requirements of § 73.55 through its physical security plan, training and qualification plan, safeguards contingency plan, and cybersecurity plan. Licensees that would rely on active measures could limit the scope of their physical protection program by ensuring that the credited active measures will be implemented when needed in response to threats.
• If a licensee could demonstrate that achievable target sets exist, then the licensee would be required to implement the requirements of § 73.55 through its physical security plan,
The current physical security requirements use a combination of performance criteria (
Prescriptive physical barrier requirements in current § 73.55(e) would be revised to remove the details concerning the specific considerations and criteria for each barrier, including isolation zones. Isolation zones have been removed from the requirements to provide greater flexibility for licensee programs implementing detection measures. In certain conditions, these clear areas are not necessary to meet detection and assessment requirements due to site-specific configurations. Additionally, advancements in detection and assessment technologies have significantly reduced, or eliminated, the need for clear areas to identify unauthorized access into protected areas. The proposed rule would continue to require licensees to detect attempted or actual penetrations using detection and assessment equipment capable of meeting the performance objectives outlined in 10 CFR 73.55(b).
These specifics would be retained in guidance as voluntary considerations for licensee physical protection programs. Licensees would still be required by proposed § 73.55(e)(1) to ensure that physical barriers are sufficient to meet the performance criteria (
Access control measures in current § 73.55(g) would be revised to remove the prescriptive requirements regarding access to different areas of a facility. These specifics would be retained in guidance as voluntary considerations for licensee physical protection programs. Licensees would still be required by proposed § 73.55(g)(1) to ensure that their access control measures meet the performance criteria (
The specific methods for how vehicles, materials, and personnel are searched in current § 73.55(h) would be revised with performance criteria applicable to searches conducted in various areas (
Prescriptive detection and assessment requirements in current § 73.55(i) would be revised to allow licensees the flexibility to use technology for surveillance and illumination to meet the performance criteria to detect and assess at all times. Advanced technology systems provide flexible capabilities to licensees offering superior detection range, accuracy, and reliability compared to human observation under 0.2 foot-candle illumination. Replacing a prescriptive lighting level with a technology-based detection strategy aligns with the performance-based approach. Because modern technologies provide detection and assessment capabilities that meet or exceed those enabled by the historical lighting and surveillance requirements, the overall security posture would continue to satisfy the standard of reasonable assurance of adequate protection against radiological sabotage. This proposed change would support the effective implementation of the licensee's protective strategy by allowing site-specific applications that align with the licensee's facility layout and operational needs.
Current requirements in § 73.55(k) identify the minimum number of ten armed responders to implement a site's protective strategy to meet the performance objective to protect against the design basis threat of radiological sabotage. The proposed rule would remove this prescriptive number, allowing licensees flexibility to determine the minimum number of armed responders necessary to implement the site protective strategy and respond to the design basis threat of radiological sabotage. The proposed requirements would continue to allow licensees to use armed responders and armed security officers to form an armed response team to meet response requirements. The proposed rule would add an alternative in § 73.55(k)(5) for current and future licensees that voluntarily elect to rely partially or solely on law enforcement or other offsite armed response personnel to meet the response requirements for their facilities. Licensees that rely solely on law enforcement or offsite armed responders would be required to obtain prior Commission approval before using these entities to meet the site response requirements.
The NRC proposes to remove § 73.58, “Safety/security interface requirements for nuclear power reactors,” from part 73 to streamline requirements and to eliminate rule text that provides a level of detail more appropriate for guidance. A performance-based requirement for safety/security interface would be added to § 73.55(l)(1). The proposed safety/security interface requirement would require licensees to evaluate and manage changes to safety and security activities to prevent or mitigate potential adverse effects that could impact plant safety or security at power reactors.
The current requirements in § 73.55(l) regarding physical protection for reactor facilities using mixed-oxide (MOX) fuel would be removed. These provisions have never been applied to any applicant or licensee.
The prescriptive requirements for conducting a security program review at a periodicity of every 24 months in
The proposed rule would revise § 73.55 to be more technology-inclusive. Designed-in features, structures, systems, and components, as well as engineered and administrative controls, could be used to provide flexibility in implementing an acceptable physical protection program for different reactor designs.
In several areas of the proposed requirements, licensees would be provided with voluntary alternatives to existing regulations to achieve the required performance objectives. These alternatives would be technology neutral (
Licensees that retain their current physical protection program would be able to elect to change their security plans and implementing procedures to reference the new proposed regulatory requirements through the § 50.54(p) process.
The NRC proposes to revise the general criteria for security personnel in 10 CFR part 73, appendix B, to address the minimum age for employment, for the use of a qualified training instructor for the attestation of training documentation, and to provide flexibility for the use of a nationally recognized course of fire for all weapons identified in this appendix. For the security training that is outlined in appendix B, sections I through VI, the majority of prescriptive requirements would be removed. The requirements for suitability would be streamlined for all security personnel that are identified in appendix B to part 73. Also, the NRC proposes changes to the training for power reactor licensees in the implementation of licensee Performance Evaluation Programs. The proposed rule would reduce the required frequency of tactical response drills from four per year to two per year. In addition, the requirement for each member of each shift to participate in one force-on-force exercise annually would be modified to once every three years. The proposed modifications to the performance evaluation program reflect that licensees have mature, established training programs that have consistently demonstrated that licensee security forces maintain the knowledge, skills, and abilities for effective contingency response. Tactical response drills would continue to be based on target set scenarios and would provide a practical demonstration of defense against specific design basis threat attributes. The proposed adjustment to the frequency of participation in the licensee's full-scale force-on-force exercises recognizes that full-scale exercises are the most resource intensive to conduct. While valuable, this activity is only one component of a comprehensive performance evaluation program. This proposed change recognizes that the broader performance evaluation program is sufficiently robust without relying on annual force-on-force participation. On an annual basis, licensees would conduct at least one fully integrated force-on-force exercise to test the protective strategy as a whole. The licensee's performance evaluation program would continue to ensure that any degradation in security force member performance and potential protective strategy deficiencies would be identified and corrected through the corrective action program. Additionally, several prescriptive training requirements would be removed from appendix B to part 73 (
The removal of the prescriptive security equipment lists from appendix B to part 73 would allow licensees to select equipment that best meets their operational needs and integrate new technologies as appropriate. The removal would reduce the need for exemptions or license amendments.
The proposed rule would remove the prescriptive requirements for 40 hours of on-the-job training, and would instead use a performance-based approach that allows a licensee to determine the appropriate number of on-the-job training hours. Modern training methodologies, job-specific competencies, and improved
The changes proposed in appendix C to part 73 would remove the prescriptive periodicity associated with the review of safeguards contingency plans to provide licensee flexibility in these types of reviews.
The proposed rule would expand the regulatory options for physical security for new applicants under parts 50 and 52. Specifically, applicants would be able to select the most appropriate physical security rule for their design and approach for licensing by complying with either § 73.55 or § 73.100, “Technology-inclusive requirements for physical protection of licensed activities at advanced nuclear plants against radiological sabotage,” which was developed for reactors licensed under part 53. The distinctions between § 73.55 and § 73.100 largely reflect the fact that the existing reactor fleet was built without accounting for security during the initial design phase. The proposed revisions to § 73.55 in this rule would address the current configuration of the operating fleet and, similar to § 73.100, provide increased flexibility to accommodate the wide range of current and future reactor technologies. Currently, applicants under part 53 have the option of complying with either § 73.55 or § 73.100 for physical security. Extending this flexibility to applicants under parts 50 and 52 would ensure that future applicants have appropriate physical security options for licensing when designing their physical protection programs under part 50, 52, or 53. This proposal would include revisions to §§ 50.34, 52.79, and 73.100 to reflect this expanded regulatory flexibility for future applicants.
The NRC is proposing revisions to its access authorization requirements under §§ 73.55 and 73.56 to promote program efficiency by providing appropriate flexibilities to licensees and reducing unnecessary program burdens, while maintaining safety and security. The proposed revisions would also provide additional relief from requirements for those licensees and applicants who demonstrate that no achievable target sets exist in accordance with proposed § 73.55(f).
The proposed rule includes a risk-informed change that would extend the implementation milestone for when a licensee or other entity must transition from its construction-phase security measures (employed through appropriate site procedures for the control of personnel, access controls, and pre-employment screening during the construction phase) to an operational access authorization program that meets all of the applicable requirements of § 73.56.
Under the existing regulations, § 73.56(a)(3) requires licensees to implement the requirements of § 73.56 before fuel is allowed onsite (in the protected area). The proposed rule would change the milestone for implementation of an access authorization program from before fuel is allowed onsite (
This proposed milestone change is based on recent operating experience from implementing phased subpart K FFD programs and pre-employment screening at power reactor construction sites. Specifically, the NRC issued an exemption to the licensee for Vogtle Electric Generating Plant, Units 3 and 4, to delay implementing the access authorization program requirements of § 73.56 until initial fuel load (86 FR 67734; November 29, 2021). The NRC has reassessed the risks presented during the construction of nuclear power reactors and has determined that the currently established milestone for transition to an operations-phase access authorization program is not commensurate with current risk insights. The risk associated with unirradiated fuel does not increase when the fuel arrives onsite, because its engineered safety features, storage, and configuration have not changed since the fuel was in transit. (For transit and receipt onsite, physical protection requirements under § 73.67 are applied to protect the fuel.) Safety and security risks associated with unirradiated nuclear fuel only begin to increase once the process of loading the fuel into its operating configuration begins. The operational milestone “before initial fuel load into the reactor” therefore corresponds more closely to the start of NRC-licensed activities that could result in consequences adverse to public health and safety or the common defense and security than does the current milestone of receipt of nuclear fuel onsite.
The proposed changes to access authorization program requirements would revise and/or eliminate program elements that have been identified as being unnecessarily costly or burdensome and not adding commensurate value to site safety or security. Requirements in § 73.56 would be revised to reflect insights gained from operating experience in the years since the requirements were last revised in the Power Reactor Security Requirements final rule in 2009 (74 FR 13970; March 27, 2009). These changes would promote efficiency and effectiveness for commercial nuclear power plant licensees and applicants, while adequately maintaining safety and security.
Proposed revisions to § 73.56(d)(3) would remove prescriptive requirements for the verification of true identity. Some approved methods for verifying true identity (
Proposed revisions to § 73.56(i)(1)(v) would remove the requirement to perform a credit history re-evaluation as part of the process for determining the continued trustworthiness and reliability of individuals. Operating experience has shown that, although conducting a credit history evaluation at the time that unescorted access is initially authorized is important towards making an initial determination
The proposed rule would adjust the requirements in § 73.56(i)(1)(iv) regarding supervisory review for personnel who are maintaining unescorted access. As proposed by the NRC, if an individual's supervisor were to interact with that individual with a frequency that allows the supervisor to form an informed and reasonable opinion regarding the individual's behavior, trustworthiness, and reliability, then the supervisor would not be required to conduct an annual supervisory review. Otherwise, the individual would be subject to an annual (within 365 calendar days) supervisory review conducted in accordance with the requirements of the licensee's or applicant's behavioral observation program. This proposed adjustment would reduce the unnecessary redundancy of annual reviews for cases where an individual is already subject to regular review by their supervisor, while still ensuring that individuals would undergo supervisor review in instances where contact is less frequent, ensuring that the objectives of the behavior observation program would be met.
The proposed rule would modernize program requirements by adjusting the frequency of certain requirements (
The FBI Rap Back service is a subscription-based program that provides continuous, automated notifications of new criminal activity associated with individuals who have undergone a fingerprint-based background check. Enrolling in such a service can substantially reduce the need for a licensee to rely on repeated background checks to ensure the continued trustworthiness and reliability of personnel. The proposed rule would reflect these benefits by reducing the frequency of required checks for those licensees enrolled in such a program. This change would help enable licensees to modernize their programs and reduce unnecessary burden, while ensuring that security is adequately maintained through the use of appropriate alternative processes.
The proposed rule would reduce the frequency of audits required under § 73.56(n), “Audits and corrective action,” by extending audit intervals from 12 months to 24 months for contractors or vendors, and from 24 months to 36 months for licensee and applicant programs. The proposed audit interval for contractors or vendors would be shorter than the interval for licensee and applicant programs because contractor and vendor activities operate outside licensees' routine processes and are less easily observable by licensees. The proposed rule would also reduce the records retention period in § 73.56(o)(2) from 5 years to 3 years. These proposed changes would reduce costs and administrative burdens while enhancing overall efficiency. With these changes, there would still be reasonable assurance that security will continue to be adequately maintained because licensees would still be required to periodically review the effectiveness of their programs, and the NRC would maintain the ability to effectively oversee program effectiveness through its inspection and oversight of licensee performance.
The proposed rule would provide relief from certain human reliability requirements for licensees and applicants who could demonstrate no achievable target sets exist in accordance with proposed § 73.55(f) and who would not credit any active measures (
Under the requirements of § 73.120, eligible licensee facilities would be relieved from the requirements to perform psychological assessments and reassessments in § 73.56(e), “Psychological assessment,” and to establish a full training program for behavioral observation (
The proposed changes to § 73.46 would reduce burden on current and future licensees. The proposed changes for facilities licensed to possess or use a Category I quantity of SNM are in the areas of security training, specifically for drills, exercises, and physical fitness requirements. The proposed rule would reduce the required frequency of security training exercises from four to a maximum of three per year. On an annual basis, the licensee would need to ensure that each shift participates in at least two tactical response drills, one of which would test the security response using the response force and a mock adversary team. Additionally, the licensee would need to conduct at least one force-on-force exercise annually and ensure that each shift that implements the safeguards contingency plan protective strategy participates in one force-on-force exercise every three years. Licensees would continue to ensure the effectiveness of their security programs, as security officers would maintain the knowledge, skills, and abilities necessary for contingency response activities through annual recurring training.
The proposed changes for security drills and exercises captured in 10 CFR 73.46(b)(9) and the physical fitness test captured in 10 CFR 73.46(b)(10) would be revised to align with the approach taken for power reactors. These changes are being proposed to decrease the burden in the implementation of licensee security training programs and to allow for increased flexibility, while maintaining safety and security.
These revisions would streamline the current requirements for security drills, exercises, and the physical fitness test to eliminate certain prescriptive
The NRC proposes to modify § 73.67(d) for physical protection for fixed site facilities for SNM of moderate strategic significance. This proposal would build on previous efforts to risk-inform physical security regulations by shifting from prescriptive to performance-based requirements that would increase flexibility for current and future licensees; reduce unnecessary burden on licensees; and, where appropriate, allow for alternatives. The proposed changes to § 73.67 would support the agency's mission to enable the deployment of nuclear energy technologies (
This proposed rulemaking for Category II quantities of SNM would address regulatory gaps and create a standardized approach for physical security. This would provide a consistent set of requirements for new applicants that use this type of SNM. Additionally, these changes would support efficiencies in the NRC's licensing and oversight programs.
The existing security requirements for possession and use of Category II quantities of SNM were originally established in 1979. Since that time, the NRC and other governmental agencies completed several studies to evaluate the risk and consequences associated with the physical protection of SNM. These studies were performed following the terrorist events of September 11, 2001, in part to evaluate and address changes in the threat environment. These studies and changes in the threat environment identified new vulnerabilities and risks that were not addressed by the then-existing regulations.
Subsequently, the NRC issued orders containing additional security measures to fuel cycle facilities licensed to possess Categories I and III quantities of SNM. At the time these orders were issued, the only facilities licensed to possess a Category II quantity of SNM were non-power reactors. To address the threat at these non-power reactor facilities, in 2002 and 2003, the NRC issued confirmatory action letters documenting the implementation of compensatory measures. However, additional security measures specific to a Category II quantity of SNM were not developed.
The NRC proposes to modify requirements in § 73.67 for Category II quantities of SNM to be largely performance-based, only retaining the prescriptive requirements that would be expected for all licensees subject to the requirements of § 73.67(d). The proposed rule would allow greater flexibility for both material and potential reactor licensees who would utilize these requirements for physical protection. This would permit licensees to adjust their security to better correspond to what is needed to ensure adequate physical protection.
The performance objectives in § 73.67(d)(1)(ii) and (iii) would require licensees to provide prompt detection for Category II quantities of SNM, instead of the early detection standard used in § 73.67(a)(2)(i) and (ii). Additional measures contained in § 73.67(d)(1) would provide requirements to store material in a controlled access area, mitigate and delay the bulk theft of special nuclear material, analyze and identify site-specific conditions that affect the protective strategy, provide defense in depth, coordinate the physical security plan with other onsite plans to avoid conflicts, and manage the potential for adverse effects on safety, security, and material control. These proposed changes would allow licensees possessing Category II quantities of SNM at a fixed site to implement protective strategies that are commensurate to the attractiveness of the material.
Proposed § 73.67(d)(2) would include performance requirements for the physical protection capabilities of detection, assessment, response, communication, and access authorization. Proposed § 73.67(d)(2)(xiii) would add requirements for compensatory measures. This addition would specify performance objectives for compensatory actions that should be taken when an item relied on for security is in a degraded condition. This addition would ensure the effectiveness of the physical protection system under abnormal operating conditions such as inclement weather and equipment malfunctions.
The NRC proposes to remove the current § 73.67(d)(3) and replace it with a new proposed § 73.67(d)(3). The proposed replacement § 73.67(d)(3) would allow the Commission to adjust physical security requirements—either adding or removing measures—based on the specific risk posed by the individual facility and site conditions to ensure adequate protection. The NRC is issuing draft Regulatory Guide (DG)-5088, “Physical Protection of Special Nuclear Material of Moderate or Low Strategic Significance,” proposed Revision 2 to RG 5.59, for public comment with this proposed rule to support implementation of the proposed requirements.
Proposed § 73.67(d)(4), “Alternative measures,” as revised, would provide a regulatory method for licensees who may wish to use different protective measures that are demonstrated to meet the performance objectives and requirements in § 73.67(a) and (b)(1).
Existing licensees that are in compliance with § 73.67 as of the effective date of the final rule, if this proposed change is made effective in a final rule, would be in compliance with the proposed revisions to the regulation and would not be required to modify their current physical protection programs. However, existing licensees would be able to voluntarily adopt certain performance-based alternatives, which would allow for greater flexibility in implementing the requirements of § 73.67.
Licensees that would elect to implement the proposed revised performance objective would be required by proposed § 73.67(d)(1)(vi), (viii), (ix), and (x) to perform an analysis to identify the necessary plant equipment, mitigative measures, detection capabilities, assessment processes, and response needed to ensure the site's physical protection program would be designed to prevent theft and diversion of SNM.
Alternatively, licensees that would elect to retain their existing physical protection programs to protect against theft and diversion of special nuclear material would be in compliance with the proposed performance objectives. All current licensees approved to possess a Category II quantity of SNM have approved security plans that include site-specific, performance-based security requirements that meet the proposed performance objectives, so an analysis of the proposed performance objectives would not be required. These licensees would continue to meet and implement the current requirements as relates to site-specific analysis for their physical protection program.
Licensees that would retain their current physical protection program
The proposed rule would address an identified regulatory gap in the security requirements in § 73.67 for the protection of Category II and Category III special nuclear material among power reactor license holders. Paragraphs 73.67(d) and (f) would be modified to include an exception for part 52 licensees who will use Category II quantities of SNM inside a protected area. This change would align with Commission direction in SRM-SECY-22-0052, “Staff Requirements—SECY-22-0052—Proposed Rule: Alignment of Licensing Processes and Lessons Learned from New Reactor Licensing (RIN 3150-AI66),” dated November 20, 2024, to make security requirements for Category II and Ill quantities of special nuclear material brought on site at nuclear power reactors for new and existing facilities licensed under part 50 consistent with those requirements for facilities licensed under part 52. Under the current regulations, a part 50 licensee is exempt from the regulations, but a part 52 licensee is not. By providing this exemption for part 52 licensees, the proposed rule eliminates the need for part 52 licensees to comply with both § 73.67 and the more stringent § 73.55 requirements when the material is located inside a protected area. The § 73.55 requirements are designed to protect irradiated fuel from sabotage events at nuclear power reactors. Given the relative risks of irradiated and unirradiated fuel, it is acceptable to protect unirradiated reactor fuel and other nonfuel SNM brought onsite at a nuclear power reactor in accordance with § 73.67 until that material is protected in accordance with § 73.55. The change in this proposed rulemaking would reduce unnecessary regulatory burden and provide consistency between parts 50 and 52 applicants by providing the same exception for part 52 licensees. This proposed change is discussed further in Section VIII, “Backfitting and Issue Finality,” in this document.
Sections 73.22 and 73.23 currently restrict licensees to transmitting SGI using NRC-approved technology and storage on standalone computers, transmitting SGI for voice communications using only technology approved by the NRC, and processing documents only on a standalone computer. Historically, the NRC has expected SGI to be treated more like classified information. These current regulations are very restrictive and not consistent with the threat environment, SGI's status as sensitive unclassified information, and the design basis threat's focus on threats posed by non-state actors.
The NRC is proposing to revise its regulations for the protection of SGI in §§ 73.22 and 73.23 to expand the means through which SGI can be transmitted for voice communications and to provide an option through which SGI can be viewed on networked computer systems. Sections 73.22(f)(3) and 73.23(f)(3) would be revised to allow an individual to transmit SGI for voice communications using commercially available digital technology that uses encryption algorithms that are compliant with or validated against an active and approved version of Federal Information Processing Standard (FIPS) 140. Additionally, the proposed rule would expand the ability to process SGI on computer systems. Currently, SGI may be stored on only standalone computers. The proposed rule would provide an option in § 73.22(g)(2) to store and process SGI on computer systems that permit viewing of the information on networked computers, using a virtual desktop or thin client architecture, provided that the systems storing the SGI would implement security controls that ensure the information is protected against unauthorized disclosure.
The proposed rule would expand the means through which SGI could be transmitted for voice communications. The proposed changes in § 73.22(f)(3) would enable licensees to communicate SGI by voice using encryption algorithms that have been approved by the National Institute of Standards and Technology (NIST), rather than also requiring that they be submitted to the NRC for review and approval. Draft guidance changes would discuss appropriate measures to protect against spills (
Current § 73.23(f)(3) requires that SGI be transmitted only by NRC-approved secure electronic devices, encrypted by a method (FIPS 140-2 or later) approved by the NRC. Under the proposed § 73.23(f)(3), SGI would be transmitted only using a commercially available encryption system compliant with an active, approved version of FIPS 140. This change would eliminate the requirement for entities to seek NRC approval prior to using an encryption system, as long as it meets the FIPS 140 standard.
The proposed rule would provide an option through which SGI could be viewed on networked computer systems. Processing SGI on standalone computers creates a significant burden, particularly for new reactor vendors incorporating security by design principles. Additionally, the cybersecurity field has matured significantly since the SGI regulations were last modified. The proposed changes in § 73.22(g)(2) would give licensees the option to use networked systems that would implement security controls specified by NIST as being appropriate for controlled unclassified information (NIST SP 800-171) using a thin client or virtual desktop architecture that would protect SGI from unauthorized disclosure and from being transmitted or stored on unapproved computers.
As discussed in Section IV.B.(i), “Security Requirements for ISFSIs Located Outside a Reactor's Protected Area,” of this document, this proposed rule would streamline and expedite the reduction of resources needed to implement the physical protection program as a site in decommissioning transitions from storing fuel in the spent fuel pool to dry storage. Those proposed changes are consistent with the draft amendments presented to the Commission in SECY-24-0011.
This proposed rule would revise part 73 definitions, physical security event notification requirements, and suspicious activity reporting requirements to resolve industry concerns and challenges from the 2023 Enhanced Weapons final rule (88 FR 15864; March 14, 2023).
The proposed amendments would modify requirements issued in the 2023 Enhanced Weapons final rule that posed concerns and challenges for industry to effectively and efficiently implement. Industry identified these concerns and challenges to the NRC and requested exemptions from these requirements (
Section 73.1200 would be revised in several locations to increase consistency between facility-based and transportation-based event notifications (
Sections 73.1205 and 73.1210 would be revised to correct unnecessary records retention requirements by replacing the phrase “whichever is later” (which implied an obligation after license termination) with “whichever is earlier.” Section 73.1205 would also be revised to remove the requirement for written follow-up reports subsequent to 15-minute and 8-hour event notifications to reduce industry burden. For events of high security significance requiring notification within 15 minutes (
The NRC would make conforming changes to NRC Form 366, “Licensee Event Reports,” to remove references to § 73.77, “Cybersecurity event notifications,” which would be revised by this rulemaking as discussed in Section IV.C.(x).
Section 73.1215 would be revised to use more generic language for suspicious activity reports to the FAA. Specifically, references to “aircraft” would be revised to “crewed/uncrewed aviation-related assets” and the term “local FAA control tower” would be revised to “applicable FAA facility.” The revised language would provide greater flexibility in implementing the reporting provisions and making these reports while meeting FAA operational (workload and airspace) considerations. The NRC proposes to add language on the elimination of duplication to address suspicious activity reports that would otherwise be required under both § 73.1215 and § 37.57, “Reporting of events” (
Section 73.70, “Records,” would be revised to add a conforming change to reflect the proposal in § 73.55(g)(6)(ii) to allow licensees to use a personnel identification system, rather than specifically requiring numbered badges. With this change, licensees would have an option for the method of compliance for logging individuals that have been issued identification to enter a protected area. This proposed change could also reduce the cost of providing access to individuals that have access to a protected area.
Under the current § 73.70, certain licensees are required to maintain records of the names, addresses, and badge numbers of all individuals authorized to have access to vital equipment or special nuclear material, and the vital areas and material access areas to which authorization is granted. This proposed change would require licensees who elect to use an alternative personnel identification system to retain the records for individuals enrolled in that system. By adding this option, power reactor licensees would have an option for complying that also reduces the cost of producing badges for personnel that have access to vital areas or special nuclear material.
Section 73.2 would be updated to reflect various regulatory changes in 10 CFR part 73 that affect multiple categories of licensees by revising the definitions of “Physical barrier,” and “Contraband.” A new definition for “Target set” would be added. As it relates to the relevant sections, these proposed changes would enhance clarity and promote consistency.
The definition for “Physical barrier” would be revised to allow for increased flexibility in licensee methods for meeting part 73 requirements. This change would reduce the need for licensees to submit licensing actions to modify their physical barriers in ways that depart from the current, prescriptive requirements. Instead, licensees could adopt a performance-based approach based on the function of the barrier in the physical protection program.
The definition of “Contraband” would be revised to remove reference to “disease causing agents” because the ability to identify these agents would exceed the reasonable capabilities of a licensee's physical protection program. With the removal of “disease causing agents,” the term “dangerous materials” would be redundant to the existing terms in the definition of contraband and therefore would also be removed. Separately, language in the definition of contraband regarding electronic devices would be removed. The existing requirements in 10 CFR part 95, “Facility Security Clearance and Safeguarding National Security Information and Restricted Data,” and 32 CFR part 117, “National Industrial Security Program Operating Manual (NISPOM),” are sufficient to protect classified information from unauthorized electronic devices, which pose an information security concern rather than a physical security concern.
A definition for “Target set” would be added in § 73.2. This term was previously defined in regulatory guidance, including RG 5.81, Revision 1, “Target Set Identification and Development for Nuclear Power Reactors,”
The existing regulatory framework for cybersecurity under § 73.54 is
The NRC is proposing to update RG 5.71 to reflect lessons learned from operating experience while ensuring that licensees continue to maintain reasonable assurance of safety and security. The proposed RG 5.71 updates would effectively result in reducing regulatory burden by, for example, focusing on safety and security over general cybersecurity hygiene—cutting approximately 19 percent of controls—and allowing licensees to take credit for cybersecurity best practices already in use (beyond those specified in RG 5.71).
The requirements for commercial nuclear power plant licensees to notify the NRC of certain cybersecurity-related events that adversely impact or could have impacted SSEP functions are defined in § 73.77, with supporting guidance in RG 5.83, “Cybersecurity Event Notifications.” To date, no licensee has made a notification under these provisions. In lieu of reporting incidents in accordance with the requirements of § 73.77, licensees have used the existing notification processes under §§ 50.72 and 50.73 (for safety-related events) and § 73.1200 (for security-related events). This proposal would simplify the regulation in § 73.77 by eliminating specific event notifications and instead redirect licensees to the aforementioned notification processes (
To support innovation and modernization of the existing cybersecurity regulatory framework, this proposed rule would expand the regulatory options for new applicants under parts 50 and 52. Specifically, applicants would be able to select the most appropriate cybersecurity rule for their design and risk profile by complying with either § 73.54 or § 73.110, “Technology-inclusive requirements for protection of digital computer and communication systems and networks,” which was developed for part 53. Differences between the § 73.54 requirements and those in § 73.110 are primarily based on the implementation of a consequence-based approach to cybersecurity in § 73.110 that provides flexibility to accommodate the wide range of reactor technologies to be assessed by the NRC. A graded approach based on consequences would account for the differing risk levels among reactor technologies.
This proposal would include revisions to §§ 73.54, 73.55, 73.77, and 73.110; the companion regulatory guidance for § 73.110, DG-5103 (proposed Revision 1 to RG 5.96), “Establishing Risk-Informed and Technology-Inclusive Cybersecurity Programs for Commercial Nuclear Plants”; and §§ 50.34 and 52.79 to reflect this expanded regulatory flexibility.
This proposal would eliminate the existing introductory paragraph of § 73.54. That statement was originally intended to require that operating nuclear power plants, at the time of rule implementation in 2009, establish, implement, and maintain a cybersecurity program. All currently operating nuclear power plants have fully implemented their cybersecurity plans and will continue to maintain their plans per the requirements of § 73.55 and § 73.54.
The NRC is also proposing revisions to § 73.54(g) as conforming changes to align with the expansion of regulatory options for new applicants. Specifically, the cybersecurity program review requirement would be independent of the physical security program.
The NRC is proposing amendments to § 50.34(a)(3)(i) and § 52.79(a)(4)(i) to require that safety and security be considered together in the design process such that, where possible, security issues are effectively resolved through design and engineered security features. This approach, which is consistent with the requirement in § 53.440(f), ensures consideration is given to safety and security together throughout the plant's lifetime, including the design process and prior to implementing changes to plant configurations, to ensure risks are effectively managed. This evaluation helps determine whether enhancements to the design basis or physical protection system are warranted. Incorporating security strategies and design features early in the design process can be significantly more efficient and cost-effective than retrofitting these measures after the plant has been designed or constructed.
The proposed rule would revise 10 CFR part 95 to remove requirements that are duplicative and ensure alignment with 32 CFR part 117 by providing references to 32 CFR part 117 where appropriate. Furthermore, specific NRC prescriptive requirements would be eliminated to resolve any conflicting regulations.
Part 95 establishes requirements for licensees, applicants, and other entities that obtain a facility security clearance from the NRC, as well as the requirements for the protection of classified matter. These requirements are based on the National Industrial Security Program Operating Manual (NISPOM), which was codified in regulation in February 2021, at 32 CFR part 117. Part 95 ensures that entities that fall under NRC cognizance meet the requirements of the NISPOM.
The regulations in 32 CFR part 117 establish the NRC as the cognizant security agency for NRC-cleared entities that are issued facility security clearances. Currently, cleared entities under NRC cognizance are subject to both 10 CFR part 95 and 32 CFR part 117, which has resulted in the establishment of duplicative and inconsistent regulatory requirements for cleared entities.
Under this proposed rule, the NRC would revise 10 CFR part 95. The proposed changes would not affect any existing regulatory guidance, but inspection procedures related to part 95 would be updated. The NRC would remove requirements from 10 CFR part 95 that are duplicative or inconsistent with the requirements in 32 CFR part 117. Part 95 would retain only those requirements and processes that are unique to NRC-cleared entities.
Section 95.1, “Purpose,” would be revised to identify that the purpose of part 95 is to implement the National Industrial Security Program, as described in 32 CFR part 117.
Section 95.5 would be revised to remove unused definitions or those definitions that are duplicative to definitions in 32 CFR part 117.
Section 95.11, “Specific exemptions,” would be revised to change the section title to “Specific exemptions and waivers,” to include reference to the NRC's ability to issue waivers in accordance with 32 CFR part 117.
Section 95.17, “Processing facility clearance,” would be renamed “Facility clearance process” for clarity. Requirements unrelated to the facility clearance process that had previously been in § 95.17 were moved to other more relevant sections. Other revisions would clarify that the review referred to in § 95.17 is an operational readiness review (rather than a security review). The NRC would revise § 95.17 to use the definition of “key management personnel” found in 32 CFR part 117.
The NRC proposes to delete §§ 95.18, “Key personnel”; 95.25, “Protection of National Security Information and Restricted Data in storage”; 95.27, “Protection while in use”; 95.29, “Establishment of Restricted or Closed areas”; 95.31, “Protective personnel”; 95.35, “Access to matter classified as National Security Information and Restricted Data”; 95.45, “Changes in classification”; and 95.51, “Retrieval of classified matter following suspension or revocation of access authorization,” because they duplicate provisions in 32 CFR part 117.
Section 95.19, “Changes to security practices and procedures,” would be revised to remove the requirement to resubmit the Standard Practice Procedures Plan every 5 years. This change would result in a reduction in licensee burden.
The NRC proposes to add § 95.24, “Safeguarding National Security Information and Restricted Data,” which would be a new section. This section would retain existing requirements from 95.25, “Protection of National Security Information and Restricted Data in storage,” related to the maintenance of keys and padlocks used to protect classified information. There would be no additional licensee burden associated with this change.
Sections 95.33, “Security education,” 95.34, “Control of visitors,” 95.37, “Classification and preparation of documents,” 95.39, “External transmission of documents and material,” 95.43, “Authority to reproduce,” and 95.47, “Destruction of matter containing classified information,” would be modified to remove specific requirements and instead require that cleared entities conduct these activities in accordance with 32 CFR part 117.
Section 95.49, “Security of automatic data processing (ADP) systems,” would be renamed “Authorization to operate national security systems,” consistent with usage in 32 CFR part 117. Specific requirements would be deleted, and the revised section would require cleared entities to process classified information on information technology or operational technology systems in accordance with 32 CFR part 117.
The NRC would revise § 95.57, “Reports,” to establish reporting requirements consistent with the provisions in 32 CFR part 117 that state that the cognizant security agency (CSA) (in this case, the NRC) will provide guidance on reporting security events. The proposed revision would provide that all actual or suspected losses or compromises of classified information would be reported to the NRC Headquarters Operations Center within one hour of discovery, with a written follow-up submitted within 48 hours. If it is determined that no loss, compromise, or suspected compromise occurred, a written report documenting this determination would be submitted in accordance with § 95.9, “Communications,” within 48 hours of reaching that conclusion. If the NRC is not the CSA, the entity would first report to their applicable CSA and then to the NRC. This revision would also eliminate the previous requirement for monthly logs.
The NRC is seeking advice and recommendations from the public on the proposed rule. The NRC is particularly interested in comments with supporting rationales from the public on the following questions. In addition to the general discussion in Section IV, additional context is provided for certain questions in order to help the public comment on these issues.
Part 73 establishes requirements for the physical protection of licensed activities and facilities, which includes nuclear power reactors and Category I facilities. Section 73.2 defines vital areas and vital area equipment. The vital area concept focuses protective measures and access controls on locations housing equipment and functions essential to preventing significant radiological consequences from malevolent acts.
The licensees and the NRC have gained additional experience implementing the requirements associated with vital areas. The current approach for power reactors to protect their facilities focuses on the use of target sets (plant equipment and operator actions) that may or may not involve vital equipment. Evolving plant design changes, digital modernization, and operational practices may warrant an assessment of whether the vital area concept remains optimally defined and implemented across 10 CFR part 73 are clear, efficient, and risk-informed.
Under current part 73, licensees subject to § 73.55 must meet the performance objective in § 73.55(b)(3) of protecting against significant core damage and spent fuel sabotage. The NRC is proposing to change the performance objective from protecting against significant core damage and spent fuel sabotage to a broader goal of preventing release of radionuclides from any source that exceeds the dose reference values defined in § 50.34(a)(1)(ii)(D)(
a. How would this change impact the security programs of current licensees?
b. Would changing the performance objective in § 73.55(b)(3) provide any benefit to future licensees given that § 73.100 already offers a flexible, technology-inclusive performance objective for new reactors?
Part 26 establishes requirements for FFD programs at NRC-licensed facilities. These requirements have been developed over time to provide, in part, a level of detail needed to support licensee legal considerations (
The proposed rule includes several changes to prescriptive security and fitness-for-duty requirements that are based on the operating experience and performance history of the operating reactor fleet. Examples of such changes for power reactors include the proposed reduction in the number of required tactical response drills and force-on-force exercises, elimination of the annual reports of waivers and fatigue management program information, and reduction in annual random testing rate for employees that do not perform critical safety- or security-related activities. New reactor licensees and applicants, however, may lack similar operating experience and performance history in these areas.
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 NRC requests public comment on the draft regulatory analysis. The regulatory analysis is available as indicated in the “Availability of Documents” section of this document. Comments on the draft analysis may be submitted to the NRC as indicated under the ADDRESSES caption of this document. As discussed in Section IV.A.(i)(k) of this document, the NRC also requests public input on the costs and benefits of subpart F of 10 CFR part 26.
The Commission has completed a backfitting and issue finality assessment for this proposed rule under §§ 50.109, “Backfitting”; 53.1590, “Backfitting”; 70.76, “Backfitting”; and 72.62, “Backfitting,” and the issue finality provisions of part 52 and part 53. Also, a number of the changes in this proposed rule would not be subject to the backfitting and issue finality requirements. This assessment is available as indicated in the “Availability of Documents” section of this document.
One set of changes in this proposed rule would constitute backfitting, as that term is defined in § 50.109 and described in NRC Management Directive 8.4, “Management of Backfitting, Forward Fitting, Issue Finality, and Information Requests.” The proposed changes to §§ 73.67(d) and 73.67(f) to clarify the appropriate security requirements for Category II and III quantities of SNM stored within the owner-controlled area but outside the protected area at 10 CFR part 50 nuclear power reactors could impose a change to those licensees' required physical security programs, thereby meeting the definition of “backfitting” in § 50.109(a)(1). As described in the backfitting assessment, these proposed backfits would be justified on the basis that the proposed changes would be necessary to ensure that these facilities provide adequate protection to the health and safety of the public and are in accord with the common defense and security.
The NRC is issuing fifteen DGs that, if finalized, would provide guidance on the methods acceptable to the NRC for complying with aspects of this proposed rule. As discussed in the DGs, applicants and licensees would not be required to comply with the positions set forth in the DGs. Therefore, issuance of the DGs in final form would not constitute backfitting or forward fitting, as that term is defined and described in Management Directive 8.4, or affect the issue finality of any approval issued under part 52.
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. The NRC is proposing a compliance (implementation) date that will be 180 days after the date of publication of the final rule. Does this provide sufficient time to implement the proposed requirements and associated guidance? 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 Commission has determined under the National Environmental Policy Act of 1969, as amended, and the Commission's regulations in subpart A, “National Environmental Policy Act—Regulations Implementing Section 102(2),” of part 51, “Environmental Protection Regulations for Domestic Licensing and Related Regulatory Functions,” that this proposed rule, if adopted, would not be a major Federal action significantly affecting the quality of the human environment, and an environmental impact statement would not be required, because
The preliminary determination of the Commission's environmental assessment and finding of no significant impact is that there would be no significant effect on the quality of the human environment from this rulemaking action. Comments on any aspect of this environmental assessment and finding of no significant impact may be submitted to the NRC as indicated under the
This proposed rule contains new or amended collections of information subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
• FFD Programs. The NRC is proposing effectiveness and efficiency improvements to the drug and alcohol testing and fatigue management requirements based on lessons learned from implementing 10 CFR part 26, to align with select changes made by other Federal agency drug testing programs, and to address several petitions for rulemaking.
• Security Requirements for ISFSIs. The proposed rule would revise security requirements for ISFSIs to improve clarity and consistency between the requirements for general license ISFSIs and specific license ISFSIs.
• Physical Security Requirements. The NRC is proposing to modernize and streamline physical security requirements for nuclear power reactors and materials by shifting from prescriptive rules to performance-based, risk-informed criteria.
• Facility Security Clearance and Safeguarding of National Security Information and Restricted Data. The NRC is proposing to revise 10 CFR part 95 to remove requirements that are duplicative and to ensure alignment with 32 CFR part 117.
The proposed rule would impose burden associated with new optional information collections in NRC Form 891. NRC Form 366 would be updated to remove a regulatory reference. In addition, if paragraph 26.203(e) were deleted as proposed, the NRC would no longer need NRC Form 892.
The NRC is seeking public comment on the potential impact of the information collection(s) contained in this proposed rule and on the following issues:
1. Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility? Please explain your response.
2. Is the estimate of the burden of the proposed information collection accurate? Please explain your response.
3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? Please explain your response.
4. How can the burden of the proposed information collection on respondents be minimized, including the use of automated collection techniques or other forms of information technology?
A copy of the OMB clearance package and proposed rule are available in the “Availability of Documents” section of this document 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 collections, including suggestions for reducing the burden and on the above issues, by the following method:
Submit comments by July 27, 2026. Comments received after this date will be considered if it is practical to do so, but the NRC staff is able to ensure consideration only for comments received on or before this date.
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 a significant regulatory action under section 3(f) of E.O. 12866, though not economically significant under section 3(f)(1). Accordingly, the NRC submitted this 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 can be found in Section VII of this document, “Regulatory Analysis.”
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. The NRC estimates that this rule generates $45.2 million in annualized costs savings at a 7 percent discount rate, discounted relative to year 2024, over a perpetual time horizon. Details on the estimated costs of this proposed rule can be found in Section VII of this document.
E.O. 14267 requires the NRC to identify anti-competitive regulations for rescission or modification. The NRC identified several such changes in 10 CFR part 26. The proposed rescission/modification of the regulations supports the objectives of E.O. 14267 by removing regulatory requirements that could create unnecessary barriers to entry for new market entrants.
First, by expanding the acceptable credentials to serve as an SAE to include licensed marriage and family therapists, the proposed rule would allow licensees to consider additional candidates to potentially serve as SAEs. Second, by revising the medical degree requirements for MROs to include medical degrees obtained in foreign countries that are equivalent to a Doctor of Medicine or Doctor of Osteopathy degree obtained in the United States, the proposed rule would expand the potential pool of candidates available to provide MRO services. Finally, proposed changes to the blind performance testing programs would include the removal of the requirement for licensees to submit additional blind performance test samples in the initial 90 days of testing with a new HHS-certified laboratory. This change would enhance competitiveness for new market entrants by removing a potential disincentivizing factor for a licensee that may want to change to another HHS-certified laboratory.
Additionally, the proposed rule would remove outdated provisions no longer in use by industry. These pertain to LTFs and reflect how the free market has driven changes in the drug testing programs under 10 CFR part 26. At the inception of 10 CFR part 26 FFD programs in 1990, many licensees utilized LTFs at their sites to perform initial drug testing. Over time, the advantages of LTF testing decreased as the performance and capabilities at HHS-certified laboratories (price-competitive, private, and for-profit entities), significantly improved. LTFs have not been a viable testing option for licensees because of the increasing sophistication and complexity of drug testing (
E.O. 14270 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 part of the NRC's regulatory permitting scheme authorized by the AEA, ERA, or NWPA. Therefore, the NRC views this rulemaking to be outside the scope of E.O. 14270 and did not insert conditional sunset dates for the regulatory changes in this proposed rule.
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 would revise the NRC's requirements in 10 CFR parts 26, 72, 73, and 95 to modernize security and FFD programs by updating and clarifying regulatory provisions, streamlining administrative processes, and providing additional compliance flexibilities. These proposed changes are tailored to the unique safety and security needs of NRC licensees and would not create a broadly applicable technical standard suitable for adoption by voluntary
The NRC is issuing draft guidance for public comment, as described in this section, to support implementation of the proposed requirements in this rulemaking. The draft guidance is available at
Draft Regulatory Guides DG-5087, “Standard Format and Content of Safeguards Contingency Plans for Nuclear Power Plants” (proposed Revision 2 to RG 5.54), and DG-5094, “Physical Protection Programs at Nuclear Power Reactors” (proposed Revision 2 to RG 5.76), contain SGI and are therefore withheld from public disclosure. In accordance with NRC policy, these DGs will be made available only to affected licensees and cleared stakeholders who have an established “need-to-know” and meet the access requirements of § 73.22(b). Because the majority of the changes to these DGs are limited to conforming changes needed to align with this proposed rulemaking, and considering the level of information provided in this notice, the NRC has determined that access to these DGs is not necessary for the general public to offer informed comment on the proposed rule. The publicly available draft guidance documents supporting this rulemaking are:
• DG-5069, “Fitness-For-Duty Programs at New Reactor Construction Sites,” proposed Revision 1 to RG 5.84;
• DG-5085, “Cybersecurity Programs for Nuclear Power Reactors,” proposed Revision 2 to RG 5.71;
• DG-5088, “Physical Protection of Special Nuclear Material of Moderate or Low Strategic Significance,” proposed Revision 2 to RG 5.59;
• DG-5089, “Security Event Notifications, Reports, and Records,” proposed Revision 4 to RG 5.62;
• DG-5090, “Access Authorization Program for Nuclear Power Plants,” proposed Revision 3 to RG 5.66;
• DG-5093, “Training and Qualification of Security Personnel at Nuclear Power Reactor Facilities,” proposed Revision 2 to RG 5.75;
• DG-5095, “Insider Mitigation Program,” proposed Revision 2 to RG 5.77;
• DG-5097, “Preemption Authority, Enhanced Weapons Authority, and Firearms Background Checks,” proposed Revision 2 to RG 5.86;
• DG-5098, “Suspicious Activity Reports Under 10 CFR part 73,” proposed Revision 2 to RG 5.87;
• DG-5099, “Fatigue Management for Nuclear Power Plant Personnel,” proposed Revision 1 to RG 5.73;
• DG-5102, “Protection of Safeguards Information,” proposed Revision 1 to RG 5.79;
• DG-5103, “Establishing Risk-Informed and Technology-Inclusive Cybersecurity Programs for Commercial Nuclear Plants,” proposed Revision 1 to RG 5.96; and
• DG-5104, “Access Authorization Program for Commercial Nuclear Plants,” proposed Revision 1 to RG 5.95.
The NRC is proposing to withdraw RG 5.83, “Cybersecurity Event Notifications.” As discussed in Section IV.C.(x), “Cybersecurity,” of this document, the NRC is proposing to eliminate specific cyber event notification requirements under § 73.77 and instead redirect licensees to established notification processes under parts 50, 53, and 73. RG 5.62 would be updated to include cybersecurity event notifications.
The NRC is proposing to withdraw NUREG-1304, “Reporting of Safeguards Events.” NUREG-1304, Revision 0, was temporarily withdrawn following publication of the NRC's final rule on “Enhanced Weapons, Firearms Background Checks, and Security Event Notifications” (88 FR 15864; March 14, 2023). At that time, the NRC indicated its intent to conduct a public workshop after implementation of the new regulations in §§ 73.1200, 73.1205, and 73.1210, and to issue the workshop results as NUREG-1304, Revision 1. In light of the proposed regulatory changes in this rulemaking and the accompanying proposed updates to the associated guidance, the NRC has determined that NUREG-1304 is no longer necessary and proposes to withdraw the NUREG.
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
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.
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, Antitrust, Combined license, Early site permit, Emergency planning, Fees, Inspection, Issue finality, Limited work authorization, Manufacturing license, Nuclear power plants and reactors, Probabilistic risk assessment, Prototype, Reactor siting criteria, Redress of site, Penalties, Reporting and recordkeeping requirements, Standard design, Standard design certification.
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, Incorporation by reference, Nuclear energy, Nuclear materials, Nuclear power plants and reactors, Penalties, Reporting and recordkeeping requirements, Security measures.
Classified information, Criminal penalties, Penalties, Reporting and recordkeeping requirements, Security measures.
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 26, 50, 52, 72, 73, and 95 as follows:
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 M of this part, and implement the FFD program before the initial fuel load into the reactor.
(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 part, except for subparts I, K, and M of this part.
(c) Before the initial fuel load into the reactor, the following licensees and other entities shall comply with the requirements of this part, except for subparts I and M of this part; and, no later than initial fuel load into the reactor, the following licensees and other entities shall comply with the requirements of this part, except subpart M of this part:
The revisions and addition read as follows:
(e) * * *
(1) Serves as security personnel required by the NRC before the initial fuel load into the reactor, at which time individuals who serve as security personnel required by the NRC must meet the requirements applicable to
(5) Supervises or manages the construction of safety- or security-related SSCs;
(6) * * *
(iv) Conducting background investigations or psychological assessments used by the licensee or other entity to make access authorization determinations, except that he or she shall be subject to behavioral observation only when he or she is present at the location where the nuclear power plant will be constructed and operated, and licensees and other entities may rely on a local hospital or other organization that meets the requirements of 49 CFR part 40 to collect his or her specimens for drug and alcohol testing;
(vii) Performing any of the activities or having any of the duties listed in paragraph (e)(6) of this section for any C/V upon whom the licensee's or other entity's access authorization program will rely; or
(7) Escorts an individual or small group of individuals, as determined by the licensee or other entity.
(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 M of this part, unless the licensee or other entity subjects the individuals to an FFD program that meets all of the requirements of this part, except for subparts I, K, and M of this part, or if the individual is escorted.
The revisions and additions read as follows:
(c) * * *
(4) Describe the process to be followed if an individual's behavior raises a concern regarding the possible use, sale, or possession of illegal drugs on or off site; the possible possession or consumption of alcohol on site; or impairment from any cause which in any way could adversely affect the individual's ability to safely and competently perform his or her duties. The procedure must require that individuals who have an FFD concern about another individual's behavior shall contact the personnel designated in the procedures to report the concern; and
(5) For licensees and other entities that allow escorting of individuals performing activities described in 10 CFR 26.4(f), but do not implement an FFD program under subpart K or subpart M during construction, describe the process that the licensee or other entity will use for the processing, escorting, and control of individuals under escort and the duties and responsibilities of escorts.
(c) * * *
(2) Individuals shall complete refresher training on a nominal 24-month frequency, or more frequently where the need is indicated. Indications of the need for more frequent training
(b) * * *
(1) * * *
(v) FFD program personnel shall be subject to a behavioral observations program designed to assure that they continue to meet the highest standards of honesty and integrity. The MRO, MRO staff, and SAE shall be subject to behavioral observation when on site at a licensee's or other entity's facility.
(d) * * *
(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. At a minimum, the FFD program must—
(vii) Ensure that the number of random tests performed annually meets the sampling requirements described in § 26.31(d)(2)(vii)(A) and (B), or in § 26.31(d)(2)(vii)(C) when applicable.
(A) Random tests must be performed annually for at least 50 percent of the population of individuals subject to the FFD program that is comprised of all contractors/vendors and the following licensee employees: those who are licensed under 10 CFR part 55 to operate a power reactor, security personnel under § 26.4(a)(5), FFD program personnel under § 26.4(g), and supervisory personnel directing the operation or maintenance of safety- or security-related SSCs or directing the performance of security duties under § 26.4(a)(5).
(B) Random tests must be performed annually for at least 25 percent of the licensee employee population subject to the FFD program that is not covered by random testing performed under § 26.31(d)(2)(vii)(A).
(C) If the number of individuals subject to random testing is such that § 26.31(d)(2)(vii)(A) and (B) cannot be implemented without predictable outcomes, then the licensee or other entity must use a C/TPA to manage the random testing pool and make selections for testing throughout the year. In such instances, the C/TPA must ensure that testing rates for the random testing pool from which they sample meet the requirements described in § 26.31(d)(2)(vii)(A) and (B).
(3) * * *
(i) Testing of specimens collected under § 26.83(b) must be performed in a laboratory that is certified by HHS for that purpose, consistent with its standards and procedures for certification. Urine specimens sent to HHS-certified laboratories must be subject to initial validity and initial drug testing by the laboratory. Oral fluid specimens sent to HHS-certified laboratories must be subject to initial drug testing by the laboratory. Specimens for initial validity or initial drug testing that yield positive, positive and dilute, adulterated, substituted, or invalid test results must be subject to confirmatory testing by the laboratory, except for invalid specimens that cannot be tested. Licensees and other entities shall ensure that laboratories report results for all specimens sent for testing, including blind performance test samples.
(ii) At a minimum, licensees and other entities shall apply the cutoff levels specified in § 26.163(a)(1) for initial drug testing and in § 26.163(b)(1) for confirmatory drug testing at the HHS-certified laboratory. At their discretion, licensees and other entities may implement programs with lower cutoff levels in testing for drugs and drug metabolites.
(a) Licensees and other entities shall ensure that the individuals who are subject to this subpart are subject to behavioral observation.
(b) Behavioral observation must be performed by individuals who are trained under § 26.29 to detect behaviors that may indicate possible use, sale, or possession of illegal drugs; use or possession of alcohol on site or while on duty; or impairment from fatigue or any cause that, if left unattended, may constitute a risk to public health and safety or the common defense and security.
(c) Individuals who are subject to this subpart shall report any FFD concerns about other individuals to the personnel designated in the FFD policy.
(a)
(c) C/Vs.
(1) FFD services that are provided to a licensee or other entity by C/V personnel who are off site or are not under the direct daily supervision or observation of the licensee's or other entity's personnel must be audited on a nominal 12-month frequency.
(2) Licensees and other entities need not audit organizations and professionals who may provide an FFD program service to the licensee or other entity, but who are not routinely involved in providing services to a licensee's or other entity's FFD program, as specified in § 26.4(i)(1).
(g)
(1) Licensees and other entities shall review audit records and reports to identify any areas that were not covered by the shared or accepted audit.
(2) Licensees and other entities shall ensure that FFD program elements and services on which the licensee or entity relies are audited, if the program elements and services were not addressed in the shared audit.
(3) Sharing licensees and other entities need not re-audit the same C/V for the same period of time.
(4) Each sharing licensee and other entity shall maintain a copy of the shared audit, including findings, recommendations, and corrective actions.
(h) A licensee or other entity may not terminate an individual's authorization and may not subject the individual to other administrative action based solely on a positive drug test result that has not been reviewed by the MRO under § 26.185, unless other evidence, including information obtained under the process set forth in § 26.189, indicates that the individual is impaired or might otherwise pose a safety hazard.
(i) [Reserved]
(b) Collect only urine or oral fluid specimens for both initial and confirmatory tests for drugs.
(1) For each condition for testing under § 26.31(c), the licensee or other entity shall establish through its policy and procedures when a urine or oral fluid specimen is to be collected.
(2) For each observed collection condition under § 26.115(a), the licensee or other entity shall always collect and test the same specimen type.
(a) Licensees and other entities who are subject to this subpart shall establish a predetermined quantity of urine that donors are requested to provide when submitting a specimen. At a minimum, the predetermined quantity must include 30 milliliters (mL) to ensure that a sufficient quantity of urine is available for initial and confirmatory validity and drug tests at an HHS-certified laboratory, and for retesting of an aliquot of the specimen if requested by the donor under § 26.165(b). The licensee's or other entity's predetermined quantity may include more than 30 mL, if the testing program follows split specimen procedures or tests for additional drugs. Where collected specimens are to be split under the provisions of this subpart, the predetermined quantity must include an additional 15 mL.
(d) Any specimen of 15 mL or more that the collector suspects has been diluted, substituted, or adulterated, and any specimen of 15 mL or more that has been collected under direct observation under paragraph (c) of this section, must be sent to the HHS-certified laboratory for testing.
(c) Licensees and other entities may use aliquots of the specimen collected for initial validity and drug testing, as permitted under § 26.31(d)(3)(ii), or to test for additional drugs, as permitted under § 26.31(d)(1)(i)(A), but only if sufficient urine is available for this testing after the specimen has been split into Bottle A and Bottle B.
(f) The specimens and Federal CCFs must be packaged for transfer to the HHS-certified laboratory. If the specimens are not immediately prepared for transfer, they must be appropriately safeguarded during temporary storage.
(g) While any part of the chain of custody procedures is being performed, the specimens and custody documents must be under the control of the involved collector, except as provided in § 26.109(b)(1)(ii) for the Federal CCF. The collector may not leave the collection site during the interval between presentation of the specimen by the donor and securing of the specimens with identifying labels bearing the donor's specimen identification numbers and seals initialed by the donor. If the involved collector momentarily leaves his or her workstation, the sealed specimens and Federal CCFs must be secured or taken with him or her. If the collector is leaving for an extended period of time, the specimens must be packaged for transfer to the HHS-certified laboratory and secured before the collector leaves the collection site.
(h) The specimen(s) sealed in a shipping container must be immediately transferred, appropriately safeguarded during temporary storage, or kept under the personal control of an authorized individual until transferred. These minimum procedures apply to the shipping of specimens to HHS-certified laboratories. As an option, licensees and other entities may ship several specimens by courier in a locked or sealed shipping container.
(i) Collection site personnel shall ensure that a Federal CCF is packaged with its associated specimen bottle. The sealed and labeled specimen bottles, with their associated Federal CCFs that are being transferred from the collection site to the HHS-certified laboratory, must be placed in a second, tamper-evident shipping container. The second container must be designed to minimize the possibility of damage to the specimen during shipment (
(j) Collection site personnel shall arrange to transfer the collected specimens to the HHS-certified laboratory. Licensees and other entities shall take appropriate and prudent actions to minimize false negative results from specimen degradation. Urine specimens that have not shipped to the HHS-certified laboratory within 24 hours of collection and any urine specimen that is suspected of having been substituted, adulterated, or tampered with in any way must be maintained cooled to not more than 6 °C (42.8 °F) until they are shipped to the HHS-certified laboratory. Oral fluid specimens shall be stored under the conditions specified by the oral fluid specimen collection device manufacturer. Specimens must be shipped from the collection site to the HHS-certified laboratory as soon as reasonably practical but, except under unusual circumstances, the time between specimen shipment and receipt of the specimen at the HHS-certified laboratory should not exceed 2 business days.
(f) * * *
(2) The laboratory shall 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;
(a) Testing split specimens.
(1) If a specimen has been split into Bottle A and Bottle B at the collection site, the HHS-certified laboratory shall perform initial and confirmatory validity and drug testing, if required, on the specimen in Bottle A.
(2) If the specimen in Bottle A is free of any evidence of drugs or drug metabolites, and is a valid specimen, then the HHS-certified laboratory may discard the specimens in Bottles A and B.
(b) * * *
(5) As soon as reasonably practical and not more than 1 business day following the day of the donor's request, as permitted in paragraph (b)(3) or (b)(4) of this section, the MRO shall ensure that the HHS-certified laboratory forwards an aliquot of a single specimen or Bottle B of a split specimen (as appropriate), to a second HHS-certified laboratory that did not test the specimen in Bottle A.
(f) * * *
(2) If a donor requests that Bottle B be tested or that an aliquot of the single specimen be retested, and either Bottle B or the single specimen are not available due to circumstances outside of the donor's control (including, but not limited to, circumstances in which there is an insufficient quantity of the single specimen or the specimen in Bottle B to permit retesting, either Bottle B or the original single specimen is lost in transit to the second HHS-certified laboratory, or Bottle B has been lost at the HHS-certified laboratory), the MRO shall cancel the test, report a cancelled test result to the licensee or other entity for the donor's specimen, and inform the licensee or other entity that another collection is required under direct observation as soon as reasonably practical. The donor shall receive no notice of the collection requirement before he or she is instructed to proceed to the collection site. The licensee or other entity shall continue to administratively withdraw the individual's authorization, as required by § 26.165(f)(1) until the results of the second specimen collection have been received by the MRO. The licensee or other entity shall eliminate from the donor's personnel and other records any matter that could link the donor to the original positive, adulterated, or substituted test result(s) and any temporary administrative action, and may not impose any sanctions on the donor for a cancelled test. If test results from the second specimen collected are positive, adulterated, or substituted and the MRO determines that the donor has violated the FFD policy, the licensee or other entity shall impose the appropriate sanctions specified in subpart D of this part, but may not consider the original confirmed positive, adulterated, or substituted test result that was reported as a cancelled test by the MRO under § 26.159(b)(2) in determining the appropriate sanctions.
(d) * * *
(1) Any initial drug test performed by an HHS-certified laboratory must use an immunoassay or an alternate technology that is permitted for use in Federal workplace drug testing programs for this purpose.
(a) Each licensee and other entity shall submit blind performance test samples to each HHS-certified laboratory under contract to perform specimen testing.
(1) A licensee or other entity may submit blind performance test samples for each site (
(2) In each calendar quarter, the number of blind performance test samples submitted must be a minimum of one percent of all specimens (up to a maximum of 100) or ten blind performance test samples, whichever is greater.
(3) In each calendar quarter, licensees and other entities should attempt to submit blind performance test samples at a frequency that corresponds to the submission frequency for other specimens.
(b) Approximately 60 percent of the blind performance test samples submitted to the HHS-certified laboratory must be positive for one or more drugs or drug metabolites per sample and submitted so that all of the drugs for which the FFD program is testing are included at least once each calendar quarter.
(c) The positive blind performance test samples must be positive for only those drugs for which the FFD program is testing and formulated at concentrations established in paragraph (g)(2) of this section.
(d) To challenge the HHS-certified laboratory's ability to limit false negatives, approximately 10 percent of the blind performance test samples submitted to the laboratory each quarter or at least one sample per quarter, whichever is greater, must be formulated at the concentrations established in paragraph (g)(3) of this section.
(f) Approximately 10 percent of the blind performance test samples submitted to the HHS-certified laboratory each quarter or at least one sample per quarter, whichever is greater, must be negative, as specified in paragraph (g)(1) of this section.
(i) * * *
(1) The licensee or other entity shall submit blind performance test samples to the HHS-certified laboratory using the same channels (
(2) The collector shall use a Federal CCF, place fictional initials on the specimen bottles' labels/seals, and indicate for the MRO on the MRO's copy that the specimen is a blind performance test sample; and
(3) The licensee or other entity shall ensure that all blind performance test samples include split samples, when the FFD program includes split specimen procedures.
(h) * * *
(4) Number of specimens reported as adulterated;
(5) Number of specimens reported as substituted;
(6) Number of specimens reported as positive and dilute;
(7) Number of specimens reported as invalid; and
(a)
(b)
(c)
(1) In carrying out these responsibilities, the MRO shall examine alternate medical explanations for any positive, positive and dilute, adulterated, substituted, or invalid test result. This action may include, but is not limited to, conducting a medical interview with the donor, reviewing the donor's medical history, or reviewing any other relevant biomedical factors. The MRO shall review all medical records that the donor may make available when a positive, positive and dilute, adulterated, substituted, or invalid test result could have resulted from responsible use of legally prescribed medication, a documented condition or disease state, or the demonstrated physiology of the donor.
(2) The MRO may only consider the results of tests of specimens that are collected and processed under this part, including the results of testing split specimens, in making his or her determination, as long as those split specimens have been stored and tested under the procedures described in this part.
(d) * * *
(2) * * *
(ii) The staff reviews of positive, positive and dilute, adulterated, substituted, and invalid test results must be limited to reviewing the Federal CCF to determine whether it contains any errors that may require corrective action and to ensure that it is consistent with the information on the MRO's copy. The staff may resolve errors in Federal CCFs that require corrective action(s), but shall forward the Federal CCFs to the MRO for review and approval of the resolution.
(iii) The staff may not conduct interviews with donors to discuss positive, positive and dilute, adulterated, substituted, or invalid test results nor request medical information from a donor. Only the MRO may request and review medical information related to a positive, positive and dilute, adulterated, substituted, or invalid test result or other matter from a donor.
(iv) Staff may not report nor discuss with any individuals other than the MRO and other MRO staff any positive, positive and dilute, adulterated, substituted, or invalid test results received from the HHS-certified laboratory before those results have been reviewed and confirmed by the MRO. Any MRO staff discussions of confirmed positive, adulterated, substituted, invalid, or dilute test results must be limited to discussions only with the licensee's or other entity's FFD program personnel and may not reveal quantitative test results or any personal medical information about the donor that the MRO may have obtained in the course of reviewing confirmatory test results from the HHS-certified laboratory.
(b)
(j) * * *
(3) If the MRO determines that the donor has used another individual's prescription medication, the MRO shall report to the licensee that the donor has violated the FFD policy.
(m)
(b) * * *
(4) A licensed or certified employee assistance professional;
(5) A State-licensed or -certified marriage and family therapist; or
(g) * * *
(1) The SAE shall make determinations of fitness in at least the following three circumstances:
(c) A determination of fitness that is conducted for cause (
The revisions and additions read as follows:
(d) * * *
(4) The documentation of work hour reviews that is required in § 26.205(e)(3) and (e)(4);
(5) The documentation of fatigue assessments that is required in § 26.211(g); and
(6) The documentation of utilization of the exception for sequestration events that is required in § 26.207(e)(3), including the bases for utilization of the exception.
(a) * * *
(1) * * *
(ii) * * * For licensees and other entities in § 26.3(a), (c), (d), and (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 26.608.
(e)
(1) During the sequestration event, the licensee shall implement alternative work hour controls and fatigue management measures that provide reasonable assurance that personnel sequestered on site will continue to meet the performance objectives of § 26.23(e) for the duration of the sequestration event.
(2) During the sequestration event, the licensee shall implement alternative work hour controls that, at a minimum, ensure:
(i) Individuals shall not work more than 16 hours in any 24-hour period and not more than 86 hours in any 7-day period, excluding shift turnover time;
(ii) A minimum 10-hour break is provided between successive work periods;
(iii) 12-hour shifts are limited to no more than 14 consecutive days;
(iv) A minimum of 6 days off is provided in any rolling 30-day period;
(3) Licensees shall document the bases for invoking a sequestration event exception.
(4) Licensees shall restore compliance with § 26.205(c) and (d) as soon as practicable following the conclusion of a sequestration event, but no more than 60 days following the start of the event.
(b) * * * For licensees and other entities in § 26.3(a), (c), (d), and (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 26.608.
(b) Licensees and other entities who intend to implement an FFD program under this subpart shall submit a description of the FFD program and its implementation as part of the license, permit, or limited work authorization application.
(a) Licensees and other entities who implement an FFD program under this subpart shall ensure that a clear, concise, written FFD policy statement is provided to individuals who are subject to the program or escorted. The 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.
(b) * * *
(4) The processing, escorting, and control of individuals under escort and the duties and responsibilities of escorts.
The revisions and addition read as follows:
(c) * * *
(3) Post-event. As soon as practical after an event involving a human error that was committed by an individual specified in § 26.4(f), where the human error may have caused or contributed to the event. The licensee or other entity shall test the individual(s) who committed the error(s), and need not test individuals who were affected by the event but whose actions likely did not cause or contribute to the event. The individual(s) who committed the human error(s) shall be tested if the event resulted in—
(f) Testing of urine and oral fluid specimens for drugs and validity must be performed in a laboratory that is certified by HHS for that purpose, consistent with its standards and procedures for certification. Specimens for initial validity or initial drug testing that yield positive, adulterated, substituted, or invalid test results must
(g) Licensees and other entities shall provide for an MRO review of positive, positive and dilute, adulterated, substituted, and invalid confirmatory drug and validity test results to determine whether the donor has violated the FFD policy, before reporting the results to the individual designated by the licensee or other entity to perform the suitability and fitness evaluations required under § 26.419.
Licensees and other entities who implement FFD programs under this subpart shall develop, implement, and maintain procedures for evaluating whether to assign individuals to the duties specified in § 26.4(f). These procedures must provide reasonable assurance that the individuals are fit to safely and competently perform their duties, and are trustworthy and reliable, as demonstrated by the avoidance of substance abuse.
The revision and addition read as follows:
(b) * * *
(6) Measures to prevent subversion of drug and alcohol tests conducted onsite and offsite, and
(7) For licensees and other entities that allow escorting of individuals performing activities described in 10 CFR 26.4(f), but do not implement an FFD program under subpart K (or a program that meets all the requirements of part 26, except subpart M and subpart K) during construction, describe the process that the licensee or other entity will use for the processing, escorting, and control of individuals under escort and the duties and responsibilities of escorts.
(b) * * *
(2) * * *
(vi) * * * 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).
(c) * * *
(4) For all test conditions in paragraph (b) of this section and for MRO-directed tests under § 26.185, drug testing must be performed at an HHS-certified laboratory for the specific biological specimen to be tested. Only HHS-certified laboratory test results from urine and oral fluid specimens may be used for the issuance of a sanction required under this part.
(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 permit representatives of the NRC and any licensee or other entity using the laboratory's services to inspect or audit the laboratory at any time, including unannounced inspections;
(ii) Laboratory records and documents must be provided and/or able to be photocopied and removed from the premises to support the inspection or audit;
(iii) The laboratory must comply with the applicable provisions of any State licensor requirements;
(iv) 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;
(v) The laboratory shall maintain test records in confidence, consistent with the requirements of § 26.37, and use them with the highest regard for individual privacy.
(vi) 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; and
(vii) 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.
(a) Collection sites providing services to licensees and other entities who are subject to this subpart and HHS-certified laboratories shall maintain and make available documentation of all aspects of the testing process for at least 2 years or until the completion of all legal proceedings related to a determination of an FFD violation, whichever is later. This 2-year period may be extended on written notification by the NRC or by any licensee or other entity for whom services are being provided.
(b) Documentation that must be retained includes, but is not limited to, the following:
(1) Personnel files, including training records, for all individuals who have been authorized to have access to specimens, but are no longer under contract to or employed by the collection site;
(2) Chain of custody documents (other than forms recording specimens with negative test results and no FFD violations or anomalies, which may be destroyed after appropriate summary information has been recorded for program administration purposes);
(3) Quality assurance and quality control records;
(4) Superseded procedures;
(5) All test data (including calibration curves and any calculations used in determining test results);
(6) Test reports;
(7) Records pertaining to performance testing;
(8) Records pertaining to the investigation of testing errors or unsatisfactory performance discovered in quality control or blind performance testing, in the testing of actual specimens, or through the processing of appeals and MRO reviews, as well as any other errors or matters that could adversely reflect on the integrity of the testing process, investigation findings, and corrective actions taken, where applicable;
(9) Performance records on certification inspections;
(10) Records that summarize any test results that the MRO determined to be scientifically insufficient for further action;
(11) Either printed or electronic copies of computer-generated data;
(12) Records that document the dates, times of entry and exit, escorts, and purposes of entry of authorized visitors, maintenance personnel, and service personnel who have accessed secured areas of HHS-certified laboratories; and
(13) Records of the inspection, maintenance, and calibration of EBTs.
The revisions to read as follows:
(b) * * *
(7) Number of subversion attempts by type; and
(8) Summary of management actions.
(b)
(2) Any acts by any person licensed under 10 CFR part 55 to operate a power reactor, as well as any acts by SSNM transporters, FFD program personnel, or any supervisory personnel directing the operation or maintenance of safety- or security-related SSCs or directing the performance of security duties under § 26.4(a)(5) who are authorized under this part, if such acts—
(c)
(1) Within 30 days of completing an investigation of any testing errors or unsatisfactory performance discovered in performance testing at an HHS-certified laboratory, in the testing of quality control or actual specimens, or through the processing of reviews under § 26.39 and MRO reviews under § 26.185, as well as any other errors or matters that could adversely reflect on the integrity of the random selection or testing process, the licensee or other entity shall submit to the NRC a report of the incident and corrective actions taken or planned. If the error involves an HHS-certified laboratory, the NRC shall ensure that HHS is notified of the finding.
(2) If a false positive or false negative error occurs on a blind performance test sample submitted to an HHS-certified laboratory, the licensee or other entity shall notify the NRC within 24 hours after discovery of the error.
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.
(a) * * *
(3) * * *
(i) The principal design criteria for the facility. Appendix A, General Design Criteria for Nuclear Power Plants, establishes minimum requirements for the principal design criteria for water-cooled nuclear power plants similar in design and location to plants for which construction permits have previously been issued by the Commission and provides guidance to applicants for construction permits in establishing principal design criteria for other types of nuclear power units. For each application for an operating license for a utilization facility submitted after [EFFECTIVE DATE], safety and security must be considered together in the design process such that, where possible, security issues are effectively resolved through design and engineered security features;
(ii) The design bases and the relation of the design bases to the principal design criteria; and
(c) * * *
(2) Each applicant for an operating license for a utilization facility that will be subject to the requirements of § 73.55 or § 73.100 of this chapter must include a physical security plan, a training and qualification plan in accordance with the criteria set forth in appendix B to part 73 of this chapter or § 73.100 of this chapter, and a cybersecurity plan in accordance with the criteria set forth in § 73.54 or § 73.110 of this chapter.
(d) * * *
(2) Each application for a license to operate a utilization facility that will be subject to § 73.55 or § 73.100 of this chapter must include a licensee safeguards contingency plan in accordance with the criteria set forth in section II of appendix C to part 73 of this chapter. The “implementing procedures” required in section II of appendix C to part 73 of this chapter do not have to be submitted to the Commission for approval.
(e) Protection against unauthorized disclosure. Each applicant for an operating license for a production or utilization facility, who prepares a physical security plan, a safeguards contingency plan, a training and qualification plan, or a cybersecurity plan, shall protect the plans and other related Safeguards Information against unauthorized disclosure in accordance with the requirements of § 73.21 of this chapter.
(f) * * *
(2) * * *
(xxviii) Evaluate potential pathways for radioactivity and radiation that may lead to control room habitability problems under accident conditions resulting in an accident source term
Atomic Energy Act of 1954, secs. 103, 104, 147, 149, 161, 181, 182, 183, 185, 186, 189, 223, 234 (42 U.S.C. 2133, 2134, 2167, 2169, 2201, 2231, 2232, 2233, 2235, 2236, 2239, 2273, 2282); Energy Reorganization Act of 1974, secs. 201, 202, 206, 211 (42 U.S.C. 5841, 5842, 5846, 5851); 44 U.S.C. 3504 note.
The revisions read as follows:
(a) * * *
(4) * * *
(i) The principal design criteria for the facility. Appendix A to part 50 of this
(ii) The design bases and the relation of the design bases to the principal design criteria; and
(36) * * *
(ii) A training and qualification plan in accordance with the criteria set forth in appendix B to 10 CFR part 73 or § 73.100 of this chapter;
(iii) A cybersecurity plan in accordance with the criteria set forth in § 73.54 or § 73.110 of this chapter;
(iv) A description of the implementation of the safeguards contingency plan, training and qualification plan, and cybersecurity plan; and
(v) Each applicant who prepares a physical security plan, a safeguards contingency plan, a training and qualification plan, or a cybersecurity plan, shall protect the plans and other related Safeguards Information against unauthorized disclosure in accordance with the requirements of § 73.21 of this chapter.
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) The following sections apply to activities associated with a general license, where the licensee has elected to provide for physical protection of the spent fuel in accordance with § 72.212(b)(9)(iv): § 72.1; § 72.2(a)(1), (b), (c), and (e); §§ 72.3 through 72.6(c)(1); §§ 72.7 through § 72.13(a) and (e); § 72.30(b), (c), (d), (e), and (f); § 72.32(c) and (d); § 72.44(b) and (f); § 72.48; § 72.50(a); § 72.52(a), (b), (d), and (e); § 72.60; § 72.62; §§ 72.72 through 72.80(f); §§ 72.82 through 72.86; §§ 72.104 through 72.106; §§ 72.122 through 72.126; §§ 72.140 through 72.176; §§ 72.180 through 72.186; § 72.190; § 72.194; §§ 72.210 through 72.220; and § 72.240(a).
(b) * * *
(9) Protect the spent fuel against the design basis threat of radiological sabotage in accordance with the same provisions and requirements as are set forth in the licensee's physical security plan pursuant to § 73.55 of this chapter with the following additional conditions and exceptions:
(i) The physical security organization and program for the facility must be modified as necessary to assure that activities conducted under this general license do not decrease the effectiveness of the protection of vital equipment in accordance with § 73.55 of this chapter;
(ii) Storage of spent fuel must be within a protected area, in accordance with § 73.55 of this chapter, but need not be within a separate vital area. Existing protected areas may be expanded for the purpose of storage of spent fuel in accordance with this general license;
(iii) For the purpose of this general license, the licensee is exempt from requirements to interdict and neutralize threats in § 73.55 of this chapter;
(iv)(A) When a separate protected area is established outside of an existing protected area for the purpose of storage of spent fuel, the licensee may, as an alternative to the requirements of § 72.212(b)(9)(i) and (b)(9)(ii), provide for the physical protection of the spent fuel under subpart H of this part and § 73.51 of this chapter;
(B) Upon NRC docketing of the certifications required under § 50.82(a)(1) of this chapter or § 52.110(a) of this chapter or § 53.1070(a) of this chapter, and when all spent fuel has been placed in dry cask storage at the facility, the licensee may, as an alternative to the requirements of § 72.212(b)(9)(i) and (b)(9)(ii), provide for physical protection of the spent fuel under subpart H of this part and § 73.51 of this chapter;
(C) A licensee who elects to provide physical protection under subpart H of this part and § 73.51 of this chapter must submit their physical security plan to the NRC under § 50.54(p) of this chapter; and
(v) Each general licensee that receives and possesses power reactor spent fuel and other radioactive materials associated with spent fuel storage shall protect Safeguards Information against unauthorized disclosure in accordance with the requirements of § 73.21 and the requirements of § 73.22 or § 73.23 of this chapter, as applicable.
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, Public Law 96-295, 94 Stat. 789 (42 U.S.C. 5841 note).
(1) Fencing composed of durable wire fabric, topped by barbed wire or similar material on brackets, with an overall height sufficient to achieve the purpose for which the barrier is intended, as determined by a site-specific analysis;
(2) Building walls, ceilings and floors constructed of stone, brick, cinder block, concrete, steel or comparable materials (openings in which are secured by grates, doors, or covers of construction and fastening of sufficient strength such that the integrity of the wall is not lessened by any opening), or walls of similar construction, not part of a building, provided with a barbed or similar material topping as described in paragraph (1), and of a height as described in paragraph (1).
(3) Any other physical obstruction constructed in a manner and of materials suitable for the purpose for which the obstruction is intended that is considered equivalent to paragraphs (1) and (2).
(b) * * *
(2) With respect to the possession and use of firearms by all other NRC licensees, the Commission's requirements in effect before April 13, 2023, remain applicable, except to the extent that those requirements are modified by an NRC order or regulations applicable to these licensees.
(s) * * *
(3) Licensees must have completed their transition from the confirmatory orders to the requirements of this rule by January 8, 2024.
(4) Effective January 8, 2024, the following orders were withdrawn:
(a) In addition to any other requirements of this part, each licensee who is authorized to operate a spent fuel reprocessing plant pursuant to part 50 or part 70 of this chapter; possesses or uses formula quantities of strategic special nuclear material at any site or contiguous sites subject to control by the licensee; is authorized to transport or deliver to a carrier for transportation pursuant to part 70 of this chapter formula quantities of strategic special nuclear material; takes delivery of formula quantities of strategic special nuclear material free on board (f.o.b.) the point at which it is delivered to a carrier for transportation; or imports or exports formula quantities of strategic special nuclear material, shall establish and maintain or make arrangements for a physical protection system which will have as its 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. The physical protection system shall be designed to protect against the design basis threats of theft or diversion of strategic special nuclear
(f) * * *
(3) Except under emergency or extraordinary conditions, Safeguards Information shall be transmitted outside an authorized place of use or storage only by encrypted means, provided that transmitters and receivers implement processes that will provide reasonable assurance that Safeguards Information is protected before and after the transmission or electronic mail through the internet. Digital voice communication of Safeguards Information shall utilize a commercially available encryption system that is compliant with an active, approved version of Federal Information Processing Standard (FIPS) 140. Documents containing Safeguards Information shall be processed on a self-contained secure computer system and only transferred to a networked system for transmission once it has been appropriately encrypted. The recipient shall only decrypt the Safeguards Information on a self-contained computer system. Symmetric keys or passwords for encrypted Safeguards Information shall be transmitted to the recipient by a means other than that used to transmit the encrypted data. Physical or cybersecurity events required to be reported pursuant to the reporting requirements in this part are considered to be extraordinary conditions.
(g) Processing of Safeguards Information on electronic systems.
(1) Safeguards Information may be stored, processed or produced on a stand-alone computer (or computer system) for processing of Safeguards Information. “Stand-alone” means a computer or computer system to which access is limited to individuals authorized access to Safeguards Information. A stand-alone computer or computer system shall not be physically or in any other way connected to a network accessible by users who are not authorized access to Safeguards Information.
(i) Each computer not located within an approved and lockable security storage container that is used to process Safeguards Information must have a removable storage medium with a bootable operating system. The bootable operating system must be used to load and initialize the computer. The removable storage medium must also contain the software application programs. Data may be saved on either the removable storage medium that is used to boot the operating system, or on a different removable storage medium. The removable storage medium must be secured in a locked security storage container when not in use.
(ii) A mobile device (such as a laptop computer) may also be used for the processing of Safeguards Information provided the device is secured in a locked security storage container when not in use. Other systems may be used if approved for security by the appropriate NRC office.
(iii) Any electronic system that has been used for storage, processing or production of Safeguards Information must be free of recoverable Safeguards Information prior to being returned to nonexclusive use.
(2) As an alternative to paragraph (g)(1) of this section, Safeguards Information may be stored, processed or produced on a computer or computer system and viewed through a network connection, provided that the computer or computer system used to store the Safeguards Information is stored in a security storage container and information security controls are implemented that ensure the Safeguards Information is accessible only by individuals authorized access to Safeguards Information.
(i) Authorized users may access the Safeguards Information using a thin client, virtual desktop, or similar architecture that ensures the Safeguards Information cannot be intentionally or inadvertently transferred or stored on computers not authorized to store the information.
(ii) Computers or servers used to implement this alternative shall be physically located within a security storage container.
(iii) Computers or servers used to implement this alternative shall be protected by the cybersecurity controls described in an active and approved version of National Institute of Standards and Technology (NIST) Special Publication 800-171, Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations.
(iv) Persons implementing this alternative shall describe in processes, procedures, and other records how the security controls in NIST SP 800-171 are implemented.
The revision to read as follows:
(f) * * *
(3) Except under emergency or extraordinary conditions, Safeguards Information designated as Safeguards Information-Modified Handling must be transmitted electronically only by protected telecommunications circuits (including facsimile) that utilizes a commercially available encryption system that is compliant with an active, approved version of Federal Information Processing Standard (FIPS) 140. For the purpose of this section, emergency or extraordinary conditions are defined as any circumstances that require immediate communications in order to report, summon assistance for, or respond to a security contingency event or an event that has potential security significance. Physical security events required to be reported pursuant to §§ 73.1200 and 73.1205 are considered to be extraordinary conditions.
The revision reads as follows:
(b) Security organization.
(1) The licensee shall establish a security organization, including guards. If a contract guard force is utilized for site security, the licensee's written agreement with the contractor will clearly show that (i) the licensee is responsible to the Commission for maintaining safeguards in accordance with Commission regulations and the licensee's security plan, (ii) the NRC may inspect, copy, and take away copies of all reports and documents required to be kept by Commission regulations, orders, or applicable license conditions whether such reports and documents are kept by the licensee or the contractor, (iii) the requirement, in § 73.46(b)(4) of this section that the licensee demonstrate the ability of physical security personnel to perform their assigned duties and responsibilities, include demonstration
(2) The licensee shall have onsite at all times at least one full time member of the security organization with authority to direct the physical protection activities of the security organization.
(3) The licensee shall have a management system to provide for the development, revision, implementation, and enforcement of security procedures. The system shall include:
(i) Written security procedures which document the structure of the security organization and which detail the duties of the Tactical Response Team, guards, watchmen, and other individuals responsible for security. The licensee shall retain a copy of the current procedures as a record until the Commission terminates the license for which these procedures were developed and, if any portion of these procedures is superseded, retain the superseded material for three years after each change; and
(ii) Provision for written approval of such procedures and any revisions thereto by the individual with overall responsibility for the security function.
(4) The licensee may not permit an individual to act as a Tactical Response Team member, armed response person, guard, or other member of the security organization unless the individual has been trained, equipped, and qualified to perform each assigned security duty in accordance with the licensee security plans and appendix B of this part, “General Criteria for Security Personnel.” In addition, Tactical Response Team members, armed response personnel, and guards shall be trained, equipped, and qualified for use of their assigned weapons in accordance with paragraphs (b)(6) and (b)(7) of this section. Tactical Response Team members, armed response personnel, and guards shall also be trained and qualified in accordance with paragraph (b)(10) of this section. Upon the request of an authorized representative of the Commission, the licensee shall demonstrate the ability of the physical security personnel, whether licensee or contractor employees, to carry out their assigned duties and responsibilities. Each Tactical Response Team member, armed response person, and guard, whether a licensee or contractor employee, shall requalify in accordance with appendix B of this part. Tactical Response Team members, armed response personnel, and guards shall also requalify in accordance with paragraph (b)(7) of this section at least once every 12 months. The licensee shall document the results of the qualification and requalification. The licensee shall retain the documentation of each qualification and requalification as a record for 3 years after each qualification and requalification.
(5) Within any given period of time, a member of the security organization may not be assigned to, or have direct operational control over, more than one of the redundant elements of a physical protection subsystem if such assignment or control could result in the loss of effectiveness of the subsystem.
(6) Each guard shall be armed with a handgun, as described in appendix B of this part. Each Tactical Response Team member shall be armed with a 9-mm semiautomatic pistol. All but one member of the Tactical Response Team shall be armed additionally with either a shotgun or semiautomatic rifle, as described in appendix B of this part. The remaining member of the Tactical Response Team shall carry, as an individually assigned weapon, a rifle of no less caliber than .30 inches or 7.62 mm.
(7) In addition to the weapons qualification and requalification criteria of appendix B of this part, Tactical Response Team members, armed response personnel, and guards shall qualify and requalify, at least every 12 months, for day and night firing with assigned weapons in accordance with appendix H of this part. Tactical Response Team members, armed response personnel, and guards shall be permitted to practice fire prior to qualification and requalification but shall be given only one opportunity to fire for record on the same calendar day. If a Tactical Response Team member, armed response person, or guard fails to qualify or requalify, the licensee shall remove the individual from security duties which require the use of firearms and retrain the individual prior to any subsequent attempt to qualify or requalify. If an individual fails to qualify or requalify on two successive attempts, he or she shall be required to receive additional training and successfully fire two consecutive qualifying scores prior to being reassigned to armed security duties.
(i) In addition, Tactical Response Team members, armed response personnel, and guards shall be prepared to demonstrate day and night firing qualification with their assigned weapons at any time upon request by an authorized representative of the NRC.
(ii) The licensee or the licensee's agent shall document the results of weapons qualification and requalification for day and night firing. The licensee shall retain the documentation of each qualification and requalification as a record for 3 years after each qualification and requalification.
(8) In addition to the training requirements contained in appendix B of this part, Tactical Response Team members shall successfully complete training in response tactics. The licensee shall document the completion of training. The licensee shall retain the documentation of training as a record for three years after training is completed.
(9) The licensee shall conduct Tactical Response Team and guard exercises to demonstrate the overall security system effectiveness and the ability of the security force to perform response and contingency plan responsibilities and to demonstrate individual skills in assigned team duties. The licensee shall use these exercises to demonstrate its capability to respond to attempts of theft or diversion of strategic special nuclear material. On an annual basis, each shift that implements the safeguards contingency plan and licensee protective strategy must participate in two tactical response drills, one of which must test security response using the minimum necessary response force and a mock adversary team to execute the scenario. Every 3 years, each shift that implements the safeguards contingency plan and licensee protective strategy must participate in one force-on-force exercise. The licensee must conduct at least one force-on-force exercise annually. Force-on-force exercises conducted to satisfy the NRC triennial evaluation requirement can be used to satisfy the annual force-on-force requirement for the personnel that participate in the capacity of the security response organization. The licensee shall document the results of all exercises. The licensee shall retain the documentation of each exercise as a record for three years after each exercise is completed.
(10) In addition to the medical examinations and physical fitness requirements of paragraph I.C of appendix B of this part, each Tactical Response Team member, armed response person, and guard, except as provided in paragraph (b)(10)(v) of this section, shall participate in a physical fitness training program, to include a
(i) The licensee must administer a physical fitness test to all Tactical Response Team members, armed response personnel, and guards once every 6 months. Individuals who exceed 6 months without having been administered the test due to excused time off from work must be tested within 15 calendar days of returning to duty as a Tactical Response Team member, armed response person, or guard.
(ii) The physical fitness test must address the physical capabilities needed by armed response personnel during strenuous tactical engagements, and include physical exertion, levels of stress, and exposure to the elements as they pertain to each individual's assigned security duties for both normal and emergency operations. The test must simulate site specific conditions under which the individual will be required to perform assigned duties and responsibilities.
(iii) The licensee shall give Tactical Response Team members, armed response personnel, and guards a medical examination including a determination and written certification by a licensed physician that there are no medical contraindications, as disclosed by the medical examination, to participate in the physical fitness test. The medical examination must be given within 30 days prior to the first administration of the physical fitness test, and on an annual basis thereafter.
(iv) Licensees may temporarily waive an individual's participation in the physical fitness test on the advice of the licensee's examining physician, during which time the individual may not be assigned duties as a Tactical Response Team member, armed response person, or guard.
(v) Guards whose duties are to staff the central or secondary alarm station and those who control exit or entry portals are exempt from the physical fitness training program specified in paragraph (b)(10) of this section, provided that they are not assigned temporary response guard duties.
(vi) The licensee shall place Tactical Response Team members, armed response persons, and guards, who do not meet the licensee-established qualification criteria, in a monitored remedial physical fitness training program and relieve them of security duties until they satisfactorily meet the licensee-established qualification criteria.
The revisions read as follows:
(a)
(1) Under a specific license issued pursuant to part 72 of this chapter:
(i) At an independent spent fuel storage installation (ISFSI) or
(ii) At a monitored retrievable storage (MRS) installation; or
(2) At a geologic repository operations area (GROA) licensed pursuant to part 60 or 63 of this chapter; or
(3) Under a general license issued pursuant to part 72 of this chapter:
(i) When a separate protected area is established outside of an existing protected area for the purpose of storage of spent fuel and a submittal has been made to the NRC under the provisions of § 72.212(b)(9)(iv)(C) of this chapter; or
(ii) Upon the NRC's docketing of the certifications required under § 50.82(a)(1) of this chapter or § 52.110(a) of this chapter or § 53.1070(a) of this chapter, when all spent fuel has been placed in dry cask storage at the facility, and a submittal has been made to the NRC under the provisions of § 72.212(b)(9)(iv)(C) of this chapter.
(b) * * *
(1) Each licensee subject to this section shall establish and maintain a physical protection system with the objective of providing reasonable assurance that activities involving spent nuclear fuel and high-level radioactive waste do not constitute an unreasonable risk to public health and safety.
(a) Each licensee subject to the requirements of this section shall provide reasonable assurance that digital computer and communication systems and networks are adequately protected against cyberattacks, up to and including the design basis threat as described in § 73.1.
(1) The licensee shall protect digital computer and communication systems and networks associated with:
(i) Safety-related and important-to-safety functions;
(ii) Security functions;
(iii) Emergency preparedness functions, including offsite communications; and
(iv) Support systems and equipment which, if compromised, would adversely impact safety, security, or emergency preparedness functions.
(2) The licensee shall protect the systems and networks identified in paragraph (a)(1) of this section from cyberattacks that would:
(i) Adversely impact the integrity or confidentiality of data and/or software;
(ii) Deny access to systems, services, and/or data; and
(iii) Adversely impact the operation of systems, networks, and associated equipment.
(b) To accomplish this, the licensee shall:
(1) Analyze digital computer and communication systems and networks and identify those assets that must be protected against cyberattacks to satisfy paragraph (a) of this section; and
(2) Establish, implement, and maintain a cybersecurity program for the protection of the assets identified in paragraph (b)(1) of this section.
(3) [Reserved]
(c) The cybersecurity program must be designed to:
(1) Implement security controls to protect the assets identified by paragraph (b)(1) of this section from cyberattacks;
(2) Apply and maintain defense-in-depth protective strategies to ensure the capability to detect, respond to, and recover from cyberattacks;
(3) Mitigate the adverse effects of cyberattacks; and
(4) Ensure that the functions of protected assets identified by paragraph (b)(1) of this section are not adversely impacted due to cyberattacks.
(d) As part of the cybersecurity program, the licensee shall:
(1) Ensure that appropriate facility personnel, including contractors, are aware of cybersecurity requirements and receive the training necessary to perform their assigned duties and responsibilities.
(2) Evaluate and manage cyber risks.
(3) Ensure that modifications to assets, identified by paragraph (b)(1) of this section, are evaluated before implementation to ensure that the cybersecurity performance objectives
(4) Conduct cybersecurity event notifications in accordance with the provisions of § 73.77.
(e) The licensee shall establish, implement, and maintain a cybersecurity plan that implements the cybersecurity program requirements of this section.
(1) 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.
(2) The cybersecurity plan must include measures for incident response and recovery for cyberattacks. The cybersecurity plan must describe how the licensee will:
(i) Maintain the capability for timely detection and response to cyberattacks;
(ii) Mitigate the consequences of cyberattacks;
(iii) Correct exploited vulnerabilities; and
(iv) Restore affected systems, networks, and/or equipment affected by cyberattacks.
(f) The licensee shall develop and maintain written policies and implementing procedures to implement the cybersecurity plan. Policies, implementing procedures, site-specific analysis, 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.
(g) The licensee 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.
(h) The licensee shall retain all records and supporting technical documentation required to satisfy the requirements of this section as a record until the Commission terminates the license for which the records were developed, and shall maintain superseded portions of these records for at least three (3) years after the record is superseded, unless otherwise specified by the Commission.
(a)
(1) Each licensee that is licensed to operate a nuclear power plant under 10 CFR part 50 and each holder of a combined license under 10 CFR part 52 must identify achievable target sets in accordance with § 73.55(f) and develop, implement, and maintain a physical protection program under the following requirements:
(i) Each licensee that demonstrates no achievable target sets exist in accordance with § 73.55(f), and does not credit any active measures (
(ii) Each licensee that demonstrates no achievable target sets exist in accordance with § 73.55(f), and credits active measures in making that demonstration, must implement the requirements of this section through its physical security plan, training and qualification plan, safeguards contingency plan, and cybersecurity plan, referred to collectively hereafter as “security plans,” before initial fuel load into the reactor (or, for a fueled manufactured reactor, before initiating the removal of features to prevent criticality); for such licensees, the requirements of § 73.55(b)(2) and (b)(3) shall be deemed satisfied if the physical protection program is designed to ensure that the credited active measures will be implemented in response to threats up to and including the design basis threat of radiological sabotage or,
(iii) Each licensee that demonstrates achievable target sets exist, in accordance with § 73.55(f), must implement the requirements of this section through its physical security plan, training and qualification plan, safeguards contingency plan, and cybersecurity plan, referred to collectively hereafter as “security plans,” before initial fuel load into the reactor (or, for a fueled manufactured reactor, before initiating the removal of the features to prevent criticality).
(2) The implementation of security plans must identify, analyze, describe, and account for site-specific conditions, including target sets that affect the licensee's capability to satisfy the requirements of this section.
(i) The security plans must describe how the performance objective and requirements set forth in this section will be implemented.
(ii) The licensee must protect the security plans and other security-related information against unauthorized disclosure in accordance with the requirements of § 73.21.
(3) The licensee is responsible for maintaining the onsite physical protection program in accordance with Commission regulations through the implementation of security plans and written security implementing procedures.
(b)
(1) The licensee must establish, implement, and maintain a physical protection program and a security organization, which will have as its 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) 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.
(3) The physical protection program must be designed to prevent a release of radionuclides from any source that exceeds the dose reference values defined in § 50.34(a)(1)(ii)(D)(
(i) Ensure that the capabilities to detect, assess, interdict, and neutralize threats up to and including the design basis threat of radiological sabotage as stated in § 73.1, are maintained at all times.
(ii) Provide defense in depth in achieving performance requirements through the integration of engineered systems, technologies, administrative
(iii) For licensee physical protection programs that rely upon design and engineered security features to meet the requirements of this section, ensure that the reliability and availability of the structures, systems, and components (SSCs) for demonstrating compliance are maintained at all times.
(4) Upon the request of an authorized representative of the Commission, the licensee must demonstrate the ability to meet Commission requirements through the implementation of the physical protection program, including the ability of armed and unarmed personnel to perform assigned duties and responsibilities required by the security plans and licensee procedures.
(5) The licensee must establish, maintain, and implement a performance evaluation program in accordance with appendix B to this part, to demonstrate and assess the effectiveness of armed responders and armed security officers to implement the licensee's protective strategy.
(i) For licensees that rely upon SSCs in accordance with paragraph (b)(3)(iii) of this section, the performance evaluations must include methods appropriate and necessary to assess, test, and challenge the integration of the physical protection program's functions to protect against the design basis threat, including measures to protect against cyberattack and engineered systems designed to protect against the design basis threat standalone ground vehicle bomb attack.
(A) The licensee must establish the frequencies for performance evaluations of the engineered security features commensurate with their security significance to the physical protection program.
(B) The licensee must document processes and procedures for implementing the performance evaluations. The licensee must maintain records, including results, findings, and corrective actions identified during the performance evaluations.
(ii) [Reserved]
(6) The licensee must establish, maintain, and implement an access authorization program in accordance with § 73.56 and must describe the program in the Physical Security Plan.
(7) The licensee must establish, maintain, and implement a cybersecurity program in accordance with § 73.54 or § 73.110 and must describe the program in the cybersecurity plan.
(8) The licensee must establish, maintain, and implement an insider mitigation program and must describe the program in the Physical Security Plan.
(i) The insider mitigation program must monitor the initial and continuing trustworthiness and reliability of individuals granted or retaining unescorted access authorization to a protected or vital area, and implement defense-in-depth methodologies to minimize the potential for an insider (active, passive, or both) to adversely affect, either directly or indirectly, the licensee's capability to protect against the design basis threat of radiological sabotage as described in 10 CFR 73.55(b)(3).
(ii) The insider mitigation program must contain elements from:
(A) The access authorization program described in § 73.56;
(B) The fitness-for-duty program described in part 26 of this chapter;
(C) The cybersecurity program described in § 73.54 or § 73.110; and
(D) The physical protection program described in this section.
(9) The licensee must track, trend, correct and prevent recurrence of failures and deficiencies in the implementation of the requirements of this section.
(10) 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.
(11)(i) The licensee must ensure that the firearms background check requirements of § 73.17 are met for all members of the security organization whose official duties require access to covered weapons or who inventory enhanced weapons.
(ii) The provisions of this paragraph are only applicable to licensees subject to this section that are also subject to the firearms background check provisions of § 73.17.
(c)
(1) The licensee must have a management system to provide for the development, implementation, revision, and oversight of security policies and procedures that implement Commission requirements and the security plans.
(i) Implementing procedures must document the conduct of security operations, maintenance, training and qualification, contingency responses, and as applicable security design and configuration controls.
(ii) The revisions to security implementing procedures must satisfy the requirements of this section.
(2) [Reserved]
(d)
(1) The licensee must establish and maintain a security organization that is staffed, trained, qualified, and equipped to implement the physical protection program under the requirements of this section, section VI of appendix B of this part, and the security plans.
(2) The security organization must include at least one member, onsite and available at all times, who has the authority to direct the activities of the security organization and who is assigned no other duties that would interfere with this individual's ability to perform these duties in accordance with the security plans and the licensee protective strategy.
(3) As applicable, the licensee must—
(i) Establish a process for the approval of designs, policies, processes, and procedures and changes by the individual with overall responsibility for the physical protection program; and
(ii) Ensure that revisions and changes to the physical protection program and implementing policies, processes, and procedures satisfy the requirements of this section.
(e)
(1) Each licensee must implement physical barriers as needed to satisfy the physical protection program design requirements of § 73.55(b). The licensee must identify and analyze site-specific conditions to determine the specific use, type, function, and placement of the physical barriers.
(2) Consistent with the stated function to be performed, openings in any barrier or barrier system established to meet the requirements of this section must be secured and monitored to prevent exploitation of the opening.
(3) Bullet resisting physical barriers. The reactor control room, the central alarm station, and the location within which the last access control function for access to the protected area is performed must be bullet-resisting.
(4) Protected area.
(i) The protected area perimeter must be protected by physical barriers that are designed and constructed to limit access into the protected area to only those personnel, vehicles, and materials required to perform official duties.
(ii) All exterior areas within the protected area, except for areas that must be excluded for safety reasons, must be periodically checked to detect and deter unauthorized personnel, vehicles, and materials.
(5) Vital areas.
(i) Vital equipment must be located only within vital areas, which must be located within a protected area so that access to vital equipment requires
(ii) At a minimum, the following must be considered vital areas, as applicable:
(A) The reactor control room;
(B) The spent fuel pool; and
(C) The central alarm station.
(iii) At a minimum, the following shall be located within a vital area:
(A) The secondary power supply systems for alarm annunciation equipment; and
(B) The secondary power supply systems for non-portable communications equipment.
(6) Land and waterborne vehicle control measures. Consistent with the physical protection program design requirements of § 73.55(b), and in accordance with the site-specific analysis, the licensee must establish and maintain as applicable, land and waterborne vehicle control measures, as necessary, to protect against the design basis threat of radiological sabotage land and waterborne vehicle bomb assaults.
(i) Licensee must provide periodic surveillance and observation of land and waterborne vehicle barrier systems adequate to detect indications of tampering and degradation or to otherwise ensure that each vehicle barrier and barrier system is able to satisfy the intended function.
(ii) [Reserved]
(f)
(1) The licensee must identify complete and accurate target sets. Preventative operator actions may be credited as target set elements when: sufficient time to implement exists; environmental conditions allow operator actions to be completed successfully; adversary interference is precluded; all equipment required for operator actions is available, dedicated, staged, and maintained; approved procedures exist specific to the task being performed; and training is maintained for proficiency of the credited operator action.
(2) The identification of target sets must not assume the success of the security organization; except that licensees may consider delay provided by the security organization when assessing the availability of operator actions.
(3) The licensee must consider cyberattacks in the identification of target sets.
(4) The licensee must identify and analyze site-specific conditions, including achievable target sets, that may affect the physical protection program needed to implement the requirements of this section. The licensee must account for these conditions in demonstrating compliance with the requirements of this section.
(5) The licensee must document and maintain the process used to identify achievable target sets, to include the site-specific analyses and methodologies used to determine and group the target set equipment or elements, including elements not contained in a protected or vital area.
(6) The licensee must further identify achievable target sets through site-specific analyses. Achievable target sets are described by the following conditions:
(i) Are within the capabilities of the design basis threat adversary to compromise, destroy, or render non-functional;
(ii) Cannot be mitigated after adversary interference is precluded and prior to a release of radionuclides exceeding dose reference values defined in § 50.34(a)(1)(ii)(D)(
(iii) If defeated, result irreversibly in exceedance of the dose reference values defined in § 50.34(a)(1)(ii)(D)(
(7) 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.
(8) The licensee must maintain the site-specific analyses for achievable target sets as a record in accordance with paragraph (q) of this section.
(g)
(1) Barriers.
(i) Consistent with the function of each barrier or barrier system, the licensee must control personnel, vehicle, and material access, as applicable, at each access control point in accordance with the physical protection program design requirements of § 73.55(b).
(ii) As applicable, the licensee must assign an individual the responsibility for the last access control function (controlling admission to the protected area) in accordance with § 73.55(e)(3).
(2) Protected areas.
(i) Before granting access into the protected area, the licensee must:
(A) Confirm the true identity of individuals.
(B) Verify the authorization for access of individuals, vehicles, and materials.
(C) Confirm, in accordance with industry shared lists and databases that individuals are not currently denied access to another licensed facility.
(D) Search individuals, vehicles, and materials in accordance with paragraph (h) of this section.
(ii) [Reserved]
(3) Vehicles in the protected area.
(i) The licensee must exercise control over all vehicles inside the protected area to ensure that they are used only by authorized persons and for authorized purposes.
(ii) Vehicles transporting hazardous materials inside the protected area must be escorted by an armed member of the security organization.
(4) Vital areas.
(i) Licensees must control access into vital areas consistent with access authorization lists.
(ii) In response to a site-specific credible threat or other credible information, implement a two-person (line-of-sight) rule for all personnel in vital areas so that no one individual is permitted access to a vital area.
(5) Emergency or exigent conditions.
(i) The licensee shall design the access control system to accommodate the potential need for rapid ingress or egress of authorized individuals during emergency conditions or situations that could lead to emergency conditions.
(ii) In instances where licensees need to manage exigent circumstances, licensees can permit access in accordance with paragraphs (g)(7) and (8) of this section.
(6) Access control devices.
(i) The licensee must control all keys, locks, combinations, passwords and related access control devices used to control access to protected areas, vital areas and security systems to reduce the probability of compromise.
(ii) The licensee must implement a personnel identification system for all individuals authorized unescorted access to the protected area and vital areas.
(7) Visitors.
(i) The licensee may permit escorted access to protected and vital areas to individuals who have not been granted unescorted access in accordance with the requirements of § 73.56 and part 26 of this chapter. The licensee must:
(A) Implement procedures for processing, escorting, and controlling visitors.
(B) Confirm the identity of each visitor through physical presentation of a recognized identification card issued by a local, State, or Federal government agency that includes a photo or contains physical characteristics of the individual requesting escorted access.
(ii) Individuals not employed by the licensee but who require frequent or extended unescorted access to the protected area and/or vital areas to
(8) Escorts.
(i) The licensee must ensure that all escorts are trained to perform escort duties and provided a means of timely communication with security personnel to summon assistance when needed.
(ii) Each licensee must describe visitor to escort ratios for the protected area and vital areas in physical security plans. Implementing procedures must provide necessary observation and control requirements for all visitor activities.
(h)
(1) The licensee must establish and implement searches through the use of technology or personnel to detect, deter, and prevent the introduction of unauthorized firearms, explosives, incendiary devices, or other items which could be used to commit radiological sabotage. The licensee must search individuals, vehicles, and materials consistent with the physical protection program design requirements in paragraph (b) of this section, and the function to be performed at each access control point or portal before granting access into the protected area, and where necessary to meet the performance objectives, in the owner controlled area.
(i) Licensees that meet the requirements of § 73.55(b)(3)(iii) must be capable of detecting and denying unauthorized access to persons and pass-through of contraband materials (
(ii) For each vehicle access portal, the licensee must describe in implementing procedures areas of a vehicle to be searched before access is granted. Areas of the vehicle to be searched must include, but are not limited to, the cab, engine compartment, undercarriage, and cargo area.
(iii) Searches at vehicle access control points must be monitored to ensure that a response can be initiated if needed.
(2) Prior to granting access to the protected area, licensees must search all personnel, vehicles and materials to meet the requirements of § 73.55(h)(1) and ensure that all items are clearly identified.
(i) The licensee must subject all persons to search upon entry to the protected area except for official Federal, State, and local law enforcement personnel on official duty or individuals under the active protection of the United States Secret Service. Armed response personnel who are on duty and have exited the protected area may re-enter the protected area without being searched for firearms.
(ii) Exceptions to the protected area search requirements for materials may be granted for safety or operational reasons provided the design criteria of § 73.55(b) are satisfied, the materials are clearly identified, the types of exceptions to be granted are described in the security plans, and the specific security measures to be implemented for excepted items are detailed in site procedures.
(iii) To the extent practicable, excepted materials must be positively controlled, stored in a locked area, and opened at the final destination by an individual familiar with the items.
(iv) Bulk material excepted from the protected area search requirements must be escorted by an armed member of the security organization to its final destination or to a receiving area where the excepted items are offloaded and verified.
(v) To the extent practicable, bulk materials excepted from search must not be offloaded adjacent to a vital area.
(i)
(1) The licensee must establish and maintain intrusion detection and assessment systems that satisfy the design requirements of § 73.55(b) and provide, at all times, the capability to detect and assess unauthorized persons and facilitate the effective implementation of the licensee's protective strategy.
(2) Intrusion detection equipment must annunciate, and video assessment equipment must display concurrently, in at least two continuously staffed onsite alarm stations, at least one of which must be protected in accordance with the requirements of the central alarm station within this section.
(3) The licensee's intrusion detection and assessment systems must be designed to:
(i) Detect both attempted and actual penetration of the protected area perimeter barrier.
(ii) Provide real-time and play-back/recorded video images of the detected activities adjacent to the protected area perimeter barrier before and after each alarm annunciation.
(iii) Ensure that alarm devices to include transmission lines to annunciators are tamper indicating and self-checking.
(iv) Provide an automatic indication when the alarm system or a component of the alarm system fails, or when the system is operating on the backup power supply.
(v) Ensure intrusion detection and assessment equipment at the protected area perimeter remains operable from an uninterruptible power supply in the event of the loss of normal power.
(4) Alarm stations.
(i) Both alarm stations required by paragraph (i)(2) of this section must be designed and equipped to ensure that a single act, in accordance with the design basis threat of radiological sabotage defined in § 73.1(a)(1), cannot disable both alarm stations. The licensee must ensure the survivability of at least one alarm station to maintain the ability to perform the following functions:
(A) Detect and assess alarms;
(B) Initiate and coordinate an adequate response to an alarm;
(C) Summon offsite assistance; and
(D) Provide command and control.
(ii) Licensees must:
(A) Locate the central alarm station inside a protected area.
(B) Continuously staff each alarm station with at least one trained and qualified alarm station operator. The alarm station operator must not be assigned other duties or responsibilities which would interfere with the ability to execute the functions described in § 73.55(i)(4)(i) of this section.
(C) Ensure that an alarm station operator cannot change the status of a detection point or deactivate a locking or access control device at a protected or vital area portal, without the knowledge and concurrence of the alarm station operator in the other alarm station.
(D) Ensure that operators in both alarm stations are knowledgeable of the final disposition of all alarms.
(5) Surveillance, observation, and monitoring.
(i) The physical protection program must include surveillance, observation, and monitoring as needed to satisfy the design requirements of § 73.55(b), identify indications of tampering, or otherwise implement the site protective strategy.
(ii) [Reserved]
(6) Illumination.
(i) The licensee must ensure that all areas of the facility are provided with illumination, low-light, or other equivalent technology necessary to satisfy the design requirements of § 73.55(b) and implement the protective strategy.
(ii) [Reserved]
(j)
(1) The licensee must establish and maintain continuous communication capability with onsite and offsite resources to ensure effective command and control during both normal and emergency situations.
(2) A method of communication between alarm stations and security personnel must remain operable from independent power sources in the event of the loss of normal power.
(k)
(1) Response performance objective.
(i) The licensee must establish and maintain, at all times, properly trained, qualified and equipped personnel required to interdict and neutralize threats up to and including the design basis threat of radiological sabotage as defined in § 73.1, to prevent a release of radionuclides from any source from exceeding the dose reference values defined in § 50.34(a)(1)(ii)(D)(
(ii) [Reserved]
(2) Armed response personnel.
(i) The licensee must provide armed response personnel consisting of armed responders which may be augmented with armed security officers to carry out armed response duties within predetermined timelines specified by the site protective strategy.
(ii) [Reserved]
(3) Armed responders.
(i) The licensee must determine the minimum number of armed responders necessary to satisfy the design requirements of § 73.55(b) and implement the protective strategy. The licensee must document this number in the security plans.
(ii) Armed responders must be available at all times inside the protected area and may not be assigned other duties or responsibilities that could interfere with their assigned response duties.
(4) Armed security officers.
(i) Armed security officers, designated to strengthen onsite response capabilities, must be onsite and available at all times to carry out their assigned response duties.
(ii) The minimum number of armed security officers designated to strengthen onsite response capabilities must be documented in the security plans.
(5) Alternative response requirements.
(i) The licensee may fulfill the requirements of § 73.55(k)(1) through (4) through alternative means provided that the alternative is described in the physical security plan and that a technical basis is maintained for demonstrating compliance with the performance requirements of § 73.55(b).
(A) A licensee with prior approval by the Commission may entirely rely on law enforcement or other offsite armed responders.
(B) Structures, systems, and components relied on for delay functions must be designed to allow for timely security responses to adversary attacks with adequate defense in depth.
(ii) [Reserved]
(6) Offsite armed response personnel.
(i) A licensee relying entirely or partially on law enforcement or other off site armed responders must:
(A) Fully describe in the safeguards contingency plan the role that law enforcement or other offsite armed responders will implement in the licensee's protective strategy. The description must provide sufficient detail to enable the NRC to determine that the licensee's physical protection program provides reasonable assurance of adequate protection against threats up to and including the design basis threat of radiological sabotage; and
(B) The physical protection program must be designed to provide layers of security response, with each layer assuring that a single failure does not result in the loss of capability to neutralize the design basis threat adversary.
(C) Provide timely security response to interdict and neutralize adversary attacks up to and including the design basis threat of radiological sabotage.
(D) The security response may rely on the use of onsite responders, law enforcement or other offsite armed responders, or a combination thereof, to fulfill the interdiction and neutralization functions required by paragraph (b)(3)(i) of this section. A licensee relying entirely or partially on law enforcement or other offsite armed responders must—
(
(
(
(
(
(ii) [Reserved]
(7) Protective strategy.
(i) The licensee must establish, maintain, and implement a written protective strategy in accordance with the requirements of this section and part 73, appendix C, section II. Upon receipt of an alarm or other indication of a threat, the licensee must implement its safeguards contingency plan.
(ii) [Reserved]
(8) Law enforcement liaison.
(i) To the extent practicable, licensees must document and maintain current agreements with applicable law enforcement agencies to include estimated response times and capabilities.
(ii) [Reserved]
(9) Heightened security.
(i) Licensees must establish, maintain, and implement a threat warning system which identifies specific graduated protective measures and actions to be taken to increase licensee preparedness against a heightened security threat.
(ii) Licensees must ensure that the specific protective measures and actions identified for each threat level are consistent with the security plans and other emergency plans and procedures.
(iii) Upon notification by an authorized representative of the Commission, licensees must implement the specific threat level indicated by the Commission representative.
(l)
(1) The licensee must assess and manage the potential for adverse effects on safety and security, including the site emergency plan, before implementing changes to plant configurations, facility conditions, or security.
(2) [Reserved]
(m)
(1) The licensee must establish and implement security reviews to assess the effectiveness of the implementation of the physical protection program. Security reviews must be performed by individuals independent of those personnel responsible for program management and any individual who has direct responsibility for implementing the onsite physical protection program.
(2) The licensee must review each element of the physical protection
(3) The licensee must establish and perform self-assessments to ensure the effective implementation of the physical protection program functions of detection, assessment, communication, delay, and interdiction and neutralization to protect against the design basis threat of radiological sabotage. As applicable, the licensee must perform design verification and assessments of the capabilities of active and passive engineering systems relied on to protect against the design basis threat.
(4) Reviews of the security program must include, but are not limited to, an audit of the effectiveness of the physical protection program, security plans, implementing procedures, cybersecurity programs, safety/security interface activities, the testing, maintenance, and calibration program, and response commitments by local, State, and Federal law enforcement authorities.
(5) The results and recommendations of the onsite physical protection 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.
(n)
(1) The licensee must:
(i) Establish, maintain, and implement a maintenance, testing and calibration program to ensure that security systems and equipment, including secondary and uninterruptible power supplies, are tested for operability and performance at predetermined intervals, maintained in operable condition, and are capable of performing their intended functions.
(ii) Describe the maintenance, testing and calibration program in the physical security plan. Implementing procedures must specify operational and technical details required to perform maintenance, testing, and calibration activities to include, but not limited to, purpose of activity, actions to be taken, acceptance criteria, and the intervals or frequency at which the activity will be performed.
(iii) The licensee must implement corrective actions to ensure resolution of identified vulnerabilities and deficiencies to satisfy the requirements of this section.
(iv) Security equipment or systems must be tested in accordance with the site maintenance, testing and calibration procedures before being placed back in service after each repair or inoperable state.
(2) [Reserved]
(o)
(1) The licensee must identify criteria and measures to compensate for degraded or inoperable equipment, systems, and components to meet the requirements of this section.
(2) Compensatory measures must provide a level of protection that is equivalent to the protection that was provided by the degraded or inoperable, equipment, system, or components.
(3) Compensatory measures must be implemented within specific time frames necessary to meet the requirements stated in paragraph (b) of this section and described in the security plans.
(p)
(1) The licensee may suspend implementation of affected requirements of this section under the following conditions:
(i) In accordance with §§ 50.54(x) and 50.54(y) or § 53.740(h) of this chapter, the licensee may suspend any security measures under this section 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. This suspension of security measures must be approved as a minimum by a licensed senior operator or a generally licensed reactor operator before taking this action.
(ii) During severe weather, the licensee may suspend any security measures under this section when this action is immediately needed to protect the personal health and safety of security force personnel and no other immediately apparent action consistent with the license conditions and technical specifications can provide adequate or equivalent protection. This suspension of security measures must be approved, as a minimum, by a licensed senior operator or a generally licensed reactor operator, as applicable, with input from the security supervisor or manager, before taking this action.
(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 part.
(q)
(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) The licensee must retain, in accordance with § 73.70, all analyses, assessments, calculations, and descriptions of the technical basis for demonstrating compliance with the performance requirements of this section. The licensee must protect these records in accordance with the requirements for protecting safeguards information in §§ 73.21 and 73.22.
(4) 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.
(5) Review and audit reports must be maintained and available for inspection, for a period of 3 years.
(r)
(1) The Commission may authorize an applicant or licensee to provide a measure for protection against radiological sabotage other than one required by this section if the applicant or licensee demonstrates that:
(i) The measure meets the same performance objectives and requirements specified in paragraph (b) of this section; and
(ii) The proposed alternative measure provides protection against radiological sabotage equivalent to that which would be provided by the specific requirement for which it would substitute.
(2) The licensee must submit proposed alternative measure(s) to the Commission for review and approval in accordance with § 50.4 and § 50.90, or § 53.040 and § 53.1510 of this chapter before implementation.
(3) In addition to fully describing the desired changes, the licensee must
(4) The licensee may implement alternatives from the following specific requirements through the use of technology, without prior Commission approval, provided that the alternative is described in the physical security plan and that a technical basis is maintained for demonstrating compliance with the performance requirements of § 73.55(b):
(i) The requirement in paragraph (d)(2) of this section that a member of the security organization who has the authority to direct the activities of the security organization be onsite at all times;
(ii) The requirement in paragraph (e)(3) of this section that the reactor control room, the central alarm station, and the location within which the last access control function for access to the protected area is performed be bullet-resisting.
The revisions and additions to read as follows:
(a) * * *
(1) Except as described in § 73.120(a), each applicant for an operating license under the provisions of part 50 of this chapter, each holder of a combined license under the provisions of part 52 of this chapter, and each applicant for an operating license or holder of a combined license under part 53 of this chapter must implement the requirements of this section before initial fuel load into the reactor (or, for a fueled manufactured reactor, before initiating the removal of features to prevent criticality).
(c)
(d) * * *
(3)
(h) * * *
(4) * * *
(ii) * * *
(B)
(i) * * *
(1) * * *
(iv) The individual's supervisor interacts with the individual with a frequency that allows the supervisor to form an informed and reasonable opinion regarding the individual's behavior, trustworthiness, and reliability; or the individual is subject to an annual (within 365 calendar days) supervisory review conducted in accordance with the requirements of the licensee's or applicant's behavioral observation program.
(v) * * *
(A) A criminal history update for any individual with unescorted access. The criminal history update must be completed within 5 years of the date on which these elements were last completed or, for licensees or approved applicants that participate in a U.S. Government monitoring and notification program through a Memorandum of Understanding with the NRC, within 10 years of the date on which these elements were last completed.
(B) For individuals who perform one or more of the job functions described in this paragraph that are critical to the safe and secure operation of the facility, the trustworthiness and reliability determination must be based on a criminal history update within 5 years of the date on which these elements were last completed or, for licensees or approved applicants that participate in a U.S. Government monitoring and notification program through a Memorandum of Understanding with the NRC, within 10 years of the date on which these elements were last completed, or more frequently, based on job assignment as determined by the licensee or applicant; and a psychological re-assessment within 5 years of the date on which this element was last completed:
(
(j)
(b) * * *
(2) * * *
(v) Individuals who have a valid unescorted access authorization to a non-power reactor facility on November 7, 2012, are not required to undergo a new fingerprint-based criminal history records check pursuant to paragraph (g) of this section, until such time that the existing authorization expires, is terminated, or is otherwise to be renewed.
(j) Representatives of the International Atomic Energy Agency (IAEA) who have been certified by the NRC;
(b) * * *
(1) * * *
(i) Special nuclear material which is not readily separable from other radioactive material and which has a total external radiation level more than 1 gray (100 rad) per hour at 1 meter (3.3 feet) from any accessible surface without intervening shielding, or
(d)
(1)(i) Store or use the material only within a controlled access area;
(ii) Provide prompt detection and assessment of unauthorized access or activities by an external adversary within the controlled access area,
(iii) Provide prompt detection of removal of special nuclear material by an external adversary from a controlled access area.
(iv) Mitigate the risk of bulk theft of special nuclear material;
(v) Delay an external adversary from completing a bulk theft of special nuclear material sufficiently to allow response forces to impede the adversary and facilitate recovering the special nuclear material;
(vi) Analyze and identify in the security plan site-specific conditions that may affect the specific measures needed to implement the requirements of this subpart and must account for these conditions in the design of the physical protection program;
(vii) Provide defense-in-depth through the integration of systems, technologies, programs, equipment, supporting processes, and security implementing procedures as needed to ensure the effectiveness of the physical protection program;
(viii) Coordinate the implementation of the security plan and associated procedures with other onsite plans and procedures to preclude conflict during normal conditions and minimize conflict during emergency conditions;
(ix) Assess and manage the potential for adverse effects on safety, security, and material control and accounting before implementing changes to facility configurations, facility conditions, or security;
(x) Communicate potential conflicts among safety, security, and material control and accounting to appropriate licensee personnel and take compensatory and/or mitigating actions to maintain safety, security, and material control and accounting at the facility.
(2) In addition, the licensee must:
(i) Establish and maintain written response procedures for dealing with threats of thefts or thefts of Category II quantities of SNM.
(ii) Provide a process for the written approval of security implementing procedures and revisions by an individual with overall responsibility for the physical protection program.
(iii) Identify and analyze site-specific conditions to determine the specific use, type, function, and placement of physical barriers needed to delay an external adversary from removal of special nuclear material and completing a vehicle-assisted bulk theft of special nuclear material to allow response forces to impede the adversary or facilitate recovery of the special nuclear material.
(iv) Establish an access authorization program to include a background investigation to ensure that the individuals granted unescorted access to special nuclear material are trustworthy and reliable. The background investigation must include at a minimum:
(A) Consideration of criminal history based on fingerprinting and an FBI identification and criminal history records check in accordance with § 73.57;
(B) Verification of the true identity of the individual who is applying for unescorted access to ensure that the applicant is who he or she claims to be;
(C) Verification of employment history, including military history;
(D) Verification of the individual's educational history; and
(E) Consideration of an individual's character and reputation determination.
(v) Monitor with an intrusion alarm or other device or procedures the controlled access areas to detect unauthorized penetration or activities involving Category II quantities of SNM.
(vi) Provide surveillance, observation, and monitoring, as needed, to satisfy the general performance objective and requirements, and identify indications
(vii) Establish and maintain continuous communication capability with onsite and offsite resources to ensure effective command and control during both normal and emergency situations.
(viii) To the extent practicable, document and maintain current agreements with applicable law enforcement agencies to include estimated response times and capabilities. In addition, the licensee must provide necessary information about the site and nuclear material locations and make available periodic training to law enforcement to support response actions.
(ix) Establish, implement, and maintain a threat warning system that identifies specific graduated protective measures and actions to be taken to increase licensee preparedness against a heightened security threat.
(x) Upon receipt of an alarm or other indication of a threat, determine the existence and level of the threat in accordance with pre-established assessment methodologies, initiate response actions to promptly detect attempts to remove SNM and notify local law enforcement agencies to recover SNM in accordance with security implementing procedures.
(xi) Review each element of the physical protection program:
(A) At least every 24 months;
(B) More frequently as necessary based upon site-specific analysis, assessments, or other performance indicators; and
(C) Within 12 months following initial implementation of the physical protection program or a change in personnel, procedures, equipment, or facilities that could adversely affect security.
(xii) Establish, maintain, and implement a maintenance, testing, and calibration program to ensure that physical protection systems and equipment, including secondary and uninterruptible power supplies, are tested for operability and performance at predetermined intervals, maintained in operable condition, and can perform their intended functions.
(xiii) Identify criteria and measures to compensate for degraded or inoperable equipment, systems, and components of the physical protection program.
(A) Compensatory measures must provide a level of protection that is equivalent to the protection that was provided by the degraded or inoperable equipment, systems, or components, when fully functional.
(B) Compensatory measures must be implemented within specific timeframes necessary to meet the general performance objective and requirements and described in the security plan.
(C) Compensatory measures must not be used in lieu of performing timely repair on the degraded or inoperable equipment, systems, or components.
(xiv) Maintain all reports, records, or documents 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.
(A) The Commission may inspect, copy, and retain copies of 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.
(B) 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.
(C) Review and audit reports must be maintained and available for inspection, for a period of 3 years.
(3) In addition to the fixed-site requirements set forth in this section, the Commission may incorporate or eliminate, depending on the individual facility and site conditions, any existing, alternate, or additional measures deemed necessary to protect against theft or diversion of Category II special nuclear material.
(4)
(i) The licensee must submit the proposed alternative measures to the Commission for review and approval in accordance with § 50.90, § 53.1510, or § 70.34 of this chapter, as applicable, before implementation.
(ii) In addition to fully describing the desired changes, the licensee must submit a technical basis for each proposed alternative measure. The basis must include an analysis or assessment that demonstrates how the proposed alternative measure provides a level of protection that is at least equal to that which would otherwise be provided by the specific requirement of this subpart for which the alternative measure is proposed.
(f)
(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 § 53.1630 of this chapter or § 73.1200 of this part 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 NRC shall be notified using one of the following applicable methods:
(1) Follow up notification process as specified in § 50.72 or § 53.1630 of this chapter;
(2) Significant supplemental information process as specified in § 73.1200 of this part; or
(3) Submission of a Licensee Event Report as specified in § 50.73 or § 53.1640 of this chapter, or § 73.1205 of this part.
(a) * * *
(1) Each licensee that is licensed to operate a commercial nuclear plant
(a) Each licensee that is licensed to operate a commercial nuclear plant under 10 CFR part 53 and elects to implement the requirements of this section, and each licensee that is licensed to operate a nuclear power plant under 10 CFR part 50 or 52 after [EFFECTIVE DATE] 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 of this part. 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), § 52.47(a)(2)(iv), or § 53.210 of this chapter, as applicable.
(2) Adversely impacting the security functions performed by digital assets necessary for implementing the physical security requirements in § 53.860(a) of this chapter or § 73.55 of this part, 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 which if compromised adversely impact these functions), the licensee must— * * *
(a)
(1) Each applicant for or holder of an operating license or combined license under part 50, 52, or 53 of this chapter, who demonstrates compliance with § 73.55(a)(1)(i) or § 73.100(a)(1)(i), as applicable, must establish, maintain, and implement an access authorization program that meets the requirements of this section before initial fuel load into the reactor (or, for a fueled manufactured reactor, before initiating the removal of features to prevent criticality).
(2) The licensee or applicant may accept, in part or whole, an access authorization program implemented by a contractor or vendor to satisfy appropriate elements of their access authorization program in accordance with the requirements of this section. Only a licensee may grant an individual unescorted access, and only a licensee or applicant may certify an individual's unescorted access authorization. Licensees and applicants are responsible for maintaining, denying, terminating, or withdrawing unescorted access authorization.
The revisions and additions to read as follows:
(b) * * *
(3) * * *
(ii) Briefly describe the nature of the hostile action or event, including:
(A) Type of hostile action or event (
(B) The current status (
(c) * * *
(1) * * *
(i) Any event in which there is reason to believe that a person has committed or caused, or attempted to commit or cause, or has made a threat to commit or cause:
(A) The theft or diversion of a Category I, II, or III quantity of SSNM; a Category II or III quantity of special nuclear material (SNM); SNF; or HLW;
(B) Significant physical damage to any nuclear power reactor, to a facility possessing a Category I or II quantity of SSNM, or to a facility storing or disposing of SNF and/or HLW;
(C) The unauthorized operation, manipulation, or tampering with any nuclear power reactor's controls or with structures, systems, and components (SSCs) that results in the interruption of normal operation of the reactor; or
(D) The unauthorized operation, manipulation, or tampering with any Category I SSNM facility's SSCs that results in an accidental criticality.
(e) * * *
(1) * * *
(iv) The attempted introduction of contraband into a PA, VA, or MAA;
(v) The discovery that a weapon that is authorized by the licensee's security plan is lost within a PA, VA, or MAA;
(2) An event related to the licensee's implementation of their security program for which a notification was made to local, State, or Federal law enforcement officials (other than a suspicious activity report made under § 73.1215 of this part) provided that the event does not otherwise require a notification under paragraphs (a) through (h) of this section.
(3)(i) An event involving a law enforcement response to the facility that could reasonably be expected to result in public or media inquiries and that does not otherwise require a notification under paragraphs (a) through (h) of this section, or in other NRC regulations such as § 50.72(b), § 53.1630(b), or § 72.75(b)(2) of this chapter, or under § 73.1215 of this part.
(g)
(i) Any failure, degradation, or vulnerability in a security or safeguards system, for which compensatory measures have not been employed within the required timeframe, that could allow unauthorized or undetected access of—
(A) Unauthorized personnel into a PA, VA, MAA, or CAA; or
(B) Contraband into a PA, VA, or MAA;
(ii) The unauthorized operation, manipulation, or tampering with any nuclear power reactor's controls or with SSCs that does not result in the interruption of normal operation of the reactor;
(iii) The unauthorized operation, manipulation, or tampering with any Category I SSNM facility's SSCs that does not result in the interruption of normal operation of the facility or an accidental criticality; or
(iv) For licensees subject to the provisions of § 73.77 of this part, a cybersecurity event that impacted the ability of the facility's SSCs to perform their intended security functions.
(m)
(n)
(o) * * *
(3) Notifications required by this section that
(q) * * *
(2) Licensees desiring to retract a previous cybersecurity event notification made under paragraph (g) of this section, which has been determined to be invalid or not reportable in accordance with the requirements of paragraph (g) of this section must telephonically notify the NRC Headquarters Operations Center in accordance with paragraph (o) of this section and indicate the report that is being retracted and the basis for the retraction.
(s)
(1) Licensees with notification obligations under paragraphs (a) through (h), (m), and (n) of this section and § 50.72, 53.1630, 63.73, 70.50, 72.75, or 95.57 of this chapter may notify the NRC of events in a single communication.
(2) A licensee notifying the NRC of multiple events in a single communication must identify each regulation under which the licensee is reporting an event.
(t)
(1) A licensee's notifications regarding security events associated with the deliberate disclosure, theft, loss, compromise, or possible compromise of classified documents, information, or material must comply with the requirements found in § 95.57 of this chapter.
(2) A licensee notifying the NRC of an event involving both information security issues (regarding classified documents, information, or material) pursuant to § 95.57 of this chapter and physical security issues pursuant to paragraphs (a) through (h), (m), and (n) of this section, may notify the NRC in a single communication under paragraph (s) of this section.
(a) * * *
(2) As an exemption, licensees are not required to submit a written follow-up report subsequent to a telephonic notification made—
(i) Under the provisions of §§ 73.1200(a) and (b) regarding 15-minute event notifications;
(ii) Under the provisions of §§ 73.1200(g) and (h) regarding 8-hour event notifications;
(iii) Under the provisions of §§ 73.1200(e) and (f) regarding interactions with a Federal, State, or local law-enforcement agency;
(iv) Under the provisions of § 73.1200(m) regarding lost or stolen enhanced weapons; or
(v) Under the provisions of § 73.1200(n) regarding adverse findings from the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) for enhanced weapons possessed by the licensee.
(e)
(b) * * *
(2) Licensees must retain these records for a period up to 3 years after the last entry is recorded, or until their license is terminated, whichever is earlier.
(3) * * *
(iii) Licensees must ensure that Safeguards Information or classified security information associated with these records is created, stored, and handled in accordance with the provisions of §§ 73.21 and 73.22 of this part, or of part 95 of this chapter, as applicable.
(e)
(1) The discovery that an authorized weapon is uncontrolled within a licensee's PA, VA, or MAA.
(2) Uncontrolled authorized weapons are defined as weapons that are authorized under the licensee's security plan and are not in the possession of authorized personnel or are not in an authorized weapons' storage location.
The revisions read as follows:
(a)
(c)
(1)(i) Licensees subject to paragraphs (d), (e), and (f) of this section must report suspicious activities that are applicable to their facility, material, or shipping activity.
(ii) If a suspicious activity requires a physical security event notification pursuant to § 73.1200, then the licensee is not required to also report the occurrence as a suspicious activity pursuant to this section.
(iii) If a suspicious activity report results in a LLEA response the licensee must notify the NRC in accordance with the requirements of § 73.1200.
(iv) Licensees subject to paragraph (d) of this section and part 37 of the chapter who are reporting suspicious activities at their facility per this section are not required to submit a duplicate report under § 37.57 of this chapter.
(2)(i) Licensees must promptly assess whether an activity is suspicious. Licensees may review additional information as part of an assessment process, including interactions with their LLEA. However, such assessments and any subsequent reporting must be completed as soon as possible, but within 4 hours of the time of discovery. The licensee must base its assessment upon its best available information on the activity, which may include its knowledge of its locale and the local population.
(ii) The licensee's assessment of a potential suspicious activity, and any discussion of this activity with its LLEA, does not constitute a conclusion, in and of itself, that the activity is suspicious.
(iii) Licensees are not required to report activities that, based on their assessment, appear to be innocent or innocuous.
(3) For a suspicious activity specified under paragraph (d) of this section, the licensee must make the following reports. A licensee may depart from the standard order of precedence of these reports, if it determines the circumstances warrant such action:
(i) First, to their LLEA;
(ii) Second, to their applicable FBI field office;
(iii) Third, to the NRC Headquarters Operations Center; and
(iv) Lastly, to the applicable FAA facility if the suspicious activity involves crewed/uncrewed aviation-related assets that are engaged in overflights in proximity to the licensee's facility.
(4) For a suspicious activity specified under paragraphs (e) and (f) of this section, the licensee or its designated movement control center must make the following reports, in the order indicated. A licensee or its movement control center may depart from the standard order of precedence of these reports, if it determines the circumstances warrant such action:
(i) First, to the applicable LLEA;
(ii) Second, to the applicable FBI field office; and
(iii) Lastly, to the NRC Headquarters Operations Center.
(iv) For licensees making such reports related to shipping activities, the licensee responsible for the security of the shipment must contact the applicable FBI field office.
(v) For a movement control center making such reports related to shipping activities, the applicable FBI field office is as requested by the FBI. As such, the FBI may direct the use of the FBI field office applicable to the movement control center itself or to the FBI field office applicable to the licensee responsible for the security of the shipment.
(5)(i) Licensees subject to paragraphs (d) and (f) of this section must establish a point of contact with their applicable FBI field office.
(ii) Licensees subject to paragraph (d) of this section must establish a point of contact with their applicable FAA facility.
(6)(i) For licensees subject to paragraph (e) of this section who are responsible for the security of the shipment(s), the licensee must establish a point of contact with their applicable FBI field office.
(ii) For licensees subject to paragraph (e) of this section who are employing the services of a movement control center, the movement control center must establish a point of contact with its applicable FBI field office.
(7) Licensees and movement control centers reporting suspicious activities to the NRC must notify the NRC Headquarters Operations Center by the telephone number specified in Table 1 of appendix A of this part.
(8)(i) Licensees and movement control centers reporting suspicious activities must document the LLEA and FBI points of contact in written security communication procedures or route approvals, as applicable.
(ii) Licensees reporting suspicious crewed/uncrewed aviation-related assets engaging in overflight activities must document the FAA point of contact in written communication procedures.
Applicants and power reactor licensees subject to the requirements of § 73.55 shall comply with the requirements of section I, “Employment Suitability and Qualification,” paragraphs I.A, I.B.1.a., I.B.1.b.(1),(a)-(b), I.B.1.b.(2),(a)-(c) and section VI of this appendix for armed and unarmed individuals who are assigned security duties. All other licensees, applicants, or certificate holders shall comply only with sections I through V of this appendix.
Security personnel who are responsible for the protection of special nuclear material on site or in transit and for the protection of the facility or shipment vehicle against radiological sabotage should, like other elements of the physical security system, be required to meet minimum criteria to ensure that they will effectively perform their assigned security-related job duties. In order to ensure that those individuals responsible for security are properly equipped and qualified to execute the job duties prescribed for them, the NRC has developed general criteria that specify security personnel qualification requirements.
These general criteria establish requirements for the selection, training, equipping, testing, and qualification of individuals who will be responsible for protecting special nuclear materials, nuclear facilities, and nuclear shipments.
When required to have security personnel that have been trained, equipped, and qualified to perform assigned security job duties in accordance with the criteria in this appendix, the licensee must establish, maintain, and follow a plan that shows how the criteria will be met. The plan must be submitted to the NRC for approval and must be implemented within 30 days after approval by the NRC unless otherwise specified by the NRC in writing.
Terms defined in parts 50, 53, 70, and 73 of this chapter have the same meaning when used in this appendix.
A. Suitability.1. Before employment, or assignment to the security organization, an individual shall:
a. Possess a high school diploma or pass an equivalent performance examination designed to measure basic mathematical, language, and reasoning skills, abilities, and knowledge required to perform security duties and responsibilities;
b. Have attained the age of 18 for an unarmed capacity; or have attained the age of 18 or the minimum age required by applicable State law for an armed capacity, whichever is older;
c. Not have any felony convictions that reflect on the individual's reliability; and
d. Not be disqualified, in accordance with applicable state or Federal law from possessing or using firearms or ammunition.
(1) Licensees may use the information that has been obtained during the completion of the individual's background investigation for unescorted access to determine suitability; or
(2) Licensees may use the satisfactory completion of a firearms background check for the individual under § 73.17 of this part to also fulfill this requirement.2. The qualification of each individual to perform assigned duties and responsibilities must be documented.
B. Physical and mental qualifications.
1. Physical qualifications:
a. Individuals whose security tasks and job duties are directly associated with the effective implementation of the licensee physical security and contingency plans shall have no physical weaknesses or abnormalities that would adversely affect their performance of assigned security job duties.
b. In addition to a. above, guards, armed response personnel, armed escorts, and central alarm station operators shall successfully pass a physical examination administered by a licensed physician. The examination shall be designed to measure the individual's physical ability to perform assigned security job duties as identified in the licensee physical security and contingency plans. Armed personnel shall meet the following additional physical requirements:
(1) Vision:
(a) For each individual, distant visual acuity in each eye shall be correctable to 20/30 (Snellen or equivalent) in the better eye and 20/40 in the other eye with eyeglasses or contact lenses. If uncorrected distance vision is not at least 20/40 in the better eye, the individual shall carry an extra pair of corrective lenses. Near visual acuity, corrected or uncorrected, shall be at least 20/40 in the better eye. Field of vision must be at least 70° horizontal meridian in each eye. The ability to distinguish red, green, and yellow colors is required. Loss of vision in one eye is disqualifying. Glaucoma shall be disqualifying, unless controlled by acceptable medical or surgical means, provided such medications as may be used for controlling glaucoma do not cause undesirable side effects which adversely affect the individual's ability to perform assigned security job duties, and provided the visual acuity and field of vision requirements stated above are met. On-the-job evaluation shall be used for individuals who exhibit a mild color vision defect.
(b) The use of corrective eyeglasses or contact lenses shall not interfere with an individual's ability to effectively perform assigned security job duties during normal or emergency operations.
(2) Hearing:
(a) Individuals shall have no hearing loss in the better ear greater than 30 decibels average at 500 Hz, 1,000 Hz, and 2,000 Hz with no level greater that 40 decibels at any one frequency (by ISO 389 “Standard Reference Zero for the Calibration of Puritone Audiometer” (1975) or ANSI S3.6-1969 (R. 1973) “Specifications for Audiometers”). ISO 389 and ANSI S3.6-1969 have been approved for incorporation by reference by the Director of the Federal Register. A copy of each
(b) A hearing aid is acceptable provided suitable testing procedures demonstrate auditory acuity equivalent to the above stated requirement.
(c) The use of a hearing aid shall not decrease the effective performance of the individual's assigned security job duties during normal or emergency operations.
(3) Diseases—Individuals shall have no established medical history or medical diagnosis of epilepsy or diabetes, or, where such a condition exists, the individual shall provide medical evidence that the condition can be controlled with proper medication so that the individual will not lapse into a coma or unconscious state while performing assigned security job duties.
(4) Addiction—Individuals shall have no established medical history or medical diagnosis of habitual alcoholism or drug addiction, or, where such a condition has existed, the individual shall provide certified documentation of having completed a rehabilitation program which would give a reasonable degree of confidence that the individual would be capable of performing assigned security job duties.
(5) Other physical requirements—An individual who has been incapacitated due to a serious illness, injury, disease, or operation, which could interfere with the effective performance of assigned security job duties shall, prior to resumption of such duties, provide medical evidence of recovery and ability to perform such security job duties.2. Mental qualifications: a. Individuals whose security tasks and job duties are directly associated with the effective implementation of the licensee physical security and contingency plans shall demonstrate mental alertness and the capability to exercise good judgment, implement instructions, assimilate assigned security tasks, and possess the acuity of senses and ability of expression sufficient to permit accurate communication by written, spoken, audible, visible, or other signals required by assigned job duties.
b. Armed individuals, and central alarm station operators, in addition to meeting the requirement stated in paragraph a. above, shall have no emotional instability that would interfere with the effective performance of assigned security job duties. The determination shall be made by a licensed psychologist or psychiatrist, or physician, or other person professionally trained to identify emotional instability.
c. The licensee shall arrange for continued observation of security personnel and for appropriate corrective measures by responsible supervisors for indications of emotional instability of individuals in the course of performing assigned security job duties. Identification of emotional instability by responsible supervisors shall be subject to verification by a licensed, trained person.
C. Medical examinations and physical fitness qualifications—Guards, armed response personnel, armed escorts and other armed security force members shall be given a medical examination including a determination and written certification by a licensed physician that there are no medical contraindications as disclosed by the medical examination to participation by the individual in physical fitness tests. Subsequent to this medical examination, guards, armed response personnel, armed escorts and other armed security force members shall demonstrate physical fitness for assigned security job duties by performing a practical physical exercise program within a specific time period. The exercise program performance objectives shall be described in the license training and qualifications plan and shall consider job-related functions such as strenuous activity, physical exertion, levels of stress, and exposure to the elements as they pertain to each individual's assigned security job duties for both normal and emergency operations. The physical fitness qualification of each guard, armed response person, armed escort, and other security force member shall be documented by a licensee security supervisor or a qualified training instructor. The licensee shall retain this documentation as a record for three years from the date of each qualification.
D. Contract security personnel—Contract security personnel shall be required to meet the suitability, physical, and mental requirements as appropriate to their assigned security job duties in accordance with section I of this appendix.
E. Physical requalification—At least every 12 months, central alarm station operators shall be required to meet the physical requirements of B.1.b of this section, and guards, armed response personnel, and armed escorts shall be required to meet the physical requirements of paragraphs B.1.b (1) and (2), and C of this section. The licensee shall document each individual's physical requalification and shall retain this documentation of requalification as a record for three years from the date of each requalification.
F. Documentation—The results of suitability, physical, and mental qualifications data and test results must be documented by the licensee or the licensee's agent. The licensee or the agent shall retain this documentation as a record for three years from the date of obtaining and recording these results.
G. Nothing herein authorizes or requires a licensee to investigate into or judge the reading habits, political or religious beliefs, or attitudes on social, economic, or political issues of any person.
A. Training requirements—Each individual who requires training to perform assigned security-related job tasks or job duties as identified in the licensee physical security or contingency plans shall, prior to assignment, be trained to perform these tasks and duties in accordance with the licensee or the licensee's agent's documented training and qualifications plan. The licensee or the agent shall maintain documentation of the current plan and retain this documentation of the plan as a record for three years after the close of period for which the licensee possesses the special nuclear material under each license for which the plan was developed and, if any portion of the plan is superseded, retain the material that is superseded for three years after each change.
B. Qualification requirements—Each person who performs security-related job tasks or job duties required to implement the licensee physical security or contingency plan shall, prior to being assigned to these tasks or duties, be qualified in accordance with the licensee's NRC-approved training and qualifications plan. The qualifications of each individual must be documented by a qualified training instructor or a security supervisor. The licensee shall retain this documentation of each individual's qualifications as a record for three years after the employee ends employment in the security-related capacity and for three years after the close of period for which the licensee possesses the special nuclear material under each license, and superseded material for three years after each change.
C. Contract personnel—Contract personnel shall be trained, equipped, and qualified as appropriate to their assigned security-related job tasks or job duties, in accordance with sections II, III, IV, and V of this appendix. The qualifications of each individual must be documented by a qualified training instructor or a licensee security supervisor. The licensee shall retain this documentation of each individual's qualifications as a record for three years after the employee ends employment in the security-related capacity and for three years after the close of period for which the licensee possesses the special nuclear material under each license, and superseded material for three years after each change.
D. Security knowledge, skills, and abilities—Each individual assigned to perform the security related task identified in the licensee physical security or contingency plan shall demonstrate the required knowledge, skill, and ability in accordance with the specified standards for each task as stated in the NRC approved licensee training and qualifications plan.
E. Requalification—Security personnel shall be requalified at least every 12 months to perform assigned security-related job tasks and duties for both normal and contingency operations. Requalification shall be in accordance with the NRC-approved licensee training and qualifications plan. The results of requalification must be documented and attested by a licensee security supervisor or a qualified training instructor. The licensee shall retain this documentation of each individual's requalification as a record for three years from the date of each requalification.
A. Guards, armed response personnel and armed escorts requiring weapons training to perform assigned security related job tasks or job duties shall be trained in accordance with the licensees' documented weapons training programs. Each individual shall be proficient in the use of their assigned weapon(s) and shall meet licensee-prescribed standards for firearms handling and functionality.
Qualification firing for the handgun and the rifle must be for daylight firing, and each individual shall perform night firing for
A. Individuals shall qualify with all assigned firearms through completion of a law enforcement course or an equivalent nationally recognized course of fire.
B. Qualifying score must be an accumulated total of 70 percent with handgun and shotgun, and 80 percent with semiautomatic rifle and/or enhanced weapons, of the maximum obtainable target score.
C. Enhanced weapons—Armed members of the security organization, assigned duties and responsibilities involving the use of enhanced weapons, authorized under § 73.15 of this part, must qualify in accordance with the licensee's NRC-approved training and qualification plan as specified under the provisions of § 73.15(f)(3) and (h) of this part.
D. Requalification—Individuals shall be weapons requalified at least every 12 months in accordance with the NRC approved licensee training and qualifications plan, and in accordance with the requirements stated in A, B, and C of this section.
Fixed site guards, fixed site armed response personnel, and transportation armed escorts shall either be equipped with or have available the following security equipment appropriate to the individual's assigned contingency security related tasks or job duties as described in the licensee physical security and contingency plans:
A. Automatic or semiautomatic rifles.
B. 12 gauge shotguns.
C. Semiautomatic pistols or revolvers.
D. Short-barreled rifles.
E. Ammunition.
1. Each individual assigned contingency security job duties must maintain an adequate and readily available supply of ammunition for assigned weapons as determined by security job duties and responsibilities, as described in the licensee physical security and contingency plans.
2. The quantity of ammunition available for fixed sites must be maintained at a level sufficient to ensure the effective implementation of the Commission-approved security plans.
F. The licensee shall ensure that each individual is equipped or has readily available personal equipment or devices required for the effective implementation of the Commission-approved security plans.
G. Escort vehicles must be bullet resisting and equipped with communications systems or any other equipment as needed for the effective implementation of the Commission-approved security plans.
1. The licensee must ensure that all individuals who are assigned duties and responsibilities required to implement the Commission-approved security plans, licensee response strategy, and implementing procedures, meet minimum training and qualification requirements to ensure each individual possesses the knowledge, skills, and abilities required to effectively perform the assigned duties and responsibilities.
2. Licensee physical protection programs that meet the requirements of 10 CFR 73.55(b)(3)(iii) must establish and maintain a training and qualification program that ensures personnel who are responsible for implementation of the physical protection of the facility against radiological sabotage are trained and qualified with the applicable portions of this section to effectively perform their assigned security-related job duties. The training and qualification program must be described in the Commission-approved training and qualification plan.
3. The licensee may not allow any individual to perform any security function, assume any security duties or responsibilities, or return to security duty, until that individual satisfies the training and qualification requirements of this appendix and the Commission-approved training and qualification plan, unless specifically authorized by the Commission.
4. Annual requirements must be scheduled at a nominal 12-month periodicity. Annual requirements may be completed up to 3 months before or 3 months after the scheduled date. However, the next annual training must be scheduled 12 months from the previously scheduled date rather than the date the training was actually completed.
1. Suitability.
(a) Before employment, or assignment to the security organization, an individual serving in an armed capacity must not be disqualified from possessing or using firearms or ammunition in accordance with applicable state or Federal law, to include 18 U.S.C. 922. Licensees must use information that has been obtained during the completion of the individual's background investigation for unescorted access to determine suitability.
(b) The qualification of each individual to perform assigned duties and responsibilities must be documented and attested by a qualified training instructor or a security supervisor.
2. Physical qualifications.
(a) General physical qualifications.
(1) Individuals whose duties and responsibilities are directly associated with the effective implementation of the Commission-approved security plans, licensee protective strategy, and implementing procedures, may not have any physical conditions that would adversely affect their performance of assigned security duties and responsibilities.
(2) Armed and unarmed individuals assigned security duties and responsibilities must be subject to a physical examination designed to measure the individual's physical ability to perform assigned duties and responsibilities as identified in the Commission-approved security plans, licensee protective strategy, and implementing procedures.
(3) This physical examination must be administered by a licensed health professional with the final determination being made by a licensed physician to verify the individual's physical capability to perform assigned duties and responsibilities.
(4) The licensee must ensure that both armed and unarmed individuals who are assigned security duties and responsibilities identified in the Commission-approved security plans, the licensee protective strategy, and implementing procedures, meet the following minimum physical requirements, as required to effectively perform their assigned duties.
(b) Existing medical conditions.
(1) Individuals may not have an established medical history or medical diagnosis of existing medical conditions which could interfere with or prevent the individual from effectively performing assigned duties and responsibilities.
(2) If a medical condition exists, the individual must provide medical evidence that the condition can be controlled with medical treatment in a manner which does not adversely affect the individual's fitness-for-duty, mental alertness, physical condition, or capability to otherwise effectively perform assigned duties and responsibilities.
(c) Addiction. Individuals may not have any established medical history or medical diagnosis of habitual alcoholism or drug addiction, or, where this type of condition has existed, the individual must provide certified documentation of having completed a rehabilitation program which would give a reasonable degree of confidence that the individual would be capable of effectively performing assigned duties and responsibilities.
(d) Other physical requirements. An individual who has been incapacitated due to a serious illness, injury, disease, or operation, which could interfere with the effective performance of assigned duties and responsibilities must, before resumption of assigned duties and responsibilities, provide medical evidence of recovery and ability to perform these duties and responsibilities.
3. Psychological qualifications.
(a) Armed and unarmed individuals must demonstrate the ability to apply good judgment, mental alertness, the capability to implement instructions and assigned tasks, and possess the acuity of senses and ability of expression sufficient to permit accurate communication by written, spoken, audible, visible, or other signals required by assigned duties and responsibilities.
(b) A licensed psychologist, psychiatrist, or physician trained in part to identify emotional instability must determine whether armed members of the security organization and alarm station operators in addition to meeting the requirement stated in paragraph (a) of this section, have no emotional instability that would interfere
(c) A person professionally trained to identify emotional instability must determine whether unarmed individuals in addition to meeting the requirement stated in paragraph (a) of this section, have no emotional instability that would interfere with the effective performance of assigned duties and responsibilities.
4. Medical examinations and physical fitness qualifications.
(a) Armed members of the security organization must be subject to a medical examination by a licensed physician, to determine the individual's fitness to participate in physical fitness tests.
(1) The licensee must obtain and retain a written certification from the licensed physician that no medical conditions were disclosed by the medical examination that would preclude the individual's ability to participate in the physical fitness tests or meet the physical fitness attributes or objectives associated with assigned duties.
(2) [Reserved]
(b) Before assignment, armed members of the security organization must demonstrate physical fitness for assigned duties and responsibilities by performing a practical physical fitness test.
(1) The physical fitness test must include physical attributes and performance objectives that demonstrate the strength, endurance, and agility, consistent with assigned duties in the Commission-approved security plans, licensee protective strategy, and implementing procedures during normal and emergency conditions.
(2) The licensee must describe the physical fitness test in the Commission-approved training and qualification plan.
(3) The physical fitness qualification of each armed member of the security organization must be documented and attested by a qualified training instructor or a security supervisor.
5. Physical requalification.
(a) At least annually, armed and unarmed individuals must be required to demonstrate the capability to meet the physical requirements of this appendix and the licensee training and qualification plan.
(b) The physical requalification of each armed and unarmed individual must be documented and attested by a qualified training instructor or a security supervisor.
1. On-the-job training.
(a) The licensee training and qualification program must include on-the-job training performance standards and criteria to ensure that each individual demonstrates the requisite knowledge, skills, and abilities needed to effectively carry-out assigned duties and responsibilities in accordance with the Commission-approved security plans, licensee protective strategy, and implementing procedures, before the individual is assigned the duty or responsibility.
(b) In addition to meeting the requirement stated in paragraph C.1.(a) of this appendix, before assignment, individuals (
2. Performance Evaluation Program.
(a) Licensees must develop, implement and maintain a Performance Evaluation Program that is documented in procedures which describes how the licensee will demonstrate and assess the effectiveness of their onsite physical protection program and protective strategy, including the capability of the armed response team to carry out their assigned duties and responsibilities during safeguards contingency events. The Performance Evaluation Program and procedures must be referenced in the licensee's Training and Qualifications Plan.
(b) The Performance Evaluation Program must include procedures for the conduct of tactical response drills and force-on-force exercises designed to demonstrate and assess the effectiveness of the licensee's physical protection program, protective strategy and contingency event response by all individuals with responsibilities for implementing the safeguards contingency plan.
(c) The licensee must conduct tactical response drills and force-on-force exercises in accordance with Commission-approved security plans, licensee protective strategy, and implementing procedures.
(d) Tactical response drills and force-on-force exercises must be designed to challenge the site protective strategy against elements of the design basis threat and ensure each participant assigned security duties and responsibilities identified in the Commission-approved security plans, the licensee protective strategy, and implementing procedures demonstrate the requisite knowledge, skills, and abilities.
(e) Tactical response drills, force-on-force exercises, and associated contingency response training must be conducted under conditions that simulate, as closely as practicable, the site-specific conditions under which each member will, or may be, required to perform assigned duties and responsibilities.
(f) The scope of tactical response drills conducted for training purposes must be determined by the licensee and must address site-specific, individual or programmatic elements, and may be limited to specific portions of the site protective strategy.
(g) Each tactical response drill and force-on-force exercise must include a documented post-exercise critique in which participants identify failures, deficiencies or other findings in performance, plans, equipment or strategies.
(h) Licensees must document scenarios and participants for all tactical response drills and annual force-on-force exercises conducted.
(i) Findings, deficiencies and failures identified during tactical response drills and force-on-force exercises that adversely affect or decrease the effectiveness of the protective strategy and physical protection program must be addressed to ensure that timely corrections are made to the appropriate program areas.
(j) Findings, deficiencies and failures associated with the onsite physical protection program and protective strategy must be protected as necessary in accordance with the requirements of 10 CFR 73.21.
(k) For the purpose of tactical response drills and force-on-force exercises, licensees must:
(1) Use no more than the total number of armed responders and armed security officers documented in the security plans.
(2) Minimize the number and effects of artificialities associated with tactical response drills and force-on-force exercises.
(3) Implement the use of systems or methodologies that simulate the realities of armed engagement through visual and audible means or other technologies and reflect the capabilities of armed personnel to neutralize a target through the use of firearms.
(4) Ensure that each scenario used provides a credible, realistic challenge to the protective strategy and the capabilities of the security response organization.
(l) The Performance Evaluation Program must be designed to ensure that:
(1) Each member of each shift who is assigned duties and responsibilities required to implement the safeguards contingency plan and licensee protective strategy must participate in security drills and exercises.
(i) The licensee must conduct at least one fully integrated Force-on-Force exercise on an annual basis.
(ii) Each member of each shift must participate in one fully integrated Force-on-Force exercise every 3 years.
(iii) Each member of each shift must participate in two tactical response drills, one of which must be a limited scope tactical response drill, on an annual basis.
(A) Participation in a fully integrated Force-on-Force exercise or NRC triennial evaluation would count as credit for the limited scope tactical response drill. The NRC triennial evaluation can be used to satisfy the annual fully integrated Force-on-Force exercise.
(B) [Reserved].
(2) The mock adversary force replicates, as closely as possible, adversary characteristics and capabilities of the design basis threat described in 10 CFR 73.1(a)(1), and is capable of exploiting and challenging the licensee's protective strategy, personnel, command and control, and implementing procedures.
(3) Protective strategies can be evaluated and challenged through the conduct of tactical response tabletop demonstrations.
(4) Drill and exercise controllers are trained and qualified to ensure that each controller has the requisite knowledge and experience to control and evaluate exercises.
(5) Tactical response drills and force-on-force exercises are conducted safely and in accordance with site safety plans.
(m) Scenarios.
(1) Licensees must develop and document multiple scenarios for use in conducting tactical response drills and force-on-force exercises.
(2) Licensee scenarios must be designed to test and challenge any components or combination of components, of the onsite physical protection program and protective strategy.
(3) Each scenario must use a unique target set or target sets to ensure that the combination of all scenarios challenges every component of the onsite physical protection program and protective strategy to include, but not limited to, equipment, implementing procedures, and personnel.
1. Qualification demonstration.
(a) Armed and unarmed individuals must demonstrate the required knowledge, skills, and abilities to carry out assigned duties and responsibilities as stated in the Commission-approved security plans, licensee protective strategy, and implementing procedures.
(b) [Reserved].
2. Requalification.
(a) Armed and unarmed individuals must be requalified at least annually in accordance with the requirements of this appendix and the Commission-approved training and qualification plan.
(b) The results of requalification must be documented and attested by a qualified training instructor or a security supervisor.
1. General firearms training.
(a) Armed members of the security organization must be trained and qualified in accordance with the requirements of this appendix and the Commission-approved training and qualification plan.
(b) Firearms instructors must maintain a certification for each weapon type from a national or state recognized entity.
(c) The Commission-approved training and qualification plan must describe training on firearms handling and functionality.
(d) The licensee must ensure that each armed member of the security organization is instructed on the use of deadly force as authorized by applicable State law.
1. General weapons qualification requirements.
(a) Qualification firing must be accomplished in accordance with Commission requirements and the Commission-approved training and qualification plan for assigned weapons.
(b) The results of weapons qualification and requalification must be documented and retained as a record.
2. Tactical weapons qualification. The licensee Training and Qualification Plan must describe the firearms used, the firearms qualification program, and other tactical training required to implement the Commission-approved security plans, licensee protective strategy, and implementing procedures. Licensee developed tactical qualification and requalification courses must describe the performance criteria needed to include the site specific conditions (such as lighting, elevation, fields-of-fire) under which assigned personnel must be required to carry-out their assigned duties.
3. Firearms qualification courses. The licensee must conduct the following qualification courses for each weapon used.
(a) Annual daylight qualification course. Qualifying score must be an accumulated total of 70 percent with handgun and shotgun, and 80 percent with semiautomatic rifle and/or enhanced weapons, of the maximum obtainable target score.
(b) Annual night fire qualification course. Qualifying score must be an accumulated total of 70 percent with handgun and shotgun, and 80 percent with semiautomatic rifle and/or enhanced weapons, of the maximum obtainable target score.
(c) Annual tactical qualification course. Qualifying score must be an accumulated total of 80 percent of the maximum obtainable score.
(d) Individuals shall qualify with all assigned firearms through completion of a law enforcement course or an equivalent nationally recognized course of fire.
(e) Enhanced weapons. Armed members of the security organization, assigned duties and responsibilities involving the use of any weapon or weapons not described previously, must qualify in accordance with applicable standards established by a law enforcement course or an equivalent nationally recognized course for these weapons.
4. Firearms requalification.
(a) Armed members of the security organization must be requalified for each assigned weapon at least annually in accordance with Commission requirements and the Commission-approved training and qualification plan, and the results documented and retained as a record.
(b) Firearms requalification must be conducted using the courses of fire outlined in paragraphs F.2 and F.3 of this section.
1. Firearms maintenance program. Each licensee must implement a firearms maintenance and accountability program in accordance with the Commission regulations and the Commission-approved training and qualification plan. The program must include:
(a) Semiannual test firing for accuracy and functionality.
(b) Firearms maintenance procedures that include cleaning schedules and cleaning requirements.
(c) Program activity documentation.
(d) Control and accountability (weapons and ammunition).
(e) Firearm storage requirements.
(f) Armorer certification.
2. [Reserved].
1. The licensee must retain all reports, records, or other documentation required by this appendix in accordance with the requirements of § 73.55(q).
2. The licensee must retain each individual's initial qualification record for three (3) years after termination of the individual's employment and must retain each requalification record for three (3) years after it is superseded.
3. The licensee must document data and test results from each individual's suitability, physical, and psychological qualification and must retain this documentation as a record for three (3) years from the date of obtaining and recording these results.
The licensee must review the Commission-approved training and qualification program in accordance with the requirements of § 73.55(m).
Terms defined in parts 50, 70, and 73 of this chapter have the same meaning when used in this appendix.
83. Revise and republish appendix C to part 73 to read as follows:
Licensees, applicants, and certificate holders, with the exception of those who are subject to the requirements of § 73.55 or 73.100, must comply with the requirements of section I of this appendix.
A licensee safeguards contingency plan is a documented plan to give guidance to licensee personnel in order to accomplish specific defined objectives in the event of threats, thefts, or radiological sabotage relating to special nuclear material or nuclear facilities licensed under the Atomic Energy Act of 1954, as amended. An acceptable safeguards contingency plan must contain:
1. A predetermined set of decisions and actions to satisfy stated objectives;
2. An identification of the data, criteria, procedures, and mechanisms necessary to efficiently implement the decisions; and
3. A stipulation of the individual, group, or organizational entity responsible for each decision and action.
The goals of licensee safeguards contingency plans for responding to threats, thefts, and radiological sabotage are:
1. To organize the response effort at the licensee level;
2. To provide predetermined, structured responses by licensees to safeguards contingencies;
3. To ensure the integration of the licensee response with the responses by other entities; and
4. To achieve a measurable performance in response capability.
Licensee safeguards contingency planning should result in organizing the licensee's resources in such a way that the participants will be identified, their several responsibilities specified, and the responses coordinated. The responses should be timely.
It is important to note that a licensee's safeguards contingency plan is intended to be complementary to any onsite emergency plans.
Each licensee safeguards contingency plan must include five categories of information:
1. Background
2. Generic Planning Base
3. Licensee Planning Base
4. Responsibility Matrix
5. Implementing Procedures
Although the implementing procedures (the fifth category of Plan information) are the culmination of the planning process, and therefore are an integral and important part of the safeguards contingency plan, they entail operating details subject to frequent changes. They need not be submitted to the Commission for approval, but will be inspected by NRC staff on a periodic basis. The licensee is responsible for ensuring that the implementing procedures reflect the information in the Responsibility Matrix, appropriately summarized and suitably presented for effective use by the responding entities.
The following paragraphs describe the contents of the safeguards contingency plan.
1.
a. Perceived Danger—A statement of the perceived danger to the security of special nuclear material, licensee personnel, and licensee property, including covert diversion of special nuclear material, radiological sabotage, and overt attacks. The statement of perceived danger should conform with that promulgated by the Nuclear Regulatory Commission. (The statement contained in 10 CFR 73.1 or subsequent Commission statements will suffice.)
b. Purpose of the Plan—A discussion of the general aims and operational concepts underlying implementation of the plan.
c. Scope of the Plan—A delineation of the types of incidents covered in the plan.
d. Definitions—A list of terms and their definitions used in describing operational and technical aspects of the plan.
2.
a. Identification of those events that will be used for signaling the beginning or aggravation of a safeguards contingency according to how they are perceived initially by licensee's personnel. Such events may include alarms or other indications signaling penetration of a protected area, vital area, or material access area; material control or material accounting indications of material missing or unaccounted for; or threat indications—either verbal, such as telephoned threats, or implied, such as escalating civil disturbances.
b. Definition of the specific objective to be accomplished relative to each identified event. The objective may be to obtain a level of awareness about the nature and severity of the safeguards contingency in order to prepare for further responses; to establish a level of response preparedness; or to successfully nullify or reduce any adverse safeguards consequences arising from the contingency.
3.
a. Licensee's Organizational Structure for Contingency Responses—A delineation of the organization's chain of command and delegation of authority as these apply to safeguards contingencies.
b. Physical Layout—(i) Fixed Sites—A description of the physical structures and their location on the site, and a description of the site in relation to nearby town, roads, and other environmental features important to the effective coordination of response operations. Particular emphasis should be placed on main and alternate entry routes for law-enforcement assistance forces and the location of control points for marshalling and coordinating response activities.
(ii) Transportation—A description of the vehicles, shipping routes, preplanned alternate routes, and related features.
c. Safeguards Systems Hardware—A description of the physical security and accounting system hardware that influence how the licensee will respond to an event. Examples of systems to be discussed are communications, alarms, locks, seals, area access, armaments, and surveillance.
d. Law Enforcement Assistance—A listing of available local law enforcement agencies and a description of their response capabilities and their criteria for response; and a discussion of working agreements or arrangements for communicating with these agencies.
e. Policy Constraints and Assumptions—A discussion of State laws, local ordinances, and company policies and practices that govern licensee response to incidents. Examples that may be discussed include:
(i) Use of deadly force;
(ii) Use of employee property;
(iii) Use of off-duty employees; and
(iv) Site security jurisdictional boundaries.
f. Administrative and Logistical Considerations—Descriptions of licensee practices that may have an influence on the response to safeguards contingency events. The considerations must include a description of the procedures that will be used for ensuring that all equipment needed to effect a successful response to a safeguards contingency will be easily accessible, in good working order, and in sufficient supply to provide redundancy in case of equipment failure.
4.
1. For nuclear facilities subject to the requirements of § 73.46, the licensee must provide for a review of the safeguards contingency plan at intervals not to exceed 24 months.
2. A licensee subject to the requirements of § 73.46 must ensure that the review of the safeguards contingency plan is by individuals independent of both security program management and personnel who have direct responsibility for implementation of the security program. The review must include an audit of safeguards contingency procedures and practices, and an audit of commitments established for response by local law enforcement authorities.
3. The licensee must document the results and the recommendations of the safeguards contingency plan review, management findings on whether the safeguards contingency plan is currently effective, and any actions taken as a result of recommendations from prior reviews in a report to the licensee's plant manager and to corporate management at least one level higher than that having responsibility for the day-to-day plant operation. The report must be maintained in an auditable form, available for inspection for a period of 3 years.
The safeguards contingency plan is a documented plan that describes how licensee personnel implement their physical protection program to defend against threats to their facility, up to and including the design basis threat of radiological sabotage.
Licensee safeguards contingency planning should result in organizing the licensee's resources in such a way that the participants will be identified, their responsibilities specified, and the responses coordinated. The responses should be timely and include personnel who are trained and qualified to respond in accordance with a documented training and qualification program.
The evaluation, validation, and testing of this portion of the program must be conducted in accordance with appendix B, section VI of this part, Nuclear Power Reactor Training and Qualification Plan for Personnel Performing Security Program Duties. The licensee's safeguards contingency plan is intended to maintain effectiveness during the implementation of onsite emergency plans.
Each safeguards contingency plan must include five (5) categories of information:
(1) Background.
(2) Generic planning base.
(3) Licensee planning base.
(4) Responsibility matrix.
(5) Implementing procedures.
Although the implementing procedures (the fifth category of plan information) are the culmination of the planning process, and are an integral and important part of the safeguards contingency plan, they entail operating details subject to frequent changes. They need not be submitted to the Commission for approval, but are subject to inspection by NRC staff on a periodic basis.
1. Background. This category of information must identify the perceived dangers and incidents that the plan will address and a general description of how the response is organized.
a. Perceived Danger—Consistent with the design basis threat specified in § 73.1(a)(1), licensees must identify and describe the perceived dangers, threats, and incidents against which the safeguards contingency plan is designed to protect.
b. Purpose of the Plan—Licensees must describe the general goals, objectives and operational concepts underlying the implementation of the approved safeguards contingency plan.
c. Scope of the Plan—A delineation of the types of incidents covered by the plan.
(i) How the onsite or offsite response effort is organized and coordinated to effectively respond to a safeguards contingency event.
(ii) How the onsite or offsite response for safeguards contingency events has been integrated in other site emergency response procedures.
d. Definitions—A list of terms and their definitions used in describing operational and technical aspects of the approved safeguards contingency plan.
2. Generic Planning Base. Licensees must define the criteria for initiation and termination of responses to security events to include the specific decisions, actions, and supporting information needed to respond to each type of incident covered by the approved safeguards contingency plan. To achieve this result the generic planning base must:
a. Identify those events that will be used for signaling the beginning or aggravation of a safeguards contingency event according to how they are perceived initially by licensee's personnel. Licensees must ensure detection of unauthorized activities and must respond to all alarms or other indications signaling a security event, such as penetration of a protected area, vital area, or unauthorized barrier penetration (vehicle or personnel); tampering, bomb threats, or other threat warnings—either verbal, such as telephoned threats, or implied, such as escalating civil disturbances.
b. Define the specific objective to be accomplished relative to each identified safeguards contingency event. The objective may be to obtain a level of awareness about the nature and severity of the safeguards contingency to prepare for further responses; to establish a level of response preparedness; or to successfully nullify or reduce any adverse safeguards consequences arising from the contingency.
c. Identify the data, criteria, procedures, mechanisms and logistical support necessary to achieve the objectives identified.
3. Licensee Planning Base. This category of information must include factors affecting safeguards contingency planning that are specific for each facility. To the extent that the topics are treated in adequate detail in the licensee's approved physical security plan, they may be incorporated by reference in the Safeguards Contingency Plan. The following topics must be addressed:
a. Organizational Structure. The safeguards contingency plan must describe the organization's chain of command and delegation of authority during safeguards contingency events, to include a general description of how command and control functions will be coordinated and maintained.
b. Physical Layout. The safeguards contingency plan must include a site map depicting the physical structures located on the site, including onsite independent spent fuel storage installations, and a description of the structures depicted on the map. Plans must also include a description and map of the site in relation to nearby towns, transportation routes (
c. Safeguards Systems. The safeguards contingency plan must include a description of the physical security systems that support and influence how the licensee will respond to an event in accordance with the design basis threat described in § 73.1(a). The licensee's description must begin with onsite physical protection measures implemented at the outermost facility perimeter, and must move inward through those measures implemented to protect target set equipment.
(i) Physical security systems and security systems hardware to be discussed include security systems and measures that provide defense-in-depth, such as physical barriers, alarm systems, locks, area access, armaments, surveillance, and communications systems.
(ii) The specific structure of the security response organization to include the total number of armed responders and armed security officers documented in the approved security plans as a component of the protective strategy and a general description of response capabilities must also be included in the safeguards contingency plan.
(iii) Armed responders must be available to respond from designated areas inside the protected area at all times and may not be assigned any other duties or responsibilities that could interfere with assigned armed response team duties and responsibilities.
(iv) Licensees must develop, implement, and maintain a written protective strategy to be documented in procedures that describe in detail the physical protection measures, security systems and deployment of the armed response team relative to site specific conditions, to include but not be limited to, facility layout, and the location of target set equipment and elements. The protective strategy should support the general goals, operational concepts, and performance objectives identified in the licensee's safeguards contingency plan. The protective strategy must:
(1) Be designed to meet the performance requirements and objectives of § 73.55(a) through (k) or 73.100(a) through (j), as applicable.
(2) Identify predetermined actions, areas of responsibility and timelines for the deployment of armed personnel.
(3) Contain measures that limit the exposure of security personnel to possible attack, including incorporation of bullet resisting protected positions.
(4) Contain a description of the physical security systems and measures that provide defense-in-depth, such as physical barriers, alarm systems, locks, area access, armaments, surveillance, and communications systems.
(5) Describe the specific structure and responsibilities of the armed response organization to include:
(i) The authorized minimum number of armed responders, available at all times inside the protected area.
(ii) The authorized minimum number of armed security officers, available onsite at all times.
(iii) The total number of armed responders and armed security officers documented in the approved security plans as a component of the protective strategy.
(6) Provide a command and control structure, to include response by off-site law enforcement agencies, which ensures that decisions and actions are coordinated and communicated in a timely manner to facilitate response.
d. Law Enforcement Assistance. Provide a listing of available law enforcement agencies and a general description of their response capabilities and their criteria for response and a discussion of working agreements or arrangements for communicating with these agencies.
e. Policy Constraints and Assumptions. The safeguards contingency plan must contain a discussion of State laws, local ordinances, and company policies and practices that govern licensee response to incidents and must include, but is not limited to, the following.
(i) Use of deadly force.
(ii) Recall of off-duty employees.
(iii) Site jurisdictional boundaries.
(iv) Use of enhanced weapons, if applicable.
f. Administrative and Logistical Considerations. Descriptions of licensee practices which influence how the security organization responds to a safeguards contingency event to include, but not limited to, a description of the procedures that will be used for ensuring that equipment needed to facilitate response will be readily accessible, in good working order, and in sufficient supply.
4. Responsibility Matrix. This category of information consists of the detailed
a. Licensees must develop site procedures that consist of matrixes detailing the organization and/or personnel responsible for decisions and actions associated with specific responses to safeguards contingency events. The responsibility matrix and procedures must be referenced in the licensee's safeguards contingency plan.
b. Responsibility matrix procedures must be based on the events outlined in the licensee's Generic Planning Base and must include the definition of the specific objective to be accomplished relative to each identified safeguards contingency event. The objective may be to obtain a level of awareness about the nature and severity of the safeguards contingency to prepare for further responses, to establish a level of response preparedness, or to successfully nullify or reduce any adverse safeguards consequences arising from the contingency.
c. Responsibilities must be assigned in a manner that precludes conflict of duties and responsibilities that would prevent the execution of the safeguards contingency plan and emergency response plans.
d. Licensees must ensure that predetermined actions can be completed under the postulated conditions.
5. Implementing Procedures. Licensees must establish and maintain written implementing procedures that provide specific guidance and operating details that identify the actions to be taken and decisions to be made by each member of the security organization who is assigned duties and responsibilities required for the effective implementation of the security plans and the site protective strategy.
1. Licensees must review the safeguards contingency plan in accordance with the requirements of § 73.55(m) or 73.100(f).
2. The safeguards contingency plan audit must include a review of applicable elements of the Physical Security Plan, Training and Qualification Plan, implementing procedures and practices, the site protective strategy, and response agreements made by local, State, and Federal law enforcement authorities.
3. Licensees must retain all reports, records, or other documentation required by this appendix in accordance with the requirements of § 73.55(q) or 73.100(j).
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.
The regulations in this part establish procedures for obtaining facility security clearance and for safeguarding Secret and Confidential National Security Information and Restricted Data received or developed in conjunction with activities licensed, certified or regulated by the Commission, in accordance with the National Industrial Security Program, as described in title 32 of the
The additions read as follows:
Terms defined in section 117.3 of title 32 have the same meaning when used in this part.
The NRC may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of the regulations of this part, or waivers to the provisions of 32 CFR part 117 that are—
(a) Following the receipt of an acceptable request for facility clearance, the NRC will either accept an existing facility clearance granted by a current CSA and authorize possession of license or certificate related classified information, or process the facility for a facility clearance. Processing will include—
(1) A determination based on review and approval of a Standard Practice Procedures Plan that granting of the Facility Clearance would not be inconsistent with the national interest, including a finding that the facility is not under foreign ownership, control, or influence to such a degree that a determination could not be made. An NRC finding of foreign ownership, control, or influence is based on factors concerning the foreign intelligence threat, risk of unauthorized technology transfer, type and sensitivity of the information that requires protection, the extent of foreign influence, record of compliance with pertinent laws, and the nature of international security and information exchange agreements.
(2) An acceptable operational readiness review conducted by the NRC;
(3) Submitting key management personnel, as defined in 32 CFR 117.7, for personnel clearances (PCLs); and
(4) Appointing a U.S. citizen employee as the facility security officer.
(a) Classified National Security Information and Restricted Data shall be protected in accordance with 32 CFR 117.15.
(b) Licensees will develop procedures for safeguarding National Security Information and Restricted Data in accordance with 32 CFR 117.7.
(c) Supervision of keys and padlocks. Use of key-operated padlocks are subject to the following requirements:
(1) A key and lock custodian shall be appointed to ensure proper custody and handling of keys and locks used for protection of classified matter;
(2) A key and lock control register must be maintained to identify keys for each lock and their current location and custody;
(3) Keys and locks must be audited each month;
(4) Keys must be inventoried with each change of custody;
(5) Keys must not be removed from the premises;
(6) Keys and spare locks must be protected equivalent to the level of classified matter involved;
(7) Locks must be changed or rotated at least every 12 months, and must be replaced after loss or compromise of their operable keys; and
(8) Master keys may not be made.
(a) Security training and briefings shall be conducted in accordance with 32 CFR 117.12.
(b) Records reflecting an individual's initial and refresher security briefings and security terminations must be maintained for 3 years after termination of the individual's access authorization.
Visits and meetings shall be conducted in accordance with 32 CFR 117.16.
(a) Documents shall be classified in accordance with 32 CFR 117.13.
(b) Classified documents shall be marked in accordance with 32 CFR 117.14.
Classified information shall be transmitted in accordance with 32 CFR 117.15(f).
Each licensee, certificate holder, or other person possessing classified information will follow the requirements established in 32 CFR 117.15(e)(6) for the reproduction of classified information.
Each licensee, certificate holder, or other person possessing classified information will follow the requirements established in 32 CFR 117.15(g) for the destruction of classified information.
Classified data or information may not be stored, processed, or transmitted on information technology or operational technology systems without an authority to operate issued by the NRC authorization official for licensee classified systems based on 32 CFR 117.18, “Information system security.”
Each licensee, applicant for a license, certificate holder, construction-permit holder, or other person having a facility clearance must report to the NRC any incidents specified in 32 CFR 117.8. If the NRC is not the applicable CSA, then the licensee, applicant for a license, certificate holder, construction-permit holder, or other person must first report any incidents specified in 32 CFR 117.8 to their applicable CSA and then to the NRC.
(a) All actual or suspected losses or compromises of classified information must be reported to the NRC in accordance with the requirements set forth in 32 CFR 117.8(d). Initial reports, as prescribed in 32 CFR 117.8(d)(2), must be submitted to the NRC within the following timeframes:
(1) Confirmed or Suspected Compromise: If a loss, compromise, or suspected compromise is confirmed or reasonably suspected, an initial report must be submitted to the NRC Headquarters Operations Center within 1 hour of discovery. A written confirmation of the incident must be submitted in accordance with § 95.9 of this part within forty-eight (48) hours of the event.
(2) No Compromise Determined: If it is determined that no loss, compromise, or suspected compromise occurred, a written report documenting this determination must be submitted in accordance with § 95.9 of this part within forty-eight (48) hours of reaching that conclusion.
(b) In addition, NRC requires records for all classification actions (documents classified, declassified, or downgraded) to be submitted to the NRC Division of Security Operations. These may be submitted either on an “as completed” basis or monthly. The information may be submitted either electronically by an on-line system (NRC prefers the use of a dial-in automated system connected to the Division of Security Operations) or by paper copy using NRC Form 790.
For the Nuclear Regulatory Commission.