FCA's objective in amending the high-risk loan performance categories is to ensure FCA's regulations remain consistent with GAAP. This amendment reflects GAAP changes that eliminated the recognition and measurement guidance for TDRs and replaced it with a uniform framework for evaluating loan modifications, accompanied by enhanced disclosure requirements. As discussed below, the Farm Credit Act of 1971, as amended (Farm Credit Act) and § 621.3 of FCA regulations generally require System institutions to prepare financial statements and reports in accordance with GAAP. 1 Various FCA regulations in 12 CFR parts 620, 621, 630 and 655 implement the Farm Credit Act's financial reporting requirements. 2 Because GAAP no longer recognizes TDRs as a separate accounting classification, retaining TDRs as a regulatory loan performance category is no longer consistent with current accounting standards. This final rule updates FCA's regulations to ensure continued consistency between regulatory reporting requirements and applicable accounting standards, while maintaining transparent and decision-useful financial reporting for stakeholders.

The Farm Credit Act, establishes the System as a government-sponsored enterprise to provide a reliable source of credit and related services to agriculture and rural America. The Farm Credit Act authorizes FCA to regulate and supervise System institutions to ensure their safety and soundness and their compliance with statutory and regulatory requirements.

Section 5.19(b) of the Farm Credit Act requires each System institution to prepare annual financial statements in accordance with GAAP and to include those statements in reports provided to shareholders. The Farm Credit Act also authorizes FCA to require additional financial information by regulation as necessary to carry out its supervisory responsibilities. Most relevant to this rulemaking, FCA's accounting and reporting regulations in 12 CFR part 621 implement these statutory requirements.

As part of its financial reporting framework, FCA established regulatory loan performance categories to promote consistent reporting across System institutions and to provide transparent, decision-useful information to shareholders, investors, and other stakeholders regarding credit quality and risk. These performance categories also support FCA's supervisory oversight and the preparation of meaningful, system-wide financial data.

Section 621.6 of FCA's regulations establishes high-risk loan performance categories used by System institutions in preparing financial reports required under part 621. 3 These categories provide standardized information regarding loans that exhibit elevated credit risk or other performance concerns and facilitate consistent monitoring of credit quality across the System.

In developing and maintaining these regulatory categories, FCA has historically based its regulatory loan performance categories on information from multiple sources, including GAAP, industry disclosure practices, and interagency supervisory guidance. Although FCA and the System are not subject to the reporting standards of the Federal Financial Institutions Examination Council (FFIEC), 4 FCA's loan performance categories have generally been similar, though not identical to those used by the Federal banking regulators.

The current high-risk loan performance categories in § 621.6 includes TDRs. At the time these categories were adopted, GAAP included specific recognition and measurement guidance for TDRs, which distinguished such loans from other loan modifications.

FCA last substantively amended the regulatory loan performance categories in 2020, 5 primarily to address changes related to nonaccrual loans. At that time, TDRs remained a distinct accounting and regulatory category under GAAP and were retained in FCA's high-risk loan performance framework.

In March 2022, the Financial Accounting Standards Board (FASB)  6 issued Accounting Standards Update (ASU)No. 2022-02, Financial Instruments—Credit Losses (Topic 326): “Troubled Debt Restructurings and Vintage Disclosures” that eliminated GAAP accounting recognition and measurement guidance for TDRs. 7 These changes replaced the former TDR framework with enhanced disclosure requirements for certain loan modifications made to borrowers experiencing financial difficulty. ASU 2022-02 also revised vintage disclosure requirements for public business entities.

These GAAP changes became effective for System institutions on January 1, 2023, coinciding with the System's adoption of the current expected credit losses (CECL) methodology. 8 Under the revised GAAP framework, loan modifications that previously would have been identified as TDRs are now evaluated and accounted for in the same manner as other loan modifications.

On December 30, 2022, FCA issued an informational memorandum to provide interim guidance to System institutions on implementing the GAAP changes related to TDRs while FCA evaluated appropriate regulatory amendments. The informational memorandum instructed institutions to implement the GAAP changes beginning with the first quarterly reporting period of 2023 and clarified reporting expectations during the transition period. 9

Although GAAP no longer recognizes TDRs as a distinct accounting category, references to TDRs remain in FCA's regulatory loan performance categories. This final rule addresses that inconsistency by updating FCA's regulations to remove TDRs as a high-risk loan performance category and align FCA's regulatory framework with the current GAAP treatment of loan modifications.

In December 2025, FCA published a proposed rule in the Federal Register seeking public comment on amendments to its accounting and reporting regulations governing high-risk loan performance categories. 10 The proposed rule focused on conforming FCA regulations to changes in GAAP that eliminated the recognition and measurement guidance for TDRs.

Specifically, the proposed rule would amend § 621.6(b) to remove TDRs as a high-risk loan performance category. Because GAAP no longer recognizes TDRs as a distinct accounting classification, FCA proposed this amendment to ensure consistency between its regulatory reporting framework and current accounting standards. The proposed rule also included conforming technical changes to paragraph numbering and cross-references within § 621.6.

Although the proposed rule did not include regulatory amendments related to the enhanced GAAP disclosure requirements, FCA sought public comment on its determination that existing regulations, specifically FCA regulation § 621.3(b), which requires System institutions to prepare financial statements and reports in accordance with GAAP, provide adequate authority for institutions to report required disclosures related to loan modifications to borrowers experiencing financial difficulty and vintage year disclosures. FCA further requested comment on its expectation for consistent placement of a qualitative loan modification disclosure within Management's Discussion and Analysis (MD&A), with reference to the detailed GAAP disclosures in the notes to the financial statements.

In addition, the proposed rule requested comment on whether FCA should retain the “loans 90 days past due still accruing interest” high-risk loan performance category. This request responded to prior feedback from System institutions and the Farm Credit Council (FCC)  11 regarding the continued supervisory value and reporting burden of this category. FCA explained the purpose and historical role of the category and invited commenters to provide empirical evidence supporting its retention or removal.

The proposed rule's comment period ended February 3, 2026. FCA received three comment letters in response to the proposed rule. One comment letter was submitted by the Federal Farm Credit Banks Funding Corporation (Funding Corporation) on behalf of the System Accounting Standards Work Group (Work Group) and the FCC. Two additional comment letters were submitted by Farm Credit Bank of Texas (FCBT) and Farm Credit Mid-America (FCMA).

FCBT and FCMA indicated that they participated in the Work Group and fully supported the comments submitted by the Funding Corporation. Accordingly, Funding Corporation, FCBT, and FCMA (collectively, the commenters) reflected a coordinated, System-wide response.

The commenters generally supported FCA's proposal to amend the regulatory high-risk loan performance categories by removing TDRs to reflect changes in GAAP. The commenters agreed that GAAP no longer includes recognition or measurement guidance for TDRs and supported FCA's efforts to align its regulations accordingly.

The commenters also supported FCA's determination that no regulatory amendments were necessary to implement GAAP's enhanced disclosure requirements for loan modifications to borrowers experiencing financial difficulty or the amended vintage year disclosure requirements. The commenters noted that existing FCA regulations already require System institutions to prepare financial statements and reports in accordance with GAAP and therefore that they provide appropriate guidance for incorporating these disclosures.

In addition, the commenters supported FCA's retention of the “loans 90 days past due still accruing interest” loan performance category, noting that this category provides useful information regarding credit risk trends, loan performance migration, and the overall financial condition of System institutions.

The commenters provided detailed feedback on FCA's discussion of a qualitative core loan modification disclosure in the MD&A loan portfolio section. While commenters acknowledged FCA's objective of enhancing transparency and stakeholder understanding, they expressed concern that including such discussion in MD&A could be duplicative of GAAP-required disclosures in the financial statements and related footnotes and could impose unnecessary reporting burden or focus undue attention on a specific aspect of operations.

After consideration of the comments received, FCA is adopting the proposed rule as final without changes to the regulatory text.

The commenters supported FCA's proposal to remove TDRs from the regulatory high-risk loan performance categories, noting that GAAP eliminated TDR recognition and measurement guidance and now evaluates loan modifications under a single, consistent framework. FCA agrees with the commenters that retaining TDRs as a regulatory performance category would be inconsistent with current GAAP. Accordingly, FCA is finalizing the removal of TDRs from the high-risk loan performance categories as proposed.

The commenters supported FCA's determination that no regulatory amendments were necessary to implement GAAP's enhanced disclosure requirements related to loan modifications to borrowers experiencing financial difficulty or the amended vintage year disclosure requirements. The commenters noted that FCA regulations already require financial statements and reports to be prepared in accordance with GAAP and provide sufficient guidance to incorporate evolving accounting standards. FCA agrees and, as proposed, is not adopting amendments to implement GAAP's enhanced disclosure requirements.

The commenters supported retaining the “loans 90 days past due still accruing interest” loan performance category, citing its usefulness as a leading indicator of credit risk and as a tool for assessing loan performance trends and migration. FCA agrees that this category continues to provide supervisory and informational value and is retaining it in the final rule.

The commenters expressed concern regarding FCA's discussion of a qualitative core loan modification disclosure in MD&A, stating that such discussion could be duplicative of GAAP disclosures presented in the financial statements and related footnotes and could impose unnecessary reporting burden. FCA acknowledges these concerns.

FCA emphasizes that the financial statements and related footnotes remain the authoritative source for detailed GAAP-required disclosures related to loan modifications to borrowers experiencing financial difficulty.

Accordingly, FCA clarifies that the final rule does not establish any new MD&A disclosure requirements or prescribe the placement of qualitative discussion regarding such disclosures. System institutions must continue to prepare MD&A consistent with existing FCA regulations and applicable management judgement and materiality considerations.

In this final rule, the FCA amends § 621.6 to remove TDRs from the regulatory high-risk loan performance categories.

Specifically, FCA removes § 621.6(b), which identified formally restructured loans (TDR) as a high-risk loan performance category. This amendment reflects changes in GAAP that eliminated the accounting recognition and measurement guidance for TDRs and replaced it with enhanced disclosure requirements for certain loan modifications when a borrower is experiencing financial difficulty.

The final rule does not make changes to the remaining high-risk loan performance categories in § 621.6. Farm Credit banks and associations will continue to report high-risk loans in accordance with the remaining categories and existing regulatory reporting requirements.

The Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA) has determined that this final rule is not a “significant regulatory action” as defined by Section 3(f) of Executive Order 12866, made applicable to FCA by Executive Order 14215. OIRA has also determined that this action is an Executive Order 14192 deregulatory action.

Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ), FCA hereby certifies that the rule will not have a significant economic impact on a substantial number of small entities. Each of the banks in the Farm Credit System, considered together with its affiliated associations, has assets and annual income more than the amounts that would qualify them as small entities. Therefore, Farm Credit System institutions are not “small entities” as defined in the Regulatory Flexibility Act.

Under the provisions of the Congressional Review Act (5 U.S.C. 801 et seq. ), OIRA has determined that this final rule is not a “major rule” as the term is defined at 5 U.S.C. 804(2).

For the reasons stated in the preamble, the Farm Credit Administration amends part 621 of chapter VI, title 12 of the Code of Federal Regulations 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-2026-7223; Project Identifier AD-2026-00329-A” 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 Soban Saeed, Aviation Safety Engineer, FAA, 1801 South Airport Road, Wichita, KS 67209. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The FAA was notified by Textron that the existing ALM of the ICA for Textron Model B300 and B300C airplanes contained incorrect wing inspection intervals for airplanes that are certified to or operating at a 16,500 pound (lb.) maximum takeoff weight (MTOW). As a result, Textron has revised the existing Model B300 and B300C structural inspection and repair manual (SIRM) and ALM to separate the wing inspection criteria and intervals between airplanes that are certified to or operating at a 15,000 lb. MTOW and those that are certified to or operating at a 16,500 MTOW. The new and updated inspection criteria are based upon the airplane operating hours. The FAA is issuing this AD to prevent undetected cracks in the wing or wing supporting structure. The unsafe condition, if not addressed, could result in reduced structural integrity and consequent wing separation from the fuselage in flight.

The FAA is issuing this AD because the agency determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

The FAA reviewed Textron Mandatory Service Letter MTL-57-04, Revision 1, dated March 27, 2025. This material specifies information about the new and updated wing inspection criteria for Model B300 and B300C airplanes within the SIRM and ALM based upon the airplane operating hours. 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.

This AD requires revising the ALS of the existing AMM or ICA and the existing approved maintenance or inspection program, as applicable, by incorporating the actions and associated intervals specified in the material already described.

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 the existing incorrect wing inspection intervals need to be revised to detect any crack that could develop in the wing spar or wing supporting structure due to differences in operators' mission profiles (airplanes operating at a 16,500 lb. MTOW). Current FAA data indicate that a number of airplanes are past the revised inspection intervals specified in this AD. Cracks in the wing spar or wing supporting structure could result in reduced structural integrity and consequent wing separation from the fuselage in flight. 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 FAA has determined that it has good cause to adopt this rule without prior notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 113 airplanes of U.S. registry. The FAA estimates the following costs to comply with 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, 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 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-2026-7222; Project Identifier MCAI-2026-00565-G” 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 George Weir, Aviation Safety Engineer, FAA, 1600 Stewart Avenue, Suite 410, Westbury, NY 11590. Any commentary that the FAA receives which is not specifically designated as CBI will be placed in the public docket for this rulemaking.

The European Union Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Union, has issued EASA Emergency AD 2026-0108-E, dated June 5, 2026 (referred to as the MCAI), to correct an unsafe condition on all Stemme TSA-M Model S6-RT and Stemme S 12 gliders. The MCAI states that a leaking electrical fuel transfer pump installed on a Model Stemme S 12 glider was found. The two glider models share the same electrical fuel transfer pump design. Each of these glider models have two electrical fuel transfer pumps. An investigation revealed that leakage resulted from the installation of non-conforming parts that occurred during manufacturing and that also have been delivered as spare parts. Non-conforming parts are electrical fuel transfer pumps identified with “HEP-02A” (unknown manufacturer) instead of “HEP-02” under part number 830521. To address the unsafe condition, Stemme published service material to provide inspection instructions to identify affected electrical fuel transfer pumps. This condition, if not addressed, could result in an in-flight fire and a potential explosion in the wing or center fuselage.

You may examine the MCAI in the AD docket at regulations.gov under Docket No. FAA-2026-7222.

The FAA reviewed Stemme Service Bulletin P062-980092, Revision 00, dated May 29, 2026. This material specifies procedures for a one-time inspection of the two electrical fuel pumps to verify if non-conforming parts, as defined in this AD, are installed. 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 and material 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 visual inspection of both electrical fuel transfer pumps for non-conforming parts, and replacement of any electrical fuel transfer pumps if non-conforming parts are identified. This AD also prohibits the installation of certain non-conforming parts.

The FAA considers this AD to be an interim action. If final action is later identified, the FAA might consider further rulemaking.

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 EASA issued an emergency AD indicating that fuel leakage from an electrical fuel transfer pump on TSA-M Model S6-RT and Stemme S 12 gliders could result in an in-flight fire and a possible explosion in the wing or center fuselage, which could injure occupants and persons on the ground. Thus, an inspection of these gliders is necessary before further flight. This compliance time 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 prior notice and comment, RFA analysis is not required.

The FAA estimates that this AD affects 33 gliders 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 replacements that would be required based on the results of the inspection. The agency has no way of determining the number of gliders 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, 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 FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class D and Class E airspace in Westfield, MA.

The FAA published an NPRM for Docket No. FAA-2026-5248 in the Federal Register (91 FR 27223; May 14, 2026), proposing to amend Class D and Class E airspace in Westfield, MA. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received in support of the proposal. The commenter cited practicality and perceived increases in both safety and efficiency as the reasons for their support of the proposal.

Class D and Class E airspace designations are published in paragraphs 5000 and 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the latest version of that order, FAA Order JO 7400.11K, dated August 4, 2025, and effective September 15, 2025. These amendments will be published in the next update to FAA Order JO 7400.11. FAA Order JO 7400.11K, which lists Class A, B, C, D, and E airspace areas, air traffic service routes, and reporting points, is publicly available as listed in the ADDRESSES section of this document.

This action amends 14 CFR part 71 by modifying Class D and Class E airspace over Westfield, MA. This action updates the airport name in both the Westfield Class D and Class E airspace legal descriptions from “Westfield, Barnes Municipal Airport” to “Westfield-Barnes Regional Airport.” This action also updates the geographic coordinates of the Westfield-Barnes Regional Airport in both the Class D and Class E airspace legal descriptions, specifically, from (lat. 42°09′28″ N, long. 72°42′56″ W) to (lat. 42°09′29″ N, long. 72°42′57″ W), which is one second of latitude and one second of longitude. This action also updates the verbiage in the Class D airspace legal description from “Airport/Facility Directory” to “Chart Supplement” to comply with current FAA guidance. This action also removes the exclusions for the adjacent Class E airspace areas of Northampton, MA, Palmer, MA and Windsor Locks, CT from the Westfield, MA Class E5 airspace legal description in order to comply with current FAA guidance.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Order 2100.6B, “Rulemaking and Guidance Procedure” (March 10, 2025); and (3) is expected to result in, at most, de minimis costs from compliance with applicable operating requirements or minor flight rerouting for operators choosing to navigate around the controlled airspace. Since these amendments are routine and the expected impact to operators is de minimis, the FAA certifies that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1G, “FAA National Environmental Policy Act Implementing Procedures” paragraph B-2.5(a). This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant the preparation of an environmental assessment.

In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:

Upon request, FDA (the Agency or we) has classified the prognostic test for assessment of chronic kidney disease progression into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

On August 26, 2020, FDA received Renalytix AI, Inc.'s request for De Novo classification of the KidneyIntelX.dkd device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on June 29, 2023, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 862.1223. 1 We have named the generic type of device “prognostic test for assessment of chronic kidney disease progression,” and it is identified as an in vitro diagnostic device intended to measure one or more analytes obtained from human samples as an aid in assessing the risk for progression of chronic kidney disease. This device is not intended for diagnosis of any disease, for serial monitoring of kidney disease progression, or for monitoring the effect of any therapeutic product.

FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.

Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for prognostic tests for assessment of chronic kidney disease progression. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 862 is amended as follows:

Upon request, FDA (the Agency or we) has classified the over-the-counter test to detect SARS-CoV-2 from clinical specimens into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

On May 2, 2022, FDA received Cue Health Inc.'s request for De Novo classification of the Cue COVID-19 Molecular Test. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on June 6, 2023, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 866.3984. 1 We have named the generic type of device “over-the-counter test to detect SARS-CoV-2 from clinical specimens,” and it is identified as an in vitro diagnostic device for the detection of SARS-CoV-2 in clinical specimens to aid in the diagnosis of SARS-CoV-2 infection. The device is intended to be used by lay users and without required health care provider intervention in home settings or similar environments in which lay users perform testing.

FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.

Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for over-the-counter tests to detect SARS-CoV-2 from clinical specimens. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR parts 801 and 809 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 866 is amended as follows:

Upon request, FDA (the Agency or we) has classified the diabetes digital behavioral therapeutic device into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

On September 21, 2022, FDA received Better Therapeutics' request for De Novo classification of the BT-001 device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on July 7, 2023, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 880.5735. 1 We have named the generic type of device “diabetes digital behavioral therapeutic device,” and it is identified as a prescription use software device that provides digital behavioral therapy to aid in the management of diabetes. This device is intended to provide limited secondary benefit to patients with diabetes mellitus by assisting them in managing their condition. This device is not intended to replace any primary treatment, such as diet/lifestyle changes or medication.

FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.

At the time of classification, diabetes digital behavioral therapeutic devices are for prescription use only. Prescription devices are exempt from the requirement for adequate directions for use for the layperson under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)) and 21 CFR 801.5, as long as the conditions of 21 CFR 801.109 are met.

Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for diabetes digital behavioral therapeutic devices. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 880 is amended as follows:

Upon request, FDA (the Agency or we) has classified the intraoperative surgical angle measurement tool into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

The automatic assignment of class III occurs by operation of law and without any action by FDA, regardless of the level of risk posed by the new device. Any device that was not in commercial distribution before May 28, 1976, is automatically classified into, and remains within, class III and requires premarket approval unless and until FDA takes an action to classify or reclassify the device (21 U.S.C. 360c(f)(1)). We refer to these devices as “postamendments devices” because they were not in commercial distribution prior to the date of enactment of the Medical Device Amendments of 1976, which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA may take a variety of actions in appropriate circumstances to classify or reclassify a device into class I or II. We may issue an order finding a new device to be substantially equivalent under section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that does not require premarket approval. We determine whether a new device is substantially equivalent to a predicate device by means of the procedures for premarket notification under section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).

FDA may also classify a device through “De Novo” classification, a common name for the process authorized under section 513(f)(2) of the FD&C Act (see also part 860, subpart D (21 CFR part 860, subpart D)). Section 207 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) established the first procedure for De Novo classification. Section 607 of the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) modified the De Novo classification process by adding a second procedure. A device sponsor may utilize either procedure for De Novo classification.

Under the first procedure, the person submits a premarket notification (510(k)) for a device that has not previously been classified. After receiving an order from FDA classifying the device into class III under section 513(f)(1) of the FD&C Act, the person then requests a classification under section 513(f)(2).

Under the second procedure, rather than first submitting a 510(k) and then a request for classification, if the person determines that there is no legally marketed device upon which to base a determination of substantial equivalence, that person requests a classification under section 513(f)(2) of the FD&C Act.

Under either procedure for De Novo classification, FDA is required to classify the device by written order within 120 days. The classification will be according to the criteria under section 513(a)(1) of the FD&C Act. Although the device was automatically placed within class III, the De Novo classification is considered to be the initial classification of the device.

We believe this De Novo classification will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens. When FDA classifies a device into class I or II via the De Novo process, the device can serve as a predicate for future devices of that type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C Act). As a result, other device sponsors do not have to submit a De Novo request or premarket approval application to market a substantially equivalent device (see section 513(i) of the FD&C Act, defining “substantial equivalence”). Instead, sponsors can use the less burdensome 510(k) process, when necessary, to market their device.

On February 16, 2023, FDA received Ruthless, LLC's request for De Novo classification of the Ruthless Spine RJB device. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

We classify devices into class II if general controls by themselves are insufficient to provide reasonable assurance of safety and effectiveness of the device, but there is sufficient information to establish special controls that, in combination with the general controls, provide reasonable assurance of the safety and effectiveness of the device for its intended use (see section 513(a)(1)(B) of the FD&C Act). After review of the information submitted in the request, we determined that the device can be classified into class II with the establishment of special controls. FDA has determined that these special controls, in addition to the general controls, will provide reasonable assurance of the safety and effectiveness of the device.

Therefore, on July 14, 2023, FDA issued an order to the requester classifying the device into class II. In this final order, FDA is codifying the classification of the device by adding 21 CFR 888.4560. 1 We have named the generic type of device “intraoperative surgical angle measurement tool,” and it is identified as a device that attaches to surgical instruments to measure the angle of the instrument relative to a vertical plumb line in line with gravity. The tool does not utilize anatomic landmarks or registration to patient anatomy.

FDA has identified the risks to health associated with this type of device and the measures required to mitigate these risks in table 1.

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order.

Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for intraoperative surgical angle measurement tools. This device is therefore subject to premarket notification requirements under section 510(k) of the FD&C Act.

The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not normally have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

This final order establishes special controls that refer to previously approved collections of information found in other FDA regulations and guidance. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521). The collections of information in part 860, subpart D, regarding De Novo classification have been approved under OMB control number 0910-0844; the collections of information in 21 CFR part 814, subparts A through E, regarding premarket approval have been approved under OMB control number 0910-0231; the collections of information in part 807, subpart E, regarding premarket notification submissions have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 820 regarding quality management system regulation have been approved under OMB control number 0910-0073; and the collections of information in 21 CFR part 801 regarding labeling have been approved under OMB control number 0910-0485.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 888 is amended as follows:

The final regulations (TD 10050) subject to these corrections are issued under sections 2056A(a)(2), 2056A(e), and 7805(a) of the Internal Revenue Code.

Accordingly, 26 CFR part 20 is corrected by making the following correcting amendments:

DoD is amending its regulations implementing Title VI, 42 U.S.C. 2000d-1, to more closely align them to the statute, which prohibits intentionally discriminatory conduct, see 42 U.S.C. 2000d. There are serious statutory and constitutional concerns with DoD's current Title VI regulations because the current regulations go beyond intentional discrimination by prohibiting conduct that has an unintentional disparate impact. This rule accordingly rescinds those portions of the regulations, which are in considerable tension with both the statute and the Constitution and do not sufficiently serve the public interest.

Specifically, this rule rescinds in full 32 CFR 195.4(b)(2), which prohibits the use of “criteria or methods of administration which have the effect of subjecting individuals to discrimination because of their race, color, or national origin . . . .” This rule also rescinds 32 CFR 195.4(b)(4), which permits and, in some instances, requires affirmative-action programs based on race, color, or national origin. Additionally, this rule eliminates the use of the phrase “or effect” in 32 CFR 195.4(b)(1)(iii). This rule also rescinds the full text of 32 CFR 195.4(b)(5), which addresses employment practices subject to Federal financial assistance. Finally, this rule makes minor technical corrections.

The rule's revisions also conform to Executive Order 14281, Restoring Equality of Opportunity and Meritocracy, 90 FR 17537 (Apr. 23, 2025). That Order states 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. Although DoD would take this action independent of Executive Order 14281, the Order supports this action.

These amendments also better align DoD's regulations with current agency policy. Consistent with Executive Order 14185, Restoring America's Fighting Force, 90 FR 8763 (Feb. 3, 2025), and as summarized in the 29 January 2025 Secretarial issuance, “Restoring America's Fighting Force,” it is the policy of DoD to promote meritocracy and uniform standards and eliminate unlawful and unconstitutional policies that discriminate based on race, national origin, or other immutable characteristics. Disparate-impact liability casts doubt on the validity of such facially neutral policies for fear that they might lead to disparate outcomes without a showing of intentional discrimination, which contravenes DoD policy.

In sum, this rule clarifies that Title VI does not prohibit conduct or activities that unintentionally lead to disparate impacts. Rather, as implemented by DoD, Title VI only prohibits intentional discrimination, and DoD will not pursue Title VI disparate-impact liability against its Federal-funding recipients.

Title VI of the Civil Rights Act of 1964, as amended, states: “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 only 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 provide any Federal department or agency with authority to prohibit unintentional disparate impact. And despite having ample opportunities, Congress has enacted no subsequent amendments to Title VI to impose disparate-impact liability.

DoD has implemented Title VI via regulation since 1964. See 29 FR 19291 (Dec. 31, 1964). DoD's 1964 regulations contained one reference to disparate-impact liability, see id. Subsequent amendments to these regulations, see 38 FR 17959 (July 5, 1973), added additional disparate-impact and affirmative-action language.

The Supreme Court has held 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, the Supreme Court held that Congress intended Title VI to prohibit “only those racial classifications that would violate the Equal Protection Clause” if committed by a government actor. 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, the Supreme Court held that the Equal Protection Clause prohibits only 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 then-existing “disparate-impact regulations” issued by the Department of Justice (DOJ). Id. at 285-87. DoD's current regulations mirror those at issue in Sandoval. Although 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 DOJ'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. And although the Supreme Court in Sandoval “assume[d],” without deciding, that DOJ's disparate-impact regulations were valid, the Court explained that the then-current version of the regulations were in “considerable tension” with the Supreme Court's Title VI precedents. Similarly, the regulations did 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 doing so, 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 so long as 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 restates the “bedrock principle of the United States . . . that all citizens are treated equally under the law.” 90 FR at 17537. The Order explains 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 explains that disparate-impact liability “endangers this foundational principle.” Id. Disparate-impact liability, the Order reasons, “all but requires individuals and businesses to consider race and engage in racial balancing to avoid potentially crippling legal liability.” Id. As the Order explains, 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 relays that because of these 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. Accordingly, this rule revises DoD's currently existing Title VI regulations, consistent with the Order's policy and purpose.

In any event, DoD 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, DoD would have taken steps to adopt the policy to eliminate the use of disparate-impact liability under Title VI. The Order states, and DoD 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.

Imposing disparate-impact liability endangers these policy objectives. Disparate-impact liability also raises serious constitutional concerns, is in considerable tension with 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, DoD concludes that these reasons support eliminating disparate-impact liability from DoD's Title VI regulations. In any event, DoD concludes that each reason is an independent basis for eliminating disparate-impact liability from DoD's Title VI regulations.

32 CFR 195.4(b), entitled “Specific discriminatory actions prohibited,” contains several provisions that go beyond Title VI and the Constitution by prohibiting conduct or activities causing an unintentional disparate impact. And in some instances, these provisions may encourage or even require unlawful discrimination labeled as “affirmative action.” Section 195.4(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.” Beyond that general prohibition, § 195.4(b)(1)(iii) addresses a Federal funding recipient's selection of the site or location of facilities and includes one reference to “effect” that extends to conduct with unintentional disparate impact. Section 195.4(b)(4) addresses “affirmative action,” and provides that funding recipients may (and sometimes must) use race, color, or national origin to overcome unintentional disparate “effects.” But this provision does not expressly specify that the funding recipient must narrowly tailor such use nor that this use must serve a compelling governmental interest, as is required to satisfy strict scrutiny. Finally, § 195.4(b)(5) addresses prohibited discriminatory employment practices and extends beyond intentional discrimination to prohibiting conduct that “tends” to have a discriminatory effect.

There are serious statutory and constitutional concerns with DoD's Title VI disparate-impact regulations. DoD 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. Sandoval calls into serious doubt the legality of DoD's “disparate-impact regulations.” Sandoval, 532 U.S. at 281-82, 284-85 (noting that DOJ's then-existing regulations were 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 DoD cannot extend Title VI beyond its best 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, DoD 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 prohibition of conduct having 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 DoD'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 DoD'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 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. The serious constitutional concerns raised by these perverse incentives further confirm that the best reading of Title VI is that it prohibits only intentional discrimination and does not authorize DoD 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 encouraged or coerced 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. 32 CFR 195.4(b)(4). 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 DoD's disparate-impact regulations. But even if the regulations were legal, DoD 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, DoD 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.

DoD also has serious policy concerns with the imposition of disparate-impact liability. Although DoD 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, “On a practical level, disparate-impact liability has hindered businesses from making hiring and other employment decisions based on merit and skill, their needs, or the needs of their customers because of the specter that such a process might lead to disparate outcomes, and thus disparate-impact lawsuits. This has made it difficult, and in some cases impossible, for employers to use bona fide job-oriented evaluations when recruiting, which prevents job seekers from being paired with jobs to which their skills are most suited—in other words, it deprives them of opportunities for success.” 90 FR at 17537. Moreover, the legal concerns identified above have caused uncertainty and confusion for Federal-funding recipients as to whether and when they need to comply with the disparate-impact regulations and when they can or must consider race, color, and national origin. As explained above, Sandoval casts substantial doubt on the validity of the disparate-impact regulations that many Federal departments and agencies have promulgated pursuant to Title VI. 532 U.S. at 280-82.

Additionally in practice, and as explained above, disparate-impact liability leads covered entities to engage in racial balancing even as Title VI forbids intentional racial discrimination. This tension tends to create confusion and undermine public confidence in the nation's civil rights laws and in the rule of law itself, as the law seems to both forbid and require the same conduct.

These problems are amplified by the arbitrary nature of the racial and ethnic categories typically used to measure disparate effects, which, by virtue of their arbitrariness, typically lack a meaningful connection to a compelling interest. 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. DoD 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.

DoD 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 DoD has considered. And in any event, eliminating disparate-impact liability does not preclude the use of data on disparate outcomes to help prove intentional discrimination. Indeed, under DoD'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.” 32 CFR 195.7(b). Both DoD 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 conduct having an unintentional disparate impact.

DoD has also considered the alternative of trying to adopt a modified version of disparate-impact liability, for example, by requiring covered entities to remedy so-called unintentional discrimination for only certain types of cases. But any version of imposing liability for so-called unintentional discrimination is inconsistent with Title VI. Regardless, even a modified version of disparate-impact liability would not eliminate DoD's serious legal and policy concerns. DoD determines that any benefits from adopting alternative versions of disparate-impact liability are outweighed by DoD'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. DoD believes that the better course is to avoid the complexities, costs, and litigation associated with this alternative, even if eliminating disparate-impact liability would ultimately leave some problems unaddressed and others inadequately addressed.

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

DoD 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 DoD 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, DoD finds that, regardless of the legality of DoD'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 that the Supreme Court raised in Sandoval and the other legal and policy concerns discussed above, harmonize the implementing regulations with Title VI, promote consistent enforcement among private plaintiffs and Federal departments and agencies, and provide much needed clarity to the courts and Federal funding recipients and beneficiaries.

For the reasons summarized above, DoD amends the following provisions in its Title VI implementing regulations that explain the particular types of discrimination prohibited, located at 32 CFR 195.4.

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 195.4(b)(1)(iii) 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 “with the purpose or effect of defeating or substantially impairing the accomplishment of the objectives of” Title VI or the DoD's implementing regulations. The paragraph's reference to “effect” extends its scope to unintentional disparate impacts. This rule deletes the “or effect” reference to conform paragraph (b)(1)(iii) more closely to Title VI and to address the legal and policy considerations and determinations described in this document.

Section 195.4(b)(2) is the general prohibition of conduct having an unintentional disparate impact. It imposes liability on Federal-funding recipients who “utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination.” Because § 195.4(b)(2)'s only purpose is to prohibit disparate-impact discrimination, this rule deletes this paragraph in its entirety. It thus amends the regulations to conform to 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 195.4(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 the Equal Protection Clause.

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 ground of race, color, or national origin.” This provision goes beyond the Equal Protection Clause, which permits, 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 simply “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 racial preferences when the recipient may not want to. This is contrary to DoD'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 195.4(b)(5) addresses prohibited discriminatory employment practices. Paragraph (b)(5) extends the prohibition on discrimination to employment practices of the funding recipient even “[w]here a primary objective of the Federal financial assistant is not to provide employment” if discrimination in the non-funded “employment practices . . . tends, on the ground of race, color, or national origin of the intended beneficiaries, to exclude intended beneficiaries from participation in, to deny them the benefits of, or to subject them to discrimination under any program to which this Directive applies.” This paragraph does not prohibit only intentional discrimination but rather extends the prohibition to conduct that “tends” to have a discriminatory effect.

Moreover, DoD notes that paragraph (b)(5)'s extension to employment practices where the Federal funding's primary objective is not to provide employment conflicts with 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 (b) to amend the regulation so that it more closely adheres to Title VI and to address the legal and policy considerations and determinations described in this document.

This rule is issued pursuant to 42 U.S.C. 2000d-1.

DoD's position is that each of the amendments described in this rule serve a vital, related, but distinct purpose. DoD 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. DoD would adopt any of the amendments independently of the invalidity of a separate amendment.

DoD is issuing this final rule without prior public notice and comment or a delayed effective date pursuant to 5 U.S.C. 553(a)(2), which exempts from such procedure rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.”

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.” 35 CFR 195.2(d); see also 35 CFR 195.6 (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 DOJ 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 guidance issued by the Office for Management and Budget (OMB) 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 DoD, all the forms of Federal financial assistance set forth under 2 CFR 200.1 that DoD administers would fall under the exception for “public property, loans, grants, benefits, or contracts.” Thus, DoD issues this final rule without prior public notice and comment or a delayed effective date under 5 U.S.C. 553(a)(2).

OMB has determined that this rulemaking is a “significant regulatory action” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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), Improving Regulation and Regulatory Review, 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 DoD regulations to Executive Order 14281, address serious legal concerns regarding DoD's Title VI regulation based on the Supreme Court's reading of Title VI in Sandoval, harmonize the implementing regulation with Title VI, 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 DoD's Title VI regulations. Indeed, with respect to § 195.4(b)(4)(ii), the changes 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 DoD'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. For enforcement actions that relate to both intentional discrimination and conduct having an unintentional disparate impact, DoD does not track and cannot reliably quantify the costs attributable to the disparate-impact portions of enforcement actions. That the existence of a disparate impact is sometimes a factor that may be considered in evaluating intentional discrimination further impedes monetizing costs and benefits. Therefore, the overall cost effect on DoD is difficult to quantify. The deregulatory action should decrease DoD's enforcement costs, however. It should also have the benefit, also difficult to quantify, of bringing DoD's conduct in line with the law. Similarly, DoD 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.

DoD does not envision that this rule will appreciably increase administrative or compliance costs for funding recipients who must also adhere to the regulations of another department or agency. This deregulatory action does not create any new obligations for funding recipients. On the contrary, by eliminating disparate-impact liability from the regulation, this rule eliminates a source of regulatory confusion, narrows 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. These contractual assurances 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. And in any event, DoD notes that other agencies are currently amending their regulations to align with the changes made in this rule, so DoD anticipates that there will be little, if any, disparity in federal requirements regarding disparate-impact liability going forward.

Based on the analysis of the practical qualitative costs and benefits noted above, DoD 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, DoD 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 generally requires agencies to repeal ten existing regulations for every new regulation added. This rule reduces regulatory burden by eliminating the requirement that DoD financial-assistance recipients avoid facially neutral actions that unintentionally lead to disparate impacts. As such, this rule is a deregulatory action under Executive Order 14192.

Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has federalism implications. This rule will not have a substantial effect on State and local governments. Indeed, this rule reduces regulatory compliance costs and burdens on funding recipients, including States, and it does not preempt State law. This rule merely aligns existing DoD regulations with statutory law.

Executive Order 13175 establishes certain requirements that an agency must meet when it promulgates a rule that imposes substantial direct compliance costs on one or more Indian Tribes, preempts Tribal Law, or effects the distribution of power and responsibilities between the Federal Government and Indian Tribes. This final rule will not have a substantial effect on Indian tribal governments.

The Congressional Review Act, 5 U.S.C. 801, et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each house of the Congress and to the Comptroller General of the United States. DoD will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States. The Office of Information and Regulatory Affairs has determined that this final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (2 U.S.C. 1532) requires agencies to assess anticipated costs and benefits before issuing any rule that mandates require spending in any one year of $100 million, updated annually for inflation. However, UMRA does not apply to any 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). UMRA therefore does not apply to this rulemaking.

This final rule is not subject to the Regulatory Flexibility Act (RFA) because, as explained above, notice-and-comment rulemaking is not required under 5 U.S.C. 553(a)(2). 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, DoD believes this rule will not have a significant economic impact on a substantial number of small entities. Indeed, this rule reduces regulatory burden on funding recipients and continues to apply existing statutory law; it does not impose new obligations. Therefore, the RFA, as amended, does not require DoD to prepare a regulatory flexibility analysis.

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

Pursuant to section 1-202 of Executive Order 12250, DOJ has the responsibility to “review . . . proposed rules . . . of the Executive agencies” implementing nondiscrimination statutes such as Title VI in order to identify those which are inadequate, unclear or unnecessarily inconsistent.” Additionally, section 1-101 of Executive Order 12250 delegated the President's responsibility to approve Title VI regulations to the Attorney General. See 42 U.S.C. 2000d-1. DOJ has reviewed and approved this rule.

Accordingly, DoD amends 32 CFR part 195 as follows:

The Coast Guard is correcting a notification of enforcement of regulation that published May 22, 2026. The Coast Guard is making this change to ensure interested persons have accurate information about the Hamburg Beach Blast (Event (G)(32) in Table 1 to 33 CFR 165.939).

In the Federal Register of May 22, 2016, in FR Doc. 2026-10265, on page 91 FR 30214, in the first column, in the last line of the second full paragraph, “July 26, 2026” is corrected to read “July 25, 2026”.

The Coast Guard will enforce a safety zone regulation in 33 CFR 165.930(a)(4) on the main branch of the Chicago River between Michigan Avenue Bridge (Mile Marker 326.5) and the Columbus Drive Bridge (Mile Marker 326.7) for the Chicago Ducky Derby event from 11:30 a.m. until 2 p.m. on August 6, 2026. This action is being taken to provide for the safety of life on the navigable waterway during the Annual Chicago Ducky Derby marine event. Our regulation for marine events within the Great Lakes Coast Guard District, § 165.930(c)(1), specifies that the Captain of the Port (COTP) may enforce this safety zone in whole, in segments, or by any combination of segments. The COTP Lake Michigan may suspend the enforcement of any segment of this safety zone for which notice of enforcement has been given.

Pursuant to § 165.930, during the enforcement period, entry into, transiting, or anchoring within safety zone is prohibited unless authorized by the COTP Lake Michigan or a designated on-scene representative. Additionally, all vessels must obtain permission from the COTP Lake Michigan or designated representative to enter, move within, or exit a safety zone when the safety zone is enforced. Vessels and persons granted permission to enter the safety zone must obey all lawful orders or directions of the COTP Lake Michigan designated representative. Upon being hailed by the Coast Guard by siren, radio, flashing light or other means, the operator of a vessel must proceed as directed.

In addition to this notification of enforcement in the Federal Register , the Coast Guard will provide the maritime community with notification of this enforcement period via Broadcast Notice to Mariners. The COTP Lake Michigan may be reached by contacting the Coast Guard Sector Lake Michigan Command Center at (833) 900-2247. An on-scene designated representative may be reached via VHF-FM Channel 16.

On May 7, 2026, the Department published in the Federal Register (91 FR 24763) a proposal to waive the requirements in the Education Department General Administrative Regulations that generally prohibit project periods exceeding five years and extend the project periods with funding to enable 36 NACTEP projects under Assistance Listing Number (ALN) 84.101A, currently in their fifth year, to receive funding for an additional period, not beyond September 30, 2027.

There are no differences between the notice of proposed waiver and extension of the project period with funding and this notice of final waiver and extension of the project period with funding, as discussed in the Analysis of Comments and Changes section of this document.

In response to the Department's invitation in the notice of proposed waiver and extension of the project period with funding, 15 parties submitted 15 comments.

Generally, the Department does not address technical and other minor changes or suggested changes the law does not authorize the Department to make under the applicable statutory authority. In addition, the Department does not address general comments that raised concerns not directly related to the proposed waiver and extension of the project periods with funding.

An analysis of the comments follows.

Comment: Fourteen commenters submitted comments in support of the extension of the project periods with funding, stating the extension is necessary for the continuity of career and technical education (CTE) services to existing NACTEP program participants. One of the 14 commenters cited that extending the project period would preclude programs from competing for available funds, limiting opportunities to expand services to new students; however, the commenter advocated that current recipients should receive an additional year of services.

Discussion: We appreciate the commenters' support for the waiver and extension and agree that funding this extension will continue to provide CTE services to existing participants.

Change: None.

Comment: One commenter did not support a waiver and extension, expressing concern that not having a new competition would lead to program stagnation.

Discussion: The Department appreciates the commenter's feedback on the NACTEP program. As discussed in the proposed waiver and extension, the Department intends to hold a new competition in FY 2027. The Department believes the waivers and extensions will not cause stagnation; on the contrary, they are important to ensure continuity of program services.

Change: None.

The Department believes that it is in the public interest to extend the NACTEP program in lieu of running a new competition in FY 2026.

Extending the project end dates of the 36 NACTEP grants for one year allows for efficient continuity of CTE services for current recipients. Pending FY 2027 appropriations, there may be new competitions for all eligible applicants.

For these reasons, the Department waives the requirements in 34 CFR 75.250, which prohibit project periods exceeding five years, as well as the requirements in 34 CFR 75.261(a) and (b)(2), which allow the extension of a project period only if the extension does not involve the obligation of additional Federal funds. These waivers allow the Department to consider FY 2026 continuation awards to the 36 NACTEP projects (ALN 84.101A) based on their Year 5 planned amount. It is estimated that each grantee's continuation award will be at the amounts listed within the Proposed Waivers and Extensions as published in the Federal Register (91 FR 24763), pending review and discussion of carryover.

Any activities to be carried out during the year of these continuation awards have to be consistent with, or a logical extension of, the scope, goals, and objectives of the grantees' applications as approved in the FY 2021 NACTEP competition. The FY 2021 NACTEP Notices Inviting Applications continue to govern each grantee's project during the extension. The requirements for continuation awards are set forth in 34 CFR 75.253.

The Secretary certifies that the waivers and extensions of the project periods with funding would not have a significant economic impact on a substantial number of small entities. The extension of existing project periods imposes minimal compliance costs, and the activities required to support the additional year of funding would not impose additional regulatory burdens or require unnecessary Federal supervision. The only entities that are affected by the waiver and extension of the project period are the 36 ALN 84.101A grantees.

The final waiver and extension of the project period with funding do not contain any information collection requirements.

This action is not subject to Executive Order 12372 and the regulations in 34 CFR part 79.

Accessible Format: On request to the program contact person listed under FOR FURTHER INFORMATION CONTACT , individuals with disabilities can obtain this document in an accessible format. The Department will provide the requestor with an accessible format that may include Rich Text Format (RTF) or text format (txt), a thumb drive, an MP3 file, braille, large print, audiotape, or compact disc, or other accessible format.

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The Department is rescinding portions of its regulations promulgated pursuant to Title VI, 42 U.S.C. 2000d-1, to more closely align the regulations with Title VI's prohibition on intentionally discriminatory conduct. There are serious statutory and constitutional concerns with the legality of the provisions of the Department's Title VI regulations that go beyond prohibiting intentional discrimination to additionally prohibit conduct giving rise to unintentional disparate impacts. This rule accordingly rescinds those portions of the regulations that impose disparate-impact liability, which are in considerable tension with the statute and the Constitution, cause confusion and uncertainty, increase compliance costs for recipients of Federal financial assistance, and do not serve the public interest.

The rule's revisions are also consistent with Executive Order (E.O.) 14281, Restoring Equality of Opportunity and Meritocracy, 90 FR 17537 (Apr. 28, 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 E.O. 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 5 of the E.O. specifically directs, through the Attorney General's leadership and coordination authority, the repeal or amendment of Title VI regulations “for all agencies to the extent they contemplate disparate-impact liability,” and in a manner consistent with applicable law. Id. Though the Department would take this action independently of E.O. 14281, that Order supports this action.

The modifications in this rule will clarify for recipients of Federal financial assistance from the Department that the Department's Title VI regulations prohibit intentional discrimination and do not prohibit conduct or activities that have an unintentional disparate impact, and that accordingly, the Department will not pursue Title VI disparate-impact liability against its Federal funding recipients. This rule also removes from the Department's regulations various provisions that have no statutory justification.

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, including the Department of Education, to “effectuate the provisions of” Title VI “by issuing rules, regulations, or orders of general applicability.” Id. at 2000d-1. The section of Title VI that sets forth the prohibited conduct, 42 U.S.C. 2000d, prohibits 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.”). 1 The statute does not explicitly provide any Federal department or agency with authority to prohibit unintentional disparate impact. And despite ample opportunity, Congress has not amended Title VI to impose disparate-impact liability.

The initial set of model regulations for Title VI was issued by the then-Department of Health, Education, and Welfare (HEW) on December 4, 1964; those regulations included one reference to the “effect of” certain conduct in the “discrimination prohibited” provision of the rule. See 29 FR 16298, 16299 (Dec. 4, 1964) (currently located at 34 CFR 100.3(b)(2)). In 1973, HEW published approximately 18 revisions to its Title VI regulations. See 38 FR 17978 (July 5, 1973). All but three also applied uniformly to all agencies that provide Federal financial assistance to recipients. Id. These 1973 revisions included the addition of both a requirement for “affirmative action” to overcome the effects of past discrimination and a statement of permission for entities to take “affirmative action to overcome the effects of conditions which resulted in limited program participation by persons of a particular race, color, or national origin,” 38 FR at 17978 (currently located at 34 CFR 100.3(b)(6)(i) and (ii)); clarification of nondiscrimination requirements with respect to the selection of sites and locations for facilities which affect the provision of federally assisted benefits, id. (currently located at 34 CFR 100.3(b)(3)); and the addition of a subparagraph to “state the rule concerning discriminatory employment practices which result in excluding individuals from participation in, denying them the benefits of, or subjecting them to discrimination under any program or activity to which this regulation applies,” id. (currently located at 34 CFR 100.3(c)(3)).

In 1980, after passage of the Department of Education Organization Act, the new Department of Education issued a final rule establishing the Department's regulations, including its civil rights regulations and their disparate-impact provisions, by transferring regulations from HEW, the Department's predecessor agency. The regulations were transferred from 45 CFR part 80 to 34 CFR part 100. The Department last updated its Title VI regulations in 2000 to clarify the definitions of “program” and “program or activity” and to conform the meaning of these terms to the Civil Rights Restoration Act of 1987. 65 FR 68050, 68053 (Nov. 13, 2000). This update occurred prior to the Supreme Court's 2001 decision in Alexander v. Sandoval, 532 U.S. 275 (2001), which reaffirmed that Title VI's implied private right of action reaches intentional discrimination and not conduct causing disparate impacts. The Department's implementing regulation at 34 CFR part 100 currently prohibits conduct that would have an unintentional disparate impact.

The Supreme Court has concluded 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 intentional discrimination. In 1978, the Supreme Court concluded 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) (opinion of 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). 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, prohibits intentional discrimination.

In 2001, the Supreme Court, in Alexander v. Sandoval, reaffirmed that settled understanding of Title VI. See 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 Justice 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 Justice 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 Justice Department's disparate-impact regulations were valid, the Court explained that the regulations were in “considerable tension” with the Supreme Court's Title VI precedents. Similarly, the Court made clear that 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.”).

In 2023, the Court emphasized that “the equal protection clause requires equality of treatment before the law for all persons without regard to race or color.” Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., 600 U.S. 181, 205 (2023) (“ SFFA” ) (cleaned up). In reviewing the admissions policies of certain higher education institutions, the Court explained that the Constitution requires “eliminating all” racial discrimination. Id. at 206. To that end, it held that “[a]ny exception to the Constitution's demand for equal protection must survive a daunting two-step examination known in our cases as `strict scrutiny,' ” which requires that racial classifications “ `further compelling government interests' ” and be “ `narrowly tailored'—meaning `necessary'—to achieve [such] interest[s].” Id. at 206-07. Moreover, the Court explained that its “precedents have identified only two compelling interests that permit resort to race-based government action,” only one of which is relevant in general government administration: “remediating specific, identified instances of past discrimination that violated the Constitution or a statute.” Id. at 207.

In 2024, the Court overruled Chevron U.S.A. Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837 (1984), in part because “statutes . . . have a single, best meaning” that is “ `fixed at the time of enactment.' ” Loper Bright Enters. v. Raimondo, 603 U.S. 369, 400, 409-12 (2024) (quoting Wis. Cent. Ltd. v. United States, 585 U.S. 274, 284 (2018)). Accordingly, 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. And while a different statutory provision in Title VI “authorize[s] and direct[s]” the Department “to effectuate the provisions of section 2000d of this title . . . by issuing rules, regulations, or orders of general applicability which shall be consistent with achievement of the objectives of the statute authorizing the financial assistance,” 42 U.S.C. 2000d-1, that provision too has a “single, best meaning” that is “ `fixed at the time of enactment.' ” Loper Bright, 603 U.S. at 400. Because section 2000d was enacted to prohibit intentional discrimination, the best meaning of the effectuation provision excludes the prohibition of conduct undertaken without any discriminatory intent whatsoever.

Finally, in 2026, the Supreme Court reiterated “the general rule that the Constitution almost never permits the Federal Government or a State to discriminate on the basis of race.” Louisiana v. Callais, 146 S. Ct. 1131, 1152 (2026). Again, it stated that “[s]uch discrimination triggers strict scrutiny, and [the Supreme Court's] precedents have identified `only two compelling interests' that can satisfy that standard.” Id.

Callais also reaffirmed that a law that prohibits intentional discrimination is not “enforce[d]” via the prohibition of “mere disparate-impact” because the government “cannot `enforce a constitutional right by changing what the right is.' ” Id. at 1155 (quoting City of Boerne v. Flores, 521 U.S. 507, 519 (1997)).

On April 23, 2025, the President issued E.O. 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.

This 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. Disparate-impact liability, the Order explained, “not only undermines our national values but also runs contrary to equal protection under the law and, therefore, violates our Constitution.” Id.

Accordingly, the Order relayed 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. 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. The Order also directed the Attorney General to “initiate appropriate action to repeal or amend the implementing regulations for Title VI . . . for all agencies to the extent they contemplate disparate-impact liability.” Id. All of these actions were to be undertaken consistent with applicable law. Id.

The Justice Department recently revised its Title VI regulations, removing disparate-impact liability from their scope. See Rescinding Portions of Department of Justice Title VI Regulations To Conform More Closely With the Statutory Text and To Implement Executive Order 14281, 90 FR 57141 (Dec. 10, 2025). Following the Justice Department's leadership and coordination process, see Executive Order 12250, Leadership and Coordination of Nondiscrimination Laws, 45 FR 72995 (Nov. 4, 1980), this rule revises Department regulations that effectuate E.O. 14281's policy and purpose.

In any event, the Department would have independently initiated steps toward making these changes, regardless of E.O. 14281. Even if E.O. 14281 did not exist, the Department would have taken steps to adopt the policy to eliminate the use of disparate-impact liability under Title VI. The Department agrees with E.O. 14281 that equal treatment under the law for all citizens is a bedrock principle of the United States. 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 a colorblind society, not race-, color-, or national-origin-based favoritism. And adherence to this principle, including in the issuance of grants, is essential to creating opportunity, encouraging achievement, and sustaining the American Dream.

But disparate-impact liability endangers these policy objectives. Disparate-impact liability also raises serious constitutional concerns, is in considerable tension with the single, best meaning of Title VI, creates confusion, increases the costs of compliance, and does not serve the public interest. After considering the relevant issues and weighing the relevant considerations, the Department concludes that these reasons, both separately and collectively, support eliminating disparate-impact liability from the Department's Title VI regulations.

The Department's regulation at 34 CFR 100.3, entitled “Discrimination prohibited,” as well as its “illustrative application” of the regulations at 34 CFR 100.5, contain several provisions that prohibit conduct or activities causing unintentional disparate impact, without a statutory or constitutional basis for doing so. In some instances, these regulations encourage or even require unlawful discrimination labeled as “affirmative action.”

Section 100.3(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.” 34 CFR 100.3(b)(2). Beyond that general prohibition, section 100.3(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. 34 CFR 100.3(b)(3). Section 100.3(b)(6) concerns the use of “affirmative action” and provides that funding recipients may (and sometimes must) use race, color, or national origin to overcome unintentional disparate “effects,” but does not expressly specify that such use must be narrowly tailored to serve a compelling governmental interest, as is required to satisfy strict scrutiny. 34 CFR 100.3(b)(6).

Section 100.3(c)(2) references the since-rescinded E.O. 11246, which mandated affirmative action and has been superseded by E.O. 14173. 34 CFR 100.3(c)(2). Section 100.3(c)(3) addresses prohibited discriminatory employment practices where a primary objective of the Federal financial assistance is not to provide employment and extends beyond intentional discrimination to prohibiting conduct that “tends” to have a discriminatory effect. 34 CFR 100.3(c)(3). Moreover, paragraph (c)(3) extends the Department's enforcement jurisdiction beyond the limitation placed on it by 42 U.S.C. 2000d-3, which forecloses any “action” 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.

In illustrating the application of the affirmative action provisions of the Department's regulation at 34 CFR 100.3(b)(6), sections 100.5(g), (h), and (i) provide examples of disparate-impact liability or affirmative action; the Department believes these illustrations may cause confusion and promote illegal race discrimination.

The disparate-impact provisions are improperly general and vast in scope, rather than limited to particular, clearly defined circumstances, as required by Supreme Court precedent. See Callais, 146 S. Ct. at 1152-53; SFFA, 600 U.S. at 207 (internal citations omitted) (“[O]ur precedents have identified only two compelling interests that permit resort to race-based government action. One of them is remediating specific, identified instances of past discrimination that violated the Constitution or a statute. The second is avoiding imminent and serious risk to human safety in prisons, such as a race riot.”); see also Callais, 146 S. Ct. at 1152. Both 34 CFR 100.3(b)(3) (regarding the “selection of facility sites or locations”) and 34 CFR 100.3(c) (regarding employment practices), for example, regulate broad areas of a recipient's activities and do not tailor their disparate-impact provisions. Section 100.3(b)(2) is even more sweeping, referring to all “criteria or methods of administration.” It is written in a way that could be construed as providing the Department with far broader discretion than Congress delegated to the agency. Prudential reasons also favor amending the regulations, given that they create confusion and uncertainty, 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. The Supreme Court has made clear that Title VI prohibits intentional discrimination and “permits” facially neutral policies that result in disparate outcomes when there is no discriminatory intent. Sandoval, 532 U.S. at 280-81, 286 n.6. That is the “single, best meaning” of Title VI. See Loper Bright, 603 U.S. at 400. As summarized above, the Supreme Court's Sandoval decision calls the legality of the Department's disparate-impact regulations into doubt. 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 enforceability in private suits for damages, rather than in the course of Federal enforcement, subsequent cases, such as Loper Bright, have made clear that the Department cannot extend Title VI beyond its single, best meaning. See 603 U.S. at 412-13 (holding that “courts must . . . ensur[e] that [an] agency acts within” its statutory authority). And while a different provision in Title VI “authorize[s] and direct[s]” the Department “to effectuate the provisions of section 2000d of this title . . . by issuing rules, regulations, or orders of general applicability which shall be consistent with achievement of the objectives of the statute authorizing the financial assistance,” 42 U.S.C. 2000d-1, the Department has determined that regulations that run contrary to the intent of Title VI simply do not “effectuate” Title VI. Title VI prohibits intentional discrimination, whereas the disparate-impact regulations prohibit acts taken without any discriminatory intent whatsoever. The word “effectuate” cannot be interpreted to authorize regulations that exceed their statutory and Constitutional authority. Cf. Callais, 146 S. Ct. at 1155 (“to lie within Congress's authority, § 2 of the Voting Rights Act must `effectuate by appropriate measures the constitutional prohibition' in § 1 of the Fifteenth Amendment,” which the statute's disparate-impact provisions exceeded). In any event, even if the statute's effectuation provision in 42 U.S.C. 2000d-1 could be interpreted (on its own) so broadly as to authorize basically any regulation, the Department has decided, as a matter of policy, to “effectuate” Title VI in a manner consistent with Congress's policy determinations, as reflected in 42 U.S.C. 2000d.

There are also serious concerns about whether the Department's Title VI regulations pass muster under the Constitution's equal-protection guarantees—concerns that further confirm the best reading of Title VI is that it prohibits intentional discrimination and does not authorize the Department to impose disparate-impact liability. See Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Const. 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))). As the Supreme Court has held, “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.” SFFA, 600 U.S. at 206 (internal quotation marks omitted) (quoting Yick Wo v. Hopkins, 118 U.S. 356, 369 (1886), and Bakke, 438 U.S. at 289-90 (opinion of Powell, J.)). Despite the promises of the Constitution's equal-protection guarantees, 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, including, but not limited to, conducting an impact analysis. They may also be coerced to proactively consider race, color, and national origin and potentially use those classifications to prevent unintended disparate outcomes. In sum, disparate-impact liability improperly encourages and, in some cases, requires recipients of Federal financial assistance from the Department to engage in the intentional use of race and racial balancing to eliminate disparate outcomes to defend against complaints of purported “discrimination.”

This use of race, color, or national origin violates the Constitution's equal-protection guarantees unless it survives the “daunting” strict-scrutiny standard. SFFA, 600 U.S. at 206 (describing a “daunting two-step examination”); 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.' ”). 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” provisions authorize and sometimes require the intentional use of race without requiring that this intentional use be narrowly tailored to serve a recognized compelling interest. Instead, those provisions encourage intentional racial balancing. For substantially the same reasons stated above, the “affirmative action” provisions raise serious constitutional concerns.

As summarized above, there are serious concerns with the legality of the Department's Title VI disparate-impact regulations. But even if the regulations were legal, the Department finds that eliminating the constitutional concerns addressed above independently justifies 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 as discussed below, even if the regulations are legal and do 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 independently justifies the repeal of the regulations.

The Department also has serious policy concerns with the Title VI regulations' imposition of disparate-impact liability, many of which are set forth in E.O. 14281. Again, the Department agrees that a “bedrock principle of the United States is that all citizens are treated equally under the law.” 90 FR at 17537. “This principle guarantees equality of opportunity, not equal outcomes.” Id. “It promises that people are treated as individuals, not components of a particular race or group.” Id. And adherence to this principle, including in the issuance of Federal funding, “is essential to creating opportunity, encouraging achievement, and sustaining the American Dream.” Id. Additionally, as noted in section 1 of the Order:

Id. These problems are magnified by the uncertainty that recipients of Federal financial assistance face in determining what the law actually requires of them. 2 As explained above, Sandoval casts doubt on the validity of the disparate-impact regulations that many Federal departments and agencies have promulgated pursuant to Title VI. 532 U.S. at 280-82. The natural effect of the conflicting signals given by regulations and precedent is uncertainty and confusion over how recipients comply with disparate-impact regulations and whether or when they can or must consider race, color, and national origin.

Additionally, in practice, and as explained above, the disparate-impact regulations lead recipients to engage in racial balancing, even as the underlying statute forbids intentional racial discrimination. This tension tends to create confusion and undermine public confidence in the nation's civil rights laws and in the rule of law itself, as the law seems to both forbid and require the same conduct.

These problems are amplified by the arbitrary nature of the racial and ethnic categories typically used to measure disparate effects, which, by virtue of their arbitrariness, typically lack a meaningful connection to a compelling interest. See, e.g., SFFA, 600 U.S. at 216-17 (explaining that the “[racial] categories” used in the programs at issue were “themselves imprecise in many ways” and “the use of these opaque racial categories undermine[d], instead of promote[d], [their] goals”). The inherent ambiguity in such distinctions undermines principles of nondiscrimination and is evident in, among other things, many of the grant programs sponsored by the Department in past years that targeted certain racial groups through indirect benefits to higher education institutions while relying on these racial categories. Such programs include those authorized under Title III of the Higher Education Act benefiting Hispanic-serving institutions, which must have “an enrollment of undergraduate full-time equivalent students that is at least 25 percent Hispanic,” 20 U.S.C. 1101a(a)(5); and Predominantly Black institutions, which, unlike Historically Black Colleges and Universities that are not defined by any specific racial enrollment criteria, must have “an enrollment of undergraduate students . . . that is at least 40 percent Black American students,” id. at 1067q(c)(9)(C).

The Department believes that these policy concerns independently justify repealing certain parts of its regulation to cure this confusion, remove the incentive for recipients 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 an approach based on disparate-impact liability can occasionally uncover evidence of intentional discrimination. The Department agrees with the general proposition that disparate effects can provide useful evidence to help the Department determine whether a recipient has engaged in intentional discrimination. But the Department has found that the benefits of using disparate effects as the sole basis for finding a Title VI violation are outweighed by the other issues and factors the Department has considered. Eliminating disparate-impact liability does not preclude the examination of additional evidence, including the use of data, to prove intentional discrimination. 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, the discriminatory intent of a recipient materially differs from using it to impose liability for an unintentional disparate impact.

The Department also has considered the alternative of trying to adopt a modified version of disparate-impact liability, for example, by requiring recipients to remedy unintentional discrimination for only certain types of cases, such as where there is a long- established history of discrimination. But any version of imposing liability for unintentional discrimination is inconsistent with Title VI's single, best meaning. The Department determines that any potential benefits from a regulation adopting an alternative version of disparate-impact liability would be outweighed by the Department's legal and policy concerns. 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 recipients 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 based on the disparate-impact regulations. The Sandoval decision, however, cast doubt on the continuing viability of the regulations more than 25 years ago. At least since Sandoval, the Department's enforcement of its Title VI disparate-impact regulations has been sporadic. And E.O. 14281 directed all agencies to “deprioritize enforcement of all statutes and regulations to the extent they include disparate-impact liability,” including the Department's Title VI disparate-impact regulations. 90 FR at 17538. Additionally, the Department finds that the recipients of its funding have little or no reliance interest at stake because the amendments made in this final rule remove improper legal burdens from the regulations. As such, any reliance interests are minimal and do not outweigh the Department's legal and policy concerns. Further, each of the Department's concerns, whether considered cumulatively or separately, outweighs any reliance interests.

Overall, after considering the relevant issues and weighing the relevant considerations, the Department finds that, regardless of the legality of the Department's disparate-impact regulations, the above summarized concerns, when viewed separately and 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, and provide much needed clarity for the courts and Federal funding recipients and beneficiaries. For the reasons summarized above, the Department makes amendments to 34 CFR 100.3, the section of the Department's Title VI regulations that enumerates prohibited types of discrimination, and 34 CFR 100.5, which includes “illustrative application” of the regulations.

The table below specifies the textual changes made in this final rule.

Like the Justice Department's Title VI regulation at 28 CFR 42.104(b)(2), 34 CFR 100.3(b)(2) is the regulation's general prohibition of conduct giving rise to unintentional disparate impact. The paragraph extends prohibited conduct from intentional discrimination to “utiliz[ing] criteria or methods of administration which have the effect of subjecting individuals to discrimination.” This final rule removes this paragraph and thus amends the Department's regulation to hew more closely to congressional intent and the law's single, best meaning. It thus conforms the regulation to the scope of coverage Congress intended when it enacted Title VI and addresses the legal and policy considerations and determinations described in this final rule. The word “Reserved” is inserted in place of the removed paragraph to maintain the ordering of the remaining subsections for citation and reference purposes.

This subsection pertains to the selection of facility sites or locations. It uses the noun “effect” in two instances to extend unintentional disparate-impact liability to funding recipients' or applicants' decision-making in this area. This final rule replaces the first reference to “effect” with “purpose” and removes the second reference to “or effect” to proscribe only intentional discrimination, consistent with congressional intent and the text of Title VI, as well as to address the legal and policy considerations and determinations described in this final rule. As discussed below, subsection 34 CFR 100.5(g) illustrates application of the “effect” language in depicting a scenario involving construction of school libraries that suggests recipients would be subject to disparate-impact liability for any racially disparate “effects” that would result from either site selection, project approval, or both. This rule removes the example provided in subsection (g) from the illustrative application at 34 CFR 100.5.

This portion of the regulation references “affirmative action.” Paragraph (b)(6)(i) requires that a recipient “take affirmative action to overcome the effects of prior discrimination” if in “administering a program” the “recipient has previously discriminated.” This provision goes well beyond the Equal Protection Clause, which, in limited circumstances permits, but does not mandate, a government to take action to remedy the effects of its “specific, identified instances of past discrimination that violated the Constitution or a statute.” SFFA, 600 U.S. at 207; see also Callais, 146 S. Ct. at 1152; Constitutionality of Race-Based Dep't of Educ. Programs, 49 Op. O.L.C.__, slip op. at 6-8 (Dec. 2, 2025), https://www.justice.gov/olc/media/1421576/dl (discussing the need to show particular instances of past discrimination to establish a compelling interest as well as relevant factors for evaluating narrow tailoring). Moreover, even putting aside the mandatory language in paragraph (b)(6)(i), this provision does not require sufficiently narrow tailoring to address particular instances of past discrimination but rather broad “affirmative action to overcome the effects of prior discrimination” generally. This provision accordingly promotes potential illegal race discrimination because of a lack of tailoring. Moreover, it wrongly coerces recipients to consider and use race preferences when the recipient does not want to consider or use such preferences. This is contrary to the Department's goal of promoting and defending a culture of nondiscrimination, and destructive of the public's understanding of and faith in the nation's civil rights laws. After the repeal of this provision, recipients are still free to use race in the limited circumstances the Equal Protection Clause permits. The Department, however, will no longer mandate this use of race through its regulation.

34 CFR 100.3(b)(6)(ii) authorizes affirmative action even in the absence of specific instances of prior discrimination that violated the Constitution or a statute. The Department has determined that this authorization is inconsistent with decades of Supreme Court precedent and its strict-scrutiny framework for evaluating race-based policies, most recently described in Callais, 146 S. Ct. at 1146-47, 1152-53. See also SFFA, 600 U.S. at 207; Parents Involved in Cmty. Sch. v. Seattle Sch. Dist. No. 1, 551 U.S. 701, 720-21 (2007); City of Richmond v. J.A. Croson Co., 488 U.S. 469, 498, 503 (1989); Wygant v. Jackson Bd. of Educ., 476 U.S. 267, 275-76 (1986).

This rule removes section 100.3(b)(6) and thereby avoids authorizing and mandating race-based policies by recipients that would likely violate the Equal Protection Clause. As discussed below, subsection 34 CFR 100.5(h) references 34 CFR 100.3(b)(6) in mandating affirmative action or permitting it without satisfying the narrow tailoring requirement. This rule removes subsection (h) from the illustrative application at 34 CFR 100.5.

34 CFR 100.3(c) sets out the limited circumstances in which Title VI's prohibition on discrimination extends to employment. 34 CFR 100.3(c)(2) states that “[t]he requirements applicable to construction employment under any [relevant] program shall be those specified in or pursuant to Part III of Executive Order 11246 or any Executive order which supersedes it.” Executive Order 11246 required affirmative action in government contracting, demanding that Federal contractors set goals and timetables to increase the representation of minorities among their employees based on mere statistical disparities in the workforce. This type of racial balancing triggers strict scrutiny and is presumptively unlawful under well-established Supreme Court precedent. Moreover, E.O. 14173 superseded E.O. 11246. This rule removes this outdated reference to the rescinded E.O.

To the extent that aspects of paragraph (c)(2) were helpful in that they clarified that the Department's regulations reached the conduct of Federal contractors and subcontractors, the Department notes that paragraph (c)(2) was redundant with paragraph (b)(1), which is unchanged by this final rule. Paragraph (b)(1) expressly clarifies that recipients may not violate Title VI “directly or through contractual or other arrangements,” 34 CFR 100.3(b)(1), which plainly means that contractors and subcontractors must comply with Title VI regulations. The Department thus finds that amending paragraph 100.3(c)(2) is unnecessary. The Department therefore removes paragraph 100.3(c)(2). Because this final rule removes all of paragraph 100.3(c), except for the portion designated as 100.3(c)(1), the word “Reserved” is inserted in place of paragraph 100.3(c)(2) to maintain the numbering of paragraph 100.3(c) for citation and reference purposes.

Paragraph 100.3(c)(3) extends the prohibition on discrimination to employment practices of the funding recipient even “[w]here a primary objective of the Federal financial assistance is not to provide employment,” in specified circumstances where the discrimination “tends . . . to exclude individuals” on the basis of race, color, or national origin. Attaching liability even where employment practices merely “tend[ ]” to cause harm simply disguises disparate-impact liability by using alternate language.

The Department further finds that simply modifying paragraph (c)(3) to remove the disparate-impact language would be inconsistent with the Supreme Court's direction under Loper Bright that courts must use the “single, best meaning” of a statute, which is “fixed at the time of enactment.” 603 U.S. at 400 (internal quotation marks omitted). It follows that Federal agencies, too, must look to the “single, best meaning” of a statute. See id. at 412-13 (holding that “courts must . . . ensur[e] that [an] agency acts within” “its statutory authority”). Congress has directed:

42 U.S.C. 2000d-3. Paragraph (c)(3) extends the Department's jurisdiction to certain employment matters where “a primary objective of the Federal financial assistance is not to provide employment,” 34 CFR 100.3(c)(3) (emphasis added), putting it in obvious tension with 42 U.S.C. 2000d-3. While the Department is aware that some courts reviewing paragraph (c)(3) before Loper Bright concluded that paragraph (c)(3) employs a permissible interpretation of section 2000d-3, see, e.g., Ahern v. Bd. of Educ. of City of Chicago, 133 F.3d 975, 977-78 (7th Cir. 1998) (Wood, J.), paragraph (c)(3) does not reflect the single, best meaning of section 2000d-3. The statute prohibits the Department's exercise of jurisdiction under the circumstances, with one clearly delineated exception. The Department's regulation creates an additional exception and does so in a manner that runs contrary to the intent of Congress. The Department finds that Loper Bright prohibits the expansion of jurisdiction created by paragraph (c)(3) because that provision contravenes the plain meaning of section 2000d-3. This final rule thus removes paragraph (c)(3).

34 CFR 100.5 contains examples that “illustrate the programs aided by Federal financial assistance of the Department.” Subsection (g) asserts that recipients “may not take action that is calculated to bring about indirectly what this regulation forbids it to accomplish directly.” This statement clearly prohibits a form of intentional discrimination. However, the example provided immediately thereafter suggests that recipients could be subject to disparate-impact liability for choices that “have the effect of defeating or of substantially impairing accomplishments of the objectives of the Federal assistance as respects individuals of a particular race, color or national origin.” This rule deletes the text after the first sentence.

Subsection (h), by cross referencing 34 CFR 100.3(b)(6), illustrates situations that would require affirmative action or permit affirmative action without satisfying the narrow tailoring requirement discussed above in explaining this rule's revision of 34 CFR 100.3(b)(6). Because this rule removes paragraph (b)(6) and its unlawful reference to affirmative action, the rule likewise removes subsection (h) from this portion of the regulations. Given that this rule also removes subsection (i), discussed below, no placeholder is required after the removal of subsection (h).

Like 34 CFR 100.5(h), subsection (i) attempts to illustrate the application of the Department's Title VI regulations to a specific situation. It describes circumstances in which an “applicant or recipient has never used discriminatory policies” but that would permit giving “special consideration to race, color, or national origin to make the benefits of its program more widely available to such groups, not then being adequately served.” This phrasing is not only unclear, it also suggests that affirmative action can be pursued in the absence of prior discrimination, in violation of Title VI. The Department finds that eliminating the confusion generated by this example, including its problematic promotion of potential illegal race discrimination, independently justifies its removal. Therefore, this rule removes this subsection.

The Department's position is that each of the amendments in this rule serves 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 independently and regardless of the invalidity of a separate amendment.

The Department issues this final rule without prior public notice and comment pursuant to the Administrative Procedure Act's exemption 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 nondiscrimination conditions for the receipt of Federal financial assistance, and, more particularly, for the receipt of various Federal “grants and loans,” “donation[s],” “personnel,” and any other “Federal agreement, arrangement, or other contract which has as one of its purposes the provision of assistance” that is “authorized to be extended to a recipient under a law administered by the Department.” 34 CFR 100.2, 100.13(f); 34 CFR part 100 app. A. Recipients are required, as a condition on the approval of any request for Federal financial assistance and the subsequent extension of any Federal financial assistance, to provide the Department with an “assurance” of “compliance with all requirements imposed by or pursuant to [Title VI].” 34 CFR 100.4; see 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)).

Section 553(a)(2) exempts from notice and comment rulemaking matters “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.” The Department has carefully reviewed those broad categories of exempt matters together with the definition of Federal financial assistance at 34 CFR 100.13(f), the specific requirements of 34 CFR 100.2, 100.4, and the types of Federal financial assistance provided by the Department. Based on this review, the Department has concluded that all of the types of Federal financial assistance provided by the Department that are implicated in this final rule are within the categories of exempt activities listed in 5 U.S.C. 553(a)(2). This final rule is thus exempt from notice and comment rulemaking.

Similarly, the Department's reliance on 5 U.S.C. 553(a)(2) is consistent with the definition of Federal financial assistance provided by the Office of Management and Budget (OMB) 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.

Courts have found that rules related to these forms of financial assistance are exempt from notice-and-comment rulemaking. See, e.g., Cal. Dep't of Educ. v. Bennett, 849 F.2d 1227, 1236 (9th Cir. 1988) (holding that Education Department rule concerning the return of Federal funds used for improper purposes did not require notice-and-comment rulemaking procedures); Nat'l Wildlife Fed'n v. Snow, 561 F.2d 227, 229 (D.C. Cir. 1976) (holding that a Federal Highway Administration rule governing the issuance of Federal funding for highways was exempt from notice-and-comment procedures); Texas v. Becerra, 577 F. Supp. 3d 527, 547 (N.D. Tex. 2021) (“The APA specifically exempts matters relating to `grants,' and Head Start is a federal grant program.”).

This rule relates to the public property, loans, grants, benefits and contracts that constitute Federal financial assistance because it eliminates disparate-impact liability as a condition imposed on the receipt of that assistance. The `relating to' standard is a broad one, easily satisfied by this rule. See Cummings, 596 U.S. at 217-18 (observing that Congress enacted Title VI “[p]ursuant to its authority to `fix the terms on which it shall disburse federal money'” (citation omitted)). As one court explained, “Section 553(a)(2) cuts a wide swath” and “a broad domain is preserved for its operation.” Humana of S.C., Inc. v. Califano, 590 F.2d 1070, 1082 (D.C. Cir. 1978). “[T]o the extent that any one of the enumerated categories is clearly and directly involved in the regulatory effort at issue, the Act's procedural compulsions are suspended.” Id. (internal quotation marks omitted). The rule is therefore exempt under 5 U.S.C. 553(a)(2). Cf. Education Programs or Activities Receiving or Benefitting From Federal Financial Assistance, 82 FR 46655 (Oct. 6, 2017) (invoking exception to amend Title IX regulations to “promote consistency in the enforcement of Title IX for [Department of Agriculture] financial assistance recipients”); Preserving Community and Neighborhood Choice, 85 FR 47899 (Aug. 7, 2020) (invoking 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 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 exception to suspend Department of Justice guidelines regarding the prohibition of disability discrimination in transportation programs and activities receiving Federal financial assistance).

Thus, the Department issues this final rule without prior public notice and comment under 5 U.S.C. 553(a)(2). Further, because the exception in section 553(a)(2) applies to section 553 as a whole, the Department issues this action without the delayed effective date typically required by 5 U.S.C. 553(d)(1).

E.O. 12250 delegates to the Attorney General the President's function of approving rules, regulations, and orders of general applicability under section 602 of the Civil Rights Act of 1964. The Department of Justice has reviewed and approved this rule.

E.O. 12866, 58 FR 51735 (Oct. 4, 1993), requires agencies to consider both the quantitative and qualitative costs and benefits of a rule and to adopt a regulation only if the rule justifies its costs. This rule has been drafted and reviewed in accordance with section 1(b) of E.O. 12866, as well as with E.O. 13563, 76 FR 3821 (Jan. 21, 2011), which supplements and explicitly affirms the principles of E.O. 12866. Section 2(c) of E.O. 13563 states that agencies may consider qualitative values that are either difficult or impossible to quantify, while section 3 directs agencies to harmonize their regulations to simplify their burden and to avoid inconsistent and overlapping requirements. As discussed in the preamble, this rule is necessary to align the regulations more closely with statutory authority and congressional intent, update them in light of Supreme Court decisions, increase clarity for recipients as to the scope of their liability, and harmonize the regulations with the Department of Justice's Title VI regulatory amendments adopted following the issuance of E.O. 14281 as well as with that Order's direction regarding agency Title VI regulations.

The overall costs incurred by the Department due to its disparate-impact regulations are difficult to quantify because the Department does not track the portion of its enforcement and technical assistance activities that relate specifically to disparate-impact.

The costs of disparate-impact requirements on recipients are also difficult to quantify, but it is clear that the requirements entail considerable legal and administrative costs, training and compliance costs, and now, in light of the changing legal landscape since the Supreme Court's decision in SFFA, 600 U.S. at 223, potential litigation risks and attendant compensatory damages and attorneys' fees awards. No less are the social costs attending the disparate-impact regime. Compliance with the disparate-impact regulations forces recipients to engage in impermissible race-conscious decision-making to avoid potential liability. The disparate-impact provisions perfectly “illustrate[ ] the crucial importance of making a distinction between intentions and consequences,” including “the incentives they create, rather than the hopes that inspired them.” Thomas Sowell, Basic Economics: A Common Sense Guide to the Economy 45 (4th ed. 2011).

Although the overall cost effect on the Department is difficult to quantify, this deregulatory action should decrease the Department's enforcement and technical assistance costs. Reducing the regulatory uncertainty that the disparate-impact provisions impose on recipients should reduce their compliance costs and litigation risks and increase the efficiency of their operations by ensuring they are not engaging in needlessly complex and unlawful race-conscious decision-making. The Department has determined that this rulemaking is a “significant regulatory action” under section 3(f) of E.O. 12866, but it is not an “economically significant” action. Accordingly, OMB has reviewed this rule.

E.O. 14219, 90 FR 10583 (Feb. 25, 2025), directs agencies to identify regulations that, among other things, are unconstitutional or are constitutionally suspect, based on unlawful delegations of legislative power, or that are based on anything but the best reading of the authorizing statute. As discussed above, the disparate-impact provisions are constitutionally suspect, if not outright unconstitutional, in that they proscribe conduct beyond what the Equal Protection Clause allows. They potentially require unlawful intentional discrimination and racial balancing. The text of Title VI controls, and the Department's disparate-impact provisions are not based on the best reading of the statute. This rule is issued in furtherance of E.O. 12419.

Executive Order 14192, 90 FR 9065 (Feb. 6, 2025), establishes a regulatory budget process for agencies and requires them to offset new regulatory burdens or costs. This rule is expected to be a deregulatory action that will not increase the Department's total incremental costs; in fact, it is likely to decrease them. This rule would eliminate unnecessary regulation by revising the Department's current Title VI regulations, which extend prohibited conduct to include conduct giving rise to unintentional disparate impact and thus expand the scope of those regulations to a vastly broader range of conduct than the statute prohibits. Accordingly, the Department expects this rule to be a deregulatory action under E.O. 14192.

E.O. 13132, 64 FR 43255 (Aug. 10, 1999), prohibits an agency from publishing any rule that has federalism implications if the rule imposes substantial direct compliance costs on State and local governments and is not required by statute or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the E.O.. This rule will not have a substantial direct effect on the relationship between the Federal government and the States, on distribution of power and responsibilities among various levels of government, or on States' policymaking discretion. State and local recipients of Federal funding voluntarily comply with Title VI as a condition of receiving the funding. This rule does not subject recipients to new obligations. As a result, and in accordance with section 6 of E.O. 13132, the Department has determined that these amendments to the Department's regulations do not have sufficient federalism implications to warrant preparation of a federalism summary impact statement as outlined in section 6(c)(2).

This rule meets the applicable standards set forth in sections 3(a) and (b)(2) of E.O. 12988, 61 FR 4729 (Feb. 7, 1996), to specify provisions in clear language. Pursuant to section 3(b)(1)(I) of the E.O., nothing in this final rule or any previous rule (or in any administrative policy, directive, ruling, notice, guideline, guidance, or writing) directly relating to the programs that are the subject of this final rule is intended to create any legal or procedural rights enforceable against the United States.

E.O. 14294, 90 FR 20363 (May 14, 2025), requires agencies promulgating regulations with 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. This rule does not impose a criminal regulatory penalty and is thus exempt from E.O. 14294's requirements.

Pursuant to the Paperwork Reduction Act, agencies must consider whether a rule will create additional burdens related to recordkeeping, paperwork, or information collection. This rule will not impose any additional burdens or requirements in these respects.

The Regulatory Flexibility Act (“RFA”), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996, requires an agency to prepare and make available to the public a final regulatory flexibility analysis that describes the effect of a rule on small entities ( i.e., small businesses, small organizations, and small governmental jurisdictions) when the agency is required “to publish a general notice of proposed rulemaking” prior to issuing the final rule. See 5 U.S.C. 604(a). Because this rule is being issued without a prior notice of proposed rulemaking, on the grounds set forth above, a regulatory flexibility analysis is not required under the RFA. Further, even if the RFA were applicable here, the Department would find that this rule will not have a significant economic impact on a substantial number of small entities because these regulatory changes do not impose any new substantive obligations on Federal funding recipients. This rule simply amends an existing regulation by eliminating improper burdens on recipients, clarifies its scope for the public, and brings it into accordance with the best reading of Title VI. All Federal funding recipients remain bound by the Title VI regulations that are already in place.

The Unfunded Mandates Reform Act of 1995 requires agencies to prepare assessments of any rule that would result in the annual expenditure of more than $100 million by State, local, or Tribal governments, or the private sector. 2 U.S.C. 1503(2) exempts from the Act's coverage a proposed or final rule such as this one that “establishes or enforces any statutory rights that prohibit discrimination on the basis of race, color, religion, sex, national origin, age, handicap, or disability.” This rule is therefore not subject to the provisions of the Act.

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

For the reasons discussed in the preamble, the Secretary of Education amends part 100 of title 34 of the Code of Federal Regulations as set forth below:

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 a SNUR under TSCA section 5(a)(2) for the chemical substance identified in this document. This chemical substance was the subject of a PMN and is 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 SNUR identifies 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 Order, consistent with TSCA section 5(f)(4). The SNUR requires persons who intend to manufacture or process this chemical substance for an activity that is designated as a significant new use in the SNUR to notify EPA at least 90 days before commencing that activity.

Previously, EPA proposed a SNUR for this and other chemical substances in the Federal Register of June 5, 2026 (91 FR 34480 (FRL-13126-01-OCSPP)). EPA is finalizing the SNUR for P-22-163 as proposed. The remaining SNURs from the proposed rule will be finalized in a separate action. 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 substance 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 the subject chemical substance (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 the 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 SNUN reporting requirements for potential manufacturers and processors of the chemical substance 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 substance covered by this SNUR, 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 substance 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. One comment by Cnano Technology USA, Inc. requested expedited finalization and publication of the SNUR for P-22-163. EPA is finalizing the SNUR for P-22-163 as proposed. The remaining SNURs from the proposed rule will be finalized at a later date.

EPA designates the date of publication of the proposed rule as the cutoff date for determining whether the new use is ongoing, i.e., June 6, 2026 (91 FR 34480 (FRL-13126-01-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 the chemical substance subject to this SNUR:

• 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 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 substance 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, this SNUR includes a PMN substance that is subject to an order issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). This TSCA Order requires protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. As such, the SNUR identifies 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 Order, 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 a SNUR for a new chemical substance that was the subject of a PMN. 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 this proposed SNUR 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 this SNUR. 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 2026 Policy on Children's Health also does not apply. Although the establishment of this SNUR 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 U.S. Department of Health and Human Services (Department or HHS) is rescinding portions of its regulations, 45 CFR part 80, promulgated pursuant to Title VI of the Civil Rights Act of 1964, 42 U.S.C. 2000d et seq. (Title VI), to remove disparate-impact liability and related effects-based provisions and to reflect that Title VI prohibits intentional discrimination, see 42 U.S.C. 2000d.

For purposes of this rule, disparate-impact liability refers to a theory under which a facially neutral policy or practice gives rise to a presumption of unlawful discrimination based on protected characteristics ( e.g., race or national origin) where there are disparities in outcomes among different groups. Under disparate-impact liability, this presumption would apply even without a facially discriminatory policy or practice, and even if equal opportunity is provided.

There are serious statutory and constitutional concerns with the Department's current Title VI regulatory provisions that go beyond the statutory prohibition of intentional discrimination by prohibiting conduct that has an unintentional disparate impact or outcome. See Alexander v. Sandoval, 532 U.S. 275, 280 (2001) (stating that it is “beyond dispute” that Title VI reaches only intentional discrimination). This rule, accordingly, removes those portions of the Department's Title VI regulations that impose or exemplify liability based on disparate impact or outcomes, which are in considerable tension with both the underlying Title VI statutory prohibition and the Constitution and do not sufficiently serve the public interest.

Consistent with Title VI's text and Supreme Court precedent, this rule: (i) removes and reserves 45 CFR 80.3(b)(2); (ii) revises 45 CFR 80.3(b)(3); (iii) removes and reserves 45 CFR 80.3(b)(6) and 80.3(c)(3); (iv) removes and reserves 45 CFR 80.5(g), 80.5(i), and 80.5(j); and (v) revises 45 CFR 80.5(h).

The rule's revisions also conform to Executive Order (E.O.) 14281, Restoring Equality of Opportunity and Meritocracy, 90 FR 17537 (Apr. 28, 2025). E.O. 14281 states 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. E.O. 14281 directs the Attorney General to, among other things, review Title VI regulations and “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. at 17538. Section 3 of the E.O. specifically revokes the Presidential approvals of certain DOJ Title VI regulations that address disparate-impact liability promulgated under 42 U.S.C. 2000d-1, id. at 17538, which is reflected in certain provisions in HHS's Title VI regulations. Although the Department would take this regulatory action independent of E.O. 14281, the E.O. supports and reinforces the Department's approach.

This rule clarifies that Title VI prohibits only intentional discrimination, not conduct or activities that merely result in a disparate impact or outcome, and that the Department, thus, will not pursue Title VI disparate-impact liability against its Federal funding recipients. Because there is no private right of action for disparate-impact claims under Title VI, and the Department has the discretion to determine how it enforces Title VI, these modifications will not adversely affect the rights of any third party and are justified by the Department's statutory, constitutional, administrability, and policy determinations.

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, makes no reference to unintentional disparate effects or impact. Further, the Supreme Court has stated that the statute prohibits only intentional discrimination. See Sandoval, 532 U.S. at 280 (“[I]t is . . . beyond dispute—and no party disagrees—that [the statutory prohibition of Title VI] prohibits only intentional discrimination.”). The statute does not provide any Federal department or agency with authority to prohibit conduct having an unintentional disparate impact. And despite having ample opportunities, Congress has enacted no subsequent amendments to Title VI to impose disparate-impact liability.

Pursuant to E.O. 12250, Leadership and Coordination of Nondiscrimination Laws, “[t]he Attorney General shall coordinate the implementation and enforcement by Executive agencies of . . . Title VI.” 45 FR 72995, 72995 (Nov. 4, 1980). Accordingly, the Department of Justice is the lead Federal agency responsible for coordinating the implementation of Title VI's prohibition of discrimination on the basis of race, color, and national origin in programs or activities receiving Federal financial assistance. E.O. 12250 directed DOJ, among other things, to “develop standards and procedures for taking enforcement actions and for conducting investigations and compliance reviews.” Id.

Prior to the issuance of E.O. 12250, the Department, then the Department of Health, Education, and Welfare (HEW), issued its initial Title VI regulations on December 4, 1964, which included only two uses of the “effect of” language in the “discrimination prohibited” provision of the rule. See 29 FR 16298, 16299 (Dec. 4, 1964) (codified at 45 CFR 80.3(b)(2)). HEW's 1964 rule also included illustrative examples. One example addressed grants requiring recipients to consider the interests of all significant racial or ethnic groups in the service population. Another example prohibited recipients from taking actions calculated to bring about indirectly what it is forbidden to accomplish directly, such as using criteria that have the effect of defeating or substantially impairing the accomplishment of the objectives of the Federal financial assistance. See id. at 16301 (codified at 45 CFR 80.5(g)-(h)). DOJ largely adopted these model regulations, at 28 CFR 42.101 through 42.112, in 1966, which likewise contained only two instances of the “or effect” language at 28 CFR 42.104(b)(2). 31 FR 10265, 10266 (July 29, 1966).

In 1973, DOJ substantively amended its regulatory description of prohibited discrimination. See 38 FR 17955 (July 5, 1973). These substantive changes included, among other things, the addition of 28 CFR 42.104(b)(3) (which added the “or effect” language to an additional provision), 28 CFR 42.104(b)(6) (which introduced the “affirmative action” language to the regulations), and 28 CFR 42.104(c)(2) (which extends the rule to Federal financial assistance the primary objective of which is not to provide employment). Id. at 17955. On the same day, HEW adopted (on top of other changes) similar additions in 45 CFR 80.3(b)(3) (barring site selection criteria with the purpose or effect of discriminating on the ground of race, color or national origin), 45 CFR 80.3(b)(6) (requiring or permitting affirmative action in certain circumstances), and 45 CFR 80.3(c)(3) (addressing employment practices in programs receiving Federal financial assistance). 38 FR 17978, 17979-80 (July 5, 1973). HEW also added two illustrative examples of affirmative action. Id. at 17980-81 (codified at 45 CFR 80.5(i)-(j)).

In 2003, DOJ 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). The Department adopted similar amendments to implement the Civil Rights Restoration Act in 2005. See 70 FR 24314 (May 9, 2005).

In 2025, DOJ issued a final rule amending its Title VI regulations to eliminate disparate-impact liability. 90 FR 57141 (Dec. 10, 2025). First, the rule rescinded the full text of 28 CFR 42.104(b)(2), which prohibited 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.” Id. Second, the rule removed the two uses of the word “effect” from 28 CFR 42.104(b)(3). Id. Third, the rule rescinded the full text of 28 CFR 42.104(b)(6). Id. Fourth, the rule rescinded the full text of 28 CFR 42.104(c)(2), which addresses employment practices subject to Federal financial assistance. Id. This rulemaking will align the Department's Title VI regulations with DOJ's updated Title VI regulations.

The Supreme Court has held 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, the Supreme Court held that Congress intended Title VI to prohibit “only those racial classifications that would violate the Equal Protection Clause” if committed by a government actor. Regents of the Univ. of Cal. v. Bakke, 438 U.S. 265, 287 (1978) (opinion of Powell, J.); id. at 325, 328, 352-53 (Brennan, White, Marshall, and Blackmun, JJ., concurring in part and dissenting in part). Shortly before Bakke, the Supreme Court held that the Equal Protection Clause prohibits only 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.”); Pers. Adm'r of Mass. v. Feeney, 442 U.S. 256, 279 (1979) (emphasizing that “discriminatory purpose” requires that the decision-maker acted “because of, not merely in spite of,” adverse effects on an identifiable group). Thus, the prohibition in Title VI section 601 (42 U.S.C. 2000d) on intentional discrimination by recipients is generally coextensive with the Equal Protection Clause standard. See Students for Fair Admissions, Inc. v. President & Fellows of Harvard Coll., 600 U.S. 181, 198 n.2 (2023) ( SFFA ) (noting that violating the Equal Protection Clause when committed by a recipient of Federal financial assistance also constitutes a Title VI violation). 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 understanding. In Sandoval, the Supreme Court held that private plaintiffs lack a private right of action to enforce DOJ's then-existing “disparate-impact regulations.” 532 U.S. at 285-87. Although the Supreme Court had previously found an implied private cause of action to enforce Title VI section 601's bar on intentional discrimination, id. at 279-80, that conclusion did not extend to enforcing DOJ'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 in 42 U.S.C. 2000d, as the regulations “forbid conduct that § 601 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. And although the Supreme Court in Sandoval “assume[d],” without deciding, that DOJ's disparate-impact regulations were valid, the Court explained that the then-current regulations were in “considerable tension” with the Supreme Court's Title VI precedents. Similarly, the regulations did 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 (“[42 U.S.C. 2000d] 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 doing so, 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 operative statutory prohibition can only have one best 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 so long as there is no discriminatory intent. Sandoval, 532 U.S. at 280, 286 n.6.

On April 23, 2025, the President issued E.O. 14281. E.O. 14281 restates the “bedrock principle of the United States . . . that all citizens are treated equally under the law.” 90 FR at 17537. It explains 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.

E.O. 14281 also states that disparate-impact liability “endangers this foundational principle.” Id. Disparate-impact liability, it reasons, “all but requires individuals and businesses to consider race and engage in racial balancing to avoid potentially crippling legal liability.” Id. As E.O. 14281 explains, 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.

E.O. 14281 states that, because of the problems and issues associated with disparate-impact liability, “[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. Section 3 of E.O. 14281 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 E.O. 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. E.O. 14281 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. See 90 FR at 17537. And adherence to this principle, including in the issuance of Federal financial assistance, “is essential to creating opportunity, encouraging achievement, and sustaining the American Dream.” Id. Imposing disparate-impact liability endangers these policy objectives.

Accordingly, this rule revises the Department's Title VI regulations under 45 CFR part 80, consistent with E.O. 14281's policy and purpose. The Department independently adopts the principles reflected in E.O. 14281 as a basis for this rule. In other words, the Department would have independently initiated steps toward making these changes regardless of E.O. 14281.

Disparate-impact liability also raises serious constitutional concerns, is in considerable tension with the best reading of Title VI, creates confusion and increases the costs of compliance for funding recipients, and overall does not serve the public interest. Having thoroughly examined the relevant legal, policy, and operational considerations, the Department has determined that, taken together, these reasons support eliminating disparate-impact liability from the Department's Title VI regulations. Each of those reasons also provides an independent basis for removing disparate-impact liability from the Department's Title VI regulations.

Part 80 currently includes provisions that extend beyond Title VI by imposing or illustrating disparate-impact liability. Other provisions encourage or require recipients to consider race-, color-, or national-origin-based measures when designing or administering programs. Those provisions create a material mismatch between the statute and the regulations, create incentives to engage in racial balancing, and risk encouraging conduct that may violate constitutional constraints. The Department has an independent responsibility to ensure its regulations are consistent with Title VI and to avoid administering funding conditions that exceed statutory authorization or raise serious constitutional concerns. See Loper Bright, 603 U.S. at 400 (explaining that statutes have a “single, best meaning” and courts must ensure agencies act within their statutory authority); Edward J. DeBartolo Corp. v. Fla. Gulf Coast Bldg. & Constr. Trades Council, 485 U.S. 568, 575 (1988).

Several sections exemplify the need for rulemaking. First, 45 CFR 80.3, entitled “Discrimination prohibited,” contains several provisions that go beyond the statute and the Constitution by prohibiting conduct or activities causing unintentional disparate impact. And in some instances, these provisions may encourage or even require unlawful discrimination labeled as “affirmative action.” Section 80.3(b)(2) is the general prohibition on conduct that causes a disparate impact, 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, 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.”

Beyond that general prohibition, 45 CFR 80.3(b)(3) addresses a Federal funding recipient's selection of the site or location of facilities and includes effects-based language that extends the scope of prohibited conduct to include conduct with an unintentional disparate impact. Section 80.3(b)(6) concerns the use of “affirmative action” and provides that funding recipients may (and sometimes must) use race, color, or national origin to overcome unintentional disparate “effects.” Additionally, 45 CFR 80.3(c) addresses prohibited discriminatory employment practices and extends beyond intentional discrimination to prohibit conduct that “tends” to have a discriminatory effect.

Similarly, the Department's regulations at 45 CFR 80.5, entitled “Illustrative application,” contain several examples of conduct or activities causing an unintentional disparate impact that are prohibited or of circumstances in which affirmative action is required or permitted ( e.g., “due consideration” for “all significant racial or ethnic groups” (paragraph 80.5(g)); criteria with the “effect of defeating” or “substantially impairing” objectives (paragraph 80.5(h)); “additional steps” to make benefits “fully available,” including “special arrangements . . . to `insure' groups are “adequately served” (paragraph 80.5(i)); “special consideration to race” where benefits are “not in fact . . . equally available,” including “special recruitment policies” (paragraph 80.5(j))).

Overall, there are serious statutory and constitutional concerns with the Department's Title VI disparate-impact regulations. The Department also has serious policy concerns with these provisions because they inject substantial legal uncertainty into recipients' obligations, erode public confidence in the administration of the nation's civil rights laws, and impose significant and often unnecessary compliance, investigative, and litigation burdens. These amendments clarify that, consistent with Title VI and governing precedent, part 80 prohibits only intentional discrimination.

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. See Loper Bright, 603 U.S. at 400. Sandoval casts serious doubt on the continued validity of the Department's “disparate-impact regulations.” See Sandoval, 532 U.S. at 281-82, 284-85 (noting that the DOJ's then-existing regulations were in “considerable tension” with the Supreme Court's Title VI precedents); see also id. at 286 n.6 (“[42 U.S.C. 2000d] permits the very behavior that the regulations forbid.”).

Although Sandoval resolved only the question of private enforceability of Title VI, subsequent cases, such as Loper Bright, have made clear that the Department cannot extend Title VI beyond its best meaning. See 603 U.S. at 412-13 (holding that “courts must . . . ensur[e] that [an] agency acts within” its statutory authority). Even in the absence of Supreme Court precedent, the Department would read Title VI to prohibit 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' prohibition of conduct having 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 (“[42 U.S.C. 2000d] permits the very behavior that the regulations forbid.”). Thus, the disparate-impact regulations do not “effectuate” Title VI. See 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) (quoting Yick Wo v. Hopkins, 118 U.S. 356, 369 (1886), and Bakke, 438 U.S. at 289-90 (Powell, J.)); see also Adarand Constructors, Inc. v. Peña, 515 U.S. 200, 227 (1995) (“[T]he . . . Fourteenth Amendment[] to the Constitution protect[s] persons, not groups.”). Despite the promises of the Equal Protection Clause, a funding recipient's risk of disparate-impact liability under the Department's current 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, in practice, revise policies related to race, color, and national origin disparities, even when the original policy is neutral and adopted without discriminatory intent.

In short, disparate-impact liability encourages and, in some cases, requires funding recipients 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 that the Equal Protection Clause forbids. See SFFA, 600 U.S. at 206-07; Adarand, 515 U.S. at 227. The serious constitutional concerns raised by these perverse incentives further confirm 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., 485 U.S. at 575 (“[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 Chicago, 440 U.S. 490, 499-501, 504 (1979))).

This encouraged or coerced 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, 606 U.S. 461, 484 (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))); Adarand, 515 U.S. at 227 (“All racial classifications, imposed by whatever federal, state, or local governmental actor, must be analyzed by a reviewing court under strict scrutiny.”). 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” provisions authorize and sometimes require the intentional use of race without requiring that this intentional use be narrowly tailored to serve a recognized compelling interest. Instead, they encourage intentional racial balancing “to overcome the effects of” unintended racial disparities. See, e.g., 45 CFR 80.3(b)(6). Thus, for substantially the same reasons as above, the “affirmative action” provisions raise serious constitutional concerns.

As summarized above, there are serious statutory and constitutional concerns with the Department's disparate-impact regulations. Even assuming the regulations were otherwise legal, the Department concludes that avoiding the potential constitutional concerns above would independently support these amendments. 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 to “avoid[ ] raising a non-trivial constitutional question”). Separately, 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 revising these regulations.

The Department also has serious policy concerns with the imposition of disparate-impact liability. Although the Department expresses its policy concerns with disparate-impact liability independent of E.O. 14281, that E.O. sets forth valid policy considerations concerning disparate-impact liability. As noted in section 1 of E.O. 14281, “[o]n a practical level, disparate-impact liability has hindered businesses from making hiring and other employment decisions based on merit and skill, their needs, or the needs of their customers because of the specter that such a process might lead to disparate outcomes, and thus disparate-impact lawsuits.” 90 FR at 17537. Moreover, the legal concerns identified above have caused uncertainty and confusion for Federal-funding recipients as to whether and when they need to comply with the disparate-impact regulations and when they can or must consider race, color, and national origin. As explained above, Sandoval casts substantial doubt on the validity of the disparate-impact regulations that many Federal departments and agencies have promulgated pursuant to Title VI. 532 U.S. at 280-82.

Additionally in practice, and as explained above, disparate-impact liability can create incentives for funding recipients to engage in racial balancing ( i.e., considering race to reduce perceived enforcement risk), even though Title VI forbids intentional discrimination on the basis of race, color, and national origin. This tension creates confusion and undermines public confidence in both the nation's civil rights laws and in the rule of law itself, as the law seems to both forbid and require the same conduct.

These problems are amplified by the arbitrary nature of the racial and ethnic categories typically used to measure disparate effects, which, by virtue of their arbitrariness, typically lack a meaningful connection to a compelling interest. See, e.g., SFFA, 600 U.S. at 216-17 (explaining that the “[racial] categories” utilized in the racial preference programs at issue were “themselves imprecise in many ways” and “the use of these opaque racial categories undermine[d], instead of promote[d], [their] goals”). In practice, this dynamic can shape how recipients structure and describe program design, outreach, and recruitment, sometimes in explicitly race-focused terms, because they anticipate that compliance will be evaluated through demographic “effects” metrics. For example, certain Departmental program guidance has historically encouraged recipients to address “diversity” in ways that can generate pressure toward race-based decision-making. See, e.g., National Institutes of Health Grants Policy Statement, Section 11.3.3.4 (Dec. 2021), https://grants.nih.gov/grants/policy/nihgps/nihgps_2021.pdf (recipient-facing grants administration guidance requiring a “Recruitment Plan to Enhance Diversity,” which includes, inter alia, “diversify[ing] their student and faculty populations to enhance the participation of individuals from groups that are underrepresented in the bio-medical, clinical, behavioral and social sciences, such as . . . [i]ndividuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis”). The Department believes that these policy concerns independently justify repealing certain parts of its regulations to cure this confusion, remove the incentive for funding recipients 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 other issues and factors that the Department has considered. And in any event, eliminating disparate-impact liability does not preclude the use of data on disparate outcomes to help prove intentional discrimination. Indeed, under provisions of the Department's Title VI regulations, which the current amendments 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 and participants in federally-assisted programs.” 45 CFR 80.6(b). Both the Department and private litigants may 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 conduct having 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 funding recipients to remedy unintentional disparate effects for only certain types of cases, such as in medical research or medical education. But any version of liability for conduct producing unintentional disparate effects is inconsistent with the best reading of Title VI. 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 adopting alternative versions of disparate-impact liability are outweighed by the legal and policy concerns described above. 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 funding recipients face. The Department believes that the better course is to avoid the complexities and costs associated with this alternative, even if eliminating disparate-impact liability may leave some disparate outcomes unremedied absent proof of discriminatory intent.

The Department has considered the potential reliance interests of funding recipients and other stakeholders on the existing disparate-impact regulations. Sandoval cast serious doubt on the continuing viability of the Title VI disparate-impact regulations more than twenty-five years ago. At least since Sandoval, the Department's enforcement of its Title VI disparate-impact regulations has been minimal and sporadic and subject to the Department's discretion as to whether to pursue such claims or not. Moreover, E.O. 14281 directed all agencies to “deprioritize enforcement of all statutes and regulations to the extent they include disparate-impact liability,” including the Department's Title VI disparate-impact regulations. 90 FR at 17538. The Department accordingly believes that the existing reliance interests are minimal and do not outweigh the Department's legal and other policy concerns. Further, each of the Department's concerns, whether considered individually or cumulatively, outweighs any reliance interests.

While there may be some difference between a private litigant's ability to pursue a discrimination claim under Title VI and the Department's authority to enforce Title VI and its implementing regulations, the Department notes that Sandoval has also led to unwarranted 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's existing regulations could be read to allow administrative pursuit of disparate-impact liability. Repealing the disparate-impact regulations would eliminate this unwarranted incongruence.

Overall, the Department has weighed the relevant issues and factors and finds that the above-summarized policy concerns, when viewed individually or cumulatively, justify the repeal of its disparate-impact regulations addressed in this final rule. That conclusion is independent of the Department's statutory and constitutional concerns.

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

For the reasons summarized above, the Department amends the following provisions in its Title VI implementing regulations, located at 45 CFR 80.3 and 80.5.

The table below reflects the final wording changes carried into the revised regulatory text. 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 or otherwise reflected in the final revised text.

Section 80.3(b)(2) contains a general prohibition of conduct having an unintentional disparate impact. It imposes liability on Federal funding recipients who “utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination, 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.” Because 45 CFR 80.3(b)(2)'s principal purpose is to prohibit unintentional disparate impact, this rule removes this paragraph in its entirety. Thus, it amends the Department's Title VI implementing regulations to conform to Title VI and to address the legal and policy considerations and determinations described above. The rule replaces paragraph (b)(2) with a placeholder to maintain numbering accuracy.

Section 80.3(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 “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 “effect” references and replaces the first reference to “effect” with “purpose” to conform paragraph (b)(3) more closely to Title VI and to address the legal and policy considerations and determinations described in this document.

Section 80.3(b)(6) deals with “affirmative action.” Paragraph (b)(6)(ii) authorizes affirmative action even in the absence of a finding of prior discrimination in a program “to overcome the effects of conditions which resulted in limiting participation by persons of a particular race, color, or national origin.” This provision points not to intentional discrimination, but rather to the unintentional “effects of conditions.” It consequently encourages intentional race-, color-, or national-origin-based classifications, preferences, and other actions without specifying the compelling governmental interest and the narrow tailoring that the Equal Protection Clause demands. The Department has determined that this provision is unlawful under the Equal Protection Clause.

Paragraph (b)(6)(i) requires that a recipient “must take affirmative action to overcome the effects of prior discrimination” if, in “administering a program,” the funding “recipient has previously discriminated against persons on the ground of race, color, or national origin.” This provision goes beyond the Equal Protection Clause, which permits, 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 simply “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, despite their own preferences, to consider and even adopt race-based preferences. This is contrary to the Department's goal of promoting and ensuring nondiscrimination and is destructive to the public's understanding of and faith in the nation's civil rights laws. This rule, therefore, removes and reserves paragraph (b)(6).

Section 80.3(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 where providing employment is not a “primary objective” of the financial assistance, 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 benefits of, or to subject them to discrimination under any program to which this regulation applies.” The “tends . . . to exclude” formulation extends beyond intentional discrimination to encompass effects-based and disparate-impact theories, which the Department is eliminating from this regulation for the legal and policy reasons described above.

Additionally, 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 more closely adhere to Title VI and to address the legal and policy considerations and determinations described above.

Section 80.5(g) provides as an illustrative example that “[e]ach applicant for a grant for the construction of educational television facilities is required to provide an assurance that it will, in its broadcast services, give due consideration to the interests of all significant racial or ethnic groups within the population to be served by the applicant.” This example functions as a directive to structure program delivery around racial or ethnic group interests. Section 80.5(g) thus promotes and requires race- and ethnicity-based compliance activities, contrary to the legal principles discussed throughout this rule and contrary to the principles set forth in E.O. 14281 that “all citizens are treated equally under the law,” guaranteeing “equality of opportunity, not equal outcomes” and “promis[ing] that people are treated as individuals, not components of a particular race or group.” The Department accordingly removes this example from Section 80.5 and reserves paragraph (g).

Section 80.5(h) states that “[a] recipient may not take action that is calculated to bring about indirectly what this regulation forbids it to accomplish directly” and illustrates this prohibition with a disparate-impact example: “a State . . . may not base its selections or approvals on criteria which have the effect of defeating or of substantially impairing accomplishments of the objectives of the Federal assistance as respects individuals of a particular race, color or national origin.” The first sentence of 45 CFR 80.5(h) should be read as an anti-circumvention, anti-pretext principle that prohibits “calculated” ( i.e., intentional) actions, but the second sentence employs an effects test, making it an example of disparate impact. Accordingly, in this rule, the Department removes that second sentence.

Section 80.5(i) provides an example of where, pursuant to 45 CFR 80.3(b)(6), affirmative action would be required: “In some situations . . . the consequences of [past discriminatory] practices continue to impede the full availability of a benefit . . . it will become necessary under the requirement stated in (i) of 45 CFR 80.3(b)(6) for such applicant or recipient to take additional steps to make the benefits fully available to racial and nationality groups previously subject to discrimination . . . for example, special arrangements for obtaining referrals or making selections which will insure that groups previously subjected to discrimination are adequately served.” As framed, the example encourages intentional racial or nationality classifications, preferences, and other actions without requiring the compelling governmental interest and the narrow tailoring that the Equal Protection Clause demands. This example, accordingly, promotes potentially illegal race and national-origin discrimination. And, in some instances, it may coerce recipients to consider and use racial or national-origin preferences when the recipient does not desire to do so. This is contrary to the Department's goal of promoting and ensuring nondiscrimination and is destructive to the public's understanding of and faith in the nation's civil rights laws. In addition, the example is based upon the requirement set forth in current 45 CFR 80.3(b)(6)(i), which the Department is rescinding. For those reasons, the Department removes and reserves 45 CFR 80.5(i).

Section 80.5(j) provides an example of affirmative action that is permissible even in the absence of past discrimination, as set forth in 45 CFR 80.3(b)(6)(ii): “Even though an applicant or recipient has never used discriminatory policies, the services and benefits . . . may not in fact be equally available to some racial or nationality groups. In such circumstances, an applicant or recipient may properly give special consideration to race, color, or national origin to make the benefits . . . more widely available to such groups, not then being adequately served. For example . . . it may establish special recruitment policies . . . and take other steps to provide that group with more adequate service.” As with 45 CFR 80.3(b)(6)(ii), this example illustrates not intentional discrimination, but rather conduct that has unintentional disparate effects. It consequently encourages intentional racial classifications, preferences, and other race-based actions without requiring the compelling governmental interest and the narrow tailoring that the Equal Protection Clause requires, and without any past discrimination that might justify such remedial actions. For the reasons set forth above, the Department removes and reserves paragraph (j).

The Department believes that each of the amendments described by this rule serves a vital, related, but distinct purpose. Each amendment is intended to operate independently of the others. It is the Department's intent that the potential invalidity of one amendment should not affect the other amendments. The Department would adopt any of the amendments independently of the invalidity of a separate amendment.

The Department issues this final rule without prior public notice and comment under 5 U.S.C. 553(a)(2), which excludes from section 553's notice-and-comment requirements matters relating to agency management or personnel or to public property, loans, grants, benefits, or contracts.

Title VI concerns nondiscrimination conditions on the receipt of Federal financial assistance, and relates 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.” 45 CFR 80.13(f); see also 45 CFR 80.4 (requiring applications for Federal financial assistance to “contain or be accompanied by an 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)); Nat'l Fed'n of Indep. Bus. v. Sebelius, 567 U.S. 519, 577 (2012) (“if Congress intends to impose a condition on the grant of federal moneys, it must do so unambiguously”) (quoting Pennhurst State Sch. & Hosp. v. Halderman, 451 U.S. 1, 17 (1981)). 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 U.S. Department of Agriculture's] financial assistance recipients”); Preserving Community and Neighborhood Choice, 85 FR 47899 (Aug. 7, 2020) (invoking the exception to repeal U.S. Department of Housing and Urban Development's 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 U.S. Department of Transportation's 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 DOJ guidelines regarding prohibiting disability discrimination in transportation programs and activities receiving Federal financial assistance).

The Department's definition of Federal financial assistance under Title VI is found at 45 CFR 80.13(f), which provides that such assistance includes: “(1) grants and loans of Federal funds, (2) the grant or donation of Federal property and interests in property, (3) the detail of Federal personnel, (4) the sale and lease of, and the permission to use (on other than a casual or transient basis), Federal property or any interest in such property without consideration or at a nominal consideration, or at a consideration which is reduced for the purpose of assisting the recipient, or in recognition of the public interest to be served by such sale or lease to the recipient, and (5) any Federal agreement, arrangement, or other contract which has as one of its purposes the provision of assistance.” The Department has carefully reviewed the categories of activities listed in the 5 U.S.C. 553(a)(2) exception to notice-and-comment rulemaking, the definition of Federal financial assistance at 45 CFR 80.13(f), and the types of Federal financial assistance provided by the Department. Based on this review, the Department has concluded that the categories of exempt activities in the Administrative Procedure Act encompass all the categories contained in the Department's definition at 45 CFR 80.13(f) and all types of Federal financial assistance provided by the Department. Thus, 5 U.S.C. 553(a)(2) applies to this rulemaking.

First, 45 CFR 80.13(f)(1)'s reference to “grants and loans of Federal funds” is covered by 5 U.S.C. 553(a)(2)'s inclusion of “a matter relating to . . . loans [and] grants” in the exemption from the requirements of section 553. Second, the inclusion of “the grant or donation of Federal property and interests in property” as Federal financial assistance under 45 CFR 80.13(f)(2) is covered by the exemption in 5 U.S.C. 553(a)(2) for “a matter relating to . . . public property [or] grants.” Third, Federal financial assistance in the form of “the detail of Federal personnel” under 45 CFR 80.13(f)(3) is covered by 5 U.S.C. 553(a)(2)'s exception for “a matter relating to agency management or personnel.” Furthermore, the detailing of Federal personnel occurs within the context of, or in lieu of, funds disbursed under grants, which are explicitly covered in 5 U.S.C. 553(a)(2). Fourth, 45 CFR 80.13(f)(4)'s inclusion of “the sale and lease of, and the permission to use (on other than a casual or transient basis), Federal property or any interest in such property without consideration or at a nominal consideration, or at a consideration which is reduced for the purpose of assisting the recipient, or in recognition of the public interest to be served by such sale or lease to the recipient” as Federal financial assistance is encompassed by 5 U.S.C. 553(a)(2)'s exception for “a matter relating to . . . public property.” Fifth, 45 CFR 80.13(f)(5)'s inclusion of “any Federal agreement, arrangement, or other contract which has as one of its purposes the provision of assistance” as Federal financial assistance falls within and is covered by 5 U.S.C. 553(a)(2)'s exemption for “a matter relating to . . . personnel or to public property, loans, grants, benefits, or contracts.”

Indeed, the original HEW Title VI regulations, adopted just months after the passage of the Civil Rights Act of 1964, were finalized without notice and comment. See Nondiscrimination in Federally-Assisted Programs of the Department of Health, Education, and Welfare—Effectuation of Title VI of the Civil Rights Act of 1964, 29 FR 16298 (Dec. 4, 1964). Moreover, in 1964 and 1966, several other Federal agencies published their Title VI regulations without notice and comment. See 29 FR 16274 (U.S. Department of Agriculture); 29 FR 16287 (General Services Administration); 29 FR 16280 (Housing and Home Finance Agency); 29 FR 16293 (U.S. Department of Interior); 29 FR 16284 (U.S. Department of Labor); 29 FR 16305 (National Science Foundation); 31 FR 10265 (DOJ). These rulemakings support applying the 5 U.S.C. 553(a)(2) exception here. 1

Further, invoking 5 U.S.C. 553(a)(2) is consistent with guidance issued by the Office of Management and Budget (OMB) 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 under section 553(a)(2) of the Administrative Procedure Act.

Finally, because 5 U.S.C. 553(a)(2) applies to section 553 as a whole, section 553(d)'s delayed-effective-date requirement does not apply.

E.O. 12250, 45 FR 72995 (Nov. 4, 1980), directs the Attorney General to coordinate the implementation and enforcement by Federal agencies of Title VI of the Civil Rights Act of 1964 and related nondiscrimination authorities. E.O. 12250 also delegates to the Attorney General the approval function vested in the President by section 602 of Title VI, 42 U.S.C. 2000d-1, for rules, regulations, and orders of general applicability issued to effectuate Title VI. Consistent with E.O. 12250 and 42 U.S.C. 2000d-1, DOJ has reviewed and approved this final rule.

The Department has determined that this rulemaking is a “significant regulatory action” under section 3(f) of E.O. 12866, 58 FR 51735, 51738 (Oct. 4, 1993), but it is not significant 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 E.O. 12866 section 1(b), id. at 51735, and in accordance with E.O. 13563 section 1(b), 76 FR 3821, 3821 (Jan. 21, 2011), which supplements and reaffirms the principles of E.O. 12866. These 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. E.O. 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 qualitative values that are difficult or impossible to quantify. Id.

As explained above, the regulatory modifications this rule makes are necessary to conform the Department's Title VI regulations to the statute as described in Sandoval, to harmonize the implementing regulations with Title VI, to address serious constitutional concerns under the Equal Protection Clause, to promote appropriate consistency in enforcement among private plaintiffs and Federal departments and agencies, and to 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 45 CFR 80.3(c) of the Department's Title VI implementing regulations, the changes this rule makes are 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 regulations to existing statutory law, as interpreted by the Supreme Court.

Data limitations make the costs and benefits of the rule difficult to quantify. The Department does not maintain data that would allow it to identify, across its full portfolio of Federal financial assistance, the subset of awards, recipients, program activities, or compliance actions that would be affected by revisions to this rule. Nevertheless, because Title VI operates as a condition on Federal financial assistance, the scale of the Department's overall awards provides contextual information about the breadth of the funding environment in which the rule's clarified standard may apply, even though it does not measure the rule's incremental economic impact. Over the past four fiscal years, the Department has issued approximately 251,992 separate awards totaling approximately $7.42 trillion. In FY 2025 alone, the Department issued approximately 47,656 separate awards totaling $2.02 trillion. 2 These aggregate figures are provided solely to describe the overall magnitude of the Department's financial assistance programs; they are not an estimate of the share of awards or activities subject to Title VI compliance issues addressed by this rule.

The Department does not track which of its investigations and compliance reviews involve solely allegations of disparate impact. 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 disparate-impact-related portions of enforcement actions. In addition, disparate-outcome evidence may be considered in evaluating intentional discrimination, which further prevents reliable separation and monetization of “disparate-impact-only” costs and benefits. Accordingly, the Department cannot reliably quantify the incremental enforcement costs associated with disparate-impact provisions, or the corresponding cost savings from removing those provisions.

Notwithstanding these data limitations, the Department expects that this deregulatory action will reduce enforcement and administrative burden by narrowing the operative legal standards, eliminating effects-based presumptions and associated lines of inquiry, and improving administrability and predictability for both the Department and regulated parties. The Department also expects to derive non-quantifiable benefits from aligning its implementation and enforcement posture with governing law and eliminating obligations for recipients to adopt race-based measures to manage effects-based outcomes. The Department likewise cannot quantify ex ante how recipients will adjust policies and compliance practices in response to these revisions. However, the Department anticipates that clarifying the applicable standard and removing effects-based requirements will provide recipients with greater operational flexibility and lower compliance and documentation costs, including reducing the need for outcome-tracking, impact analyses, and related remedial adjustments undertaken solely to mitigate disparate-impact risk.

This deregulatory action 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 the scope of prohibited conduct, 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 separate contractual assurances with each funding entity. See, e.g., 45 CFR 80.4. These contractual assurances already impose varying requirements that each Federal funding source deems necessary, and recipients will remain subject to any applicable assurances and regulations imposed by other Federal funding agencies. And in any event, the Department notes that other agencies are currently amending their regulations to align with the changes made in DOJ's rule, so the Department anticipates that there will be little, if any, disparity in Federal requirements regarding disparate-impact liability going forward.

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 E.O. 12866 and E.O. 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.

E.O. 14192 requires an agency, unless prohibited by law, to identify at least 10 existing regulations to be repealed when the agency publicly proposes for notice and comment or otherwise promulgates a new regulation. 90 FR 9065, 9065 (Feb. 6, 2025). In furtherance of this requirement, section 3(c) of the E.O. requires that “any new incremental costs associated with new regulations shall, to the extent permitted by law, be offset by the elimination of existing costs associated with at least 10 prior regulations.” Id. This rule eliminates unnecessary regulation 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. Accordingly, the Department expects this rule to be a deregulatory action under E.O. 14192.

E.O. 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 14, 2025). This rule does not impose a criminal regulatory offense; thus, E.O. 14294's requirements do not apply.

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 Title VI implementing regulations. Therefore, in accordance with section 6 of E.O. 13132, 64 FR 43255, 43257-58 (Aug. 10, 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 E.O. 12988 to specify provisions in clear language. See 61 FR 4729, 4731-32 (Feb. 7, 1996). Pursuant to section 3(b)(1)(I) of the E.O., id. at 4731, nothing in this rule or any previous rule (or in any administrative policy, directive, ruling, notice, guideline, guidance, or writing) directly relating to Title VI compliance 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 (RFA), 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 conforms the Department's regulations to the Equal Protection Clause standards and harmonizes the scope of its regulations for consistency with Title VI, which does not prohibit conduct having an unintentional disparate impact. All Federal funding recipients will remain subject to the longstanding Title VI obligation to not discriminate intentionally on the basis of race, color, or national origin.

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 has found 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, the Department of Health and Human Services amends part 80 of title 45 of the Code of Federal Regulations as follows:

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared and recommended by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2026 TAC of Pacific ocean perch in the West Yakutat District of the GOA is 1,993 metric tons (mt) as established by the final 2026 and 2027 harvest specifications for groundfish of the GOA (91 FR 11902, March 11, 2026).

In accordance with § 679.20(d)(1)(i), the Regional Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the 2026 TAC of Pacific ocean perch in the West Yakutat District of the GOA has been or will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 1,923 mt, and is setting aside the remaining 70 mt as incidental catch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been or will be reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the West Yakutat District of the GOA to prevent exceeding the Pacific ocean perch TAC in the West Yakutat District of the GOA.

While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data on Pacific ocean perch catch in a timely fashion and would delay the closure of directed fishing of Pacific ocean perch in the West Yakutat District of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data on catch of Pacific ocean perch in the West Yakutat District of the GOA only became available as of July 21, 2026.

There is good cause under 5 U.S.C. 553(d)(3) to establish an effective date less than 30 days after date of publication. This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.

NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared and recommended by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.

The 2026 TAC of dusky rockfish in the West Yakutat District of the GOA is 204 metric tons (mt) as established by the final 2026 and 2027 harvest specifications for groundfish of the GOA (91 FR 11902, March 11, 2026).

In accordance with § 679.20(d)(1)(i), the Regional Administrator, Alaska Region, NMFS (Regional Administrator) has determined that the 2026 TAC of dusky rockfish in the West Yakutat District of the GOA has been or will be reached. Therefore, the Regional Administrator is establishing a directed fishing allowance of 150 mt, and is setting aside the remaining 54 mt as incidental catch to support other anticipated groundfish fisheries. In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been or will be reached. Consequently, NMFS is prohibiting directed fishing for dusky rockfish in the West Yakutat District of the GOA to prevent exceeding the dusky rockfish TAC in the West Yakutat District of the GOA.

While this closure is effective the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.

NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act. This action is required by 50 CFR part 679, which was issued pursuant to section 304(b) of the Magnuson-Stevens Act, and is exempt from review under Executive Order 12866.

Pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and an opportunity for public comment on this action, as notice and comment would be impracticable and contrary to the public interest, as it would prevent NMFS from responding to the most recent fisheries data on dusky rockfish catch in a timely fashion and would delay the closure of directed fishing of dusky rockfish in the West Yakutat District of the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data on catch of dusky rockfish in the West Yakutat District of the GOA only became available as of July 21, 2026.