The Homeland Security Act of 2002, Public Law 107-296, 116 Stat. 2135 (Nov. 25, 2002), codified as amended at 6 U.S.C. 101 et seq., created DHS and transferred to it many functions related to homeland security, including the handling of natural and manmade crisis and emergency planning. See, e.g., 6 U.S.C. 111, 311-323. Pursuant to the Homeland Security Act, the Federal Emergency Management Agency (FEMA) was merged into DHS effective March 1, 2003. 1 As part of the establishment of procedures, DHS issued an interim final rule on March 6, 2003, to effectuate Title VI, which prohibits discrimination on the basis of race, color, or national origin in any programs or activities receiving Federal financial assistance. 2 The DHS Title VI regulations (DHS rule) were included in a new Part 21 of Title 6 of the Code of Federal Regulations (CFR).

The DHS rule effectuated the provisions of Title VI by providing for the conduct of investigations and procedures for effecting compliance, among other requirements. The rule generally mirrored rules in effect at that time at other departments, including those applicable to the constituent components that were transferred to DHS. See, e.g., 44 CFR part 7, subpart A. Because FEMA had previously issued a Title VI rule under its own preexisting authority, 3 that rule, at 44 CFR part 7, subpart A (FEMA rule), remained in effect for FEMA under the terms of the DHS rule. 4

Pursuant to Executive Order 12250, “[t]he Attorney General shall coordinate the implementation and enforcement by Executive agencies of . . . Title VI of the Civil Rights Act of 1964 (42 U.S.C. 2000d et seq. ).” Accordingly, DOJ acts as the lead federal agency responsible for defining the nature and scope of Title VI's prohibition of discrimination on the basis of race, color, and national origin in programs or activities receiving Federal financial assistance. Executive Order 12250 directs DOJ, among other things, to “develop standards and procedures for taking enforcement actions and for conducting investigations and compliance reviews.” Further, as part of this responsibility, Executive Order 12250 provides that the Attorney General must approve other agencies' Federal regulations implementing Title VI.

On December 10, 2025, DOJ issued a final rule (DOJ rule) amending portions of its Title VI regulations to more closely align its regulations to the scope of intentionally discriminatory conduct that Congress prohibited in Title VI. 90 FR 57141 (Dec. 10, 2025). DOJ explained that there were serious statutory and constitutional concerns with the Title VI regulations, which went beyond intentional discrimination by prohibiting conduct that has an unintentional disparate impact. 90 FR at 57141. DOJ also explained that policy concerns independently supported amending its Title VI regulations to no longer cover conduct that has an unintentional disparate impact. 90 FR at 57143-57145. The DOJ rule accordingly rescinded those portions of the regulations that prohibited conduct having a disparate impact. Id.

DOJ also explained that its revised rule is consistent with Executive Order 14281 “ Restoring Equality of Opportunity and Meritocracy ” (90 FR 17537 (Apr. 28, 2025)). 90 FR at 57142-43. 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.” 90 FR 17537. The Order directed the Attorney General to, among other things, review Title VI regulations and “initiate appropriate action to repeal or amend” these regulations “to the extent they contemplate disparate-impact liability.” Id. at 17538. DOJ explained that although DOJ would have issued its rule independent of Executive Order 14281, the Order supports the DOJ rule. 90 FR 57141. Like DOJ, DHS would issue its rule independent of Executive Order 14281, but the Order also supports DHS's rule.

DOJ explained that the deletions make clear to DOJ Federal-funding recipients that DOJ's Title VI regulations prohibit intentional discrimination and do not prohibit conduct or activities that have an unintentional disparate impact, and DOJ thus will not pursue Title VI disparate-impact liability against its Federal-funding recipients. Id. at 57141.

DOJ also included a detailed discussion of the statutory and regulatory history surrounding Title VI and disparate-impact theories of discrimination, canvassed relevant Supreme Court precedent casting doubt on the lawfulness of existing regulations, and expressed serious policy concerns with the disparate-impact and affirmative-action aspects of then-existing DOJ regulations. Id. at 57141-45. DHS agrees with the substance of DOJ's final rule and adopts and incorporates DOJ's final rule preamble discussion in full, including the sections addressing: (1) statutory and regulatory history of Title VI; (2) relevant Supreme Court precedents; (3) serious legal and constitutional concerns; (4) serious policy concerns; (5) regulatory alternatives; and (6) reliance interests.

DHS's regulations at 6 CFR 21.5, entitled “Discrimination prohibited,” and FEMA's regulations at 44 CFR 7.5, entitled “Specific discriminatory actions prohibited,” contain several provisions that go beyond the statutory text and constitutional requirements by prohibiting facially neutral policies that have a disparate impact and in some instances encourage or even require unlawful discrimination labeled as “affirmative action.” There are serious statutory and constitutional concerns with the legality of DHS's and FEMA's Title VI disparate-impact regulations. DHS 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. Alexander v. Sandoval, 532 U.S. 275, 280, 286 n.6 (2001). That is the “single, best meaning” of Title VI. Loper Bright Enterprises v. Raimondo, 603 U.S. 369, 400 (2024). Sandoval calls into serious doubt the legality of DHS's “disparate-impact regulations.” Sandoval, 532 U.S. at 281-82, 284-85 (noting that DOJ's 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 DHS cannot extend Title VI beyond its original public meaning. See 603 U.S. at 412-13 (holding that “courts must . . . ensur[e] that [an] agency acts within” its statutory authority). And even in the absence of Supreme Court precedent, DHS would have concluded that the best reading of Title VI is that it prohibits only intentional discrimination.

Title VI authorizes agencies to promulgate regulations “to effectuate” the statute's prohibition of intentional discrimination. 42 U.S.C. 2000d-1. The current regulations' extension of prohibited conduct to include conduct with an unintentional disparate impact reaches a vastly broader scope than the statute itself. This scope is too broad to be considered a simple prophylactic measure aimed at preventing intentional discrimination. See Sandoval, 532 U.S. at 286 n.6 (“[Title VI] permits the very behavior that the regulations forbid.”). Thus, the disparate-impact regulations do not “effectuate” Title VI. 42 U.S.C. 2000d-1.

There are also serious concerns about whether DHS's Title VI regulations pass constitutional muster under the Equal Protection Clause. As the Supreme Court recently held in Students for Fair Admissions, Inc. v. President & Fellows of Harvard College (“ 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. 181, 206 (2023) (internal quotation marks omitted) (first quoting Yick Wo v. Hopkins, 118 U.S. 356, 369 (1886) and then quoting Regents of Univ. of Cal. v. Bakke, 438 U.S. 265, 289-90 (1978) (Powell, J.)). Despite the promises of the Equal Protection Clause, a funding recipient's risk of disparate-impact liability under DHS's regulations is triggered by unintentional disparate outcomes, which the recipient may not even know about without investigation. To evaluate and avoid this risk, the funding recipient must incur investigatory costs, such as conducting an impact analysis, and is coerced to proactively consider race, color, and national origin, and potentially use it to change the unintended disparate outcomes. In short, disparate-impact liability encourages and, in some cases, requires covered entities to engage in the intentional use of race and racial balancing to eliminate those disparate outcomes by treating certain racial groups differently from others—the exact conduct the Equal Protection Clause forbids. See id. 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 DHS 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. 6 CFR 21.5(b)(6). Thus, for substantially the same reasons as above, the “affirmative action” provision raises serious constitutional concerns.

As summarized above, there are serious statutory and constitutional concerns with DHS's disparate-impact regulations. But even if the regulations were consistent with the statute, DHS 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, DHS 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.

DHS also has serious policy concerns with the Title VI regulations' imposition of disparate-impact liability. While DHS 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, lack a meaningful connection to a compelling interest. See, e.g., SFFA, 600 U.S. at 216-17 (explaining that the “[racial] categories” utilized by Harvard and University of North Carolina were “themselves imprecise in many ways” and “the use of these opaque racial categories undermine[d], instead of promote[d], [their] goals”). This confusion undermines the law's ability to teach principles of nondiscrimination and is evident in, among other things, many of the grant proposals that agencies awarded funds to in past years. Many of the past grant solicitations explicitly targeted certain racial groups. See, e.g., DHS-23-CISA-127-CWDT-0001, Cybersecurity Workforce Development and Training for Underserved Communities, https://www.grants.gov/search-results-detail/347949 (posted May 5, 2023).

DHS 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 DHS has considered. And in any event, the concern is mitigated by the fact that eliminating disparate-impact liability does not preclude the use of data on disparate outcomes to help prove intentional discrimination. Indeed, under DHS's Title VI regulations, which the current changes do not alter, “recipients should have available for the Secretary racial and ethnic data showing the extent to which members of minority groups are beneficiaries of Federal financial assistance.” 6 CFR 21.9(b). Both DHS and private litigants rely on such data as a potential indicator of intentional discrimination. This use of statistical disparity to help establish, as an evidentiary matter, liability for intentional discrimination materially differs from using it to impose liability for an unintentional disparate impact.

DHS has also considered the alternative of trying to adopt a modified version of disparate-impact liability, for example, by requiring covered entities to remedy unintentional discrimination for only certain types of cases in education, disaster assistance, or housing. But any version of imposing liability for unintentional discrimination is inconsistent with Title VI's original public meaning. Regardless, even a modified version of disparate-impact liability would not eliminate DHS's serious legal and policy concerns. DHS determines that any benefits from adopting alternative versions of disparate-impact liability are outweighed by DHS'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. DHS 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 parts of the problem unaddressed and others inadequately addressed.

DHS 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,” including specifically DHS's Title VI disparate-impact regulations. 90 FR at 17538. DHS accordingly believes that any reliance interests should be minimal and do not outweigh DHS's legal and other policy concerns. Further, each of DHS's concerns, whether considered cumulatively or separately, outweighs any reliance interests.

DHS 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 DHS can 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, DHS finds that, regardless of the legality of DHS's disparate-impact regulations, the above-summarized policy concerns, when viewed separately or cumulatively, independently justify the repeal of its disparate-impact regulations.

DHS is revising its Title VI regulations at 6 CFR part 21 and FEMA's regulations at 44 CFR part 7 consistent with the DOJ rule, Title VI, Executive Order 14281, and related case law, as described in the DOJ rule. 5 The changes collectively:

• Remove all disparate-impact language from DHS and FEMA Title VI regulations;

• Delete the affirmative-action provisions; and

• Ensure that DHS and FEMA regulations align with DOJ regulations, the statutory text of Title VI, Supreme Court precedent, and Executive Order 14281.

The practical effect of these changes is to make clear that DHS's Title VI regulations do not prohibit conduct or activities that have an unintentional disparate impact and prohibit only intentional discrimination, and that DHS will not pursue Title VI disparate-impact liability against DHS funding recipients.

A section-by-section analysis follows.

DHS is updating the authority citation for 6 CFR part 21 to correct an apparent typographical error (prior text erroneously referenced 5 U.S.C. 310, and this rule corrects it to 5 U.S.C. 301) and add a reference to the Homeland Security Act.

DHS is removing and reserving paragraph 21.5(b)(2), which prohibited recipients from utilizing policies that merely have the effect of subjecting persons to discrimination because of their race, color, or national origin or substantially impairing program objectives with respect to individuals of a particular race, color, or national origin. This paragraph expanded prohibited conduct from purposeful discrimination to impose liability on Federal funding recipients who “utilize criteria or methods of administration which have the effect of subjecting individuals to discrimination.”

The removal makes clear that DHS will no longer pursue Title VI disparate-impact liability; only intentionally discriminatory conduct is prohibited. The paragraph is reserved to preserve numbering continuity. Note that nothing in this rule precludes DHS from considering statistical disparities as relevant evidence in determining whether discrimination was intentional. Consistent with DOJ's final rule, although disparate-impact liability is eliminated, data regarding disparate outcomes may still be probative of discriminatory purpose. Indeed, under DHS's Title VI regulations that the current changes do not alter, “recipients should have available for the Secretary racial and ethnic data showing the extent to which members of minority groups are beneficiaries of programs receiving Federal financial assistance.” 6 CFR 21.9(b); cf. also 44 CFR 7.10(b). This use of statistical disparity to help establish, as an evidentiary matter, liability for intentional discrimination materially differs from using it to impose liability for an unintentional disparate impact.

In paragraph (b)(3) (which relates to how recipients or applicants determine the site or location of facilities), DHS is removing both instances of the words “or effect.” The paragraph now bars selections made with the purpose of discrimination or defeating Title VI objectives, thereby limiting liability to intentional discrimination. This rule deletes both “or effect” references to conform paragraph (b)(3) more closely to the scope of liability Congress intended when it enacted Title VI and to address the legal and policy considerations and determinations described above.

DHS is removing paragraph (b)(6). This provision encourages, if not requires, recipients to take discriminatory actions to overcome effects of prior discrimination. It is deleted because it goes beyond the Equal Protection Clause, which permits in limited circumstances, but does not mandate, a government to take narrowly tailored action to remedy the effects of its identified past discrimination. See, e.g., Bakke, 438 U.S. at 307 (Powell, J.). Moreover, even putting aside the mandatory language, this provision does not expressly require narrow tailoring to counter the 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 race, color, or national origin preferences when the recipient may not want to. This is contrary to DHS'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. DHS will no longer encourage or require this use of race, color, or national origin through its regulation.

DHS is revising paragraph (c) to clarify the scope of Title VI coverage for employment practices and is deleting paragraphs (c)(2) and (c)(3). Revised paragraph (c) affirms that whenever a primary objective of the Federal financial assistance is to provide employment, recipients may not intentionally discriminate on the basis of race, color, or national origin in employment practices under such programs. That prohibition also applies to programs in which a primary objective of the Federal financial assistance is (i) to assist individuals, through employment, to meet expenses incident to the commencement or continuation of their education or training, or (ii) to provide work experience that contributes to the education or training of the individuals involved. The applicable requirements for construction employment remain those specified in or pursuant to part III of Executive Order 11246, or any Executive Order that supersedes it. This revision conforms to 42 U.S.C. 2000d-3, removes the prior “tends to” extension beyond the statute, and removes the affirmative-action mandates currently contained in paragraphs (c)(1) and (c)(3). These changes amend the regulation so that it more closely adheres to the scope of conduct Congress prohibited with Title VI and the legal and policy considerations and determinations described in this document.

DHS is updating the authority citation for 44 CFR part 7 to align with the authority citation for 6 CFR part 21. The only edit to regulatory text is to remove and reserve paragraph 7.5(b), which is analogous to the removal of 6 CFR 21.5(b)(2).

DHS notes that the Stafford Act contains a nondiscrimination provision calling for “such regulations as may be necessary for the guidance of personnel carrying out Federal assistance functions at the site of a major disaster or emergency.” 42 U.S.C. 5151(a). The regulations must “include provisions for insuring that the distribution of supplies, the processing of applications, and other relief and assistance activities shall be accomplished in an equitable and impartial manner, without discrimination on the grounds of race, color, religion, nationality, sex, age, disability, English proficiency, or economic status.” Id. FEMA implements this provision at 44 CFR 206.11, which will continue to impose such requirements. See 44 CFR 206.11(b).

The Stafford Act provision and its implementing regulation identify multiple additional protected classes (beyond race, color, and national origin) and require the provision of disaster assistance in an equitable and impartial manner, but do not expressly prohibit or otherwise reference unintentional disparate-impact discrimination. Accordingly, FEMA has not made changes to 44 CFR 206.11 as part of this rulemaking. FEMA may in the future further interpret these Stafford Act-specific requirements as appropriate.

FEMA is also subject to 42 U.S.C. 5196f, a separate Stafford Act provision that directs FEMA to, among other things, (1) identify, in coordination with State and local governments, population groups with limited English proficiency and take into account such groups in planning for an emergency or major disaster; and (2) ensure that information made available to individuals affected by a major disaster or emergency is made available in formats that can be understood by certain populations. This rule does not change FEMA's implementation of those separate statutory requirements.

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

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

Title VI concerns non-discrimination conditions on the receipt of Federal financial assistance, and more particularly to the receipt of federal “[g]rants and loans,” “property,” “personnel” and “[a]ny Federal agreement, arrangement, or other contract which has as one of its purposes the provision of assistance.” See 6 CFR 21.4(c); 44 CFR 7.2(c); see also 6 CFR 21.7; 44 CFR 7.7 (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'” (citation omitted)). Cf. Education Programs or Activities Receiving or Benefitting from Federal Financial Assistance, 82 FR 46655-01 (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 47899-01 (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 18285-02 (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 40687-01 (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 the Office for Management and Budget's (OMB) definition for “Federal financial assistance” under 2 CFR 200.1, which defines “Federal financial assistance” with the same categories as the Administrative Procedure Act's exception for rules “relating to agency management or personnel or to public property, loans, grants, benefits, or contracts,” 5 U.S.C. 553(a)(2). With potentially limited exceptions not applicable to the Department, all the forms of Federal financial assistance set forth under 2 CFR 200.1 that the Department administers would fall under the “public property, loans, grants, benefits, or contracts” exception. Thus, the Department issues this final rule without prior public notice and comment or a delayed effective date under 5 U.S.C. 553(a)(2).

Prompt alignment with DOJ's Title VI rule is necessary to ensure uniform, government-wide administration of Title VI, eliminate regulatory uncertainty for DHS funding recipients, and avoid inconsistent enforcement. Although FEMA's general policy at 44 CFR 1.3 encourages public participation, that policy does not create enforceable rights and permits FEMA to depart from it in its discretion. DHS departs here to promptly harmonize its rule with DOJ's rule and mitigate confusion and compliance costs for recipients.

Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. 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. Executive Order 14192 (Unleashing Prosperity Through Deregulation) directs agencies to significantly reduce the private expenditures required to comply with Federal regulations and provides 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.”

The Office of Management and Budget (OMB) has designated this rule a “significant regulatory action” under section 3(f) of Executive Order 12866, although not economically significant under section 3(f)(1). Accordingly, the rule has been reviewed by the Office of Management and Budget.

This final rule is considered an Executive Order 14192 deregulatory action.

As explained in the preamble, the regulatory modifications this rule makes are necessary to conform DHS regulations to the corresponding DOJ regulations, Title VI, Executive Order 14281, and related case law. The practical effect of these changes is to make clear that DHS's Title VI regulations do not prohibit conduct or activities that have a disparate impact but prohibit only intentional discrimination and that DHS will not pursue Title VI disparate-impact liability against DHS funding recipients.

As with the DOJ rule, data limitations make the costs and benefits of this rule difficult to quantify. This rule affects DHS funding recipients. DHS issued approximately 274,000 separate awards totaling approximately $140 billion from FY2022-FY2024. 6 In FY2024 alone, DHS issued approximately 35,000 separate awards totaling $43.4 billion. Table 1 shows the number of grants and grant awards for DHS for FY2024.

DHS does not have ready access to comprehensive information regarding which of its Title VI-related investigations and compliance reviews involve solely allegations of disparate-impact discrimination. For enforcement actions that relate to both intentional discrimination and unintentional disparate impact, DHS cannot reliably quantify the costs attributable to the varying disparate-impact portions of enforcement actions. Further impeding monetizing costs and benefits is that disparate impact is sometimes a factor that is considered in determining whether discrimination is intentional. Therefore, the overall cost effect on DHS is difficult to quantify. However, this deregulatory action should decrease DHS's enforcement costs. In addition, a benefit of this rule is to align DHS's regulations with DOJ regulations, statutory text, and Supreme Court precedent, as well as to address DHS's serious policy concerns with the existing regulations.

DHS is similarly 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. DHS recognizes that a funding recipient may receive additional federal funds from sources other than DHS. DOJ noted in its rule that DOJ expected its rule to cause other federal departments and agencies to consider similarly revising their Title VI regulations. Like DOJ, DHS does not envision that this rule will appreciably increase administrative costs or compliance costs for funding recipients who must also adhere to the regulations of another department or agency. 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, as discussed in section I.C.2 of this preamble, and narrows the conduct prohibited. This rule therefore reduces the costs of compliance and potential liability. Moreover, recipients who receive funds for the same program or activity from more than one Federal entity already enter into separate contractual assurances with each funding entity, see, e.g., 6 CFR 21.7. These contractual assurances already impose varying requirements that each Federal funding source deems necessary. Funding recipients will continue to be held to the most stringent contractual assurance and regulation.

Based on the analysis of the practical qualitative costs and benefits noted above, DHS 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, DHS adopt a regulation only upon a reasoned determination that its benefits justify its costs and choose a regulatory approach that maximizes net benefits.

Pursuant to Executive Order 12250, the Department of Justice 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, Executive Order 12250 delegated the President's responsibility to approve Title VI regulations to the Attorney General. See 42 U.S.C. 2000d-1. The Department of Justice has reviewed and approved this rule.

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) only if the agency was required “to publish a general notice of proposed rulemaking” prior to issuing the final rule. See 5 U.S.C. 604(a). However, even if these regulations were subject to general notice requirements, DHS, in accordance with 5 U.S.C. 605(b), has reviewed these regulations and certifies that the rule's changes will not have a significant economic impact on a substantial number of small entities, in large part because these regulatory changes do not impose any new substantive obligations on Federal funding recipients. The rule amends and clarifies existing regulations that are required by Title VI. The rule merely brings DHS into compliance with the Equal Protection Clause and harmonizes the scope of its regulations with the scope of Title VI, which does not prohibit conduct having an unintentional disparate impact. All Federal funding recipients have been bound by the existing standards that will remain in place after this rule since their initial promulgation.

Under the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number issued by the OMB. This rule does not propose any new, nor any revisions to existing, “collection[s] of information” as that term is defined under the Paperwork Reduction Act of 1995 and its implementing regulations, 5 CFR part 1320.

The Unfunded Mandates Reform Act of 1995 (“UMRA”) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and Tribal governments. Title II of the UMRA requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed rule (or final rule for which the agency published a proposed rule) that includes any Federal mandate that may result in an expenditure of $100 million or more (adjusted annually for inflation) in any one year by State, local, and Tribal governments, in the aggregate, or by the private sector. The term “Federal mandate” means a Federal intergovernmental mandate or a Federal private sector mandate. See 2 U.S.C. 658(6), 1502(1). A “Federal intergovernmental mandate,” in turn, is a provision that would impose an enforceable duty upon State, local, or Tribal governments (except as a condition of Federal assistance or a duty arising from participation in a voluntary Federal program). See 2 U.S.C. 658(5). And the term “Federal private sector mandate” refers to a provision that would impose an enforceable duty upon the private sector (except as a condition of Federal assistance or a duty arising from participation in a voluntary Federal program). See 2 U.S.C. 658(7).

This rule is not subject to the UMRA because DHS did not publish a proposed rule prior to this action. In addition, the UMRA's requirements do not apply to any provision in a 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). This rule is exempted from the UMRA on that basis. In addition, DHS has determined that this rulemaking will not result in the expenditure by state, local, and tribal governments, in the aggregate, nor by the private sector, of $100 million or more in any one year as a result of a Federal mandate, and it will not significantly or uniquely affect small governments. Therefore, no actions are deemed necessary under the UMRA.

The Office of Information and Regulatory Affairs has determined that this rule is not a major rule as defined by Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996. 5 U.S.C. 804(2).

DHS and its components analyze final actions to determine whether the National Environmental Policy Act (NEPA), 42 U.S.C. 4321 et seq., applies to them and, if so, what degree of analysis is required. DHS Directive 023-01 Rev. 01 and Instruction Manual 023-01-001-01 Rev. 01 (Instruction Manual) establish the policies and procedures that DHS and its components use to comply with NEPA, 42 U.S.C. 4321 et seq.

NEPA allows Federal agencies to establish categories of actions that experience has shown do not, individually or cumulatively, have a significant effect on the human environment and, therefore, do not require an environmental assessment (EA) or environmental impact statement (EIS). See 42 U.S.C. 4336(a)(2), 4336e(1). The Instruction Manual, Appendix A lists the DHS Categorical Exclusions.

Under DHS NEPA implementing procedures, for an action to be categorically excluded, it must satisfy each of the following three conditions: (1) The entire action clearly fits within one or more of the categorical exclusions; (2) the action is not a piece of a larger action; and (3) no extraordinary circumstances exist that create the potential for a significant environmental effect. See Instruction Manual 023-01 at V.B(2)(a)-(c).

This rule aligns the conduct prohibited by DHS regulations more closely to the conduct Congress prohibited when enacting Title VI, consistent with Executive Order 14281. DHS has reviewed the rule and finds that the rule is of a strictly administrative or procedural nature; implements, without substantive change, statutory requirements; and amends an existing regulation without changing its environmental effect.

Accordingly, DHS finds that the rule clearly fits within categorical exclusion A3(a), (b), and (d) established in DHS's NEPA implementing procedures, and no further NEPA analysis is required.

A rule has implications for federalism under Executive Order 13132 (Federalism) if it has substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. DHS has analyzed this rule under this order and determined it does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.

This rule meets applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 (Civil Justice Reform) to minimize litigation, eliminate ambiguity, and reduce burden.

For the reasons set forth in the preamble, under the authority of 6 U.S.C. 112, the Secretary of Homeland Security amends 6 CFR part 21 and 44 CFR part 7, as follows:

On May 16, 2025, DOE published a NOPR (90 FR 20826) to amend the application process codified at 10 CFR 205.300 through 10 CFR 205.309 concerning authorization to transmit electric energy to a foreign country pursuant to section 202(e) of the FPA. 16 U.S.C. 824a(e). 1 Section 202(e) requires that DOE “shall issue such order [authorizing the export of electricity to a foreign country] upon application unless, after opportunity for hearing, it finds that the proposed transmission would impair the sufficiency of electric supply within the United States or would impede or tend to impede the coordination in the public interest of facilities subject to the jurisdiction of [DOE].”

DOE proposed to amend the application process by removing §§ 205.301 through 205.309 and modifying the language of § 205.300. DOE sought comment on all aspects of the proposal, including but not limited to the prior rule's consistency with statutory authority and the Constitution, national security, its contemporary relevance, its costs and benefits, and its effect on small business, entrepreneurship, and private enterprise. 90 FR 20826, 20826. Public comments were requested by July 15, 2025.

DOE received four comments in response to the NOPR: one in support and three opposing. Below is a summary of the comments received and DOE's responses.

IECA commented in support of the proposed amendment, stating it will “[excise] unnecessary and burdensome information requirements”; strictly adhere to Congress' intent under section 202(e) of the FPA; and remove compliance risks for applicants seeking renewal. (DOE HQ-2025-0019-0005 at 2-4). IECA stated the proposed amendment will “aid in improving economic efficiency, competition in the electric energy markets, lower electric energy prices, and drive the least-cost dispatch of electric energy across the grid.” (DOE HQ-2025-0019-0005 at 2). DOE acknowledges IECA's feedback and support for the proposed amendments.

Additionally, IECA recommended that the DOE “issue guidelines for applicants setting forth examples of the various types of information that would enable DOE to find that the proposed transmission will not impair the sufficiency of the electric supply within the United States and will not impede or tend to impede the coordination in the public interest of facilities subject to the FPA.” ( Id. at 4). IECA also recommended including “that a timely application for renewal effectuates an extension of existing authorization until such time as DOE issues an order on the renewal application.” ( Id. ) DOE recognizes IECA feedback and intends to publish supplemental materials outside of the Code of Federal Regulations to assist prospective applicants with preparing applications. DOE will consider incorporating IECA's recommendation regarding the effect of renewal submissions at a later time, but at this point DOE is obliged to abide by authorization expiration date.

Three comments opposed the proposed amendments. Collectively, the commenters asserted that such amendments violate the Administrative Procedure Act (APA), the FPA, and the National Environmental Policy Act (NEPA). DOE acknowledges these comments and addresses them in the following three parts: rulemaking, statutory authority, and environmental compliance. Lastly, this final rule discusses several editorial edits being adopted.

Two commenters, CBD and T P, expressed opposition to the process by which DOE is undertaking a rulemaking. CBD asserted that DOE`s action violates the APA, stating that the NOPR is arbitrary and capricious, and that DOE failed to provide a rational basis for the policy change by not offering justification grounded in data or analysis. (DOE HQ-2025-0019-0004 at 2-3). T P contended that the proposed rulemaking contradicts Executive Order (E.O.) 14192 because T P contends that increased export of electricity would raise the cost of electricity for American consumers, and DOE's NOPR failed to detail actual costs of implementing the proposed rule. (DOE HQ-2025-0019-0002).

DOE acknowledges that the APA prohibits agency actions from being “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” See 5 U.S.C. 706(2)(A). However, the proposed amendment intends to align agency procedures to current policy by removing economic, administrative, and procedural burdens on applicants tied to outdated application requirements. See 90 FR 20826; E.O. 14154 and 14192.

The existing regulations regarding authorization to transmit electric energy to a foreign country, as amended, were last updated in 1981. The regulations that were in place prior to this final rule did not contemplate the existence of Regional Transmission Organizations, Independent System Operators, balancing authorities or other such entities that ensure that regional transmission systems are operated reliably. The 1981 regulations were crafted at a time when exports of electricity were conducted only by vertically-integrated utilities that owned international transmission facilities. Since the time those regulations were promulgated, many significant developments have transformed the electric power industry and regulatory framework. For example, the Federal Energy Regulatory Commission (FERC) has issued several open access orders, including Order Nos. 888 and 889, which led to the rise of electric power marketers. Power marketers have no franchised service area and no physical transmission or generation assets because they do not produce electricity. Instead, they purchase and sell electricity on the open market and thereby improve the efficiency of electric power markets. Since the mid-1990's power marketers have been the main applicants for electricity Export Authorizations that are subject to the regulations at issue in this final rule. These entities vary greatly from the traditional vertically integrated utility model where a single utility generated, transmitted, and sold all electricity in a franchised service area. On the contrary, power marketers do not produce the power they sell. They increase efficiency by facilitating the use and purchase of electricity that might otherwise go unsold or unutilized to a customer in an area that has a need for it.

In response to major changes in the electric power industry, the Department has intended to amend the regulations to modernize the 1981 regulations at 10 CFR part 205. For example, a proposal appeared in the Office of Information and Regulatory Affairs' Unified Agenda and Regulatory Plan in Fall 2023. 2 This final rule modernizes the regulations to reflect the realities of the current electric transmission sector, as discussed previously. The FPA authorizes DOE, as an expert agency, to establish such implementing regulations as it deems necessary. FPA section 391; 16 U.S.C. 825h. Accordingly, the amendments adopted in the final rule are a logical exercise of that statutory authority and are not arbitrary, capricious, an abuse of discretion, or otherwise contrary to law.

This final rule establishes simplified procedures under which persons may apply for authorization to transmit electric energy to a foreign country. This simplified process is appropriate because Congress provided only limited decision-making authority to the Department for considering export authorization applications. FPA section 202(e); 16 U.S.C. 824a(e). As noted above, the statute provides that DOE “shall” authorize energy export unless it finds that the proposed transmission would either impair the sufficiency of electric supply within the United States or impede or tend to impede the coordination in the public interest of facilities subject to DOE's jurisdiction. Finally, the revisions adopted in this final rule ease the existing regulatory burden on both applicants and the DOE by reducing the amount of information and the number of documents required in an application. It also reduces the financial burden placed on applicants by eliminating the $500 application filing fee, which is estimated to reduce the annual application burden by $10,000.

DOE further recognizes that section 202(e) of the FPA requires that DOE provide “opportunity for hearing.” The FPA does not indicate that an “opportunity for hearing” requires a formal process, nor does it define “hearing.” Historically, DOE's regulations applicable to the consideration of authorization applications to transmit electric energy to a foreign country at 10 CFR 205.300-309 have not specified a process by which DOE hears or considers opposing views about the applications. DOE's practice has been to use the Federal Register for noticing applications and receiving public comments. In soliciting public comments, DOE's practice has been to use FERC's Rule 211 process (18 CFR 385.211) for receiving protests, and FERC's Rule 214 process (18 CFR 385.214) for receiving motions to intervene.

However, there is no legal requirement for DOE to adopt the mentioned FERC procedures for the consideration of energy export authorization applications, and DOE does not consider the voluntary use of FERC's procedures has added value to the Department's consideration process. In fact, the use of these procedures unnecessarily delays and complicates the process, especially given that Congress only granted limited authority to the Department to deny applications. Therefore, DOE will discontinue the practice of voluntarily inviting protests and motions via FERC procedural rules.

DOE intends to satisfy its obligation to offer opportunity for hearing by continuing to publish notice of applications, either on its applicable Departmental website or in the Federal Register , and placing any timely public comments or feedback received to electricity.exports@hq.doe.gov in the public file associated with the application. DOE will consider all comments relevant to its decision-making authority for considering export authorization applications.

DOE expects that this amendment will reduce the burden for applicants and DOE. These effects of the rule are not expected to exceed $100 million annually or otherwise be adverse to any group.

CBD and Public Citizen further assert that the amendment violates section 202(e) of the FPA. Both CBD and Public Citizen assert that the FPA's purpose is to assure the abundant supply of domestic electricity (DOE HQ-2025-0019-0004 at 4; DOE-HQ-2025-0019-0003 at 2). Public Citizen further states that the DOE's rationalization for the NOPR is unsupported by the statutory language of the FPA and contradicts E.O. 14156, “Declaring A National Energy Emergency” (DOE-HQ-2025-0019-0003 at 2-3).

Under FPA section 202(e), DOE “shall issue such order upon application unless, after opportunity for hearing, it finds that the proposed transmission would impair the sufficiency of electric supply within the United States or would impede or tend to impede the coordination in the public interest of facilities subject to the jurisdiction of [DOE].” 16 U.S.C. 824a(e).

DOE interprets the first criterion to mean that sufficient generating capacity and electric energy must first exist such that the export could be made without compromising the energy needs of the exporting region, including serving all load obligations in the region while maintaining appropriate reserve levels. DOE interprets the second criterion primarily as an issue of the operational reliability of the domestic electric transmission system. Accordingly, the export must not compromise transmission system security and reliability. For these reasons, each Export Authorization Order that DOE issues asserts this interpretation; each Export Authorization requires that “sufficient generating capacity and electric energy must exist such that the export could be made without compromising the energy needs of the exporting region, including serving all load obligations in the region while maintaining appropriate reserve levels” and that “the export must not compromise transmission system security and reliability.” See, e.g., BP Energy Co., Order No. EA-314, at 1-2 (Feb. 22, 2007), renewed, Order No. EA-314-A, at 2 (May 3, 2012), Order No. EA-314-B, at 2 (Feb. 28, 2017), renewed, Order No. EA-314-C, at 4 (Dec. 20, 2021).

To determine whether such a proposed export would impair domestic sufficiency of supply or impede the coordinated use of the U.S. power supply, DOE relies on market mechanisms and reliability oversight. FERC, influenced by the Energy Policy Acts (EPAct) of 1992 and 2005, has fostered competitive wholesale energy markets across the United States. 3 These markets, characterized by open access to transmission facilities and the presence of regional transmission organizations and independent system operators, allow market participants, including exporters, to access available supplies efficiently. Furthermore, entities such as power marketers operate within these markets. As these marketers do not have an obligation to serve a franchised territory or native load, their exports allow for the transfer of electricity that might not otherwise be utilized to a willing customer. Thus, exports are not drawn from resources earmarked for specific domestic customer obligations. DOE finds that absent demonstrable flaws in these markets, exports authorizations do not impair the sufficiency of electric supply within the United States.

The Energy Policy Act of 2005 empowered FERC to certify an electric reliability organization, leading to the establishment of the North American Electric Reliability Corporation (NERC). 16 U.S.C. 824o; FERC issued Order No. 672. NERC, in conjunction with FERC and regional entities, develops and enforces mandatory reliability standards for the bulk-power system across North America. These standards encompass various operational aspects, from resource balancing to emergency preparedness, and apply to all bulk-power system owners, operators, and users. Critically, reliability coordinators and balancing authorities have the authority and responsibility to manage power generation and transmission, ensuring adequate reserves and, when necessary, curtailing or denying scheduled flows, including exports, to maintain regional reliability and prevent system disturbances. This multi-layered enforcement mechanism provides assurance that approved exports will not lead to operational reliability issues on the domestic transmission system.

Two commenters, CBD and T P, voiced opposition to the DOE's interpretation of NEPA compliance and one commenter, IECA, voiced support. Both CBD and T P disagreed with the DOE's Categorical Exclusion determination, arguing that the NOPR's intended results of facilitating electricity exports, including that of fossil fuel-generated electricity, would result in direct and indirect environmental impacts and risks. (DOE HQ-2025-0019-0004 at 5; DOE HQ-2025-0019-0002). ICEA expressed support for the Categorical Exclusion. (DOE HQ-2025-0019-0005 at 2).

As outlined in section II of May 2025 NOPR, DOE conducted a review of the potentially applicable categorical exclusions to this proposed action in accordance with the NEPA and DOE's Implementing Regulations at 10 CFR part 1021 (part 1021), as in effect at the time of the NOPR's publication. In May 2025, DOE had determined that the NOPR was excluded from further NEPA review pursuant to a categorical exclusion (CX) that appeared in “appendix A to subpart D of part 1021—Categorical Exclusions Applicable to General Agency Actions.” The relevant CX was entitled, “A6 Procedural Rulemakings.” In July 2025, DOE revised part 1021 with the publication of the “U.S. Department of Energy National Environmental Policy Act (NEPA) Implementing Procedures” (DOE NEPA Implementing Procedures). The DOE NEPA Implementing Procedures retitled appendix A, including “A6 Procedural rulemakings,” as “Administrative and Routine Actions Excepted from NEPA Review.” This change in title was based on the Fiscal Responsibility Act of 2023 and its amendment to the definition of “major Federal action” in NEPA section 111(10). 42 U.S.C. 4336e. Therefore, DOE has no obligation to review the final rule pursuant to NEPA because this action is within the scope of the now retitled appendix A.

Regarding the NEPA applicability to applications for electricity export authorization, DOE's NEPA Implementing Procedures maintains the longstanding “Appendix B Categorical Exclusions Applicable to Specific Agency Actions.” Both the prior and current versions of appendix B identify “B4.2 Export of Electric Energy” (CX B4.2). CX B4.2 applies to the export of electric energy as provided by section 202(e) of the FPA over existing transmission systems or using transmission system changes that are themselves categorically excluded as a category of actions which do not normally have a significant effect on the human environment. DOE's NEPA review of proposed export authorizations will continue unchanged pursuant to this updated procedural regulation.

In this final rule, DOE has decided to include two editorial revisions to the text of 10 CFR 205.300 to more clearly implement the Department's goal of burden reduction and align with the FPA.

In the NOPR, DOE referred to an “ entity subject to DOE jurisdiction under part II of the Federal Power Act.” However, FPA section 202(e) refers to “a person” applying to transmit electric energy from the United States. Therefore, this final rule adopts the language “a person” rather than “an entity subject to DOE.” This updated text does not alter the scope of the rule or the requirements for export applicants and appropriately aligns with statutory language.

Additionally, the NOPR included the following sentence in the proposed regulatory text of 10 CFR 205.300, “DOE has a strong policy in favor of approving applications, and doing so quickly and expeditiously.” In this final rule, DOE is removing the proposed sentence because it is a policy statement and not necessarily helpful or relevant in regulatory text. Furthermore, the statement could be misleading, as the FPA requires that DOE “shall issue” export authorizations unless the export would impair the sufficiency of electric supply or impede the coordination of facilities subject to DOE.

For the reasons discussed in the preceding sections of this document, DOE is not withdrawing the May 2025 NOPR and is adopting the amendments as proposed in the May 2025 NOPR, with minor editorial revisions. The regulatory text at §§ 205.301 through 205.309 is hereby removed, and § 205.300 is hereby modified.

Section 6(a) of Executive Order (“E.O.”) 12866, “Regulatory Planning and Review,” 58 FR 51735 (Oct. 4, 1993), requires agencies to submit “significant regulatory actions” to the Office of Information and Regulatory Affairs (“OIRA”) in the Office of Management and Budget (“OMB”) for review. OIRA has determined that this regulatory action does not constitute a “significant regulatory action” under section 3(f) of E.O. 12866. Accordingly, this action was not submitted to OIRA for review under E.O. 12866.

DOE has examined this final rule and has determined that it is consistent with the policies and directives outlined in E.O. 14154 “Unleashing American Energy,” E.O. 14192, “Unleashing Prosperity Through Deregulation,” and Presidential Memorandum, “Delivering Emergency Price Relief for American Families and Defeating the Cost-of-Living Crisis.” This final rule is an E.O. 14192 deregulatory action because it reduces cost by reducing hours applicants will spend preparing export authorization applications for submission to DOE. DOE further estimates that on average, the Department. receives about 20 applications per year and by eliminating the $500 application fee, this action will result in a burden reduction of approximately $10,000 per year.

The Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) requires preparation of an initial regulatory flexibility analysis (“IRFA”) and a final regulatory flexibility analysis (“FRFA”) for any rule that by law must be proposed for public comment, unless the agency certifies that the rule, if promulgated, will not have a significant economic impact on a substantial number of small entities. As required by E.O. 13272, “Proper Consideration of Small Entities in Agency Rulemaking,” 67 FR 53461 (Aug. 16, 2002), DOE published procedures and policies on February 19, 2003, to ensure that the potential impacts of its rules on small entities are properly considered during the rulemaking process. 68 FR 7990. DOE has made its procedures and policies available on the Office of the General Counsel's website ( www.energy.gov/gc/office-general-counsel).

DOE reviewed this final rule under the provisions of the Regulatory Flexibility Act and the policies and procedures published on February 19, 2003. This final rule reduces regulatory requirements for export authorization order applications so that less time is needed to prepare applications. This final rule will reduce time needed to prepare applications, meaning that applicant exporters will have additional time to devote to other matters. This time savings will provide a minor economic benefit to all applicants. Therefore, DOE concludes that the impacts of the rule would not have a “significant economic impact on a substantial number of small entities,” and that the preparation of an FRFA is not warranted. DOE will transmit this certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).

This final rule imposes no new information collection requirements subject to the Paperwork Reduction Act and OMB clearance is not required. (44 U.S.C. 3501 et seq. ).

Pursuant to the National Environmental Policy Act of 1969 (“NEPA”), DOE has analyzed this final rule in accordance with NEPA and DOE's NEPA implementing regulations (10 CFR part 1021). As discussed in section II, the final rule is a procedural rule and is exempted from NEPA review, per the DOE NEPA Implementing Procedures, appendix A, specifically “A6 Procedural rulemakings.”

Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have federalism implications. The Executive order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735.

DOE has examined this final rule and has determined that it would not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, no further action is required by Executive Order 13132.

With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (February 7, 1996), imposes on Executive agencies the general duty to adhere to the following requirements: (1) eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. With regard to the review required by section 3(a), section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this final rule meets the relevant standards of Executive Order 12988.

Title II of the Unfunded Mandates Reform Act of 1995 (“UMRA”) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect them. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820. DOE's policy statement is also available at www.energy.gov/sites/prod/files/gcprod/documents/umra_97.pdf.

DOE examined this final rule according to UMRA and its statement of policy and determined that the final rule does not contain a Federal intergovernmental mandate, nor is it expected to require expenditures of $100 million or more in any one year by State, local, and Tribal governments, in the aggregate, or by the private sector. As a result, the analytical requirements of UMRA do not apply.

Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This final rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.

Pursuant to E.O. 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 18, 1988), DOE has determined that this final rule would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.

Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for Federal agencies to review most disseminations of information to the public under information quality guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). Pursuant to OMB Memorandum M-19-15, Improving Implementation of the Information Quality Act (April 24, 2019), DOE published updated guidelines which are available at: www.energy.gov/cio/department-energy-information-quality-guidelines. DOE has reviewed this final rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.

Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy, or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.

The final rule amends specific sections of 10 CFR 205.300 to reduce regulatory burden and remove out of date requirements. By amending the regulations, the final rule allows applicants to include the information the applicant deems relevant to DOE's consideration for making any authorizations under the Federal Power Act. This final rule is a non-significant regulatory action under E.O. 12866 and will not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as such by the Administrator at OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.

As required by 5 U.S.C. 801, DOE will submit to Congress a report regarding the issuance of this final rule prior to the effective date set forth at the outset of this rule. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).

The Secretary of Energy has approved publication of final rule.

This document of the Department of Energy was signed on June 16, 2026, by Catherine Jereza, Assistant Secretary, Office of Electricity, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

For the reasons set forth in the preamble, DOE amends part 205 of Chapter II of title 10, Code of Federal Regulations, as set forth below:

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 establishes Class E airspace extending upward from 700 feet above the surface at Lane Airpark, Rosenberg, TX, to support IFR operations at this airport.

The FAA published an NPRM for Docket No. FAA-2026-4093 in the Federal Register (91 FR 20598; April 17, 2026) proposing to establish Class E airspace at Lane Airpark, Rosenberg, TX. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. Three comments were received. Two comments were duplicates supporting the proposal based on its safety benefits. Last, one anonymous comment was received opposing the proposal, claiming that it is unnecessary and increases costs and burdens for regulated parties. Pursuant to FAA Order JO 7400.2R, Section 18-2-3, the airspace designation is necessary to contain instrument flight procedures (IFPs) that have been developed for the affected airport, which are not protected by other controlled airspace. Although the designation of Class E airspace could result in costs or burdens for regulated parties, these have been determined to be de minimis.

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

This action modifies 14 CFR part 71 by establishing Class E airspace extending upward from 700 feet above the surface within a 6.5-mile radius of Lane Airpark, Rosenberg, TX. This action is the result of instrument procedures being developed for this airport to support IFR operations.

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), which categorically excludes from further environmental impact review rulemaking actions that designate or modify classes of airspace areas, airways, routes, and reporting points (see 14 CFR part 71, Designation of Class A, B, C, D, and E Airspace Areas; Air Traffic Service Routes; and Reporting Points); and paragraph B-2.5(k), which categorically excludes from further environmental impact review the publication of existing air traffic control procedures that do not essentially change existing tracks, create new tracks, change altitude, or change concentration of aircraft on these tracks. As such, this action is not expected to result in any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant 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 simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples into class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness of the device. In addition, we believe this action will enhance patients' access to beneficial innovation, in part by reducing regulatory burdens by placing the device into a lower device class than the automatic class III assignment.

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

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

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

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

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

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

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

On July 8, 2022, FDA received InBios International, Inc.'s request for De Novo classification of the Active Anthrax Detect Plus Rapid 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 February 3, 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 866.3046. 1 We have named the generic type of device “simple in vitro diagnostic device for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples,” and it is identified as a prescription in vitro diagnostic device used to detect and presumptively identify B. anthracis and other Bacillus spp. in human clinical samples as an aid in the diagnosis of anthrax and other diseases caused by Bacillus spp. This device is simple to use and does not involve sample manipulation or measurement of an analyte that could be affected by conditions such as sample turbidity or cell lysis. This device may be used to aid in the presumptive diagnosis of anthrax in individuals who have signs and symptoms consistent with anthrax and a likelihood of exposure. Bacillus infections include anthrax (cutaneous, inhalational, or gastrointestinal) caused by B. anthracis, gastrointestinal disease, non-gastrointestinal infections, and an anthrax-like illness caused by B. cereus.

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, simple in vitro diagnostic devices for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples are for prescription use only. Therefore, these devices are subject to the prescription labeling requirements for in vitro diagnostic (IVD) products (see 21 CFR 809.10(a)(4) and (b)(5)(ii)).

Under the FD&C Act, submission of a premarket notification under section 510(k) is required to reasonably assure the safety and effectiveness of class II devices unless FDA determines that the device type should be exempt under section 510(m) of the FD&C Act. At this time FDA has not made this determination for simple IVD devices for the detection of secreted proteins from Bacillus species (spp.) in human clinical samples. 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 endoscopic light-projecting measuring 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 August 9, 2021, FDA received RQMIS Inc.'s request for De Novo classification of the AccuMeasure System. FDA reviewed the request in order to classify the device under the criteria for classification set forth in section 513(a)(1) of the FD&C Act.

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

Therefore, on July 26, 2022, 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 876.1530. 1 We have named the generic type of device “endoscopic light-projecting measuring device,” and it is identified as a device that projects light on a mucosal surface and uses software to determine the dimensions of observable features of interest.

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

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order. FDA supports the principles of the “3Rs,” to replace, reduce, and/or refine animal use in testing when feasible. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method.

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 endoscopic light-projecting measuring 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 876 is amended as follows:

Upon request, FDA (the Agency or we) has classified the endoscopic traction 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 January 14, 2022, FDA received Covidien LLC's request for De Novo classification of the ProdiGI 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 13, 2022, 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 876.4410. 1 We have named the generic type of device “endoscopic traction device,” and it is identified as a prescription device that is endoscopically applied to retract tissue in the gastrointestinal tract during dissection procedures to increase visualization of the dissection plane and assist in tissue resection, exposure, and removal.

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

FDA has determined that special controls, in combination with the general controls, address these risks to health and provide reasonable assurance of safety and effectiveness of the device. For a device to fall within this classification, and thus avoid automatic classification in class III, it would have to comply with the special controls named in this final order. The necessary special controls appear in the regulation codified by this final order. FDA supports the principles of the “3Rs,” to replace, reduce, and/or refine animal use in testing when feasible. We encourage sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible. We will consider if such an alternative method could be assessed for equivalency to an animal test method.

At the time of classification, endoscopic traction 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 endoscopic traction 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 876 is amended as follows:

Subject to OSM's oversight, section 503(a) of SMCRA permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the West Virginia program on January 21, 1981. You can find additional background information on the West Virginia program, including the Secretary's findings, the disposition of comments, and conditions of approval of the West Virginia program in the January 21, 1981, Federal Register (46 FR 5915). You can also find later actions concerning West Virginia's program and program amendments at 30 CFR 948.10, 948.12, 948.13, 948.15, and 948.16.

In 2011, the West Virginia Legislature passed revisions to WVSCMRA and the state regulations through Senate Bill 121 (SB 121) (March 11, 2011) and House Bill 2955 (HB 2955) (approved March 18, 2011). See 2011 W. Va. Acts Chs. 109 and 166. SB 121 codified several revisions to the CSR, establishing an incremental bonding rate that we approved on an interim basis in 2011, see 76 FR 37996 (June 29, 2011), revising provisions to accommodate electronic permit filing, establishing trust funds and annuities as an alternative to traditional performance bond for long-term water treatment, and making other miscellaneous revisions discussed below. HB 2955 established or revised several permit-related fees that we approved in our 2011 interim rule.

By letter dated April 21, 2011 (Administrative Record Number WV-1557), the West Virginia Department of Environmental Protection (WVDEP) submitted to us a program amendment, which we docketed at SATS No. WV-117-FOR, that included the permit fee revisions from HB 2955, along with the revisions to the CSR from SB 121 that established the incremental bonding rate. HB 2955 increased the filing fee for the State's surface mining permit to $3,500, increased the permit renewal fee to $3,000, and established various fees for other permit-related actions like significant permit revisions and notices of intent to prospect. We approved the increase in permit fees on an interim basis. In our interim approval on June 29, 2011, we requested public comments and provided an opportunity for a public hearing on the permit fees and incremental bonding rate revisions (Administrative Record No. 1560). 1 West Virginia subsequently submitted, and we approved, significant revisions to its incremental bonding provisions in a program amendment, which we docketed at SATS No. WV-126-FOR. WV-129-FOR rendered the incremental bonding revision from WV-117-FOR moot. See 89 FR 19262, 19266 (Mar. 18, 2024). Therefore, we will not further address our interim approval of that revision here.

By letter dated April 25, 2011, (Administrative Record Number WV-1561), WVDEP submitted to us a program amendment, which we docketed at SATS No. WV-118-FOR, that included the remaining regulatory revisions to West Virginia's CSR authorized by SB 121. We announced receipt of the proposed amendment on November 2, 2011. 76 FR 67637. In the same notice, we opened a public comment period and provided an opportunity for a public hearing on these provisions (Administrative Record Number WV-1573). The public comment period closed on December 2, 2011. We received comments from three Federal agencies, which we address in detail below. We also approved West Virginia's new rule at CSR 38-2-11.3.f (regarding trust funds and annuities for long-term postmining pollutional discharges) in our 2024 decision on WV-126-FOR, referenced above. See 89 FR 19265-66. Therefore, we will not further address that rule here.

We are making the following findings concerning these amendments, as required by SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving the amendment as described below. Any revisions not specifically discussed, such as replacing the term “Director” with the term “Secretary” to reflect an earlier agency reorganization, are non-substantive editorial changes that do not render the West Virginia program any less effective at meeting the requirements of SMCRA and the Federal regulations. We also subsequently clarified with WVDEP that several of the revisions use the word “proscribed” when they should have used “prescribed,” and that WVDEP implements them accordingly. We found that the intended terms are clear enough from their context that we consider them typographical errors that do not compromise WVDEP's implementation of the regulations as intended. As described in more detail below, we approve the provisions we initially approved in our 2011 interim rule (76 FR 37996), as well as other miscellaneous revisions. The amendment can be viewed in its entirety at www.regulations.gov.

West Virginia revised subsection (b)(2) by adding new language establishing a fee of $2000 for filing of a notice of intent to prospect and renumbering the existing provision as subsection (b)(3). Under West Virginia law, any person who intends to prospect for coal must first file a notice of intent to prospect with WVDEP. Before this amendment, the statute required the submission of a notice of intent to prospect but did not require a filing fee for that notice.

OSM's Finding: Section 512 of SMCRA, 30 U.S.C. 1262, governs coal exploration activities and requires States with approved regulatory programs to establish certain minimum requirements for coal exploration operations that substantially disturb the natural land surface. The Federal regulations at 30 CFR part 772 implement section 512, elaborating on section 512's minimum requirements and providing necessary procedural controls. Neither section 512 of SMCRA nor the Federal regulations address fees related to coal exploration activities. However, they do not prohibit States from establishing reasonable filing fees associated with the notice of intent to explore. Section 512(a) of SMCRA specifically requires that each regulatory authority include certain enumerated minimum requirements for their coal exploration programs, indicating that each State retains the discretion to include additional requirements above the minimum. West Virginia's proposed fee to cover the cost of administering and enforcing coal exploration activities related to a particular notice of intent is an additional requirement within its discretion to impose.

West Virginia's revision to W. Va. Code § 22-3-7(b) does not alter the substantive requirements governing coal exploration activities and does not reduce the State's authority to regulate coal exploration activities. Accordingly, we approve the revision because we find that it is in accordance with SMCRA and does not render W. Va. Code § 22-3-7 less effective than the Federal regulations at meeting SMCRA's requirements.

West Virginia revised subsection (a)(4) to increase the fee for a new surface mining permit application from $1,000 to $3,500.

OSM's Finding: Section 507(a) of SMCRA, 30 U.S.C. 1257(a), and 30 CFR 777.17, require that an application for a surface coal mining and reclamation permit must be accompanied by a fee determined by the regulatory authority that must not exceed the cost of reviewing, administering, and enforcing the permit. The Federal regulations set fees for permit applications under the Federal program, see 30 CFR 736.25, but do not prescribe fees in primacy States.

West Virginia increased its permit application fee from $1,000 to $3,500, which we find to be an amount that does not exceed West Virginia's cost of reviewing, administering, and enforcing the permits. The amendment neither alters the substantive requirements for obtaining a permit nor limits the State's authority to adjust the fees later to ensure they are sufficient to cover the cost of reviewing, administering, and enforcing the permits without exceeding that amount.

We find that West Virginia's revision to subsection (a)(4) is in accordance with SMCRA and as effective as the Federal regulations at meeting the requirements of SMCRA, and we therefore approve it.

West Virginia revised subsection (a)(4) to increase the filing fee for a permit renewal application from $2,000 to $3,000; revised subsection (b)(2) to establish a $500 filing fee for applications for significant permit revisions; revised subsection (b)(3) to establish a $500 filing fee for applications to extend an area covered by an existing permit; revised subsection (d) to establish a $1,500 filing fee for applications for the transfer, assignment or sale of the rights granted under an existing permit; and added a new subsection (e) to establish a $2,000 filing fee for each request for inactive status.

OSM's Finding: As discussed above, section 507(a) of SMCRA, 30 U.S.C. 1257(a), and the implementing regulations at 30 CFR 777.17, require that permit applications must be accompanied by a fee determined by the regulatory authority that does not exceed the cost of reviewing, administering, and enforcing the permit. The Federal regulation at 30 CFR 777.17 specifies that the costs used by the regulatory authority to set the fee may be actual or anticipated costs, and that the regulatory authority may develop procedures to allow the fee to be paid over the term of the permit.

We find that the permit-related fees that West Virginia revised or established in W. Va. Code § 22-3-19 are derivative of, and supported by, the requirement under section 507(a) of SMCRA. The new or revised fees account for costs from additional review, administration, and enforcement made necessary by subsequent requests by the permittee and constitute a procedure for paying over the term of the permit potential fees that the regulatory authority could otherwise estimate and account for in the initial permit application fee.

We therefore find that the revisions are in accordance with SMCRA and do not render W. Va. Code § 22-3-19 less effective than the Federal regulations at meeting the requirements of SMCRA, and therefore we approve them.

We are making the following findings about West Virginia's amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. We are approving WV-118-FOR with certain understandings as described below. The full text of the program amendment is available for review at https://www.regulations.gov.

West Virginia revised CSR 38-2-3.1.c.4., which requires applicants to provide the Federal or State permit number and an identification number issued by the Federal Mine Safety and Health Administration (MSHA), with the date of its issuance, under which each owner or controller of the applicant owned or controlled any other surface coal mining operation in the United States within five years preceding the date of application. West Virginia added language to specify that the MSHA identification number with date of issuance is required if it is available. West Virginia revised CSR 38-2-3.1.d to allow applicants to submit ownership or control information either in the permit application or in an electronic database accessible to the agency that has been updated within three months of submittal. Similarly, West Virginia revised CSR 38-2-3.1.k to allow applicants to submit violation information either in the permit application or in an electronic database accessible to the agency that has been updated within three months of submittal.

OSM's Finding: The Federal regulations at 30 CFR 778.12(a) require that permit applicants include all names under which the applicant, the operator, and any partners or principal shareholders of either, operate or previously operated a surface coal mining operation five years preceding the application. This provision does not require anything more than the names. Subsection (c)(4) of that rule requires the Federal or State permit number and corresponding MSHA number for those operations. Subsection (c)(4) formerly required the date of issuance of the MSHA number, but we deleted that part of the Federal requirement in 2000 after finding that it had no practical value in implementing SMCRA. See 65 FR 79582, 79644 (Dec. 19, 2000).

West Virginia's rule, as revised, does not distinguish between the availability of the MSHA number and the date of its issuance. We understand that the date of issuance may not always be available to the applicant but that is not the case for the MSHA number. Nonetheless, we approve West Virginia's revision because it does not render the requirement to provide the MSHA number optional, it only acknowledges that the “MSHA number with date of issuance” may not be available, and in those cases where the date of issuance is not available, the applicant must submit the MSHA number. Accordingly, we approve the revision to CSR 38-2-3.1.c.4.

West Virginia's revisions to paragraphs d and k, section 507(b) of SMCRA (30 U.S.C. 1257(b)), and the Federal implementing regulations at 30 CFR 778.12 require that permit applications include information about ownership or control of the applicant, and section 510 of SMCRA (30 U.S.C. 1260) and the Federal implementing regulations at 30 CFR 778.14 require that an applicant include relevant violation history. These provisions ensure that the regulatory authority has sufficient information to evaluate the applicant's compliance history and eligibility for a permit. Relatedly, the Federal regulations at 30 CFR 773.6(d) require that, with some limited exceptions, all applications for permits, revisions, renewals, and transfers, assignments, or sales of permit rights on file with the regulatory authority must be available at reasonable times for public inspection and copying.

West Virginia's proposed amendment allows ownership or control information to be submitted in an electronic database accessible to the agency, rather than solely within the permit application itself. OSM sought clarification from WVDEP about how ownership or control information and violation history submitted in an electronic database would be made available for public review, and WVDEP confirmed that such information is considered part of the permit application and is made available during the public comment period. It is our understanding that by “electronic database accessible to the agency,” West Virginia's regulation refers to an electronic version of the centralized ownership and control files that are maintained by related permittees, which we approved in 1996. See 61 FR 6511 (Feb. 21, 1996). We also understand that WVDEP can run reports of the information upon request. Therefore, we approve these revisions based on the understanding that WVDEP considers the information submitted in an electronic database part of the permit application and will make that information available to the public both during the public comment period and afterward in compliance with 30 CFR 773.6. With this condition, West Virginia's proposal to have an applicant separately submit the required information through an electronic database accessible to WVDEP does not make the State program less effective than the Federal regulations and meets the requirements of SMCRA. Therefore, we approve the revisions to CSR 38-2-3.1.d and 3.1.k with the understanding described above.

West Virginia revised CSR 38-2-3.2.a to replace the phrase “administratively complete” with “technically complete” in describing a complete permit application that then require advertisement and public comment.

OSM's Finding: West Virginia submitted this proposed change to us as part of its original program amendment package that we docketed as WV-118-FOR, but West Virginia later withdrew it. Based on comments received during the State's public comment period, WVDEP determined that this revision should not be included in the final rule, as indicated in a letter dated September 7, 2011, to the West Virginia Secretary of State (Administrative Record Number WV-1569). Accordingly, we do not consider this revision as part of the amendment under consideration, and we do not make any determination on it. However, WVDEP also noted that the version it had filed as final nonetheless contained the revision, but that WVDEP intends to correct it. The most recent version of West Virginia's regulations publicly available on its website contains this revision, referencing that the applicant “shall submit a technically complete surface mining permit application.” This creates a minor incongruity with the separate provision about technical completeness at CSR 38-2-3.2.g, which should be corrected, but we have not, through the course of our regular oversight, identified any issues with WVDEP implementing these distinct provisions as intended.

West Virginia revised CSR 38-2-3.4.b to allow maps to be submitted in either paper or electronic format and to specify that such maps must be in a format prescribed by the Secretary.

OSM's Finding: Sections 507 and 508 of SMCRA, 30 U.S.C. 1257 and 1258, and the Federal implementing regulations at 30 CFR 777.14, 779.24, and 783.24, require that permit applications include maps and plans sufficient to describe the proposed mining operations and related manmade and environmental features. These provisions do not prescribe the format of the maps beyond their scale and specific contents, leaving discretion with the regulatory authority to establish requirements for the format of such materials. Because West Virginia's revisions simply authorize WVDEP to prescribe the format of the maps and allow applicants to submit electronic versions so long as they are capable of being printed on appropriately sized paper, which are both well within the State's discretion, we find that the revisions do not render CSR 38-2-3.4 less effective than the Federal regulations at meeting the requirements of the Act, and we approve them.

West Virginia revised CSR 38-2-3.12.a.2.B to provide that pre-subsidence surveys of non-commercial buildings or residential dwellings and associated structures will be confidential and used only to evaluate damage related to subsidence. The revision also requires that WVDEP develop a procedure for assuring that surveys remain confidential.

OSM's Finding: Sections 507, 508, and 515 of SMCRA, 30 U.S.C. 1257, 1258, and 1265, and the Federal implementing regulations at 30 CFR 784.20 (Subsidence control plan), require that permit applications include certain information to evaluate the potential impacts of subsidence, including to structures and water supplies. In 1995, we added a requirement at 30 CFR 784.20(c) that permit applicants submit a survey of the condition of all non-commercial buildings or occupied residential dwellings within the area encompassed by the “applicable angle of draw” that may be materially damaged or for which the reasonably foreseeable use may be diminished by subsidence. This provision was later vacated in National Mining Association v. Babbitt, 172 F.3d 906 (D.C. Cir. 1999). As a result, we suspended 30 CFR 784.20(a)(3) relating to such surveys, while the rule remained in effect for water supplies and technical assessments or engineering evaluations necessarily related thereto. See 64 FR 71652, 71653 (Dec. 22, 1999) (OSM's final rule suspending regulations in part).

West Virginia, however, maintains the requirement for a survey of the condition of non-commercial buildings and residential dwellings and related structures under CSR 3.12.a.2., subject to the exemptions in subparagraphs A and B and the conditions specified therein. Due to the suspension of the Federal rule, West Virginia's inclusion of the rule and the conditions West Virginia subjects it to are at West Virginia's discretion as a more stringent State rule, which section 505 of SMCRA, 30 U.S.C. 1255, expressly allows. Therefore, West Virginia's revision to limit the availability and use of this State-required pre-subsidence survey of the condition of non-commercial buildings and residential dwellings is likewise within its discretion and does not make the State program less stringent than SMCRA nor less effective than the Federal regulations at meeting SMCRA's requirements. Accordingly, we approve the revision to CSR 38-2-3.12.a.2.B.

West Virginia revised CSR 38-2-3.15.b.3 to require that persons approved by WVDEP as authorized to prepare, sign, or certify permit applications, maps, plans, and design specifications or other similar materials necessary to complete an application, must be capable of submitting maps, plans, and all other technical data electronically in a format prescribed by the WVDEP.

OSM's Finding: West Virginia made earlier revisions to this and other paragraphs of this rule about approved persons, which we docketed at SATS No. WV-116-FOR and recently approved. See 90 FR 55658, 55659-60 (Dec. 3, 2025). As we explained in that decision, no direct Federal counterpart law or regulation creates a category of “approved persons” authorized to submit permit application materials. However, the Federal regulations at 30 CFR 777.11 explicitly give the regulatory authority broad discretion to prescribe the format of permit applications and related materials. We find that, by necessary extension of that rule, West Virginia is acting within its discretion to require that approved persons must be capable of submitting such materials in the required format. Accordingly, we approve the revision to CSR 38-2-3.15.b.3.

West Virginia revised CSR 38-2-14.11.h to allow WVDEP to grant inactive status for coal refuse sites for periods exceeding the 10-year maximum that is set under paragraph g of the rule, provided that that the permittee furnish and maintain a bond equal to the estimated actual reclamation cost, as determined by WVDEP, which remains in effect for the life of the operation. The regulation also required WVDEP to review the estimated actual reclamation cost at least every two and a half years.

OSM's Finding: West Virginia subsequently made additional revisions to this and other paragraphs of this rule about operations in an inactive status, which we docketed at SATS No. WV-124-FOR and recently approved. See 90 FR 55649, 55651-52 (Dec. 3, 2025). As we explained in that decision, the Federal regulations at 30 CFR 816.131 and 817.131 require that a permittee who is seeking inactive status must submit to the regulatory authority a notice of its intention to cease or abandon mining and reclamation operations, include a statement of the exact number of acres that will have been affected in the permit area, the extent and kind of reclamation of those areas that will have been accomplished, and identify the backfilling, regrading, revegetation, environmental monitoring, and water treatment activities that will continue during the temporary cessation. The Federal regulations do not impose a particular maximum duration on temporary cessation, but we note that they require each permittee to effectively secure the facilities and they explain that temporary cessation does not relieve a person of their obligation to comply with any provisions of the permit. Like our decision in WV-124-FOR, West Virginia's revision here does not alter the other requirements for inactive status, particularly those in CSR 14.11.a.1 through .a.9, including that the site remain in full compliance with all standards of the approved West Virginia program and permit. Accordingly, we approve the revision to CSR 38-2-14.11.h.

West Virginia revised CSR 38-2-20.4.a, relating to orders requiring a permittee to show cause why a permit should not be suspended or revoked, to require that WVDEP provide email notification of the issuance of show cause orders to members of the public who have subscribed to the WVDEP's email notification service, and to notify persons whose citizen complaints resulted in enforcement actions leading to the issuance of a show cause order.

OSM's Finding: Section 521 of SMCRA, 30 U.S.C. 1271, and the implementing regulations at 30 CFR 843.14, govern how OSM serves notices of violation and related enforcement actions, including show cause orders. Subsection (c) of the Federal rule provides that OSM must furnish copies of the orders to the State regulatory authority promptly after their issuance and may furnish copies to persons having an interest in the operation or permit area. Because West Virginia's revision requires notification to two groups of people who West Virginia believes may have an interest—those who have subscribed to WVDEP email notification service and those who filed complaints that led to the show cause order—West Virginia's provision is more stringent than its Federal counterpart at 30 CFR 843.14(c), which permits OSM to notify interested persons, but does not require it. Section 505 of SMCRA, 30 U.S.C., 1255, expressly allows States to provide more stringent requirements. Further, should a permittee file an answer to the show cause order, West Virginia's regulation at CSR 38-2-20.4.e. still requires public notice of the subsequent public hearing and notification to any interested parties who request intervenor status, in conformance with the Federal requirements at 30 CFR 843.13(b). Accordingly, we approve the revision to CSR 38-2-20.4.a.

The State amended multiple provisions throughout its regulations to replace the phrase “licensed land surveyor” with “professional surveyor” to clarify that surveyors must be certified and licensed in the State of West Virginia.

OSM's Finding: In 1983, Congress amended section 507of SMCRA, 30 U.S.C. 1257, to authorize qualified registered professional land surveyors to prepare and certify maps, plans, and cross sections for surface mining and reclamation permits in any State which authorizes land surveyors to prepare and certify such maps or plans. See 79 FR 16194 (Apr. 24, 1985).

Neither SMCRA nor the Federal regulations define “qualified registered professional” or elaborate on the relationship between those adjectives. However, in a 1988 rulemaking related to impoundments, we explained that we “consider it important to apply the minimum safety factor requirement and the requirement that the individuals certifying impoundment design and construction be licensed as professionally qualified.” 53 FR 43584, 43593 (Oct. 27, 1988). We also explained that we “must rely on State licensing authorities to ensure that land surveyors are authorized to perform only those design certifications that they are qualified to perform in consideration of their background, training and experience.” Id. at 43600. For its part, West Virginia rewrote its statute about the professional licensing of land surveyors in 2010, and at W. Va. Code 30-13A-3(gg) defined “surveyor”, “professional surveyor”, or “land surveyor” to mean a person licensed to practice surveying under the provisions of that statute. Moreover, WVDEP then ensured that the professional surveyor is qualified to perform the functions authorized under SMCRA through its “approved person” regulations at CSR 38-2-3.15. Therefore, we find that West Virginia's revisions have no effect on its approved program, which remains no less stringent than SMCRA and no less effective as the Federal regulations at meeting the requirements of the Act. Accordingly, we approve the amendments to CSR 38-2-3.15.a; 3.15.b.1; 4.2.a.7; 4.10.a.1; 4.12; 5.4.d.2; 5.4.d.3; 5.4.e.1; 5.4.e.3; 7.5.b.11; 7.5.g.1.A; and 7.5.g.2.A.

We asked for public comments on the amendment but received no comments in response to our request.

On June 30, 2011, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the West Virginia Program (Administrative Record No. WV-1563). We attached to our letters copies of our 2011 interim rule (76 FR 37996).

OSM received responses from the Natural Resources Conservation Service of the U.S. Department of Agriculture (NRCS), and the U.S. Army Corp of Engineers, Pittsburgh District (USACE), each stating they had no comments. See Administrative Record No. WV-1564 (NRCS), and Administrative Record No. WV-1568 (USACE).

On July 7, 2011, the Department of Energy (DOE) responded with two comments (Administrative Record No. 1565). The first comment addressed the proposed fee structure. DOE stated that the increase in the new fee structure for large coal operators is very small on a per-ton expense because of the large volume of coal produced. However, DOE felt that the smaller coal operators would be disadvantaged by the larger increase in cost per ton. DOE also expressed concerns like those voiced by the coal industry about the length of time it takes for the WVDEP to issue permitting actions. DOE feels that regulators should expedite the permit process for review and approval to the extent practicable and that a predictable timeframe for response from WVDEP would alleviate this concern. However, the revisions included in this amendment do not pertain to the permitting process timeline, and therefore we will not address that comment further.

We provided DOE's comments to WVDEP for consideration. However, we note that nothing in SMCRA requires that the permit fee rates reflect the coal production of the applicant, as suggested by DOE. Furthermore, West Virginia's fee revisions are only the second time that the State has increased its permit fees since we conditionally approved its program in 1981, and we find that the proposed permit fees are reasonable based on the amount of time that is required to review and approve such permit applications.

Under Federal regulations at 30 CFR 732.17(h)(11)(ii), we are required to get written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). We determined that none of the proposed State revisions in WV-117 pertain to air or water quality standards. Therefore, we did not ask EPA to concur on this amendment. However, on June 30, 2011, under 30 CFR 732.17(h)(11)(i), we requested comments from EPA on the amendment (Administrative Record No. WV-1563).

On August 2, 2011, EPA responded with comments (Administrative Record No. WV-1567). EPA submitted comments concerning sufficient bonding to cover land reclamation, including protection of the hydrologic balance and water quality. EPA noted that the State's increased amount for incremental bonding appeared limited to land reclamation and was unable to affirm that the increased bond amount would be sufficient to ensure reclamation of the hydrologic balance and water quality at all sites.

As we explain in Part II.A, above, West Virginia subsequently submitted, and we approved, significant revisions to its incremental bonding provisions in a program amendment we docketed at SATS No. WV-126-FOR that rendered the incremental bonding revision from WV-117-FOR moot. See 89 FR at 19266. Therefore, we will not further address EPA's comment on that revision other than to reiterate that the State's existing alternative bonding requirements are intended to provide sufficient funds to comply with all applicable provisions of SMCRA and the CWA.

Under Federal regulations at 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On June 30, 2011, we requested comments on West Virginia's amendment (Administrative Record No. WV1563), but we did not receive any comments from the SHPO or ACHP.

We asked for public comments on the amendment but received no comments in response to our request.

On September 22, 2011, under 30 CFR 732.17(h)(11)(i) and section 503(b) of SMCRA, we requested comments on the amendment from various Federal agencies with an actual or potential interest in the West Virginia Program (Administrative Record No. WV-1570).

OSM received responses from the Natural Resources Conservation Service of the U.S. Department of Agriculture (NRCS), the U.S. Army Corp of Engineers, Pittsburgh District (USACE), and the Mine Safety and Health Administration (MSHA), each stating they had no comments. See Administrative Record No. WV-1572 (NRCS), Administrative Record No. WV-1571 (USACE), and Administrative Record No. WV-1575) (MSHA).

Under Federal regulations at 30 CFR 732.17(h)(11)(ii), we are required to get written concurrence from EPA for those provisions of the program amendment that relate to air or water quality standards issued under the authority of the Clean Water Act (33 U.S.C. 1251 et seq. ) or the Clean Air Act (42 U.S.C. 7401 et seq. ). We determined that none of the proposed State revisions in WV-118 pertain to air or water quality standards. Therefore, we did not ask EPA to concur on this amendment, and EPA provided no comments.

Under Federal regulations at 30 CFR 732.17(h)(4), we are required to request comments from the SHPO and ACHP on amendments that may have an effect on historic properties. On September 22, 2011, we requested comments on West Virginia's amendment (Administrative Record Number WV-1570), but we did not receive any comments from the SHPO or ACHP.

Based on the above findings, we are approving the amendments sent to us by WVDEP on April 21 and April 25, 2011 (Administrative Record Numbers WV-1557 and WV-1561). However, as discussed in Finding 1 above, we are approving CSR 38-2-3.1.d and CSR 38-2-3.1.k with the understanding that ownership or control information and violation information submitted electronically will be considered part of the permit application, and such information will be made available to the public for review during the public comment period. If, in future oversight reviews, we should determine that the State is applying these provisions inconsistently with these findings, other amendments may be required.

As we discussed above, we are taking no action on West Virginia's original proposal about administratively complete applications because West Virginia withdrew it. Further, we reiterate that we are approving on a permanent basis, revisions to the State's permitting statutory fees at WVSCMRA §§ 22-3-7(b), 8(a)(4) and 19(a)(4), (b)(2), (b)(3), (d) and (e). To implement these decisions, we are amending the Federal regulations at 30 CFR part 948 which codify decisions concerning the West Virginia program. In accordance with the Administrative Procedure Act, this rule will take effect 30 days after the date of publication.

This rule would not result in a taking of private property or otherwise have taking implications that would result in public property being taken for government use without just compensation under the law. Therefore, a takings implication assessment is not required. This determination is based on an analysis of the corresponding Federal regulations.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance dated October 12, 1993, the approval of State program amendments is exempted from OMB review under Executive Order 12866.

The Department of the Interior has reviewed this rule as required by section 3 of Executive Order 12988. The Department determined that this Federal Register document meets the criteria of section 3 of Executive Order 12988, which is intended to ensure that the agency review its legislation and proposed regulations to eliminate drafting errors and ambiguity; that the agency write its legislation and regulations to minimize litigation; and that the agency's legislation and regulations provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Because section 3 focuses on the quality of Federal legislation and regulations, the Department limited its review under this Executive order to the quality of this Federal Register document and to changes to the Federal regulations. The review under this Executive order did not extend to the language of West Virginia regulatory program or amendment that West Virginia drafted.

This rule has potential federalism implications as defined under section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. West Virginia, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the State level. This rule approves an amendment to the West Virginia program submitted and drafted by the State and thus is consistent with the direction to provide maximum administrative discretion to States.

The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on the distribution of power and responsibilities between the Federal Government and Tribes.

The basis for this determination is that our decision on the West Virginia program does not include Indian lands as defined by SMCRA or other Tribal lands, and it does not affect the regulation of activities on Indian lands or other Tribal lands. Indian lands under SMCRA are regulated independently under the applicable Federal Indian program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the State proposing the amendment encompasses ancestral lands in areas with mineable coal. We are currently working to identify and engage appropriate Tribal stakeholders to devise a constructive approach for consulting on these amendments.

Executive Order 13211 requires agencies to prepare a statement of energy effects for a rulemaking that is (1) considered significant under Executive Order 12866, and (2) likely to have a significant adverse effect on the supply, distribution, or use of energy. Because this rule is exempt from review under Executive Order 12866 and is not a significant energy action under the definition in Executive Order 13211, a Statement of Energy Effects is not required.

Consistent with sections 501(a) and 702(d) of SMCRA (30 U.S.C. 1251(a) and 1292(d), respectively) and the U.S. Department of the Interior Departmental Manual, part 516, section 13.5(A), State program amendments are not major Federal actions within the meaning of section 102(2)(C) of the National Environmental Policy Act (42 U.S.C. 4332(2)(C)).

This rule does not include requests and requirements of an individual, partnership, or corporation to obtain information and report it to a Federal agency. As this rule does not contain information collection requirements, a submission to OMB under the Paperwork Reduction Act (44 U.S.C. 3501 et seq. ) is not required.

This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The rule approves revisions to the West Virginia regulatory program under SMCRA, including revisions to certain permit-related fees. The Department of Energy commented that smaller operators will be disadvantaged by a larger fee increase on cost per ton basis compared to larger operators. However, the approved revisions primarily concern fixed administrative fees associated with discrete permitting actions under the approved State program, rather than ongoing production-based operational costs. As we note above, West Virginia's amendment is only the second time it had updated its fees since 1981, and we have not seen a significant economic impact on small operators since we approved these fees on an interim basis in 2011. Therefore, the Department has determined that this rule will not have a significant economic impact on a substantial number of small entities. To the extent some disparate economic impact exists between large and small operators, SMCRA itself authorizes the regulatory authorities to charge these fees so long as they do not to exceed the cost of reviewing, administering, and enforcing the permits.

This rule is not a major rule under 5 U.S.C. 804(2). This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to constitute a major rule.

This rule does not impose an unfunded mandate on State, local, or Tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This determination is based on an analysis of the corresponding Federal regulations, which were determined not to impose an unfunded mandate. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

For the reasons set out in the preamble, 30 CFR part 948 is amended as set forth below:

On March 17, 2026, the Coast Guard received notification that fireworks will be launched from land, over the Toms River near Beachwood, NJ. On July 4 or 5, 2026. The Captain of the Port (COTP) Delaware Bay has determined that potential hazards associated with fireworks, such as being hit by falling debris or unexploded live fireworks, are a safety concern for anyone within 250 yards of the fireworks display. Under authority in 46 U.S.C. 70034, the COTP is issuing this rule to create a safety zone to protect personnel, vessels, and the marine environment in the navigable waters within 250 yards of the display.

The Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable. The time between when the Coast Guard received notification of the event and the date the fireworks display will occur is insufficient to provide notice of a proposed rule, take comments, finalize the rule, and publish it in the Federal Register

For the same reason, the Coast Guard finds that under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

This rule establishes a safety zone which will be subject to enforcement from 9 p.m. to 10 p.m. on July 4, 2026, or on a rain date of July 5, 2026. The safety zone will cover all navigable waters of the Toms River within 250 yards of the fireworks launch location, in Mayo Park, in Beachwood, NJ in approximate position 39°56′29.25″ N, 74°10′57.78″ W. Vessels and persons will not be allowed to enter the zone during this time, unless authorized by the COTP.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

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

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

I. Table of Abbreviations CFR Code of Federal Regulations COTP Captain of the Port, Delaware Bay DHS Department of Homeland Security FR Federal Register NPRM Notice of proposed rulemaking § Section U.S.C. United States Code II. Background and Authority

On April 11, 2026, the Coast Guard received notification that fireworks will be launched from a barge on the Delaware River near Pleasant Hill Park in Philadelphia, PA. The Captain of the Port (COTP) Delaware Bay has determined that potential hazards associated with fireworks are a safety concern for anyone within 300 yards of the fireworks display. Therefore, under authority in 46 U.S.C. 70034, the COTP is creating a safety zone to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.

The Coast Guard is issuing this rule without prior notice and comment. As is authorized by 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impracticable to do so. The Coast Guard does not have enough time to solicit and respond to comments and publish a final rule by July 4, the date of the event.

For the same reason, the Coast Guard finds that under 5 U.S.C. 553(d)(3), good cause exists for making this rule effective less than 30 days after publication in the Federal Register .

This rule establishes a safety zone 9 p.m. to 9:30 p.m. on July 4, 2026. The safety zone will cover all navigable waters within 300 yards of a barge on the Delaware River located near Pleasant Hill Park, in Philadelphia, PA., in approximate position latitude 40°2′22″ N longitude 074°59′22.67″ W. Vessels and persons will not be allowed to enter the zone during this time, unless authorized by the Captain of the Port.

We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders.

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

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

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

The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because publishing an NPRM is impracticable. Prompt action is needed to ensure public safety from potential hazards associated with the launch. It is impracticable to publish an NPRM because we must establish this safety zone by the start of the IAMD LFX VS26 launch window that begins on June 30, 2026.

Also, under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because prompt action is needed to respond to the potential safety hazards associated with Operation Vigilant Sentry 26 live fire exercise, which has a launch window of June 30 through July 01, 2026.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034. The Captain of the Port (COTP), U.S Coast Guard Forces Micronesia/Sector Guam has determined that potential hazards associated with the VS26 LFX will be a safety concern for anyone beneath the designated flight path within U.S. territorial seas. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during launch operations.

This rule establishes a safety zone for the hours of 10 a.m. to 6 p.m., daily, on June 30, 2026, through July 1, 2026, to align with the VS26 LFX launch window. The safety zone will correspond with the intercept missile flight path and cover all navigable waters above and below the surface bounded by the following coordinates: 13°40′1.704″ N, 144°50′36.672″ E to 13°37′52.86″ N, 144°54′26.244″ E extending along the boundary of U.S. territorial seas until 13°51′52.332″ N, 144°57′28.618″ E and 13°49′24.06″ N 145°01′17.22″ E.

The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the launch window. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or their designated representative.

We developed this rule after considering numerous statutes and Executive Orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive Orders.

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules that are not subject to notice and comment. Because the Coast Guard has, for good cause, waived the notice and comment requirement that would otherwise apply to this rulemaking, the Regulatory Flexibility Act's flexibility analysis provisions do not apply here.

Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), if this rule will affect your small business, organization, or governmental jurisdiction and you have questions, contact the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards by calling 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.

This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

We have analyzed this rule under Executive Order 13132, Federalism, and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in that Order.

Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.

As required by The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538), the Coast Guard certifies that this rule will not result in an annual expenditure of $100,000,000 or more (adjusted for inflation) by a State, local, or tribal government, in the aggregate, or by the private sector.

We have analyzed this rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321 et seq. ), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment.

This rule involves a safety zone lasting only eight hours, daily, June 30 through July 1, 2026, that will prohibit entry within the designated boundary lines. It is categorically excluded from further review under paragraph L60a of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket.

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

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

Each State has a SIP containing the control measures and strategies used to attain and maintain the national ambient air quality standards (NAAQS). The SIP is extensive, containing such elements as air pollution control regulations, emission inventories, monitoring networks, attainment demonstrations, and enforcement mechanisms.

Each State must formally adopt the control measures and strategies in the SIP after the public has had an opportunity to comment on them and then submit the proposed SIP revisions to the EPA. Once these control measures and strategies are approved by EPA, and after notice and comment, they are incorporated into the federally approved SIP and are identified in part 52, “Approval and Promulgation of Implementation Plans,” of Title 40 of the Code of Federal Regulations (40 CFR part 52). The full text of the State regulation approved by the EPA is not reproduced in its entirety in 40 CFR part 52 but is “incorporated by reference.” This means that the EPA has approved a given State regulation or specified changes to the given regulation with a specific effective date. The public is referred to the location of the full text version should they want to know which measures are contained in a given SIP. The information provided allows the EPA and the public to monitor the extent to which a State implements a SIP to attain and maintain the NAAQS and to take enforcement action for violations of the SIP.

The SIP is a living document which the State can revise as necessary to address the unique air pollution problems in the State. Therefore, the EPA from time to time must take action on proposed revisions containing new or revised State regulations. A submission from a State can revise one or more rules in their entirety, or portions of rules. The State indicates the changes in the submission (such as by using redline/strikethrough text) and the EPA then takes action on the requested changes. The EPA establishes a docket for its actions using a unique Docket Identification Number, which is listed in each action. These dockets and the complete submission are available for viewing on www.regulations.gov.

On May 22, 1997 (62 FR 27968), the EPA revised the procedures for incorporating by reference, into the Code of Federal Regulations, materials approved by the EPA into each SIP. These changes revised the format for the identification of the SIP in 40 CFR part 52, streamlined the mechanisms for announcing the EPA approval of revisions to a SIP, and streamlined the mechanisms for the EPA's updating of the IBR information contained for each SIP in 40 CFR part 52. The revised procedures also called for the EPA to maintain “SIP Compilations” that contain the federally approved regulations and source-specific permits submitted by each State agency.

The EPA generally updates these SIP Compilations every few years. Under the revised procedures, the EPA must periodically publish an informational document in the rules section of the Federal Register notifying the public that updates have been made to a SIP Compilation for a particular State. The EPA began applying the 1997 revised procedures to the Oregon SIP on December 10, 2013 (78 FR 74012). The EPA subsequently published updates to the Oregon SIP IBR materials on April 10, 2019 (84 FR 14272), December 20, 2022 (87 FR 77720), and August 7, 2025 (90 FR 38009).

In this action, the EPA is providing notification of an update to the materials incorporated by reference into the Oregon SIP as of February 1, 2026, and identified in 40 CFR 52.1970(c) and (d). This update includes SIP materials submitted by Oregon and approved by the EPA since the last IBR update. See 90 FR 38009 (August 7, 2025). This action also corrects two typographical errors. In a previous EPA approval for the Intel Corporation, we inadvertently cited “page 11” instead of the correct citation “Permit Condition 14.” See 61 FR 37393 (July 18, 1996). In an approval of the Lane Regional Air Protection Agency (LRAPA) regulations, we inadvertently titled entry 13-005 “General Duties and Powers of Board and Director” instead of the correct title “Authority of the Agency.” See 91 FR 3821 (January 29, 2026). We are therefore correcting these typographical errors.

The EPA has determined that this action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation and section 553(d)(3) which allows an agency to make an action effective immediately (thereby avoiding the 30-day delayed effective date otherwise provided for in the APA). This administrative action simply codifies provisions which are already in effect as a matter of law in Federal and approved state programs and makes minor corrections to the CFR. Under section 553 of the APA, an agency may find good cause where procedures are “impracticable, unnecessary, or contrary to the public interest.” Public comment for this administrative action is “unnecessary” and “contrary to the public interest” since the codification (and corrections) only reflect existing law. Immediate notice of this action in the Federal Register benefits the public by providing the public notification of the updated Oregon SIP Compilation and notification of corrections to the Oregon “Identification of Plan” portion of the CFR. Further, pursuant to section 553(d)(3), making this action immediately effective benefits the public by immediately updating both the SIP Compilation and the CFR “Identification of plan” section (which includes table entry corrections).

In this document, The EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, The EPA is finalizing the incorporation by reference of regulations promulgated by Oregon previously approved by the EPA and federally effective before February 1, 2026, contained in 40 CFR 52.1970(c) and (d) as described in section I of this preamble. The EPA has made, and will continue to make, these materials generally available through www.regulations.gov and at the EPA Region 10 Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Clean Air Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve State choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves State law as meeting Federal requirements and does not impose additional requirements beyond those imposed by State law. For that reason, this action:

• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);

• Is not an Executive Order 14192 (90 FR 9065, February 6, 2025) regulatory action because this action is not significant under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq. );

• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. );

• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);

• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);

• Is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it approves a State program;

• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001); and

• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act.

In addition, this action is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the rule does not have Tribal implications and will not impose substantial direct costs on Tribal Governments or preempt Tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).

This action is subject to the Congressional Review Act, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

The EPA also believes that the provisions of section 307(b)(1) of the Clean Air Act pertaining to petitions for judicial review are not applicable to this action. This is because prior EPA rulemaking actions for each individual component of the Oregon SIP Compilation previously afforded interested parties the opportunity to file a petition for judicial review in the United States Court of Appeals for the appropriate circuit within 60 days of such rulemaking action. Thus, the EPA believes judicial review of this action under section 307(b)(1) is not available.

For the reasons set forth in the preamble, 40 CFR part 52 is amended as follows:

The Environmental Protection Agency (EPA or the Agency) is promulgating this final action to amend the hazardous chemical inventory reporting regulations at 40 CFR part 370 to conform to OSHA's Hazard Communication Standard (HCS) updates of 2012 and 2024 and to make minor updates for plain language, clarity, and consistency.

In 2012, the OSHA HCS, codified at 29 CFR 1910.1200, was amended to adopt the United Nations Globally Harmonized System of Classification and Labelling of Chemicals (GHS) [77 FR 17574; March 26, 2012]. Among these 2012 OSHA HCS amendments, OSHA replaced the term Material Safety Data Sheet (MSDS) with the term Safety Data Sheet (SDS) and also stated that these two terms mean the same thing. In alignment, EPA amended its hazardous chemical reporting regulations at 40 CFR part 370 to conform to these changes [81 FR 38104; June 13, 2016, and 81 FR 47311; July 21, 2016]. The EPA 2016 amendments included adding the term SDS to the regulation so that both terms are used together throughout 40 CFR part 370. In this action, EPA is removing use of the term MSDS and revising the definition of safety data sheet to conform to the OSHA HCS and to improve readability of the regulation in the following sections: §§ 370.1, 370.3, 370.10, 370.12, 370.13, 370.14, 370.20, centered heading, 370.30, 370.31, 370.32, 370.33, 370.60, 370.62, 370.63, and 370.64.

In 2024, the OSHA HCS, codified at 29 CFR 1910.1200, was further amended to conform to revisions of the United Nations Globally Harmonized System of Classification and Labelling of Chemicals [89 FR 44144; May 20, 2024, and 89 FR 81829; October 9, 2024]. This update improves awareness of chemical hazards by instituting changes as to how chemical hazards are reported on SDSs. Hazards reported on SDSs are used for reporting hazardous chemical inventories under EPCRA sections 311 and 312 [42 U.S.C. 11021 and 11022]. In this action, EPA is amending the EPCRA hazard categories and the definition of hazard category to conform with the 2024 OSHA HCS and make conforming amendments to the following sections: §§ 370.3, 370.30, 370.41, and 370.42. The Agency is also noting that OSHA codified the following definition of combustible dust at 29 CFR 1910.1200(c): “Combustible dust means finely divided solid particulates of a substance or mixture that pose a flash-fire hazard or explosion hazard when dispersed in air or other oxidizing media.” [89 FR 44272-44274; May 20, 2024] This definition is applicable to 40 CFR part 370 by the existing reference to the OSHA HCS within the definition of hazardous chemical at 40 CFR 370.66. EPA is not making amendments to further incorporate this definition.