Background

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain PW Model PW4074, PW4074D, PW4077, PW4077D, PW4084D, PW4090, and PW4090-3 engines. The NPRM was published in the Federal Register on June 6, 2025 (90 FR 24085). The NPRM was prompted by an analysis of an event involving an IAE LLC Model PW1127GA-JM engine, which experienced an HPC IBR-7 separation that resulted in an aborted takeoff. In the NPRM, the FAA proposed to require repetitive AUSIs of the HPC 15th-stage disks, front turbine hubs, HPT 1st-stage air seals, and HPT 2nd-stage hubs for crack indications, and removal from service and replacement if necessary. The FAA also proposed to require removal from service and replacement of the HPT 1st-stage air seal for certain serial numbers. The FAA is issuing this AD to address the unsafe condition on these products.

The FAA received comments from six commenters. The commenters were the Air Line Pilots Association, International (ALPA), All Nippon Airways (ANA), The Boeing Company (Boeing), PW, United Airlines (United), and an individual. The following presents the comments received on the NPRM and the FAA's response to each comment.

ALPA, Boeing, and United expressed support for the NPRM.

ANA requested that the FAA revise the material citations specified in paragraphs (g)(2)(i) through (iv) of the proposed AD to read “or later” following the revision date. ANA stated that if the material is revised in the future, an AMOC would be required for implementation.

The FAA disagrees with the request. To incorporate by reference (IBR) the material specified in this AD, the citation must refer to a specific document, including the specific revision date. Additionally, the FAA is unable to cite a future revision to a document which does not yet exist. If any of the specified material is revised, operators may request approval of an alternative method of compliance (AMOC) in accordance with the procedures in paragraph (j) of this AD. The FAA did not change this AD as a result of this comment.

ANA requested that the FAA revise the NPRM to include revision levels for certain non-destructive inspection procedures (NDIPs) which are referenced in the material specified in the NPRM, as well as paragraph (h) of the proposed AD; or refer to the service material instead. ANA stated that the material specifies instructions for performing AUSIs based on NDIPs, but the material does not specify a revision of the non-destructive inspection procedure for those actions. Additionally, ANA indicated that maintenance, repair, and overhaul (MRO) organizations typically list compliance with service bulletins on the airworthiness release certificates, not compliance with NDIPs.

The FAA agrees to clarify. The IBR materials in this AD specify certain actions using certain NDIPs. All revisions of those specified NDIPs are acceptable for completing those actions. The FAA has not changed this AD based on this comment.

ANA requested that the FAA include the affected part numbers in the required actions specified in paragraph (g)(2) of the proposed AD and throughout the NPRM. ANA stated that the NPRM requires certain actions for specified part nomenclature but does not include the relevant part numbers.

The FAA disagrees with the request. The nomenclature of the part is sufficient to identify the necessary actions. Additionally, the affected part numbers are specified in the IBR materials which are required to complete this AD. The FAA has not changed this AD based on this comment.

ANA requested that the FAA change the part numbers for eligible parts in the NPRM to align with those provided in the EIPC. ANA stated that some of the part numbers listed as parts eligible for installation in the NPRM are not listed in the EIPC, and that ANA is unable to manage the required action without part numbers based on the EIPC.

The FAA disagrees with the request. The EIPC is intended to depict part and hardware relationships and accessibility for procurement. However, the EIPC does not define applicability for inspections or whether certain parts are eligible for installation. The part numbers specified in this AD are based on the manufacturer's service material and engineering analysis. Additionally, under the provisions of paragraph (j) of this AD, the FAA will consider requests for approval of an AMOC if sufficient data are submitted to substantiate an acceptable level of safety. The FAA has not changed this AD based on this comment.

An individual commenter requested that the FAA shorten the compliance times specified in the NPRM. The commenter stated that the current deadlines for compliance are too relaxed and do not match the urgent need to prevent dangerous failures in key engine parts. The commenter stated that the recent incident, where an HPC IBR-7 separation that resulted in an aborted takeoff, clearly shows how immediate this threat is. The commenter requested more immediate corrective measures with clear deadlines.

The FAA disagrees with the request. The commenter did not provide specific recommendations for alternative compliance times or justification for why the proposed compliance times are insufficient. In developing an appropriate compliance time, the FAA used a data-driven, quantitative risk analysis which considered the safety implications, parts availability, and normal maintenance schedules for timely accomplishment. In consideration of all these factors, the FAA selected the compliance times to appropriately mitigate the risk associated with the unsafe condition. This AD permits operators to accomplish the required actions at a time earlier than the specified compliance time. If additional data are presented that justify a shorter compliance time, the FAA may consider further rulemaking on this issue. The FAA did not change this AD as a result of this comment.

An individual commenter requested that the FAA require targeted metallurgical testing on samples from specific production campaigns where variability is suspected. The commenter discussed the nature of nickel powder metallurgy; that minor variations can create microscopic defects, which may become weaknesses under stress; and that some production batches are already shown to have resultant anomalies, which reduce component fatigue life, especially in high-pressure compressors and turbines. The commenter stated that results from the focused testing could be used to confirm whether additional parts are at risk and allow the FAA to adjust inspection intervals accordingly.

The FAA disagrees with the request. The commenter did not provide any specific recommendations for changes to the actions required by this AD. The FAA has determined that the manufacturer has improved their manufacturing and inspection processes and has identified all at-risk part populations. Additionally, metallurgical testing of this kind is industry standard as part of the manufacturing quality control process. The FAA did not change this AD as a result of this comment.

An individual commenter requested that the FAA broaden the criteria for evaluation or establish a mechanism for rapid re-evaluation of affected parts in the NPRM. The commenter stated that focusing on specific serial numbers and part numbers is overly narrow, that the risk posed by nickel powdered metal inconsistencies is not confined solely to these items, and that production variability may affect a larger fraction of similar components. The commenter indicated that parts from adjacent production campaigns or exhibiting borderline metallurgical characteristics might equally be at risk. The commenter stated that broadening the scope of the criteria would ensure additional hazardous components are identified and managed, which would reduce the potential for at-risk parts to be overlooked.

The FAA disagrees with the request. The FAA has determined that there are no adjacent production campaigns and, as stated previously, the manufacturer has identified all at-risk part populations. Therefore, this AD applies to the part numbers and serial numbers of all at-risk components. The FAA did not change this AD as a result of this comment.

An individual commenter requested that the FAA revise the NPRM to include uniform time-based inspection intervals. The commenter stated that reliance on “piece part opportunities” introduces significant variability into the safety assurance process. The commenter indicated that because each operator follows an independent maintenance schedule, some engines may continue operating with undetected degradation for extended periods, which could jeopardize the safety of the fleet.

The FAA disagrees with the request. The commenter did not provide specific recommendations for alternative time-based inspection intervals or justification for why the proposed compliance times are insufficient. The FAA acknowledges that piece-part opportunities can be variable. However, as discussed previously, in developing an appropriate compliance time, the FAA used a data-driven, quantitative risk analysis which considered the safety implications, parts availability, and normal maintenance schedules for timely accomplishment, which included both the variability and the worst-case scenarios. This information was then used to determine that piece part opportunities appropriately mitigate the risk associated with the unsafe condition. If additional data are presented that justify a uniform time-based inspection interval, the FAA may consider further rulemaking on this issue. The FAA did not change this AD as a result of this comment.

An individual requested that the FAA require mandatory reporting in the NPRM. The commenter stated that data from operators for parts with abnormal degradation, even without an in-flight failure, would offer insight into the condition of nickel powdered metal components and allow the FAA to identify trends early and prevent accidents.

The FAA disagrees with the request. This request falls outside the scope of this AD, whereas the intent is to detect nickel powder anomalies, related cracking, and replace the affected parts. The FAA has a clear understanding of the failure mode, and mandatory reporting would not increase knowledge of the unsafe condition. Additionally, these specific nickel powder components do not exhibit abnormal degradation. Failures or crack indications found during the inspections required by this AD are already subject to existing mandatory reporting requirements of the manufacturer. The FAA did not change this AD as a result of this comment.

An individual commenter requested that the FAA publicly share aggregated inspection and test results. The commenter stated that the FAA should be prompt and transparent, and that making this data publicly available would empower the aviation community to understand the full scope of the unsafe condition and collaborate in development of best practices and corrective measures. The commenter referenced similar transparency measures within the automotive and rail industries, which improved identification of emerging safety issues and allowed more effective collaborative solutions. The commenter stated that this demonstrated clear benefits of open data sharing in enhancing overall safety.

The FAA disagrees with the request to share data. Much of the requested aggregated data is proprietary and, consequently, the FAA is unable to share publicly. As discussed previously, the FAA and the manufacturer have clear understanding of the failure mode and unsafe condition. The intent of this AD is to detect nickel powder anomalies and related cracking and replace the affected parts. The FAA, the manufacturer, the rest of the industry, and many industry groups have mechanisms in place to share information and develop industry best practices. The FAA did not change this AD as a result of this comment.

PW requested that the FAA revise the NPRM to require updating the ALS instead of the actions specified in the service material. PW stated that the inspections specified in the service material for the HPC 15th-stage disks, front turbine hubs, HPT 1st-stage air seals, and HPT 2nd-stage hubs have since been included in the revised engine manual ALS and are now duplicate requirements.

The FAA partially agrees with the request. The FAA disagrees with the request to require updating the ALS rather than performing certain inspections in accordance with the service material; however, the FAA finds that updating the engine manual ALS provides acceptable mitigation of the unsafe condition. The FAA has added paragraph (i) of this AD, which provides optional terminating action for operators that update their engine manual ALS to include the actions required by paragraphs (g)(1) through (3) of this AD.

PW requested that the FAA eliminate paragraph (g)(3) of the proposed AD. PW stated that the requirement to remove the part from service is sufficiently covered by existing inspection procedures which are incorporated in the revised engine manual ALS inspections.

The FAA disagrees with the request. This AD does not require any engine manual ALS updates. Therefore, the FAA finds that including removal requirements in this airworthiness directive is both appropriate and necessary. However, as previously discussed, the FAA has added paragraph (i) of this AD which provides optional terminating action for operators that update their engine manual ALS to include the actions required by paragraphs (g)(1) through (3) of this AD. The FAA did not change this AD as a result of this comment.

PW requested that the FAA remove the definitions specified in paragraphs (h)(1)(i) through (iii) of the proposed AD. PW stated that “piece part opportunity” is already defined in the revised engine manual ALS inspections.

The FAA disagrees with the request. A definition for “piece part opportunity” is necessary for the required actions in this AD because the ALS update is an optional terminating action and not mandatory. The FAA did not change this AD as a result of this comment.

PW requested that the FAA remove the definitions specified in paragraph (h)(2) of the proposed AD. PW stated that “part eligible for installation” is already defined in the revised engine manual ALS inspections. PW proposed that the FAA allow all new manufactured parts to be eligible for installation regardless of confirmation of receiving an angle ultrasonic scan inspection (AUSI). PW indicated its fleet management plan does not require confirmation that new affected parts have received an AUSI during manufacture to be eligible for installation. PW stated that including such a requirement places an unnecessary burden on operators.

The FAA partially agrees with this request. The FAA disagrees with removing the definition of “Part Eligible for Installation” from this AD. However, the FAA agrees that operators do not have access to the necessary data to determine whether zero-time components have passed an AUSI at new part manufacture. Therefore, the FAA has determined that the responsible party may determine if the part is eligible for installation based on the date specified on the FAA Form 8130-3. The FAA has revised paragraphs (h)(2)(xiii) of this AD by removing the words “and has passed an AUSI at new part production” and replacing them with “that has an FAA Form 8130-3 from the original equipment manufacturer for new production dated July 1, 2025, or later.”

The FAA has revised the applicability of this AD to identify the type certificate holder's name as published in the most recent type certificate data sheet for the affected models.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

The FAA reviewed the following material:

• PW Alert Service Bulletin (ASB) PW4G-112-A72-365, Revision No. 1, dated June 20, 2024, which specifies procedures for performing repetitive AUSIs on affected HPC 15th-stage disks.

• PW ASB PW4G-112-A72-366, dated June 20, 2024, which specifies procedures for performing repetitive AUSIs on affected HPT 1st-stage air seals.

• PW ASB PW4G-112-A72-367, dated June 20, 2024, which specifies procedures for performing repetitive AUSIs on affected front turbine hubs.

• PW ASB PW4G-112-A72-368, dated June 20, 2024, which specifies procedures for performing repetitive AUSIs on affected HPT 2nd-stage hubs.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 124 engines installed on airplanes of U.S. registry. The FAA estimates that 124 engines will need AUSIs of the HPC 15th-stage disk, front turbine hub, HPT 2nd-stage hub, and HPT 1st-stage air seal; and 6 engines will need replacement of the HPT 1st-stage air seals.

The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any replacements that would be required based on the results of the inspection. The agency has no way of determining the number of engines that might need these replacements:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Bombardier, Inc., Model BD-700-1A10 and BD-700-1A11 airplanes. The NPRM was published in the Federal Register on February 26, 2026 (91 FR 9504). The NPRM was prompted by AD CF-2025-28, dated June 10, 2025 (Transport Canada AD CF-2025-28) (also referred to as the MCAI), issued by Transport Canada, which is the aviation authority for Canada. The MCAI states that it was reported that inappropriate tooling was used to torque the bolts securing the baggage door stop fittings, which may have resulted in an improper torque condition. The MCAI states that the fitting could migrate slightly during operation if the bolts were under-torqued. Additionally, if the bolts were over-torqued, the bolts could yield and fracture under dynamic loads. Baggage stop door fittings consist of principal structural elements where the structural integrity may be impacted. This condition, if not addressed, could potentially lead to cabin depressurization should a fitting failure occur.

In the NPRM, the FAA proposed to require a torque check of affected bolts and re-torquing, re-installing, or replacing affected bolts and nuts as applicable, as specified in Transport Canada AD CF-2025-28. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2026-2282.

The FAA received no comments on the NPRM or on the determination of the cost.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

Transport Canada AD CF-2025-28 specifies procedures for performing a torque check of affected bolts and re-torquing, re-installing, or replacing affected bolts and nuts as applicable.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 45 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has included all known costs in its cost estimate. According to the manufacturer, however, some or all of the costs of this AD may be covered under warranty, thereby reducing the cost impact on affected operators.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to certain Embraer S.A. Model ERJ 190-100 ECJ airplanes. The NPRM was published in the Federal Register on February 25, 2026 (91 FR 9193). The NPRM was prompted by AD 2024-07-01, effective July 31, 2024 (ANAC AD 2024-07-01) (also referred to as the MCAI), issued by ANAC, which is the aviation authority for Brazil. The MCAI states that a quality escape occurred during manufacturing concerning certain ODS sensing elements produced before January 31, 2021. A defective sensing element may not be able to detect a thermal bleed leak, which is a latent failure. This condition, if not addressed, could lead to an undetected thermal bleed leak that could start an ignition source in the fuel tank, damaging some electronic boxes and exposing the wing structure to high temperature gradients and unexpected thermal loads.

In the NPRM, the FAA proposed to require a detailed inspection of certain ODS sensing elements of the airplane bleed lines and replacement, if necessary, as specified in ANAC AD 2024-07-01. The NPRM also proposed to prohibit the installation of affected parts, as specified in ANAC AD 2024-07-01. The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2026-1340.

The FAA received a comment from the Air Line Pilots Association, International (ALPA) who supported the NPRM without change.

The FAA revised paragraph (h)(2) of this AD to clarify the text in ANAC AD 2024-07-01 that must be replaced.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe condition on these products. Except for minor editorial changes, and any other changes described previously, this AD is adopted as proposed in the NPRM. None of the changes will increase the economic burden on any operator.

ANAC AD 2024-07-01 specifies procedures for a detailed inspection of certain ODS sensing elements of the airplane bleed lines and replacement, if necessary. ANAC AD 2024-07-01 also prohibits the installation of an affected ODS sensing element unless the affected part passed an inspection, indicated by a marking on one face of the connector hex nut.

This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

The FAA estimates that this AD affects 8 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA has received no definitive data on which to base a cost estimate for the on-condition actions specified in this AD.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866,

(2) Will not affect intrastate aviation in Alaska, and

(3) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The FAA invites you to send any written data, views, or arguments about this final rule. Send your comments using a method listed under the ADDRESSES section. Include “Docket No. FAA-2026-4641; Project Identifier MCAI-2026-00340-T” at the beginning of your comments. The most helpful comments reference a specific portion of the final rule, explain the reason for any recommended change, and include supporting data. The FAA will consider all comments received by the closing date and may amend this final rule because of those comments.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in 14 CFR 11.35, the FAA will post all comments received, without change, to regulations.gov , including any personal information you provide. The agency will also post a report summarizing each substantive verbal contact received about this final rule.

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 AD contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to this AD, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and they will not be placed in the public docket of this AD. Submissions containing CBI should be sent to Tak Kobayashi, Aviation Safety Engineer, FAA, 2200 South 216th St., Des Moines, WA 98198; phone: 206-231-3553; email: takahisa.kobayashi@faa.gov. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2026-0073, dated April 1, 2026; corrected April 7, 2026 (EASA AD 2026-0073) (also referred to as the MCAI), to correct an unsafe condition for all Model A330-200 series airplanes; Model A330-200 Freighter series airplanes; Model A330-300 series airplanes; and Model A330-743L, -841, and -941 airplanes. Model A330-743L airplanes are not certificated by the FAA and are not included on the U.S. type certificate data sheet; this AD therefore does not include those airplanes in the applicability. The MCAI states that following an in-service event and relevant investigation, it has been determined that, under specific conditions, a dormant failure of a standby fuel pump could lead to a certain amount of fuel being trapped in the aft section of the inner tank that would be unusable. The MCAI states that this condition, if not detected and corrected, could lead to inability to use this fuel, possibly resulting in overestimating the useable fuel available on board, and subsequent uncommanded in-flight engine shutdown.

The FAA is issuing this AD to address the unsafe condition on these products.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2026-4641.

EASA AD 2026-0073 specifies procedures for a repetitive operational check of the standby fuel pumps for discrepancies ( i.e., any result does not match the applicable result identified in the “Result” column in the table of paragraph A., “Operational check of the Standby Fuel Pump,” in the service information referenced by EASA AD 2026-0073), and applicable corrective actions. Corrective action includes troubleshooting discrepancies and replacing defective affected parts ( i.e., an affected part that cannot meet all results identified in the “Result” column in the table of paragraph A., “Operational check of the Standby Fuel Pump,” in the referenced service information). Replacing includes the option of swapping and following the master minimum equipment list (MMEL) for dispatch with an inoperative fuel pump. Swapping is switching the position of the defective fuel pump from a standby pump location with a non-defective fuel pump from a non-standby pump location, which must also be checked for discrepancies before further flight. EASA AD 2026-0073 also limits the installation of affected parts under certain conditions. EASA AD 2026-0073 also provides an acceptable method of compliance for the operational check. This material is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the ADDRESSES section.

These products have been approved by the civil aviation authority of another country and are approved for operation in the United States. Pursuant to the FAA's bilateral agreement with this State of Design Authority, that authority has notified the FAA of the unsafe condition described in the MCAI referenced above. The FAA is issuing this AD after determining that the unsafe condition described previously is likely to exist or develop on other products of the same type design.

This AD requires accomplishing the actions specified in EASA AD 2026-0073 described previously, except for any differences identified as exceptions in the regulatory text of this AD.

In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA developed a process to use some civil aviation authority (CAA) ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. The FAA has been coordinating this process with manufacturers and CAAs. As a result, EASA AD 2026-0073 is incorporated by reference in this AD. This AD requires compliance with EASA AD 2026-0073 in its entirety through that incorporation, except for any differences identified as exceptions in the regulatory text of this AD. Using common terms that are the same as the heading of a particular section in EASA AD 2026-0073 does not mean that operators need comply only with that section. For example, where the AD requirement refers to “all required actions and compliance times,” compliance with this AD requirement is not limited to the section titled “Required Action(s) and Compliance Time(s)” in EASA AD 2026-0073. Material required by EASA AD 2026-0073 for compliance will be available at regulations.gov under Docket No. FAA-2026-4641 after this AD is published.

Section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C. 551 et seq. ) authorizes agencies to dispense with notice and comment procedures for rules when the agency, for “good cause,” finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under this section, an agency, upon finding good cause, may issue a final rule without providing notice and seeking comment prior to issuance. Further, section 553(d) of the APA authorizes agencies to make rules effective in less than thirty days, upon a finding of good cause.

An unsafe condition exists that requires the immediate adoption of this AD without providing an opportunity for public comments prior to adoption. The FAA has found that the risk to the flying public justifies forgoing notice and comment prior to adoption of this rule because a dormant (undetected) failure of a standby fuel pump could lead to inability to use fuel trapped in either of the aft inner tanks, possibly resulting in overestimating the useable fuel available on board, and subsequent uncommanded in-flight dual engine shutdown. Additionally, the compliance time in this AD is shorter than the time necessary for the public to comment and for publication of the final rule. Accordingly, notice and opportunity for prior public comment are impracticable and contrary to the public interest pursuant to 5 U.S.C. 553(b).

In addition, the FAA finds that good cause exists pursuant to 5 U.S.C. 553(d) for making this amendment effective in less than 30 days, for the same reasons the FAA found good cause to forgo notice and comment.

The requirements of the Regulatory Flexibility Act (RFA) do not apply when an agency finds good cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and comment. Because the FAA has determined that it has good cause to adopt this rule without notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 154 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

The FAA estimates the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. The FAA has no way of determining the number of aircraft that might need these on-condition actions:

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.

The FAA is issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: General requirements. Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

This AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

(1) Is not a “significant regulatory action” under Executive Order 12866, and

(2) Will not affect intrastate aviation in Alaska.

Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:

The Drug Enforcement Administration (DEA) issues a temporary scheduling order  1 (in the form of a temporary amendment) to add 2-(2-fluorophenyl)-2- (methylamino)cyclohexan-1-one (commonly known as 2-fluorodeschloroketamine or 2-FDCK), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, to schedule I under the Controlled Substances Act (CSA).

The CSA provides the Attorney General with the authority to temporarily place a substance in schedule I of the CSA for two years without regard to the evaluation requirements of 21 U.S.C. 811(b), if he finds that such action is necessary to avoid an imminent hazard to the public safety. 2 In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1) while the substance is temporarily controlled under section 811(h), the Attorney General may extend the temporary scheduling for up to one year. 3

Where the necessary findings are made, a substance may be temporarily scheduled if it is not listed in any other schedule under 21 U.S.C. 812, or if there is no exemption or approval in effect for the substance under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355. 4

In addition, the United States is a party to the 1971 United Nations Convention on Psychotropic Substances (1971 Convention), Feb. 21, 1971, 32 U.S.T. 543, 1019 U.N.T.S. 175, as amended. Procedures respecting changes in drug schedules under the 1971 Convention are set forth in 21 U.S.C. 811(d)(2)-(4). When the United States receives notification of a scheduling decision pursuant to Article 2 of the 1971 Convention indicating that a drug or other substance has been added to a schedule specified in the notification, the Secretary of the Department of Health and Human Services (HHS), after consultation with the Attorney General, shall first determine whether existing legal controls under subchapter I of the CSA and the FD&C Act meet the requirements of the schedule specified in the notification with respect to the specific drug or substance. In the event that the Secretary did not consult with the Attorney General, and the Attorney General did not issue a temporary order, as provided under 21 U.S.C. 811(d)(4), the procedures for permanent scheduling set forth in 21 U.S.C. 811(a) and (b) control. The Attorney General has delegated scheduling authority under 21 U.S.C. 811 to the Administrator of DEA (Administrator). 5

On June 6, 2024, the Secretariat of the United Nations advised the Secretary of State of the United States that the Commission on Narcotic Drugs (CND), during its 67th session on March 19, 2024, voted to place 2-fluorodeschloroketamine in Schedule II of the Convention on Psychotropic Substances of 1971 (CND Decision 67/4). As a signatory to this international treaty, the United States is required to place appropriate controls within the CSA on 2-fluorodeschloroketamine to meet the requirements of the treaty. To meet the minimum requirements of this treaty and to confront these emerging substances, DEA is temporarily placing 2-fluorodeschloroketamine in schedule I of the CSA.

The CSA requires the Administrator to notify the Secretary of HHS of an intent to temporarily place a substance in schedule I of the CSA ( i.e., to issue a temporary scheduling order). 6 By letter dated November 1, 2024 (the November 1 DEA letter), the previous Administrator transmitted the required notice to place 2-fluorodeschloroketamine in schedule I on a temporary basis to the then-Assistant Secretary for Health of HHS (Assistant Secretary). 7 By letter dated November 8, 2024 (the November 8 HHS letter), the previous Assistant Secretary responded to this notice and advised DEA that, based on a review by the Food and Drug Administration (FDA), there were currently no investigational new drug applications (IND) or approved new drug applications (NDA) for 2-fluorodeschloroketamine. The previous Assistant Secretary also stated that HHS had no objection to the temporary placement of this substance in schedule I of the CSA. However, DEA requested an updated response from HHS by letter dated May 28, 2025 (the May 28 DEA letter), due to the change in HHS's leadership after the November 8 HHS letter. By letter dated June 11, 2025 (the June 11 HHS letter), the then-Acting Assistant Secretary of HHS responded that, based on an updated review by FDA, there were currently no NDAs or INDs for 2-fluorodeschloroketamine. Therefore, HHS had no objections to the temporary placement of 2-fluorodeschloroketamine in schedule I. 2-Fluorodeschloroketamine is not currently listed in any schedule under the CSA, and no exemptions or approvals under 21 U.S.C. 355, are in effect for this substance.

DEA has taken into consideration the then-Acting Assistant Secretary's comments as required by 21 U.S.C. 811(h)(4). DEA has found the control of 2-fluorodeschloroketamine in schedule I on a temporary basis is necessary to avoid an imminent hazard to public safety.

As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of intent (NOI) to temporarily schedule 2-fluorodeschloroketamine in the Federal Register on January 20, 2026. 8 That NOI discussed findings from DEA's three-factor analysis dated January 2026, which DEA made available on www.regulations.gov.

To find that temporarily placing a substance in schedule I of the CSA is necessary to avoid an imminent hazard to public safety, the Administrator must consider three of the eight factors set forth in 21 U.S.C. 811(c): the substance's history and current pattern of abuse; the scope, duration, and significance of abuse; and what, if any, risk there is to public health. 9 Consideration of these factors includes any information indicating actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of this substance. 10

Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 11 Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 12

The availability of new psychoactive substances on the illicit drug market continues to pose an imminent hazard to public safety. Adverse health effects associated with the abuse of such substances and their increased popularity have become a serious concern in recent years. Such substances include 2-fluorodeschloroketamine, which has been identified on the illicit drug market in the United States and worldwide.

The positive identification of 2-fluorodeschloroketamine in law enforcement seizures and toxicology reports poses a serious concern to public safety. 2-Fluorodeschloroketamine has been detected in 61 drug seizures across 12 states since 2018, and this substance has been detected in biological samples from 3 overdose cases in the United States.

Data obtained from preclinical pharmacology studies show that 2-fluorodeschloroketamine has a pharmacological profile similar to that of other arylcyclohexylamines, such as phencyclidine (PCP) and ketamine, which are schedule II and III controlled substances, respectively. Due to these pharmacological similarities, the use of 2-fluorodeschloroketamine presents a high risk of abuse and may negatively affect users and their communities. These pharmacological similarities also lead to similar clinical presentations of intoxication that range from hallucinogenic-like adverse effects to death. Thus, 2-fluorodeschloroketamine poses an imminent hazard to public safety.

Available data and information for 2-fluorodeschloroketamine, summarized below, indicate that this substance has a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. 13 DEA's three-factor analysis is available in its entirety under “Supporting and Related Material” of the public docket for this action at www.regulations.gov under Docket Number DEA-1442.

2-Fluorodeschloroketamine belongs to a chemical structural class of substances known as arylcyclohexylamines that includes dissociative anesthetics PCP (a schedule II substance) and ketamine (a schedule III substance). Details on 2-fluorodeschloroketamine synthesis have been available since 2014, long after its first reported synthesis without details in 1987. In 2015, online forum users began to discuss the psychoactive properties of 2-fluorodeschloroketamine and commonly compared 2-fluorodeschloroketamine to ketamine. Unlike ketamine, however, 2-fluorodeschloroketamine has no currently approved medical use. In the November 8 HHS letter to DEA, the then-Assistant Secretary stated that there were no FDA-approved NDAs or INDs for 2-fluorodeschloroketamine. In the June 11 HHS letter to DEA, the then-Acting Assistant Secretary reaffirmed that there were no FDA-approved NDAs or INDs for 2-fluorodeschloroketamine.

2-Fluorodeschloroketamine emerged on the illicit drug market similarly to other dissociative anesthetics that are trafficked for their psychoactive effects; this is evidenced by the identification of this substance in forensic drug exhibits and toxicology samples. Based on available data from user reports and law enforcement seizures, individuals typically purchase 2-fluorodeschloroketamine as powder or crystals, which are then crushed and placed into capsules or solubilized. Common routes of administration include oral consumption or insufflation, while less commonly mentioned routes include intramuscular injection, sublingual administration, and rectal insertion. In addition, scientific literature and toxicological reports indicate that 2-fluorodeschloroketamine is likely co-ingested with other substances, whether as separate products or a single product containing multiple licit and illicit substances. In toxicological reports, substances co-identified with 2-fluorodeschloroketamine included, but were not limited to, 2-fluoromethamphetamine (schedule I); 3,4-methylenedioxyamphetamine (MDA; schedule I); 3,4-methylenedioxymethamphetamine (MDMA; schedule I); 4-methoxy PCP; ADB-BUTINACA (schedule I); ketamine (schedule III); fentanyl (schedule II); mitragynine; morphine (schedule II); and various prescription drugs.

Users on online forums began to discuss 2-fluorodeschloroketamine and its consumption in 2015. In 2016, government authorities in Spain first documented the appearance of 2-fluorodeschloroketamine on the illicit drug market, and this substance has since been detected in numerous countries, such as Australia, Austria, Canada, China, Denmark, Finland, France, Italy, the Netherlands, the United Kingdom, and the United States. Some of these countries actively regulated 2-fluorodeschloroketamine under psychoactive drug control regulations prior to its international control in 2024.

Law enforcement data indicate that the presence of 2-fluorodeschloroketamine is widespread in the United States. Since 2018, DEA's National Forensic Laboratory Information System (NFLIS-Drug)  14 registered a total of 61 reports, across 12 states, pertaining to the trafficking, distribution, and abuse of 2-fluorodeschloroketamine. 15 These states include California, Connecticut, Florida, Illinois, Louisiana, Michigan, New Jersey, New York, Ohio, Pennsylvania, Virginia, and West Virginia.

2-Fluorodeschloroketamine is a potent arylcyclohexylamine, and evidence suggests that users abuse this substance for its dissociative effects. Literature and case reports indicate that the clinical presentation of 2-fluorodeschloroketamine intoxication is similar to that from other arylcyclohexylamines, such as PCP (schedule II) and ketamine (schedule III), and ranges from hallucinogenic-like adverse effects to death. In nonfatal intoxications, adverse effects include acute neurological symptoms resulting in cognitive and behavioral abnormalities, as well as cardiovascular symptoms, such as hypertension and tachycardia. Literature also indicates that 2-fluorodeschloroketamine has been used as a “date rape” drug and was detected among 11 cases of drug-facilitated sexual assault internationally.

In addition, according to findings by the DEA Toxicology Testing Program (DEA TOX), 16 2-fluorodeschloroketamine has been positively identified in a total of three polysubstance overdose cases, two of which were fatal, and included both male (n = 2, both age 31) and female (n = 1, age 36) users. While toxicological and forensic case reports are available in medical and scientific literature and provide evidence of 2-fluorodeschloroketamine abuse, commonly used drug screening methods may not yet be able to identify 2-fluorodeschloroketamine. Consequently, additional emergency room admissions and fatalities involving 2-fluorodeschloroketamine have potentially occurred without report.

Lastly, U.S. law enforcement data indicate that 2-fluorodeschloroketamine has been encountered since 2018 and that this substance is easily and affordably obtainable online and on the illicit market. Due to the unknown purity and composition of drugs purchased online or on the illicit market, individuals may be unknowingly exposed to this substance despite their intentions to consume other drugs, such as bucinnazine, ketamine, or methoxphenidine. Analytical testing of seized samples indicates single and combinations of substances, suggesting that 2-fluorodeschloroketamine may be frequently used as an adulterant or ketamine substitute. The unpredictable levels of adulterant or drug purity across samples may pose significant harm to public health.

In accordance with 21 U.S.C. 811(h)(3), based on the available data and information summarized above, the uncontrolled manufacture, distribution, reverse distribution, importation, exportation, conduct of research and chemical analysis, possession, and abuse of 2-fluorodeschloroketamine pose an imminent hazard to public safety. 2-Fluorodeschloroketamine has not been approved by FDA and has not been lawfully marketed in the United States. DEA is not aware of any currently accepted medical uses for 2-fluorodeschloroketamine in the United States. A substance meeting the statutory requirements for temporary scheduling, found in 21 U.S.C. 811(h)(1), may only be placed in schedule I. Substances in schedule I must have a high potential for abuse, no currently accepted medical use in treatment in the United States, and a lack of accepted safety for use under medical supervision. Available data and information for 2-fluorodeschloroketamine indicate that this substance meets the three statutory criteria.

As required by 21 U.S.C. 811(h)(4), in the November 1 DEA letter, the then-Administrator notified the then-Assistant Secretary of DEA's intention to temporarily place 2-fluorodeschloroketamine in schedule I. HHS had no objection to the temporary placement of this substance in schedule I. However, due to the change in HHS's leadership after the November 8 HHS letter, DEA requested an updated response from HHS in the May 28 DEA letter. In the June 11 HHS letter, the then-Acting Assistant Secretary reaffirmed that HHS had no objection to the temporary placement of 2-fluorodeschloroketamine in schedule I. DEA subsequently published this NOI in the Federal Register on January 20, 2026. 17

In accordance with 21 U.S.C. 811(h)(1) and (3), the Administrator considered available data and information, herein set forth the grounds for his determination that it is necessary to temporarily schedule 2-fluorodeschloroketamine in schedule I of the CSA, and finds that placement of this substance in schedule I is necessary to avoid an imminent hazard to the public's safety.

The temporary placement of 2-fluorodeschloroketamine in schedule I of the CSA will take effect on the date the order is published in the Federal Register and will remain in effect for two years, with a possible extension of one year, pending completion of the regular (permanent) scheduling process. 18

The CSA sets forth specific criteria for scheduling drugs or other substances. Permanent scheduling actions in accordance with 21 U.S.C. 811(a) are subject to formal rulemaking procedures “on the record after opportunity for a hearing” conducted pursuant to the provisions of 5 U.S.C. 556 and 557. 19 The permanent scheduling process of formal rulemaking affords interested parties appropriate process and the government any additional relevant information needed to make a determination. Final decisions that conclude the permanent scheduling process of formal rulemaking are subject to judicial review. 20 Temporary scheduling orders are not subject to judicial review. 21

Upon the effective date of this temporary order, 2-fluorodeschloroketamine will be subject to the regulatory controls and administrative, civil, and criminal sanctions applicable to the manufacture, distribution, reverse distribution, importation, exportation, possession of, and engagement in research and conduct of instructional activities or chemical analysis with, schedule I controlled substances, including but not limited to the following:

1. Registration. Any person who handles (possesses, manufactures, distributes, reverse distributes, imports, exports, engages in research, or conducts instructional activities or chemical analysis with) or desires to handle, 2-fluorodeschloroketamine must be registered with DEA to conduct such activities, pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312, as of May 22, 2026. Any person who currently handles 2-fluorodeschloroketamine and is not registered with DEA to conduct research with a schedule I controlled substance must submit an application for registration and may not continue to handle 2-fluorodeschloroketamine as of May 22, 2026, unless DEA has approved that application for registration pursuant to 21 U.S.C. 822, 823, 957, and 958, and in accordance with 21 CFR parts 1301 and 1312.

Notwithstanding the foregoing, pursuant to 21 U.S.C. 822(h), if, on May 22, 2026, a person is conducting research on 2-fluorodeschloroketamine and is already registered to conduct research with another controlled substance in schedule I, the person may continue to conduct research on 2-fluorodeschloroketamine if they submit a completed application for registration or modification of existing registration, as applicable, to conduct research with 2-fluorodeschloroketamine not later than 90 calendar days after May 22, 2026. The person may continue to conduct such research until the person withdraws the application or the Administrator serves on the person an order to show cause proposing denial of the application pursuant to 21 U.S.C. 824(c) and in accordance with 21 CFR 1301.37. If the Administrator serves an order to show cause proposing denial of the application or modification, the person may not continue to conduct research with 2-fluorodeschloroketamine and may not receive or otherwise obtain additional 2-fluorodeschloroketamine. If an order to show cause is served and the person requests a hearing in accordance with 21 CFR 1301.37(d), the hearing shall be held in accordance with 21 CFR 1301.41-1301.46 on an expedited basis and not later than 45 calendar days after the request is made, except that the hearing may be held at a later time if so requested by the person. If the person sends a copy of the application to a manufacturer or distributor of 2-fluorodeschloroketamine, receipt of the copy by the manufacturer or distributor constitutes sufficient evidence that the person is authorized to receive 2-fluorodeschloroketamine pursuant to 21 U.S.C. 822(h)(4). Continuation of research under 21 U.S.C. 822(h) does not authorize any other handling ( e.g., distribution) of 2-fluorodeschloroketamine.

Retail sales of schedule I controlled substances to the general public are not allowed under the CSA. Possession of any quantity of 2-fluorodeschloroketamine in a manner not authorized by the CSA on or after May 22, 2026 is unlawful, and those in possession of any quantity of 2-fluorodeschloroketamine may be subject to prosecution pursuant to the CSA.

2. Disposal of Stocks. Any person who does not desire or is unable to obtain a schedule I registration to handle 2-fluorodeschloroketamine must surrender all currently held quantities of this substance.

3. Security. 2-Fluorodeschloroketamine is subject to schedule I security requirements and must be handled in accordance with 21 CFR 1301.71-1301.93, as of May 22, 2026.

4. Labeling and Packaging. All labels, labeling, and packaging for commercial containers of 2-fluorodeschloroketamine must comply with 21 U.S.C. 825 and 958(e) and 21 CFR part 1302. Current DEA registrants will have 30 calendar days from May 22, 2026 to comply with all labeling and packaging requirements.

5. Inventory. Every DEA registrant who possesses any quantity of 2-fluorodeschloroketamine on the effective date of this order must take an inventory of all stocks of this substance on hand pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11. Current DEA registrants will have 30 calendar days from the effective date of this order to comply with all inventory requirements. After the initial inventory, every DEA registrant must take an inventory of all controlled substances (including 2-fluorodeschloroketamine) on hand on a biennial basis pursuant to 21 U.S.C. 827 and 958 and in accordance with 21 CFR 1304.03, 1304.04, and 1304.11.

6. Records. All DEA registrants must maintain records with respect to 2-fluorodeschloroketamine pursuant to 21 U.S.C. 827 and 958(e) and in accordance with 21 CFR parts 1304, 1312, and 1317, and section 1307.11. Current DEA registrants authorized to handle 2-fluorodeschloroketamine shall have 30 calendar days from the effective date of this order to comply with all recordkeeping requirements.

7. Reports. All DEA registrants must submit reports with respect to 2-fluorodeschloroketamine pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304, 1312, and 1317, and sections 1301.74(c) and 1301.76(b), as of May 22, 2026. Manufacturers and distributors must also submit reports regarding 2-fluorodeschloroketamine to the Automation of Reports and Consolidated Order System pursuant to 21 U.S.C. 827 and in accordance with 21 CFR parts 1304 and 1312.

8. Order Forms. All DEA registrants who distribute 2-fluorodeschloroketamine must comply with order form requirements pursuant to 21 U.S.C. 828 and in accordance with 21 CFR part 1305 as of May 22, 2026.

9. Importation and Exportation. All importation and exportation of 2-fluorodeschloroketamine must be in compliance with 21 U.S.C. 952, 953, 957, and 958, and in accordance with 21 CFR part 1312 as of May 22, 2026.

10. Quota. Only DEA-registered manufacturers may manufacture 2-fluorodeschloroketamine in accordance with a quota assigned pursuant to 21 U.S.C. 826 and in accordance with 21 CFR part 1303, as of May 22, 2026.

11. Liability. Any activity involving 2-fluorodeschloroketamine not authorized by or in violation of the CSA, occurring as of May 22, 2026, is unlawful, and may subject the person to administrative, civil, and/or criminal sanctions.

The CSA provides for expedited temporary scheduling actions where necessary to avoid an imminent hazard to public safety. Under 21 U.S.C. 811(h)(1), the Administrator, as delegated by the Attorney General, may, by order, temporarily place substances in schedule I. Such orders may not be issued before the expiration of 30 days from: (1) the publication of a notice in the Federal Register of the intent to issue such order and the grounds upon which such order is to be issued, and (2) the date that notice of the proposed temporary scheduling order is transmitted to the Assistant Secretary, as delegated by the Secretary of HHS. 22

Inasmuch as section 811(h) directs that temporary scheduling actions be issued by order (as distinct from a rule) and sets forth the procedures by which such orders are to be issued, DEA believes the notice-and-comment requirements of the Administrative Procedure Act (APA) at 5 U.S.C. 553, which are applicable to rulemaking, do not apply to this temporary scheduling order. The APA expressly differentiates between orders and rules, as it defines an “order” to mean a “final disposition, whether affirmative, negative, injunctive, or declaratory in form, of an agency in a matter other than rule making.”   23 This contrasts with permanent scheduling actions, which are subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” and final decisions that conclude the scheduling process and are subject to judicial review. 24 The specific language chosen by Congress indicates its intent that DEA issue orders instead of proceeding by rulemaking when temporarily scheduling substances. Given that Congress specifically requires the Administrator (as delegated by the Attorney General) to follow rulemaking procedures for other kinds of scheduling actions, 25 it is noteworthy that, in section 811(h)(1), Congress authorized the issuance of temporary scheduling actions by order rather than by rule.

Even assuming that this action is subject to the notice-and-comment requirements of the APA, the Administrator finds that there is good cause to forgo these requirements pursuant to 5 U.S.C. 553(b)(B), as any further delays in the process for issuing temporary scheduling orders would be impracticable and contrary to the public interest given the manifest urgency to avoid an imminent hazard to public safety.

Although DEA believes this temporary scheduling order is not subject to the notice-and-comment requirements of the APA, DEA notes that in accordance with 21 U.S.C. 811(h)(4), the Administrator took into consideration comments submitted by the then-Acting Assistant Secretary in response to the notices that DEA transmitted to the then-Acting Assistant Secretary pursuant to such subsection.

Further, DEA believes that this temporary scheduling action is not a “rule” as defined by 5 U.S.C. 601(2), and, accordingly, is not subject to the requirements of the Regulatory Flexibility Act (RFA). The requirements for the preparation of an initial regulatory flexibility analysis in 5 U.S.C. 603(a) are not applicable where, as here, DEA is not required by the APA or any other law to publish a general notice of proposed rulemaking. Therefore, in this instance, since DEA believes this temporary scheduling action is not a “rule,” it is not subject to the requirements of the RFA when issuing this temporary action.

In accordance with the principles of Executive Orders (E.O.) 12866 and 13563, this action is not a significant regulatory action. E.O. 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health, and safety effects; distributive impacts; and equity). E.O. 13563 is supplemental to and reaffirms the principles, structures, and definitions governing regulatory review as established in E.O. 12866. E.O. 12866, Section 3(f), provides the definition of a “significant regulatory action,” requiring review by the Office of Management and Budget. Because this is not a rulemaking action, this is not a significant regulatory action as defined in Section 3(f) of E.O. 12866. In addition, DEA scheduling actions are not subject to either E.O. 14192, Unleashing Prosperity Through Deregulation, or E.O. 14294, Fighting Overcriminalization in Federal Regulations.

This action 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, it is determined that this action does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.

For the reasons set out above, DEA amends 21 CFR part 1308 as follows:

Federal agencies, including HUD, have responsibilities under the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321-4347) and other NEPA-related Federal environmental laws and authorities. (See 24 CFR 50.4). HUD's regulations implementing NEPA and other environmental requirements for programs where HUD performs environmental reviews are in 24 CFR part 50, titled “Protection and Enhancement of Environmental Quality.”

HUD's environmental procedures of July 16, 1971, published by the Council on Environmental Quality at 37 FR 22673 (October 20, 1972), established a “normal environmental clearance” and “special environmental clearance” for certain projects and set out thresholds for use of the “special environmental clearance”, including housing assistance or insurance for 100 unit multifamily structures and 100 bed nursing homes. HUD subsequently published a series of revisions to its environmental procedures, as well as a 1974 proposed rule that was not finalized. In 1979, HUD codified its environmental procedures in 24 CFR part 50, 44 FR 67906, which required completion of a “special environmental clearance,” to be concurred in by the Area Environmental Clearance Officer (ECO), for multifamily projects with over 200 units or mortgage amounts over $5,000,000. The current version of part 50, promulgated in 1996, 61 FR 50916, requires in the last sentence of § 50.32 that Environmental Assessments for projects over 200 lots/dwelling units or beds be sent to the Field Environmental Clearance Office (FECO) or, in the absence of a FECO, to the Program Environmental Clearance Officer (PECO) for review and comment.

Through this interim final rule, HUD is removing the last sentence of 24 CFR 50.32 which contains the requirement that Environmental Assessments for projects over 200 dwelling units or beds shall be sent to the FECO or PECO for review and comment. This round of review and comment is not required under the relevant environmental legal authorities, including NEPA, nor is it discussed in the preambles of HUD's 1996 rulemakings that promulgated § 50.32 in its current form. 61 FR 50914, 61 FR 15340.

Currently, the review and comment requirement in § 50.32 represents an extraneous step in the environmental review process. This requirement adds a third or fourth review to the environmental process for new construction and substantial rehabilitation projects over 200 units that have already been certified by environmental review preparers and supervisors. This extra step in the review process has the potential to add processing time to projects that often have tight closing deadlines and requires duplicative technical assistance when such assistance is already available, as needed, from HUD Program Environmental Specialists and ECOs.

This update ensures that HUD's environmental review procedures are administered in accordance with Administration priorities while meeting the statutory requirements under NEPA and other related laws and authorities, including Executive Order 14154 Unleashing American Energy. This E.O. directs relevant agencies, including HUD, to require efficiency and expediency for environmental permitting  1 and to streamline processing times for projects. Section 5(d) of E.O. 14154 specifies that HUD, in addition to other relevant agencies, must undertake all available efforts to eliminate all delays in permitting processes. Section 6(a) of E.O. 14154 directs all agencies to adhere only to statutory requirements for environmental considerations in all Federal permitting adjudications or regulatory processes, and to eliminate extraneous requirements. This interim final rule's removal of a time-consuming level of environmental review that is not required by statute aligns with E.O. 14154's directives.

This interim final rule makes no other changes to § 50.32 or other HUD regulations. Following this rulemaking, including consideration of any public comments received on this interim final rule, HUD will update relevant guidance documents  2 to reflect regulatory changes that result from this rulemaking.

In general, HUD publishes a rule for public comment in accordance with both the APA, 5 U.S.C. 553, and the agency's regulation on rulemaking at 24 CFR part 10. Both the APA and part 10, however, provide for exceptions from that general rule where HUD finds good cause to omit advance notice of the opportunity for public comment. The good cause requirement is satisfied when prior public procedure is “impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(B). See also 24 CFR 10.1. To publish a rule for effect prior to receiving and responding to public comments ( i.e., an interim final rule), the agency must make a finding that “good cause” exists.

The last sentence of 24 CFR 50.32 requires relevant HUD program staff to send assessments for new construction or substantial rehabilitation projects that are over 200 lots/dwelling units or beds to the Field Environmental Clearance Officer (FECO) or, in the absence of a FECO, to the Program Environmental Clearance Officer in Headquarters for review and comment. This is the third or fourth of several rounds of environmental review under HUD's existing regulations, and it is not required by statute or regulation. See the National Environmental Policy Act (NEPA) of 1969 (42 U.S.C. 4321-4347), and the Council on Environmental Quality's recently removed  3 regulations at 40 CFR parts 1500-1508. HUD promulgated this requirement in its current form in 1996 through a proposed and final rule, neither of which discuss the requirement or the reasoning behind its promulgation. 61 FR 50914, 61 FR 15340. HUD believes the requirement was preexisting before HUD established CEST (categorically excluded from NEPA, but subject to the related laws and authorities at 58.5 or 50.4) and Environmental Assessment level reviews and stayed in the promulgated regulation.

The additional HUD staff review required at § 50.32 for new construction or substantial rehabilitation projects that are over 200 lots/dwelling units or beds has the potential to add processing time to projects that often have very tight closing deadlines. It also requires a duplicative technical assistance process where technical assistance is already available, as needed, from HUD Program Environmental Specialists and ECOs. Additionally, this additional review would affect approximately 80 projects each year. Given that the number of projects and stakeholders affected by this IFR is minimal, HUD finds that the requirement under § 50.32 is unnecessary for HUD to implement.

Additionally, HUD's regulations at 24 CFR 10.1 state that notice and public procedure may be omitted with respect to rules governing the Department's organization or its own internal practices or procedures. This rule is limited to removing one requirement in the Department's environmental review procedures in 24 CFR part 50. HUD created the regulatory requirement removed by this rule; it is not required by statute and unnecessarily added to statutory requirements implemented in HUD's environmental review regulations. Therefore, the requirement concerns only HUD-created policy and procedure. The rule does not revise or change any statutorily required policy and procedure. Thus, this rule is not establishing policy outside of HUD's own internal procedures.

Since the requirement under § 50.32 is not required by legal authorities, would only add unnecessary, time-consuming levels of environmental review, and concerns internal practices or procedures, HUD has determined that it is unnecessary to solicit advance public comment.

Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made regarding whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned.” As previously discussed, this final rule removes unnecessary regulations and is consistent with Executive Order 13563.

This interim final rule was determined not to be a significant regulatory action under section 3(f) of Executive Order 12866 and therefore was not reviewed by OMB.

The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq. ) generally requires an agency to conduct a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Because HUD has determined that good cause exists to issue this interim final rule without prior public comment, this rule is not subject to the requirement to publish an initial or final regulatory flexibility analysis under the RFA as part of such action.

Executive Order 14192, entitled “Unleashing Prosperity Through Deregulation,” was issued on January 31, 2025. Section 3(c) of Executive Order 14192 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 interim final rule removes unnecessary and time-consuming levels of environmental review that are not required by law and therefore is a repeal of a regulation that results in reduced regulatory costs for purposes of Executive Order 14192.

Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either: imposes substantial direct compliance costs on State and local governments and is not required by statute; or preempts state law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This interim final rule does not have federalism implications and does not impose substantial direct compliance costs on state and local governments nor preempt state law within the meaning of the Executive Order.

A Finding of No Significant Impact with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The FONSI is available through the docket file at https://www.regulations.gov. The FONSI is also available for public inspection during regular business hours in the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 2415 Eisenhower Avenue, Alexandria, VA 22314. Due to security measures at the HUD Headquarters building, you must schedule an appointment in advance to review the FONSI by calling the Regulations Division at 202-708-3055 (this is not a toll-free number). HUD welcomes and is prepared to receive calls from individuals who are deaf or hard of hearing, as well as individuals with speech or communication disabilities. To learn more about how to make an accessible telephone call, please visit https://www.fcc.gov/consumers/guides/telecommunications-relay-service-trs.

Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and Tribal governments, and on the private sector. This interim final rule does not impose any Federal mandates on any State, local, or Tribal governments, or on the private sector, within the meaning of the UMRA.

Accordingly, for the reasons described in the preamble, HUD amends 24 CFR part 50 as follows:

The Coast Guard received notification that flood waters have damaged the safety cable and spillway gates of the Cheboygan Lock & Dam Complex on the Cheboygan River in Cheboygan, MI, necessitating their immediate repair. The Captain of the Port (COTP) Northern Great Lakes has determined that potential hazards associated with the repairs are a safety concern for anyone from the Lincoln Bridge to the Cheboygan Lock & Dam Complex. 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. The Coast Guard was notified of this issue on May 16, 2026, but we must establish this safety zone by May 18, 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 Federal Register .

This rule establishes a safety zone from May 18, 2026 through May 31, 2026. The safety zone will cover all navigable waters in the Cheboygan River from the Cheboygan Lock & Dam Complex to the Lincoln Bridge. 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 FOR FURTHER INFORMATION CONTACT section.

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 et seq. ), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

This rule is a safety zone. It is categorically excluded from further review under paragraph L60(d) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination will be available in the docket.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

The regulations in 33 CFR 165.939 as listed in Table 1 to § 165.939 will be enforced for the following safety zones for the dates and times specified, listed in chronological order:

(1) City of Erie 4th of July Fireworks, Erie, PA: The safety zone listed in (G)(30) will be enforced on all waters of Lake Erie contained within a 280-foot radius of the Dobbins Landing launch site located at 42°08′17.13″ N, 080°05′30.17″ W in Erie, PA from 9:15 p.m. through 10:45 p.m. on July 3, 2026.

(2) SamSen Operation/Seneca Lake Resorts 4th of July, Romulus, NY: The safety zone listed in (G)(34) will be enforced on all waters of the Seneca Lake, contained in a 420-foot radius of 42°43′39.28″ N, 076°54′59.47″ W in Romulus, NY from 9:15 p.m. through 10:45 p.m. on July 3, 2026.

(3) Town of Newfane Annual Fireworks Show, Olcott, NY: The safety zone listed in (G)(35) will be enforced on all waters of Lake Ontario within a 1,120-foot radius of land position 43°20′23.6″ N, 078°43′09.5″ W in Olcott, NY from 9:30 p.m. through 10:45 p.m. on July 3, 2026.

(4) Village of Sodus Point Fourth of July Fireworks, Sodus Point, NY: The safety zone listed in (G)(22) will be enforced on all U.S. waters of Sodus Bay within a 1,120-foot radius of land position 43°16′33″ N, 076°58′27″ W in Sodus Point, NY from 9:45 p.m. through 10:45 p.m. on July 3, 2026.

(5) Hamburg Beach Blast, Hamburg, NY: The safety zone listed in (G)(32) will be enforced on all U.S. waters of Lake Erie contained within a 280-foot radius of 42°45′59.21″ N, 078°52′41.51″ W in Hamburg, NY from 9:15 p.m. through 10:45 p.m. on July 26, 2026.

(6) Thunder on the Niagara Hydroplane Boat Races, North Tonawanda, NY: The safety zone listed in (H)(4) will be enforced on all U.S. waters of the Niagara River near the North Grand Island Bridge, encompassed by a line starting at 43°03′32.9″ N, 078°54′46.9″ W to 43°03′14.6″ N, 078°55′16.0″ W then to 43°02′39.7″ N, 078°54′13.1″ W then to 43°02′59.9″ N, 078°53′42.0″ W and returning to the point of origin from 9:30 a.m. through 5:30 p.m. on August 1, 2026 and August 2, 2026.

Pursuant to 33 CFR 165.23, entry into, transiting, or anchoring within these safety zones during an enforcement period is prohibited unless authorized by the Captain of the Port Eastern Great Lakes or their designated representative. Those seeking permission to enter these safety zones may request permission from the Captain of the Port Eastern Great Lakes via channel 16, VHF-FM. Vessels and persons granted permission to enter the safety zone must obey the directions of the Captain of the Port Eastern Great Lakes or their designated representative. While within a safety zone, all vessels must operate at the minimum speed necessary to maintain a safe course.

In addition to this Notice of Enforcement in the Federal Register , the Coast Guard will provide the maritime community with advance notification of the enforcement periods via Broadcast Notice to Mariners or other suitable means. If the Captain of the Port Eastern Great Lakes determines that the safety zone need not be enforced for the full duration stated in this notice, they may use a Broadcast Notice to Mariners to grant general permission to enter the respective safety zone.

The Coast Guard will enforce the safety zones in the Table to 33 CFR 165.918, Events (2), (3), (4), and (5), at the time, dates, and locations indicated below:

(a) Event (2), Jordan Valley Freedom Festival Fireworks (East Jordan, MI): from 10 p.m. through 10:30 p.m. on June 27, 2026. In the event of inclement weather, this event will be held on June 28, 2026, with the safety zone enforced from 10 p.m. through 10:30 p.m. on June 28, 2026.

(b) Event (3), Grand Marais Splash In (Grand Marais, MI): from 1 p.m. through 5 p.m. on June 20, 2026.

(c) Event (4), Festivals of Fireworks Celebration Fireworks (St. Ignace, MI): from 9:45 p.m. to 10:15 p.m. every Saturday from June 27, 2026, until September 18, 2026.

(d) Event (5), National Cherry Festival Airshow (Traverse City, MI): from 1 p.m. to 4 p.m. on July 4 and 5, 2026.

In addition to this notice of enforcement in the Federal Register , the Coast Guard will provide the maritime community with advance notification of this enforcement period via Broadcast Notice to Mariners or Local Notice to Mariners. If the Captain of the Port Northern Great Lakes determines that the safety zone need not be enforced for the full duration stated in this notice, he or she may suspend such enforcement and notify the public of the suspension via Broadcast Notice to Mariners and grant general permission to enter the respective safety zone.

Throughout this document, “we,” “us,” and “our” refer to the EPA.

On February 12, 2026 (91 FR 6557), the EPA proposed to approve the following submittal into the Arizona SIP.

We proposed to approve the ADEQ's submittal, “SIP Revision: Gila County, Arizona RACT Analysis and Negative Declarations for the 2015 Ozone NAAQS” (“2025 RACT SIP”), because we determined that it complies with the relevant CAA requirements. Our proposed action contains more information on the submittal and our evaluation.

The EPA's proposed action provided a 30-day public comment period. During this period, we received no comments.

No comments were submitted. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is approving the 2025 RACT SIP into the Arizona SIP.

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 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 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 et seq. );

• 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 et seq. );

• 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 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 CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 21, 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).)

For the reasons stated in the preamble, the EPA amends 40 CFR part 52 as follows:

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. Potentially affected entities may include:

• 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 FOR FURTHER INFORMATION CONTACT .

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 reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”Additionally, FFDCA section 408(b)(2)(D) requires that the Agency consider, among other things, “available information concerning the cumulative effects of a particular pesticide's residues” and “other substances that have a common mechanism of toxicity.”

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-2023-0484 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 July 21, 2026.

EPA's Office of Administrative Law Judges (OALJ), 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. See “Order Urging Electronic Filing and Service,” dated December 3, 2025, which can be found at https://www.epa.gov/system/files/documents/2025-12/2025-12-03-order-urging-electronic-filing-and-service.pdf. Although EPA's regulations require submission via U.S. Mail or hand delivery, EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/oa/eab/eab-alj_upload.nsf.

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 https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. If you wish to include CBI in your request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.

In the Federal Register of October 26, 2023 (88 FR 73571, FRL-10579-09-OCSPP), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 346a, announcing the filing of a pesticide petition (PP IN-11737) by Steptoe & Johnson, LLP on behalf of Sun Chemical (5020 Spring Grove Avenue, Cincinnati, OH 45232). The petition requested that 40 CFR be amended by establishing an exemption from the requirement of a tolerance for residues of aluminum (CAS Reg. No. 7429-90-5) when used as an inert ingredient (seed treatment colorant) in pesticide formulations for seed treatment in occupational settings only at not more than 20% of pesticide formulation under 40 CFR 180.920. That document referenced a summary of the petition prepared by Steptoe & Johnson, LLP, the petitioner, which is available in the docket. There were no relevant comments received in response to the notice of filing. The originally requested limitation was adjusted to 5%, per the applicant's request.

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 aluminum including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with aluminum 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 aluminum 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 aluminum (aluminum metal) is supported by data regarding aluminum oxide, aluminum citrate and aluminum sulfate. EPA has determined that it is appropriate to bridge aluminum oxide, aluminum citrate and aluminum sulfate data to assess aluminum as a worse-case scenario. Aluminum is insoluble in water and it is anticipated to be less toxic than the water-soluble aluminum salts.

Aluminum exhibits low levels of acute toxicity via the oral and inhalation routes of exposure. The acute dermal toxicity of aluminum is anticipated to be low. It is an eye and dermal irritant, but it is not anticipated to be a dermal sensitizer. Main effects observed in laboratory animals following repeated exposure to aluminum salts include neurotoxicity and delayed maturation starting at 100 mg aluminum/kg/day. The available data indicates that aluminum is not mutagenic nor carcinogenic.

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 dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (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 (RfD), 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 https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/overview-risk-assessment-pesticide-program.

A combined one-year developmental and chronic neurotoxicity study with aluminum citrate in rats (Semple, 2010 and Poirier et al, 2011) was selected as the main study for endpoint selection for aluminum because it was conducted under a protocol similar to OECD test guideline 426, it followed good laboratory practices and it is protective of the neurotoxicity and delayed maturation observed in the aluminum database. The NOAEL is 30 mg Al/kg/day and the LOAEL is 100 mg Al/kg/day, based on impaired hind limb grip strength and splayfoot.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to aluminum, EPA considered exposure under the proposed exemption from the requirement of a tolerance. EPA assessed dietary exposures from aluminum in food as follows:

In conducting the dietary exposure assessment using the Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 4.02, EPA used 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 aluminum. 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 memorandum titled “Update to D361707: Dietary Exposure and Risk Assessments for the Inerts” (12/21/2021) which can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2018-0090.

In the dietary exposure assessments, 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. The concentrations of active ingredients 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 aluminum, EPA made a specific adjustment to the dietary exposure assessment to account for the use limitations of the amount of aluminum that may be in pesticide formulations (limited to no more than 5%) present at the maximum limitation rather than 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 aluminum.

2. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface disinfection on walls, floors, tables).

However, residential handler exposure is not expected for aluminum as the use is for occupational (seed treatment) purposes only.

3. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

Based on the lack of toxicity in the available database, EPA has not found aluminum to share a common mechanism of toxicity with any other substances, and aluminum does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance exemption, therefore, EPA has assumed that aluminum does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/cumulative-assessment-risk-pesticides.

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 aluminum. The FQPA safety factor has been reduced to 1X because: (1) the toxicity database is adequate to characterize potential pre- and postnatal risk; (2) no teratogenic effects were observed in the available developmental studies; (3) the selected endpoints are protective of the neurotoxic and delayed maturation effects 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. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, aluminum metal is not expected to pose an acute risk.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to aluminum from food and water will utilize approximately 9.5% and 34.3% of the cPAD for the U.S. population and children 1-2 years old (the most highly exposed populations).

3. Short- and intermediate-term aggregate risks. Short- and intermediate-term aggregate exposures take into account short- and intermediate-term residential exposures plus chronic exposures to food and water (considered to be a background exposure level).

Residential handler exposure is not expected for aluminum metal as the use is for occupational (seed treatment) purposes only.

Residential post-application scenarios include short- and intermediate-term dermal (skin contact with treated surfaces) exposure for adults and children as well as short-term incidental oral exposure for children (hand-to-mouth exposure with treated surfaces). However, residential post-application exposure is not expected for aluminum metal because it will be used in occupational settings (seed treatment) only.

An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of aluminum in or on any food commodities. EPA is establishing a limitation on the amount of aluminum that may be used in pesticide formulations applied pre-harvest. This limitation will be enforced through the pesticide registration process under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136 et seq. EPA will not register any pesticide formulation for food use that exceeds 5% aluminum in the final pesticide formulation for seed treatment only.

Therefore, an exemption from the requirement of a tolerance is established for residues of aluminum (CAS Reg. No. 7429-90-5) when used as an inert ingredient (seed treatment colorant) for seed treatment only at not more than 5% of pesticide formulation under 40 CFR 180.920.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

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 et seq., because it does not contain any information collection activities.

This action is not subject to the RFA, 5 U.S.C. 601 et seq. The RFA applies only to rules subject to notice and comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule is not subject to the APA but is subject to FFDCA section 408(d), which does not require notice and comment rulemaking to take this action in response to a petition.

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 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires 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 reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is documented in the pesticide-specific registration review documents, located in the applicable docket at https://www.regulations.gov.

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 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action does not meet the criteria set forth in 5 U.S.C. 804(2).

For the reasons stated in the preamble, the EPA amends 40 CFR chapter I as follows:

This action may apply to you if you manufactured (including imported) any of the chemical substances listed in 40 CFR 716.120(d) of the regulatory text of this document. The following list of North American Industrial Classification System (NAICS) codes affected by this rule are those that align with these activities:

• Chemical manufacturers (including importers), (NAICS code 325); and

• Petroleum refineries (NAICS code 324110).

This action applies to manufacturers in these NAICS codes who are currently manufacturing (including importing) a listed chemical substance (or will do so during the chemical's reporting period) or who have manufactured (including imported) or proposed to manufacture (including import) a listed chemical substance within the last 10 years.

If you have any questions regarding the applicability of this proposed action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT .

On March 30, 2026, EPA proposed a rule to extend the reporting deadline to May 21, 2027, for all 16 chemicals covered under this rule (91 FR 15582 (FRL-13162-01-OCSPP)). EPA is finalizing this rule to extend the reporting deadline from May 22, 2026, to May 21, 2027, for the data submission period for the TSCA section 8(d) Health and Safety Data Reporting Rule.

The Health and Safety Data Reporting rule for 16 listed chemical substances is promulgated under TSCA section 8(d) (15 U.S.C. 2607(d)) and codified at 40 CFR part 716. EPA is relying upon this statutory authority to modify the reporting deadline for the final TSCA section 8(d) rule, which is the same statutory authority relied upon to promulgate the underlying rule.

The statutory provision, along with administrative agencies' authority to reconsider prior regulations, provides EPA's authority for the targeted amendment to the compliance deadline finalized in this action. Unless provided otherwise by statute, an agency may change existing positions ( e.g., reconsider, revise, or rescind prior rules) provided they acknowledge the change in position, offer a reasonable explanation for the change, and take any serious reliance interests into account. See, e.g., FDA v. Wages & White Lion Invs., L.L.C., 145 S. Ct. 898, 917 (2025); Encino Motorcars v. Navarro, 579 U.S. 211, 221 (2016); FCC v. Fox Television Stations, Inc., 556 U.S. 502, 515 (2009); Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983). As discussed in this preamble, the EPA finds that it is appropriate and consistent with the statute's purposes to extend the reporting deadline by one year. The Agency has considered reliance interests, including those asserted during the public comment period for the proposed rule published on March 30, 2026, to extend the reporting deadline, and determined that this one- year extension is the better course for the reasons set out below.

This final rule is effective immediately upon publication. Section 553(d)(1) of the Administrative Procedure Act, 5 U.S.C. 553(d)(1), provides that final rules shall not become effective until 30 days after publication in the Federal Register , with an exception for “a substantive rule [that] grants or recognizes an exemption or relieves a restriction.” The primary purpose of the prescribed 30-day waiting period is to give affected parties a reasonable time to adjust their behavior and prepare before a final rule takes effect. This rule relieves a restriction by extending the reporting deadline by one year. As such, affected parties do not need time to adjust their behavior and it is appropriate for this final rule to go into effect immediately upon publication.

EPA promulgated a final rule on December 13, 2024 (89 FR 100756 (FRL-11164-02-OCSPP)), to require manufacturers (including importers) of 16 specific chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. The 16 chemical substances were added to 40 CFR 716.120 to support ongoing and upcoming activities under TSCA section 6. On March 13, 2025, EPA extended the submission deadlines from March 13, 2025, to June 11, 2025, for vinyl chloride (CASRN 75-01-4) and from March 13, 2025, to September 9, 2025, for the remaining 15 chemical substances. See 90 FR 11899 (FRL-11164.-02-OCSPP). On June 9, 2025, EPA amended the submission deadlines for all 16 chemical substances subject to the rule to May 22, 2026. EPA published a proposed action on March 30, 2026, to extend the reporting deadline by one year to May 21, 2027. This action will provide EPA with additional time to consider the need for modifications to the substantive TSCA section 8(d) reporting requirements that impact the ability of regulated parties to comply in a manner that provides useful information, ensure that regulated entities have sufficient time to understand reporting obligations, and allow industry adequate time to prepare data submissions.

EPA is considering a proposal to modify the scope of the TSCA section 8(d) Health and Safety Data Reporting Rule, including because of legitimate concerns raised regarding the scope of the rule and obligations arising thereunder and the ability of regulated parties to comply in a cost reasonable manner that provides information that is useful to the purposes underlying the rule. The reporting deadline of May 22, 2026, is insufficient time for EPA to resolve the issues prompting modification to the rule's scope (90 FR 24228 June 9, 2025 (FRL-11164.2-02-OCSPP)). As such, EPA is extending the reporting deadline by one year to May 21, 2027.

EPA is also finalizing this action to extend the reporting period because the Agency has determined additional time is necessary to alleviate the compliance burdens associated with this one-time reporting rule while EPA considers potential modifications to the regulations, including aligning the rule with Executive Order 14219 “Ensuring Lawful Governance and Implementing the President's ‘Department of Government Efficiency’ Deregulatory Initiative” (90 FR 10583, February 19, 2025) and EPA's Powering the Great American Comeback Initiative Pillar 1: Clean Air, Land, and Water for Every American. Consistent with TSCA section 8(d), EPA is working to ensure that the information collected is necessary to carrying out the relevant statutory purposes furthered by the rule. Rather than requiring businesses to prepare submissions under a rule that is in the process of being revised, this action provides regulatory certainty and prevents duplicative or potentially inconsistent reporting. Once any substantive revisions to the rule are finalized and published, reporting requirements and updated timelines will be clearly communicated to ensure a smooth and efficient compliance process.

EPA received a total of 47 comments on the proposed extension of the TSCA section 8(d) reporting deadline. Of the 47 submissions, 27 were part of a mass campaign of letters submitted primarily by private and anonymous citizens. The remaining 20 submissions represent unique comments, including a submission by a private citizen with 4,901 signatures, 10 individual private and anonymous commenters, five industry trade associations, one state government, three non-government organizations (NGOs), and one NGO submission that included support from 49 groups. Of the total comments received, 37 opposed the proposed extension, seven supported the extension, and three were general or informational submissions that substantively aligned with concerns about delay but did not clearly state a position.

This final rule is limited to the extension of the reporting deadline under the TSCA section 8(d) Health and Safety Data Reporting Rule. The Agency is not responding to comments that raised topics outside the scope of this action. Some commenters raised issues related to general policy views on chemical safety, public health protection, and environmental justice. These issues are outside the scope of this action, which does not reopen or revise the underlying substantive requirements of the Health and Safety Reporting Data rule and are not directly related to the timing of the reporting deadline extension. The comments received on the proposal that are within the scope of this action are summarized and addressed below.

Commenters supporting the proposed one-year extension, primarily representing industry trade associations generally agreed that additional time is needed to allow EPA time to complete modifications to the scope, guidance, and implementation of the TSCA section 8(d) reporting rule prior to the submission of data currently due May 22, 2026.

Commenters emphasized that extending the deadline would help avoid duplicative or inconsistent reporting obligations, reduce compliance burden, and prevent regulated entities from preparing submissions under a rule that may change. Several commenters noted that companies would incur unnecessary costs and effort if required to submit data under requirements that are under modification. Supportive commenters further stated that the extension would allow EPA time to finalize updated guidance and provide clearer implementation expectations, thereby improving overall regulatory efficiency and consistency.

EPA acknowledges commenters' support for the proposed extension and their concerns regarding potential duplicative reporting, administrative burden, and uncertainty while the rule is under modification. EPA agrees extending the reporting deadline is necessary while EPA considers modifications to the underlying TSCA section 8(d) rule and, if modifications are implemented, to ensure that companies understand any new requirements prior to the reporting deadline.

Opposing commenters included private citizens submitting campaign letters, anonymous commenters, members of academia, state government representatives, and environmental advocacy organizations. Overall, these commenters expressed concern that extending the reporting deadline from May 22, 2026, to May 21, 2027, would postpone submissions of health and safety data needed for EPA's TSCA section 6 prioritization, risk evaluation, and risk management actions. Many commenters expressed concern that delayed submission of unpublished health and safety studies could result in risk evaluations being conducted using incomplete or less current datasets, potentially affecting the completeness of EPA's regulatory determinations for the 16 chemical substances covered by the rule. Several commenters stated that delaying reporting increases the risk that unpublished studies may be lost or discarded due to routine corporate record retention practices, reducing the availability of information needed for EPA's administrative record. A state government commenter indicated that delays in federal data collection may affect coordination with state-level chemical safety programs and could delay downstream regulatory actions that rely on EPA-generated information. Many campaign letters from private citizens reiterated concerns about environmental justice and the need for timely access to chemical safety information to support EPA's science-based decision-making. A coalition of environmental organizations raised concerns regarding the administrative and legal implications of extending the reporting deadline, including assertions that repeated extensions may delay statutory obligations and reduce transparency in the regulatory process.

EPA acknowledges commenters' concerns that extending the reporting deadline could delay the availability of health and safety data, affect TSCA section 6 risk evaluation activities, and reduce transparency. EPA disagrees that the one-year extension undermines statutory obligations or the Agency's ability to rely on the best available science. The extension is an action that allows EPA to propose and finalize modifications of the scope of the TSCA section 8(d) reporting rule, including valid concerns raised regarding the rule that impact regulated parties' ability to comply and the Agency's ability to receive useful information, and enables submitters additional time to provide complete and accurate information aligned with any updated requirements. This approach supports EPA's authority to reconsider the scope of data necessary for submission under TSCA section 8(d) collections for potential use in TSCA section 6 risk evaluation and risk management actions. This action does not alter EPA's ongoing use of existing or otherwise reasonably available information in support of TSCA section 6 activities. EPA notes that TSCA section 8(d) authorizes EPA to require submissions of unpublished health and safety studies “at such times and in such manner as the Administrator may reasonably prescribe” (15 U.S.C 2607(d)). This authority provides EPA discretion to establish and adjust reporting period deadlines as necessary to ensure effective implementation of information collection requirements. Adjusting the reporting deadline does not suspend statutory obligations but ensures that reporting requirements are implemented consistently with TSCA's risk-based framework and produce information that is relevant and usable for the Agency's statutory responsibilities. Also, this action affects only the timing of submissions for this data call and does not delay or suspend EPA's prioritization, risk evaluation, or risk management activities, which continue to proceed using the best available data sources and science, as required by TSCA section 26. EPA does not expect the extension to result in loss of relevant data, as entities remain subject to applicable recordkeeping requirements, and EPA retains authority to obtain information as needed to support ongoing risk evaluations. EPA considered potential impacts of the extension on TSCA section 6 risk evaluation activities and determined that receiving TSCA section 8(d) data by May 2027 will provide EPA sufficient time to incorporate information into the risk evaluations for the chemical substances covered by the rule. It is generally unexpected that any information received pursuant to TSCA section 8(d) will materially alter the ongoing work or outcomes of prioritization or risk evaluation or that any delay due to this extension will require rework that would delay any related TSCA section 6 activities. Commenters' broader concerns regarding TSCA section 6 considerations and issues related to Executive Branch policies or other rulemakings are outside the scope of this action. This rulemaking is limited to consideration of whether to extend the reporting deadline.

A state government commenter indicated that delays in federal data collection may affect coordination with state-level chemical safety programs and could delay downstream regulatory actions that rely on EPA-generated information. The Agency appreciates that non-EPA entities—such as other federal agencies, states, and nongovernmental organizations—may rely on and derive benefits from TSCA section 8(d) information. However, EPA understands that these entities are not entirely reliant on this data (that is, this information supplements other information used by these other entities rather than serving as a uniquely critical source of information), and EPA anticipates making non-confidential information publicly available following the submission of information pursuant to this rule. To this end, EPA is seeking to expedite the posting of information received pursuant to TSCA section 8(d) to minimize delays between receipt and public dissemination of nonconfidential submissions.

Further, EPA does not expect the deadline extension to alter state reliance on EPA-generated information because this action only extends the timing of the reporting and does not change the scope of the information collected, TSCA authorities, or existing mechanisms through which the state accesses and uses EPA data. Overall, EPA has determined that the extension appropriately balances the need for timely data collection with the considerations associated with ongoing rule modifications and will help ensure that submitted information is complete, relevant, and usable to support the Agency's statutory responsibilities under TSCA.

EPA has determined that a one-year extension of the reporting deadline for the Health and Safety Data Reporting Rule under TSCA section 8(d) is appropriate. Accordingly, EPA is finalizing this action to extend the reporting deadline to May 21, 2027. This action is effective upon publication in the Federal Register .

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

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 final rule provides burden reduction by providing relief against existing compliance deadlines.

This action does not impose any new information collection burden under the PRA, 44 U.S.C. 3501 et seq. OMB has previously approved the information collection activity contained in the existing regulation and has assigned OMB control number 2070-0224 (EPA ICR No. 2703.02). This action does not create any new reporting or recordkeeping obligations and does not otherwise change the burden estimates that were approved.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, the EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities because the rule relieves regulatory burden on the small entities subject to the rule. This final action will extend compliance dates of one data reporting rule and alleviate compliance burden on small entities subject to those actions. We have therefore concluded that this action will relieve regulatory burden for all directly regulated small entities.

This action does not contain any unfunded mandate of $100 million (adjusted annually for inflation) or more (in 1995 dollars) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This final 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 does not impose substantial direct compliance costs on federally recognized Indian tribal governments. Thus, Executive Order 13175 does not apply to this action.

Although this action does not concern an environmental health or safety risk, the information obtained from the reporting required by this rule will be used to inform the Agency's decision-making process regarding chemical substances to which children may be exposed. This information will also assist the Agency and others in determining whether the chemical substances included in this proposed rule present potential risks, allowing the Agency and others to take appropriate action to investigate and mitigate those risks.

EPA interprets Executive Order 13045 (62 FR 19885, April 23, 1997) as applying only to those regulatory actions significant under section 3(f)(1) of Executive Order 12866 and that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of Executive Order 13045.

Since this is not a “covered regulatory action,” E.O. 13045 does not apply. However, the Policy on Children's Health does apply.

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 under the NTTAA section 12(d), 15 U.S.C. 272.

This action is subject to the CRA, 5 U.S.C. 801 et seq., and 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).

Therefore, for the reasons stated in the preamble, EPA is amending 40 CFR 716 as follows:

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the factors in TSCA section 5(a)(2).

EPA is finalizing SNURs under TSCA section 5(a)(2) for the chemical substances identified in this document. These chemical substances were the subject of PMNs and are also subject to an Order issued by EPA pursuant to TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). The SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4). The SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use in the SNURs to notify EPA at least 90 days before commencing that activity.

Previously, EPA proposed SNURs for these chemical substances in the Federal Register of November 3, 2025 (90 FR 49016 (FRL-12730-01-OCSPP)). The docket includes information considered by the Agency in developing the proposed and final rules, including public comments and EPA's responses to the comments received as discussed in Unit II.D.

This action applies to you if you manufacture, process, or use the chemical substances identified in this document. 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. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), e.g., chemical manufacturing and petroleum refineries.

This action may also apply to certain entities through pre-existing import certification and export notification requirements under TSCA ( https://www.epa.gov/tsca-import-export-requirements ).

Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 40 CFR part 707, subpart B. Importers of chemical substances in bulk form, as part of a mixture, or as part of an article (if required by rule) must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including regulations issued under TSCA sections 5, 6, 7 and Title IV.

Pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance identified in this document are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.

EPA has evaluated the potential costs of establishing Significant New Use Notice (SNUN) reporting requirements for potential manufacturers and processors of the chemical substances identified in this document. This analysis, which is available in the docket, is briefly summarized here.

A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. If a SNUN is submitted, costs are an estimated $45,000 per SNUN submission for large business submitters and $14,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $37,000 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 700.45(c)(1)(ii) and (d)). These estimates reflect the costs and fees as they are known at the time of this rulemaking.

EPA has also evaluated the potential costs associated with the pre-existing export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications ( i.e., the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by these SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per unit basis is approximately $106.

Unit II. of the proposed rule provides general information about SNURs, and additional information about EPA's new chemical program is available at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

To establish a significant new use, EPA must determine that the use is not ongoing. As discussed in Unit II.E. of the proposed rule, EPA concluded that the proposed significant new uses were not ongoing. If EPA subsequently determines that such a use was ongoing as of the date of publication of the proposed rule and did not cease prior to issuance of the final rule, EPA will not designate that use as a significant new use in the final rule. EPA has no information to suggest that any of the significant new uses identified in this rule meet this criterion.

As discussed in the Federal Register of April 24, 1990 (55 FR 17376 (FRL-3658-5)), EPA believes that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule. The objective of EPA's approach is to ensure that a person cannot impede finalization of a SNUR by initiating a significant new use after publication of the proposed rule but before the effective date of the final rule. Uses arising after the publication of the proposed rule are distinguished from uses that are identified in the final rule as having been ongoing on the date of publication of the proposed rule. The former would be new uses, the latter ongoing uses, except that uses that are identified as ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule.

In the unlikely event that before a final rule becomes effective a person begins commercial manufacturing (including importing) or processing of the chemical substances for a use that is designated as a significant new use in that final rule, such a person would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacture or processing have been satisfied.

Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the internet at https://www.epa.gov/tsca-inventory .

SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, TSCA order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. To assist with EPA's analysis of the SNUN, submitters are encouraged, but not required, to provide the potentially useful information as identified for the chemical substance in Unit III.C. of the proposed rule.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.

The potentially useful information described in Unit III. of the proposed rule may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which provide detailed information about human exposure and environmental release that may result from the significant new use of the chemical substances.

EPA received public comments on the proposed SNURs and prepared a Response to Comment document that provides the Agency responses. The comments and the Response to Comment document are available in the docket, ID number EPA-HQ-OPPT-2024-0514. As described in the Response to Comment document, EPA corrected a typo (from “steams” to “streams”) in the Disposal section of the SNUR for PMN P-22-68 (40 CFR 721.12114). EPA also corrected a similar typo in the Release to Water section of the SNUR for PMN P-23-127 (40 CFR 721.12128). Additionally, EPA is not finalizing the SNURs proposed at 40 CFR 721.12115 through 721.12120 for the substances which were the subjects of PMNs P-22-95 through P-22-100 because the Agency has received new information on these substances requiring further review. These proposed SNURs, and the comment specific to these substances, will be addressed in a separate action.

EPA designates the date of publication of the proposed rule as the cutoff date for determining whether the new use is ongoing, i.e., November 3, 2025 (90 FR 49016 (FRL-12730-01-OCSPP)). This designation is explained in more detail in Unit II.B.

In Unit III.C. of the proposed rule, EPA provided the following information for each chemical substance subject to these SNURs:

• PMN number (the CFR citation assigned in the regulatory text section of this document).

• Chemical name (generic name, if the specific name is claimed as confidential business information (CBI)).

• Chemical Abstracts Service Registry Number (CASRN) or Accession Number (if assigned, for confidential chemical identities).

• Basis for the SNUR ( e.g., effective date of and basis for the TSCA Order).

• Potentially useful information.

The regulatory text section of this document specifies the chemical substances and activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated, may be claimed as CBI, as discussed in more detail in Unit II.C. of the proposed rule.

In addition, as discussed in Unit III.B. of the proposed rule, these SNURs include PMN substances that are subject to orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. As such, the SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).

Additional information about these statutes and Executive orders can be found at https://www.epa.gov/laws-regulations.

This action establishes SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993).

Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because a significant new use rule for a new chemical under TSCA section 5 is exempt from review under Executive Order 12866.

According to the PRA (44 U.S.C. 3501 et seq. ), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

The information collection requirements related to SNURs have already been approved by OMB pursuant to PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per submission. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq. ). The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, EPA has concluded that no small or large entities presently engage in such activities.

A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 7 in Federal fiscal year (FY) 2020, 9 in FY2021, 9 in FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction of these submissions were from small businesses.

In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $37,000 to $6,480. This lower fee reduces the total reporting and recordkeeping cost of submitting a SNUN to about $14,500 per SNUN submission for qualifying small firms. Therefore, the potential economic impacts of complying with these proposed SNURs are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684 (FRL-5597-1)), the Agency presented its general determination that SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by SNURs, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by these SNURs. In addition, the estimated costs of this action to the private sector do not exceed $183 million or more in any one year (the 1995 dollars are adjusted to 2023 dollars for inflation using the GDP implicit price deflator). The estimated costs for this action are discussed in Unit I.D.

This action will not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not expected to have a substantial direct effect on 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. Accordingly, the requirements of Executive Order 13132 do not apply to this action.

This action will not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 do not apply to this action.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it does not concern an environmental health or safety risk. Since this action does not concern a human health risk, EPA's 2021 Policy on Children's Health also does not apply. Although the establishment of these SNURs do not address an existing children's environmental health concern because the chemical uses involved are not ongoing uses, SNURs require that persons notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of the identified chemical substances for an activity that is designated as a significant new use by the SNUR. This notification allows EPA to assess the intended uses to identify potential risks and take appropriate actions before the activities commence.

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

This action does not involve any technical standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).

This action is subject to the CRA (5 U.S.C. 801 et seq. ), and 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).

For the reasons stated in the preamble, 40 CFR chapter I is amended as follows:

The Department is rescinding portions of its regulations promulgated pursuant to Title VI, 42 U.S.C. 2000d-1, to more closely align its regulations to the language that Congress enacted in Title VI prohibiting intentionally discriminatory conduct. See 42 U.S.C. 2000d. There are serious statutory and constitutional concerns with the legality of the Department's Title VI regulations that go beyond intentional discrimination by prohibiting conduct that has an unintentional disparate impact. This rule accordingly rescinds those portions of the regulations that prohibit conduct having a disparate impact, which are in considerable tension with both the statute and the Constitution and do not sufficiently serve the public interest. First, this rule rescinds the full text of 43 CFR 17.3(b)(2), which currently 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, or have the effect of defeating or substantially impairing accomplishment of the objectives of the program as respect individuals of a particular race, color, or national origin.” Second, this rule removes the two uses of the phrase “or effect” from 43 CFR 17.3(b)(3). Third, this rule rescinds the full text of 43 CFR 17.3(b)(4). Fourth, this rule rescinds the full text of 43 CFR 17.3(c)(3), which addresses employment practices subject to Federal financial assistance.

The rule's revisions also conform to Executive Order 14281, Restoring Equality of Opportunity and Meritocracy, 90 FR 17537 (Apr. 23, 2025). That Order stated 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.” Id. at 17537. The Order directed the Attorney General to, among other things, review Title VI regulations and “initiate appropriate action to repeal or amend” these regulations “to the extent they contemplate disparate-impact liability.” Id. at 17538. Section 3 of the Order specifically revoked the Presidential approvals of certain Interior Department Title VI regulations that address disparate-impact liability promulgated under 42 U.S.C. 2000d-1. Id. Though the Department would take this action independent of Executive Order 14281, the Order supports this action.

The practical impact of this rule's modifications will be to make clear to Department Federal-funded recipients that the Department's Title VI regulations do not prohibit conduct or activities that have a disparate impact and prohibit only intentional discrimination, and the Department thus will not pursue Title VI disparate-impact liability against its Federal-funding recipients.

Title VI of the Civil Rights Act of 1964, 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. The section of Title VI that sets forth the prohibited conduct, 42 U.S.C. 2000d, prohibits specifically intentional discrimination and makes no reference to unintentional disparate effects or impact.

See Alexander v. Sandoval, 532 U.S. 275, 280 (2001) (“[I]t is . . . beyond dispute—and no party disagrees—that [Title VI] prohibits only intentional discrimination.”). The statute does not explicitly provide any Federal department or agency with authority to prohibit unintentional disparate impact. Despite ample opportunities, Congress has enacted no subsequent amendments to Title VI to impose disparate-impact liability.

Pursuant to Executive Order 12250, “[t]he Attorney General shall coordinate the implementation and enforcement by Executive agencies of . . . Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq. ).” 45 FR 72995, 72995 (Nov. 2, 1980). Accordingly, the Department of the Interior follows the Department of Justice as it is the lead Federal agency responsible for defining the nature and scope of Title VI's prohibition of discrimination on the basis of race, color, and national origin in programs or activities receiving Federal financial assistance. The Order directs the Department, among other things, to “develop standards and procedures for taking enforcement actions and for conducting investigations and compliance reviews.” Id. Further, as part of this responsibility, the Order provides that other agencies' Federal regulations implementing Title VI are also subject to the Attorney General's approval. Id. at 72996.

The Department's Title VI implementing regulations are codified at 43 CFR 17.1, and 17.12. The initial set of model regulations for Title VI were issued by the then-Department of Health, Education, and Welfare on December 4, 1964, which included only one reference to the “effect of” language in the “discrimination prohibited” provision of the rule. See 29 FR 16298, 16299 (Dec. 4, 1964) (provision found at 45 CFR 80.3(b)(2)). In 1973, the Department substantively amended its regulatory description of prohibited discrimination. See 38 FR 17986 (July 5, 1973). These substantive changes include, among other things, the addition of 43 CFR 17.3(b)(3) (which added the “or effect” language to an additional provision), 43 CFR 17.3(b)(4) (i-ii) (which introduced the “affirmative action” language to the regulations), and 43 CFR 17.3(c)(3) (which extends the rule to Federal financial assistance whose primary objective is not to provide employment). In 2003, the Department added language regarding “program or activity” to reflect the amendment of Title VI by the Civil Rights Restoration Act of 1987. See 68 FR 51334, 51364 (Aug. 26, 2003); Public Law 100-259, sec. 6, 102 Stat. 28, 31 (1988). Thus, beyond the required updating of the phrase “program or activity” pursuant to the Civil Rights Restoration Act, the Department has not substantively updated its Title VI regulations since 1973--over 50 years ago.

The Department's implementing regulation describing the scope of prohibited discriminatory conduct, 43 CFR 17.3, currently includes prohibitions on conduct that has an unintentional disparate impact, discussed more fully below.

The Supreme Court has found that Title VI, 42 U.S.C. 2000d, 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, five years after the Department last substantively amended its Title VI regulations, the Supreme Court found that Congress intended Title VI to prohibit “only those racial classifications that would violate the Equal Protection Clause” if committed by a government actor. Regents of the Univ. of Cal. v. Bakke, 438 U.S. 265, 287 (1978) (Powell, J., announcing the judgment of the Court); id. at 325, 328, 352-53 (Brennan, White, Marshall, and Blackmun, JJ., concurring in part and dissenting in part); see also Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., 600 U.S. 181, 198 n.2 (2023) (“ SFFA” ). Shortly before Bakke' s Title VI holding, the Supreme Court held that the Equal Protection Clause requires proof of intentional discrimination and that “a law or other official act” that has a “racially disproportionate impact” alone does not violate that Clause. Washington v. Davis, 426 U.S. 229, 239 (1976); see also Vill. of Arlington Heights v. Metro. Hous. Dev. Corp., 429 U.S. 252, 265 (1977) (“Proof of racially discriminatory intent or purpose is required to show a violation of the Equal Protection Clause.”). Taken together, these Supreme Court cases establish that Title VI's statutory prohibition, like the Equal Protection Clause, extends only to intentional discrimination.

In 2001, the Supreme Court, in Alexander v. Sandoval, reaffirmed that settled understanding. 532 U.S. at 280 (“[I]t is . . . beyond dispute . . . that [Title VI] prohibits only intentional discrimination.”). In Sandoval, the Supreme Court held that private plaintiffs lacked a private right of action to enforce the Department's “disparate-impact regulations.” Id. at 285-87. Though the Supreme Court had previously found a private cause of action to enforce Title VI's bar on intentional discrimination, id. at 279-80, that conclusion did not extend to enforcing the Department's “disparate-impact regulations.” Id. at 285. As the Supreme Court explained, it is “clear” that “the disparate-impact regulations do not simply apply” the statutory prohibition, as the regulations “forbid conduct that [Title VI] permits,” so it is equally “clear that the private right of action to enforce [Title VI] does not include a private right to enforce these regulations.” Id. While the Supreme Court in Sandoval “assume[d],” without deciding, that the Department's disparate-impact regulations were valid, the Court explained that the regulations are in “considerable tension” with the Supreme Court's Title VI precedents. Similarly, the regulations do not “authoritatively” construe Title VI because the regulations “forbid conduct”—namely, policies that unintentionally result in a disparate impact—that Title VI “permits.” Id. at 281-82, 284-85; see also id. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”).

Finally, in 2024, the Supreme Court overruled Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984). See Loper Bright Enters. v. Raimondo, 603 U.S. 369, 409-12 (2024). In reaching that result, the Supreme Court made clear that “statutes . . . have a single, best meaning” that is “ `fixed at the time of enactment.' ” Id. at 400 (quoting Wis. Cent. Ltd. v. United States, 585 U.S. 274, 284 (2018)). Thus, Title VI's bar on discrimination can have only one meaning. And under Supreme Court precedent, the single, best meaning of Title VI is that it “prohibits only intentional discrimination” and “permits” facially neutral policies that result in disparate outcomes when there is no discriminatory intent. Sandoval, 532 U.S. at 280, 286 n.6.

On April 23, 2025, the President issued Executive Order 14281. This Order restated the “bedrock principle of the United States . . . that all citizens are treated equally under the law.” 90 FR at 17537. The Order 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.” Id.

That Order also explained that disparate-impact liability “endangers this foundational principle.” Id. Disparate-impact liability, the Order reasoned, “all but requires individuals and businesses to consider race and engage in racial balancing to avoid potentially crippling legal liability.” Id. As the Order explained, disparate-impact liability “not only undermines our national values, but also runs contrary to equal protection under the law and, therefore, violates our Constitution.” Id.

The Order relayed that because of disparate-impact liability's problems, “[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.” Id. The Order directed the Attorney General to, among other things, review Title VI regulations and “initiate appropriate action to repeal or amend” them “to the extent they contemplate disparate-impact liability.” Id. at 17538.

Section 3 of the Order also specifically revoked prior Presidential approvals of the disparate-impact regulations promulgated under Title VI, including the presidential approval of July 25, 1966, of 28 CFR 42.104(b)(2) and the presidential approval of July 5, 1973, of 28 CFR 42.104(b)(3), (b)(6)(ii) and (c)(2). Id. Section 5 of the Order directed the Attorney General to “initiate appropriate action to repeal or amend the implementing regulations for Title VI of the Civil Rights Act of 1964 for all agencies to the extent they contemplate disparate-impact liability.” Id. Accordingly, this rule revises the Department's currently existing Title VI regulations to effectuate the Order's policy and purpose.

In any event, the Department would have independently initiated steps toward making these changes regardless of Executive Order 14281. Even if Executive Order 14281 did not exist, in other words, the Department would have taken steps to adopt the policy to eliminate the use of disparate-impact liability under Title VI. The Order states, and the Department firmly agrees, that a “bedrock principle of the United States is that all citizens are treated equally under the law. This principle guarantees equality of opportunity, not equal outcomes. It promises that people are treated as individuals, not components of a particular race or group. It encourages meritocracy and a colorblind society,” not race-, color-, or national-origin-based favoritism. 90 FR at 17537. And adherence to this principle, including in the issuance of grants, “is essential to creating opportunity, encouraging achievement, and sustaining the American Dream.” Id. But imposing disparate-impact liability endangers these policy objectives. 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. After considering the relevant issues and factors and weighing the relevant considerations, the Department concludes that these reasons together support eliminating disparate-impact liability from the Department's Title VI regulations. In any event, the Department concludes that each reason is a separate and independent basis for eliminating disparate-impact liability from the Department's Title VI regulations.

The Department's regulation at 43 CFR 17.3, entitled “Discrimination prohibited,” contains several provisions that prohibit conduct or activities causing unintentional disparate impact, without a statutory or constitutional basis for doing so, and in some instances, may encourage or even require unlawful discrimination labeled as “affirmative action.” Section 17.3(b)(2) is the current regulation's general disparate-impact prohibition, which states that a “recipient . . . may not . . . utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination because of their race, color, or national origin.” 43 CFR 17.3(b)(2). Beyond that general prohibition, section 17.3(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. Id. 17.3(b)(3). 43 CFR 17.3(b)(4)(i-ii) 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 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. Id. 43 CFR 17.3(b)(4)(i-ii). Finally, 43 CFR 17.3(c)(3) addresses prohibited discriminatory employment practices and extends beyond intentional discrimination to prohibiting conduct that “tends” to have a discriminatory effect. Id. 43 CFR 17.3(c)(3).

There are serious statutory and constitutional concerns with the legality of the Department's Title VI disparate-impact regulations. The Department 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. Sandoval, 532 U.S. at 280, 286 n.6. That is the “single, best meaning” of Title VI. Loper Bright, 603 U.S. at 400. As summarized above, Sandoval calls into serious doubt the legality of the Department's “disparate-impact regulations.” Sandoval, 532 U.S. at 281-82, 284-85 (noting that the Department's regulations are in “considerable tension” with the Supreme Court's Title VI precedents); see also id. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”). Although Sandoval resolved only the question of private enforceability, subsequent cases such as Loper Bright have made clear that the Department cannot extend Title VI beyond its original public meaning. See 603 U.S. at 412-13 (holding that “courts must . . . ensur[e] that [an] agency acts within” its statutory authority). And even in the absence of Supreme Court precedent, the Department would have concluded that the best reading of Title VI is that it prohibits only intentional discrimination.

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. See Sandoval, 532 U.S. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”). Thus, the disparate-impact regulations do not “effectuate” Title VI. 42 U.S.C. 2000d-1.

There are also serious concerns about whether the Department's Title VI regulations pass constitutional muster under the Equal Protection Clause. As the Supreme Court recently held in SFFA, “the Equal Protection Clause . . . applies without regard to any differences of race, of color, or of nationality—it is universal in its application” and the “guarantee of equal protection cannot mean one thing when applied to one individual and something else when applied to a person of another color.” 600 U.S. at 206 (internal quotation marks omitted) (first quoting Yick Wo v. Hopkins, 118 U.S. 356, 369 (1886); and then quoting Bakke, 438 U.S. at 289-90 (Powell, J.)). Despite the promises of the Equal Protection Clause, a funding recipient's risk of disparate-impact liability under the Department's regulations is triggered by unintentional disparate outcomes, which the recipient may not even know about without investigation. To evaluate and avoid this risk, the funding recipient must incur investigatory costs, such as conducting an impact analysis, and is coerced to proactively consider race, color, and national origin, and potentially use it to change the unintended disparate outcomes. 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. See id. This serious constitutional concern further confirms that the best reading of Title VI is that it prohibits only intentional discrimination and does not authorize the Department to impose disparate-impact liability. See Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568, 575 (1988) (“[W]here an otherwise acceptable construction of a statute would raise serious constitutional problems, the Court will construe the statute to avoid such problems unless such construction is plainly contrary to the intent of Congress.” (citing NLRB v. Catholic Bishop of Chi., 440 U.S. 490, 499-501, 504 (1979))).

This use of race, color, or national origin violates the Equal Protection Clause unless it survives review under the “daunting” strict-scrutiny standard. SFFA, 600 U.S. at 206; see also Free Speech Coal., Inc. v. Paxton, 145 S. Ct. 2291, 2310 (2025) (“Strict scrutiny—which requires a restriction to be the least restrictive means of achieving a compelling governmental interest—is `the most demanding test known to constitutional law.'” (quoting City of Boerne v. Flores, 521 U.S. 507, 534 (1997)). The use of race, color, or national origin necessitated by the disparate-impact provisions runs into serious issues with the requirement of narrow tailoring to achieve a compelling interest. SFFA, 600 U.S. at 206-07.

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. 28 CFR 42.104(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 the Department's disparate-impact regulations. But even if the regulations were statutory, the Department finds that eliminating the potential constitutional concerns addressed above would independently justify the amendment of the regulations. Cf. U.S. Tel. Ass'n v. FCC, 188 F.3d 521, 528 (D.C. Cir. 1999) (concluding it was not “arbitrary and capricious” to adopt a certain policy in order to “avoid[ ] raising a non-trivial constitutional question”). And even if the regulations did not raise serious constitutional concerns, the Department finds that eliminating the costs and confusion caused by the mismatch between the statute and the disparate-impact regulations would independently justify the repeal of the regulations.

The Department also has serious policy concerns with the Title VI regulations' imposition of

disparate-impact liability. While the Department expresses its policy concerns with disparate-impact liability independent of Executive Order 14281, that Order sets forth many valid policy concerns with disparate-impact liability. As noted in section 1 of the Order,

Additionally in practice, and as explained above, disparate-impact liability leads covered entities to engage in racial balancing even as the underlying Title VI statute forbids intentional racial discrimination. This tension tends to create confusion, undermine public confidence in the nation's civil rights laws, and undermine public confidence 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. See, e.g., SFFA, 600 U.S. at 216-17 (explaining that the “[racial] categories” utilized by Harvard and University of North Carolina were “themselves imprecise in many ways” and “the use of these opaque racial categories undermine[d], instead of promote[d], [their] goals”). This confusion undermines the law's ability to teach principles of nondiscrimination and is evident in, among other things, some of the grant proposals that the Department awarded funds to in past years. The Department believes that these policy concerns independently justify repealing certain parts of its regulation to cure this confusion, remove the incentive for covered entities to engage in racial balancing, and maintain clarity and public confidence in the nation's civil rights laws.

The Department has considered the view that looking at disparate effects can sometimes be useful in uncovering or deterring subtle intentional discrimination or intentional indifference to unnecessary and arbitrary barriers. But that view's alleged benefits are outweighed by the other issues and factors the Department has considered. And in any event, the concern is mitigated by the fact that eliminating disparate-impact liability does not preclude the use of data on disparate outcomes to help prove intentional discrimination. Indeed, under the Department's Title VI regulations, which the current changes do not alter, “recipients should have available for the Department racial and ethnic data showing the extent to which members of minority groups are beneficiaries of federally assisted programs.” 43 CFR 17.5(b). Both the Department and private litigants rely on such data as a potential indicator of intentional discrimination. This use of statistical disparity to help establish, as an evidentiary matter, liability for intentional discrimination materially differs from using it to impose liability for an unintentional disparate impact.

The Department has also considered the alternative of trying to adopt a modified version of disparate-impact liability, for example, by requiring covered entities to remedy unintentional discrimination for only certain types of cases in education or housing. But any version of imposing liability for unintentional discrimination is inconsistent with Title VI's original public meaning. Regardless, even a modified version of disparate-impact liability would not eliminate the Department's serious legal and policy concerns. The Department determines that any benefits from a regulation adopting alternative versions of disparate-impact liability are outweighed by the Department's legal and policy concerns. And even if possible, developing such a rule would not solve the confusion or rule-of-law concerns expressed above, nor reduce the compliance and litigation costs that covered entities face. The Department believes that the better course is to avoid the complexities, costs, and litigation associated with this alternative, even if eliminating disparate-impact liability ultimately would leave some problems unaddressed and others inadequately addressed.

The Department has additionally considered the potential reliance interests of funding recipients and others on the disparate-impact regulations. The Sandoval decision in 2001, however, cast serious doubt on the continuing viability of the regulations more than 20 years ago. At least since Sandoval, the Department's enforcement of its Title VI disparate-impact regulations has been minimal and sporadic. And Executive Order 14281 also directed all agencies to “deprioritize enforcement of all statutes and regulations to the extent they include disparate-impact liability,” including specifically the Department's Title VI disparate-impact regulations. 90 FR at 17538. The Department accordingly believes that any reliance interests should be minimal and do not outweigh the Department's legal and other policy concerns. Further, each of the Department's concerns, whether considered cumulatively or separately, outweighs any reliance interests.

The Department notes that Sandoval has also led to a divergence between Title VI enforcement by private plaintiffs and enforcement by Federal departments and agencies. After Sandoval, private plaintiffs can enforce only Title VI's statutory prohibition on intentional discrimination, while the Department could continue to pursue disparate-impact liability.

Repealing the disparate-impact regulations would eliminate this incongruent enforcement. Overall, after considering the relevant issues and factors and weighing the relevant considerations, the Department finds that, regardless of the legality of the Department's disparate-impact regulations, the above summarized policy concerns, when viewed separately or cumulatively, independently justify the repeal of its disparate-impact regulations.

This rule's regulatory changes address the concerns regarding the statutory authority that the Supreme Court questioned in Sandoval and the other legal and policy concerns discussed above, harmonize the implementing regulations' scope with the conduct that Congress intended Title VI to prohibit, promote consistent enforcement among private plaintiffs and Federal departments and agencies, and provide much needed clarity to the courts and Federal financial assistance recipients and beneficiaries.

For the reasons summarized above, the Department amends the following provisions in its Title VI implementing regulation that explain the particular types of discrimination prohibited, located at 43 CFR 17.3.

The table below indicates the exact wording changes. For each section indicated in the left column, the text shown in the middle column is removed and the text shown in the right column is added:

Section 17.3(b)(2) is the current regulation's general prohibition of conduct with unintentional disparate impact. It expands prohibited conduct from purposeful discrimination to imposed liability on Federal funding recipients who “utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination.” Because section 43 CFR 17.3 (b)(2)'s only purpose is to extend the scope of Title VI to reach unintentional disparate-impact discrimination, this rule deletes this paragraph in its entirety. It thus amends the Department's Title VI implementing regulations to conform to the scope of coverage Congress intended when it enacted Title VI and to address the legal and policy considerations and determinations described in this document. The rule replaces paragraph (b)(2) with a placeholder to maintain the numbering accuracy of previous citations and other references to parts of this section.

Section 17.3(b)(3) addresses a Federal funding recipient's or applicant's selection of the site or location of facilities. It provides that a funding recipient may not make selections with the “purpose or effect” of discriminating, or “with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of” Title VI or the Department's implementing regulations. The paragraph's two references to “effect” extend its scope to unintentional disparate impacts. This rule deletes both “or effect” references to conform paragraph (b)(3) more closely to the scope of coverage Congress intended when it enacted Title VI and to address the legal and policy considerations and determinations described in this document.

Section 17.3(b)(4) deals with “affirmative action.” Paragraph (b)(4)(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 an Equal Protection Clause analysis.

Paragraph (b)(4)(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 grounds 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 to take narrowly tailored action to remedy the effects of its identified past discrimination. See, e.g., Bakke, 438 U.S. at 307 (Powell, J.). Moreover, even putting aside the mandatory language, this provision does not expressly require narrow tailoring to counter particular past discrimination, but rather just “affirmative action to overcome the effects of prior discrimination.” This provision accordingly promotes potentially illegal race, color, and national origin discrimination. Moreover, in some instances, it may even coerce recipients to consider and use race preferences when the recipient does not want to. This is contrary to the Department's goal of promoting and defending a culture of nondiscrimination and is destructive to the public's understanding of and faith in the nation's civil rights laws. This rule, therefore, removes paragraph (b)(4).

Section 17.3(c) addresses prohibited discriminatory employment practices. Paragraph (c)(1) prohibits intentionally discriminatory employment practices in a program when a primary objective of the Federal financial assistance that program receives is to provide employment.

Paragraph (c)(3) extends the prohibition on discrimination to employment practices of the funding recipient even when “a primary objective of the Federal financial assistance is not to provide employment” if discrimination in the non-funded “employment practices of the recipient or other persons subject to the regulation tends, on the ground of race, color, or national origin, to exclude individuals from participation in, to deny them the benefit of, or to subject them to discrimination under any program to which this regulation applies.” This paragraph does not prohibit only intentional discrimination but rather extends the prohibition to conduct that “tends” to have a discriminatory effect.

Moreover, the Department notes that paragraph (c)(3)'s extension to employment practices where the Federal funding's primary objective is not to provide employment conflicts with the statutory limitation found in 42 U.S.C. 2000d-3. That section states that “[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.” 42 U.S.C. 2000d-3; see also Johnson v. Transp. Agency, Santa Clara Cnty., 480 U.S. 616, 627-28 n.6 (1987) (citing the statutory limitation and noting Congress's intent that Title VI not “impinge” on Title VII, which prohibits discriminatory employment practices). The rule deletes paragraph (c)(3) to amend the regulation so that it more closely adheres to the scope of conduct Congress prohibited with Title VI and to address the legal and policy considerations and determinations described in this document.

The Department's position is that each of the amendments serve a vital, related, but distinct purpose. The Department also confirms that each of the amendments is intended to operate independently of each other and that the potential invalidity of one amendment should not affect the other amendments. The Department would adopt any of the amendments independent to, and regardless of, the invalidity of a separate amendment.

The Department issues this final rule without prior public notice and comment or a delayed effective date pursuant to the Administrative Procedure Act's exception for rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.” 5 U.S.C. 553(a)(2).

Title VI concerns non-discrimination conditions on the receipt of Federal financial assistance, and more particularly to the receipt of Federal “[g]rants and loans,” “property,” “personnel” and “[a]ny Federal agreement, arrangement, or other contract which has as one of its purposes the provision of assistance.” 43 CFR 17.12(e); see also 43 CFR 17.4 (requiring funding recipient sign contractual assurance of compliance with Title VI); Cummings v. Premier Rehab Keller, P.L.L.C., 596 U.S. 212, 217-18 (2022) (observing that Congress enacted Title VI “[p]ursuant to its authority to `fix the terms on which it shall disburse federal money'” (internal citation omitted)). Cf. Education Programs or Activities Receiving or Benefitting from Federal Financial Assistance, 82 FR 46655, 46655 (Oct. 6, 2017) (invoking the section 553(a)(2) exception to amend Title IX regulations to “promote consistency in the enforcement of Title IX for [the Department of Agriculture] financial assistance recipients”); Preserving Community and Neighborhood Choice, 85 FR 47899 (Aug. 7, 2020) (invoking the exception to repeal Housing and Urban Development rule regarding Federal grantees); Participation by Minority Business Enterprise in Department of Transportation Programs, 53 FR 18285 (May 23, 1988) (invoking the exception to expand coverage of Department of Transportation regulation regarding Federal Aviation Administration's airport financial assistance program); Nondiscrimination on the Basis of Handicap in Federally Assisted Programs—Suspension of Guidelines with Respect to Mass Transportation, 46 FR 40687 (Aug. 11, 1981) (invoking the exception to suspend Department of the Interior guidelines regarding prohibiting disability discrimination in transportation programs and activities receiving Federal financial assistance).

Indeed, invoking 5 U.S.C. 553(a)(2) is consistent with the Office of Management and Budget's (OMB) definition for Federal financial assistance under 2 CFR 200.1, which defines Federal financial assistance with the same categories as the Administrative Procedure Act's exception for rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,” 5 U.S.C. 553(a)(2). With potentially limited exceptions not applicable to the Department, all the forms of Federal financial assistance set forth under 2 CFR 200.1 that the Department administers would fall under the “public property, loans, grants, benefits, or contracts” exception. Thus, the Department issues this final rule without prior public notice and comment or a delayed effective date under 5 U.S.C. 553(a)(2).

In accordance with Executive Order 12550 which requires federal agencies to submit proposed changes concerning this subject matter to the Department of Justice, the Department of Justice has reviewed and determined that these changes are warranted.

The Department has determined that this rulemaking is a “significant regulatory action” under section 3(f) of Executive Order 12866, 58 FR 51735, 51738 (Sep. 30, 1993), but it is not an “economically significant” action under section 3(f)(1). Accordingly, this rule has been submitted to OMB for review.

This regulation has been drafted and reviewed in accordance with Executive Order 12866 section 1(b), id. at 51735, and in accordance with Executive Order 13563 section 1(b), 76 FR 3821, 3821 (Jan. 18, 2011), which supplements and reaffirms the principles of Executive Order 12866. These Executive Orders 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. 58 FR at 51735; 76 FR at 3821. Executive Order 13563 also recognizes that some benefits and costs are difficult to quantify and provides that, where appropriate and permitted by law, agencies may consider and discuss qualitatively values that are difficult or impossible to quantify. Id.

As explained in the preamble, the regulatory modifications this rule makes are necessary to conform Department regulations to Executive Order 14281, address serious concerns regarding the Department's Title VI regulation that the Supreme Court raised in Sandoval, harmonize the implementing regulation's scope with the scope of conduct that Congress intended Title VI to prohibit, promote consistency in enforcement among private plaintiffs and Federal departments and agencies, and provide much needed clarity to courts and Federal funding recipients and beneficiaries regarding the scope of the Department's Title VI regulations. Indeed, with respect to section 42.104(c) of the Department's Title VI-implementing regulations, the changes this rule makes are clearly necessary to bring the regulations into compliance with 42 U.S.C. 2000d-3. In short, this rule is necessary to conform the Department's regulation to existing statutory law, as interpreted by the Supreme Court.

Data limitations make the costs and benefits of the rule difficult to quantify. While not representing the monetary impact of the rule, more generally the Department of the Interior issued approximately 53,700 separate awards totaling approximately $28.4 billion over the past four years. In FY2024 alone, the Department issued approximately 31,000 separate awards totaling $8.2 billion. The Department's Title VI related, active investigations and compliance reviews regarding these funds and their recipients totaled just over 40 for FY2020 through FY2024. The Department does not track which of its investigations and compliance reviews involve solely allegations of disparate-impact discrimination. For enforcement actions that relate to both intentional discrimination and conduct having an unintentional disparate impact, the Department does not track and cannot reliably quantify the costs attributable to the varying disparate-impact portions of enforcement actions. That the existence of a disparate impact is sometimes a factor that may be considered in determining whether discrimination was intentional further impedes monetizing costs and benefits. Therefore, the overall cost effect on the Department is difficult to quantify. The deregulatory action should decrease the Department's enforcement costs, however. It should also have the benefit, also difficult to quantify, of bringing the Department's conduct in line with the law. Similarly, the Department is unable to quantify how funding recipients will respond to the regulatory changes. But the deregulatory action should result in greater flexibility and lower compliance costs for recipients.

The Department recognizes that a funding recipient may receive Federal funds from sources other than, and in addition to, the Department. The Department does not envision that this rule will appreciably increase administrative costs or compliance costs for funding recipients who must also adhere to the regulations of another department or agency. The deregulatory action the Department takes here does not create any new obligations for funding recipients. On the contrary, by eliminating disparate-impact liability from the regulation, it eliminates a source of regulatory confusion, narrows and makes more specific the conduct prohibited, and thus lessens 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, see, e.g., 28 CFR 42.105. These contractual assurances already impose varying requirements that each Federal funding source deems necessary. Funding recipients will continue to be held to the most stringent contractual assurance and regulation.

Based on the analysis of the practical qualitative costs and benefits noted above, the Department believes that this rule is consistent with the principles of Executive Orders 12866 and 13563, including the requirements that, to the extent permitted by law, the Department adopt a regulation only upon a reasoned determination that its benefits justify its costs and choose a regulatory approach that maximizes net benefits. See 58 FR at 51735; 76 FR at 3821.

Executive Order 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 Order 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.” Id. By revising the Department's current Title VI regulations, which extend prohibited conduct to include unintentional disparate impacts and thus expand the scope of those regulations to a vastly broader range of conduct than the statute prohibits, this rule eliminates unnecessary regulation. Accordingly, the Department expects this rule to be a deregulatory action under Executive Order 14192.

Executive Order 14294 requires agencies promulgating regulations with criminal regulatory offenses potentially subject to criminal enforcement to “explicitly describe the conduct subject to criminal enforcement, the authorizing statutes, and the mens rea standard applicable to” each element of those offenses. 90 FR 20363, 20363 (May 9, 2025). This rule does not impose a criminal regulatory penalty and is thus exempt from Executive Order 14294 requirements.

This rule will not have a substantial, direct effect on the relationship between the national government and the states, on distribution of power and responsibilities among various levels of government, or on states' policymaking discretion. States that choose to receive Federal financial assistance from the Department do so voluntarily and agree to comply with relevant statutory requirements as a condition of receiving such funding. This rule does not subject states or any other funding recipients or beneficiaries to new obligations. This rule amends and clarifies existing regulations that are required by statute. Therefore, in accordance with section 6 of Executive Order 13132, 64 FR 43255, 43257-58 (Aug. 4, 1999), the Department has determined that these amendments do not have sufficient Federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets the applicable standards set forth in sections 3(a) and (b)(2) of Executive Order 12988 to specify provisions in clear language. See 61 FR 4729, 4731-32 (Feb. 5, 1996). Pursuant to section 3(b)(1)(I) of the Executive Order, id. at 4731, nothing in this proposed or any previous rule (or in any administrative policy, directive, ruling, notice, guideline, guidance, or writing) directly relating to the Program that is the subject of this proposed rule is intended to create any legal or procedural rights enforceable against the United States.

This rule does not require a regulatory flexibility analysis under the Regulatory Flexibility Act, 5 U.S.C. 603, 604, because, for the reasons described above, no notice of proposed rulemaking is required under 5 U.S.C. 553. See Or. Trollers Ass'n v. Gutierrez, 452 F.3d 1104, 1123-24 (9th Cir. 2006) (noting that the RFA does not apply when an agency validly invokes an exception to the public comment requirements of 5 U.S.C. 553). Further, the Department, in accordance with 5 U.S.C. 605(b), has reviewed these regulations and certifies that the rule's changes will not have a significant economic impact on a substantial number of small entities, in large part because these regulatory changes do not impose any new substantive obligations on Federal funding recipients. The rule amends and clarifies existing regulations that are required by Title VI. The rule merely brings the Department into compliance with the Equal Protection Clause and harmonizes 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 will remain in place after this rule since their initial promulgation.

The Unfunded Mandates Reform Act of 1995 (“UMRA”), 2 U.S.C. 1501 et seq., requires agencies to prepare several analytic statements before proposing any rule that may result in annual expenditures of $100 million by state, local, or tribal governments, or the private sector. 2 U.S.C. 1532(a). The UMRA also, however, excludes from its coverage any proposed or final Federal regulation that “establishes or enforces any statutory rights that prohibit discrimination on the basis of race, color, religion, sex, national origin, age, handicap, or disability.” 2 U.S.C. 1503(2). Accordingly, this rulemaking is not subject to the provisions of the UMRA.

The Office of Information and Regulatory Affairs determined that this rule is not a “major rule” as defined by the Congressional Review Act, 5 U.S.C. 804(2).

This rule will not impose additional reporting or recordkeeping requirements under the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.

Accordingly, for the reasons set forth above, and pursuant to the authority vested in the Secretary of the Interior by law, part 17 of title 43 of the Code of Federal Regulations is amended as follows:

Atlantic BFT fisheries are managed under the 2006 Consolidated Highly Migratory Species Fishery Management Plan (HMS FMP) and its amendments, pursuant to the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act; 16 U.S.C. 1801 et seq. ) and consistent with the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971 et seq. ). ATCA is the implementing statute for binding recommendations of the International Commission for the Conservation of Atlantic Tunas (ICCAT). The HMS FMP and its amendments are implemented by regulations at 50 CFR part 635. Section 635.27(a) divides the U.S. BFT quota, established by ICCAT and as implemented by the United States among the various domestic fishing categories, per the allocations established in the HMS FMP and its amendments. NMFS is required under the Magnuson-Stevens Act at 16 U.S.C. 1854(g)(1)(D) to provide U.S. fishing vessels with a reasonable opportunity to harvest quotas under relevant international fishery agreements such as the ICCAT Convention, which is implemented domestically pursuant to ATCA.

Under § 635.28(a)(1), NMFS files a closure notice with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. Retaining, possessing, or landing BFT under that quota category is prohibited on and after the effective date and time of a closure notice for that category, for the remainder of the fishing year, until the opening of the subsequent quota period or until such date as specified.

Every year, the BFT fishing year starts on January 1 and ends on December 31. The Angling category opens on January 1 and continues through December 31 or until the applicable quota or subquota is reached or projected to be reached, whichever comes first. As described in § 635.27(a), the current baseline U.S. BFT quota is 1,316.14 metric tons (mt) (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area per § 635.27(a)(3)). The Angling category baseline quota is 297.4 mt, of which 9.2 mt (3.1 percent of the annual Angling category quota) is sub-allocated for the harvest of large medium and giant (trophy) BFT by vessels fishing under the Angling category quota, with 2.3 mt (25 percent of the annual large medium and giant BFT Angling category quota) allocated for each of the following areas: north of 42° N latitude (lat.) (the Gulf of Maine area); south of 42° N lat. and north of 39°18′ N lat. (the southern New England area); south of 39°18′ N lat. and outside of the Gulf of America (the southern area); and the Gulf of America region. Trophy BFT measure 73 inches (185 cm) curved fork length or greater. NMFS notes, when the Gulf of America trophy fishery is open, no large medium or giant BFT may be retained, possessed, landed, or sold in the Gulf of America, except one per vessel per year may be landed if caught incidentally to fishing for other species as specified at § 635.23(b)(1)(i) while the fishery is open. This closure action applies to the Gulf of America.

Separate from this action, NMFS is working on a rulemaking that would implement the 2025 ICCAT recommendation (Recommendation 25-05) regarding western BFT management. Consistent with the recommendation, that proposed rule proposes increasing the baseline U.S. BFT quota from 1,316.14 mt to 1,509.98 mt and adjusting all the subquotas accordingly. In that proposed rule, the Angling baseline quota would increase from 297.4 mt to 341.3 mt (of which, 10.6 mt would be sub-allocated for the harvest of trophy BFT). The comment period on that proposed rule ends on June 8, 2026. Any final rule implementing ICCAT Recommendation 25-05 would likely be effective in mid-2026 or later.

Based on landings data from the NMFS Automated Catch Reporting System, as well as average catch rates and anticipated fishing conditions, NMFS has determined the Angling category Gulf of America trophy BFT subquota has been reached and exceeded. Therefore, retaining, possessing, or landing large medium or giant ( i.e., measuring 73 inches (185 cm) curved fork length or greater) BFT in the Gulf of America by persons aboard HMS Angling and HMS Charter/Headboat permitted vessels (when fishing recreationally) must cease at 11:30 p.m. local time on May 21, 2026. This closure will remain effective through December 31, 2026. This action applies to HMS Angling and HMS Charter/Headboat permitted vessels when fishing recreationally for BFT, and is taken consistent with the regulations at § 635.28(a)(1). This action is intended to prevent further overharvest of the Angling category Gulf of America trophy BFT subquota. The Angling category BFT trophy fisheries for the Southern New England and Gulf of Maine areas remain open.

If needed to ensure available quotas or subquotas are not exceeded or to enhance fishing opportunities, subsequent Angling category adjustments or closures will be published in the Federal Register per § 635.27(a)(7) and § 635.28(a)(1). Information regarding the Angling category fishery for Atlantic tunas, including daily retention limits for BFT measuring 27 inches (68.5 cm) to less than 73 inches (185 cm), and any further Angling category adjustments, is available at https://hmspermits.noaa.gov. During a closure, fishermen aboard HMS Angling and HMS Charter/Headboat permitted vessels when fishing recreationally may continue to catch and release (or tag and release) BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at https://www.fisheries.noaa.gov/resource/outreach-and-education/careful-catch-and-release-brochure/.

NMFS will continue to monitor the BFT fisheries closely. Per § 635.5(c)(1), HMS Angling and HMS Charter/Headboat permitted vessel owners are required to report the catch of all BFT retained or discarded dead, within 24 hours of the landing(s) or end of each trip, by accessing https://hmspermits.noaa.gov, using the HMS Catch Reporting app, or calling (888) 872-8862 (Monday through Friday from 8 a.m. until 4:30 p.m.).

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act (16 U.S.C. 1855(d)) and regulations at 50 CFR part 635, and this action is exempt from review under Executive Order 12866.

The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice of, and an opportunity for public comment on, this action because it is impracticable and contrary to the public interest for the following reasons. Specifically, the regulations implementing the HMS FMP and its amendments provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Providing for prior notice and opportunity to comment is impracticable and contrary to the public interest as this fishery is currently underway and, based on the most recent landings information, the Angling category Gulf of America trophy BFT fishery subquota has been reached and exceeded. Delaying this action could result in further excessive trophy BFT landings that may result in future potential quota reductions for the Angling category, depending on the magnitude of a potential Angling category overharvest. NMFS must close the Gulf of America trophy BFT fishery before additional landings of these sizes of BFT occur. Taking this action does not raise conservation and management concerns, and would support effective management of the BFT fishery. NMFS notes that the public had an opportunity to comment on the underlying rulemakings that established the U.S. BFT quota and the inseason adjustment criteria.

For all of the above reasons, the AA also finds that pursuant to 5 U.S.C. 553(d)(3), there is good cause to waive the 30-day delay in effectiveness.