Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of this rule via one of the methods and by the deadline stated above. The Department also invites comments that relate to the economic, environmental, or federalism effects that might result from this rule. Comments that will provide the most assistance to the Department in developing these procedures will reference a specific portion of the rule; explain the reason for any recommended change; and include data, information, or authority that supports each recommended change.

Please note that all comments received are considered part of the public record and made available for public inspection at https://www.regulations.gov. Such information includes personally identifying information (such as your name, address, etc.) voluntarily submitted by the commenter.

If you want to submit personally identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase “PERSONALLY IDENTIFYING INFORMATION” in the first paragraph of your comment and identify what information you want redacted.

If you want to submit confidential business information as part of your comment, but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You also must prominently identify the confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on https://www.regulations.gov.

Personally identifying information located as set forth above will be placed in the agency's public docket file but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. The Department may withhold from public viewing information provided in comments that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of https://www.regulations.gov. To inspect the agency's public docket file in person, you must make an appointment with the agency. Please see the For Further Information Contact paragraph above for agency contact information.

The Department issues this IFR pursuant to section 103(g) of the Immigration and Nationality Act (“INA” or “the Act”), 8 U.S.C. 1103(g), as amended by the Homeland Security Act of 2002 (“HSA”), Public Law 107-296, 116 Stat. 2135 (as amended). The HSA provides that EOIR exists within DOJ and that it shall be “subject to the direction and regulation of the Attorney General” under section 103(g) of the INA, 8 U.S.C. 1103(g). Further, under the HSA, the Attorney General retains authority to “establish such regulations, . . . issue such instructions, review such administrative determinations in immigration proceedings, delegate such authority, and perform such other acts as the Attorney General determines to be necessary for carrying out” the Attorney General's authorities under the INA. HSA 1102, 116 Stat. at 2273-74; INA 103(g)(2), 8 U.S.C. 1103(g)(2). Those authorities include conducting removal proceedings under section 240 of the INA, 8 U.S.C. 1229a (“section 240 removal proceedings”).

In 1940, the Immigration and Naturalization Service (“INS”) and its functions were transferred to the Department, to be “administered under the direction and supervision of the Attorney General.” See Reorganization Plan No. V, 5 FR 2223 (June 14, 1940). Shortly thereafter, the Attorney General delegated various powers and authorities to the Board, or, as it was then known, the Board of Review of the INS, including ordering deportation after proceedings and considering appeals of decisions in specific types of cases. 1 See Order No. 3888, Delegation of Powers and Definition of Duties, 5 FR 2454, 2454-55 (July 3, 1940). In January 1983, a reorganization consolidated Immigration Judges and the Board into the newly created EOIR in order to “streamlin[e] the Department's management of this important function and minimiz[e] mission disparities within the INS.” Aliens and Nationality; Rules of Procedure for Proceedings Before Immigration Judges, 52 FR 2931, 2931 (Jan. 29, 1987) (explaining the 1983 reorganization).

Notably, since its inception as a component of the Department, the Board's appellate authorities have been delegated by the Attorney General and delineated by regulation, rather than by statute. See, e.g., 8 CFR 1003.1(a)(1) (“The Board members shall be attorneys appointed by the Attorney General to act as the Attorney General's delegates in the cases that come before them.”); 8 CFR 1003.1(d)(1) (“The Board shall function as an appellate body charged with the review of those administrative adjudications under the Act that the Attorney General may by regulation assign to it.”); Kucana v. Holder, 558 U.S. 233, 239 (2010) (“As adjudicator in immigration cases, the Board exercises authority delegated by the Attorney General.”). 2

Through regulation, the Attorney General has provided for appellate review by the Board of multiple case types, including decisions of Immigration Judges in exclusion, deportation, removal, asylum-only, and withholding-only proceedings; carrier fines; certain immigrant visa petition decisions by the Department of Homeland Security (“DHS”) under sections 204 and 205 of the INA, 8 U.S.C. 1154, 1155; applications for the exercise of discretion under section 212(d)(3) of the INA, 8 U.S.C. 1182(d)(3); decisions on applications for adjustment of status and rescission of adjustment of status; decisions relating to Temporary Protected Status; determinations related to bond, parole, or detention of an alien; and disciplinary proceedings involving practitioners or recognized organizations. See 8 CFR 1003.1(b).

To adjudicate such cases, the Attorney General has also, through regulation, provided the Board with multiple adjudicatory options, including summary dismissal, affirmance without opinion (“AWO”), or decision by a single Appellate Immigration Judge, a panel of three Appellate Immigration Judges, or en banc. See, e.g., 8 CFR 1003.1(a)(5), (d)(2), (e)(2)-(6). Procedures like AWO and summary dismissal were introduced to address significant appeal backlogs and have been upheld by Federal circuit courts as being well within the Department's authority. See, e.g., Executive Office for Immigration Review; Board of Immigration Appeals; Streamlining, 64 FR 56135, 56137-38 (Oct. 18, 1999) (AWO rule detailing the time-consuming appeals process and the need for more efficient adjudication measures); Albathani v. INS, 318 F.3d 365, 377 (1st Cir. 2003) (holding that “[p]romulgation of the AWO regulations is within the power of the [agency]” and the Board “can adopt, without further explication, the IJ's opinion”); Singh v. Gonzales, 416 F.3d 1006, 1015 (9th Cir. 2005) (holding that the petitioner “has not established that the BIA's regulations—authorizing summary dismissal for failure to either file a brief or specify the grounds for appeal—violated his due process rights”).

In line with these long-standing procedures, the Department is issuing this IFR to amend its summary dismissal procedures to better address lengthy appeal backlogs at the Board, as detailed in Section IV.A of this preamble.

Over time the Department has adopted measures to streamline Board review, especially when appeal receipts outpaced appeal adjudications leading to backlogs. In 1999, after a more than 9-fold increase in annual appeal and motion receipts over the course of 14 years, the Department adopted streamlining measures with four goals: (1) promoting uniformity in dispositions by Immigration Judges by providing authoritative guidance in high-quality appellate decisions; (2) deciding all incoming cases in a timely and fair manner; (3) assuring that individual cases are decided correctly; and (4) eliminating its backlog of cases. 64 FR 56136 (“In 1984, the Board received fewer than 3,000 new appeals and motions. In 1994, it received more than 14,000 new appeals and motions. In 1998, in excess of 28,000 new appeals and motions were filed.”). To do so, the Board limited the use of three-member panels to review appeals and allowed for AWO by a single Board member in specific circumstances. Id.

The streamlining process undertaken by the Board proved a success, leading to a 50 percent increase in overall Board productivity in fiscal year 2001. Operations of the Executive Office for Immigration Review (EOIR): Hearing Before the Subcomm. on Immigr. and Claims of the H. Comm. On the Judiciary, 107th Cong., 2d Sess. 48 (2002) (testimony of Kevin Rooney, Director, EOIR). The initiative was also assessed favorably by an external auditor. Arthur Andersen & Company, Board of Immigration Appeals (BIA) Streamlining Pilot Project Assessment Report (Dec. 13, 2001).

In 2002, the Department published a final rule that, while maintaining the basic AWO process, mandated the use of AWO in any case that met the regulatory threshold criteria. See Board of Immigration Appeals: Procedural Reforms To Improve Case Management, 67 FR 54878 (Aug. 26, 2002). Compare 8 CFR 3.1(a)(7)(ii) (2000) (providing that a single Board member “may” affirm without opinion), with 8 CFR 1003.1(e)(4) (2003)  3 (providing that a single Board member “shall” affirm without opinion). Under the 2002 rule, an AWO was issued if the Board member concluded that “the result reached in the decision under review was correct,” that any errors in the decision were “harmless or nonmaterial,” and that either the issues on appeal are “squarely controlled” by precedent and do not present a novel factual scenario that requires a decision to apply precedent or are not so substantial as to warrant issuance of a written opinion by the Board. 8 CFR 1003.1(e)(4)(i) (2003).

Although these changes initially helped the Board adjudicate more cases overall, their impact on how timely and efficiently the Board adjudicated individual cases is less clear. As the Department's Office of Inspector General (“DOJ OIG”) found in 2012, EOIR did not track all Board appeals the same way and used different measures rather than simple case processing times to track timely adjudication. See DOJ OIG, Management of Immigration Cases and Appeals by the Executive Office for Immigration Review (Oct. 2012), https://oig.justice.gov/reports/2012/e1301.pdf [ https://perma.cc/TPZ8-47JC ]. For example, “[d]epending on the type of review—one or three board members—EOIR counts the appeal processing time from different starting points,” and “[t]hese different starting points significantly skew the reported achievement of its completion goals for appeals and impede EOIR's effective management of the appeals process.” Id. at 50. As a result, the case processing times reported by EOIR did not accurately reflect the complete case processing times for an appeal. Id. at 49 (“While EOIR's method of calculation showed an average of 54 days to process an appeal under the one-member goal and an average of 76 days under the three-member goal, the entire time to process the appeals averaged 372 and 361 days, respectively.”). Moreover, EOIR declined to implement the DOJ OIG's recommendation to “improve its collecting, tracking, and reporting of BIA appeal statistics to accurately reflect actual appeal processing times.” Id. at 50. Additionally, despite a regulatory command to do so, see 8 CFR 1003.1(e)(8)(v), the Chief Appellate Immigration Judge declined until 2019 to both provide notice “if a Board member consistently fails to meet the assigned deadlines for the disposition of appeals” and to “prepare a report assessing the timeliness of the disposition of cases by each Board member on an annual basis”—and then declined again to do so between 2021 and 2024. See generally EOIR, Policy Memorandum 25-04, Cancellation of Policy Memorandum 21-16 2 & n.2 (Jan. 27, 2025), https://www.justice.gov/eoir/media/1386546/dl?inline [ https://perma.cc/NWE9-V7EN ].

Notwithstanding the reforms of the early 2000s, due to “gross mismanagement and poor leadership at the Board,” by 2019, the Board's case management system had become “dysfunctional.” See id. at 2. 4 As a result, on August 26, 2020, the Department published a notice of proposed rulemaking (“NPRM” or “proposed rule”) that proposed to amend EOIR's regulations to address the Board's backlog. Appellate Procedures and Decisional Finality in Immigration Proceedings; Administrative Closure, 85 FR 52491, 52491 (Aug. 26, 2020) (“Appellate Procedures NPRM”). The Appellate Procedures NPRM explained that changes to various procedures were necessary due to significant increases in the Board's backlog such that the Department needed “to again review the BIA's regulations to reduce any unwarranted delays in the appeals process and to ensure the efficient use of BIA and EOIR resources.” Id. at 52492.

Among other changes, the Appellate Procedures NPRM proposed: (1) simultaneous briefing schedules for both detained and non-detained appeals before the Board; (2) shortening the reply brief deadline; (3) limiting briefing extensions; (4) harmonizing the 90- and 180-day Board adjudication timelines to both start from when the record is complete; (5) limiting the Chief Appellate Immigration Judge's ability to hold a group of cases while awaiting certain outside actions; and (6) removing the process for Immigration Judge review of proceeding transcripts. See 85 FR 52491. The Department received 1,287 comments during the 30-day comment period. 5

On December 16, 2020, the Department published a final rule, responding to comments received during the notice-and-comment period and adopting the regulatory language proposed in the Appellate Procedures NPRM with minor changes. See Appellate Procedures and Decisional Finality in Immigration Proceedings; Administrative Closure, 85 FR 81588 (Dec. 16, 2020) (“Appellate Procedures Final Rule”). The Appellate Procedures Final Rule's effective date was January 15, 2021, but the rule was preliminarily enjoined on March 10, 2021, before its measures were implemented fully. See Centro Legal de la Raza v. EOIR, 524 F. Supp. 3d 919 (N.D. Cal. 2021).

On September 8, 2023, after reconsidering the Appellate Procedures Final Rule, including the comments received during that rulemaking and the issues identified in the Centro Legal de la Raza litigation as well as litigation in Catholic Legal Immigr. Network, Inc. v. EOIR, No. 21-00094, 2021 WL 3609986 (D.D.C. Apr. 4, 2021), the Department published an NPRM proposing to remove the preliminarily enjoined regulatory language codified by the Appellate Procedures Final Rule, with certain exceptions, as well as proposing standards for Immigration Judges and Appellate Immigration Judges to consider when adjudicating requests for the administrative closure or termination of proceedings. See Appellate Procedures and Decisional Finality in Immigration Proceedings; Administrative Closure, 88 FR 62242 (Sept. 8, 2023).

The Department finalized that rule in May 2024. See Efficient Case and Docket Management in Immigration Proceedings, 89 FR 46742 (May 29, 2024) (“ECDM Final Rule”). As a result, the relevant regulatory provisions of the Appellate Procedures Final Rule that are further addressed in this IFR were rescinded, and the relevant regulatory text was generally returned to its pre-Appellate Procedures Final Rule baseline. See id. 46742. Notably, neither the NPRM nor the final rule addressed the efficiency reasons the Department provided for those measures in the Appellate Procedures Final Rule. Indeed, despite the fact that the Board's backlog continued to grow, the 2024 rule enacted no procedures aimed at increasing case completions.

As described in Section III.B of this preamble, until 2021, with various amounts of success, the Department has instituted measures to address increasing case receipts by the Board and the backlog that has accrued when the Board has been unable to keep up with them. However, since 2021, despite a rapidly growing backlog, the only regulatory measure taken to increase case completions was to further increase the number of authorized Board members to 28. See Expanding the Size of the Board of Immigration Appeals, 89 FR 22630 (Apr. 2, 2024). 6 As the Attorney General recently explained when decreasing the size of the Board to 15 authorized members,

Reducing the Size of the Board of Immigration Appeals, 90 FR 15525, 15526 (Apr. 14, 2025). 7

Indeed, between fiscal year 2015 and the end of fiscal year 2025, the Board's pending case load increased more than five-fold—from 37,285 pending appeals to 202,946 pending appeals. EOIR, Adjudication Statistics: All Appeals Filed, Completed, and Pending (Nov. 18, 2025), https://www.justice.gov/eoir/media/1344986/dl?inline [ https://perma.cc/88C5-MU4N ]. The Board is at a point where, even were it to have additional resources and better management, without significant reforms, it would not be able to keep up with incoming filings while tackling the backlog in any meaningful way.

Given the unprecedented Board caseload, and the insufficiency of the currently available tools to manage it, the Department has reconsidered the Board's role as an appellate tribunal. The Board cannot—and does not need to—adjudicate every case on the merits with the tools at its disposal, including the ability for single Board members to issue an AWO. Thus, rather than require such adjudications, the Department is changing its regulations to provide the Board more flexibility in reviewing appeals. Instead, for appeals taken from decisions issued after this IFR becomes effective, as explained in Section IV.A of this preamble, the default will be summary dismissal unless a majority of current Board members vote to consider the appeal on the merits. And such dismissals will occur quickly—within 15 days of filing the appeal—allowing aliens to seek Federal court review expeditiously, rather than potentially waiting for years for a Board decision that in the vast majority of cases would affirm the underlying Immigration Judge decision. 8 This change in procedure will allow the Board to focus its limited resources on adjudicating the more than 200,000 pending appeals and, going forward, on selecting decisions for review that present novel issues warranting the Board's attention.

The IFR will also change the deadline for filing an appeal with the Board from 30 to 10 days, except for cases involving certain asylum applications, as discussed in more detail in Section IV.B of this preamble. And, as explained in Sections IV.C and D of this preamble, the IFR adopts other measures previously adopted by the 2020 Appellate Procedures Final Rule, which were never fully operationalized, to streamline the processes for obtaining the parties' briefs and assembling the record on appeal.

These changes, individually and together, will streamline Board appellate review so that aliens receive timely final decisions and do not have to wait years to seek Federal court review. 9 They will also allow the Board to focus on addressing the backlog and, once it is clear, on providing meaningful review in cases requiring Board intervention. 10

The Department has determined that the immigration adjudicatory system would function more efficiently if the Board were given more control over its appellate docket by summarily dismissing all appeals—with two exceptions  11 —unless a majority of the permanent Board members vote en banc to accept an appeal. Currently, unless subject to the existing, enumerated reasons for summary dismissal, the Board reviews all appeals on the merits even though there is no statutory requirement for an appellate process or for all allowable appeals to receive a decision on the merits. See Dia v. Ashcroft, 353 F.3d 228, 237 (3d Cir. 2003) (en banc) (noting the “INA says nothing whatsoever regarding the procedures of an administrative appeal, or, for that matter, any other procedures employed by the BIA”). Although there is an explicit reference to the Board in section 101(a)(47)(B) of the INA, 8 U.S.C. 1101(a)(47)(B), that reference merely establishes when an order of removal becomes final, namely when the order is affirmed by the Board or the time for filing an appeal has expired. Nothing in that provision, however, requires the Board to adjudicate every appeal on its merits; to the contrary, it is well established that the Board may summarily dismiss an appeal without reaching the merits. 12 See 8 CFR 1003.1(d)(2); accord Dia, 353 F.3d at 237 (“[8 U.S.C. 1101(a)(47)(B)] says absolutely nothing about procedures to be employed by the BIA, or the right to, or manner of, review generally; it only speaks to review by the BIA and its `affirming' the `order' of deportation . . . . Based on the fact that § 1101(a)(47)(B) contains the only mention of the BIA in the INA, it seems clear that Congress has left all procedural aspects of the BIA, especially how it hears cases, entirely to the Attorney General's discretion.”).

Importantly, because a summary dismissal “shall constitute the final decision of the Board,” 8 CFR 1003.1(d)(2)(iii) (as amended by this IFR), the Board's summary dismissal provisions—and this rule's expansion of them—do not cause any difficulty for implementing the statute or other regulatory provisions, such as the statutory and regulatory provisions that govern when a removal order becomes final. See INA 101(a)(47)(B), 8 U.S.C. 1101(a)(47)(B); 8 CFR 1241.1 (setting forth when a removal order resulting from section 240 removal proceedings becomes final). When an appeal is summarily dismissed under the provisions added by this rule, the Department intends that the Immigration Judge's decision become the final agency decision for purposes of Federal court review unless the Attorney General exercises discretion to review under 8 CFR 1003.1(h). In any petition for review of a final removal order under section 242(a)(1) of the INA, 8 U.S.C. 1252(a)(1), the Department expects that the court of appeals would review the substance of the Immigration Judge's decision as the basis for the final order. This view would not change any existing understandings regarding when a removal order becomes final or when a petition for review must be filed.

Notably, the courts of appeals that have reviewed challenges to the Board's prior streamlining process have uniformly concluded that aliens have no constitutional or statutory right to a particular form or manner of a Board decision. See Zhang v. U.S. Dep't of Justice, 362 F.3d 155, 157-58 (2d Cir. 2004); Yuk v. Ashcroft, 355 F.3d 1222, 1229-32 (10th Cir. 2004); Dia, 353 F.3d at 242; Denko v. INS, 351 F.3d 717, 729-30 (6th Cir. 2003); Falcon Carriche v. Ashcroft, 350 F.3d 845, 850-51 (9th Cir. 2003); Khattak v. Ashcroft, 332 F.3d 250, 252-53 (4th Cir. 2003); Georgis v. Ashcroft, 328 F.3d 962, 967 (7th Cir. 2003); Mendoza v. U.S. Att'y Gen., 327 F.3d 1283, 1288-89 (11th Cir. 2003); Albathani v. INS, 318 F.3d 365, 376-77 (1st Cir. 2003). Indeed, it has long been the Department's view that there is no statutory right or law requiring a particular form of decision or method of review before the Board. 67 FR 54883, 54888-90. Because the Board is established under the Attorney General's regulations, she “is free to tailor the scope and procedures of administrative review of immigration matters as a matter of discretion.” 67 FR 54882 (citing, e.g., Vt. Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519, 524-25 (1978)); see Vt. Yankee, 435 U.S. at 524-25 (“administrative agencies should be free to fashion their own rules of procedure and to pursue methods of inquiry capable of permitting them to discharge their multitudinous duties” (quoting FCC v. Pottsville Broad. Co., 309 U.S. 134, 143 (1940))).

This change will allow the Board to focus on appeals with particularly novel or complex legal questions without becoming bogged down in mine-run or straightforward cases that may already be subject to being affirmed without an opinion or summarily affirmed. Indeed, due to years of mismanagement and the accretion of a sizeable backlog of cases, as discussed in Sections III.B and IV of this preamble, 13 the Board largely functions now as simply a vessel for further delay of the eventual resolution of an alien's case. Further, the change would also help offset a peculiar asymmetry in immigration proceedings— i.e., aliens may seek Federal court review of Board decisions, but DHS cannot—by ensuring that aliens do not amplify any procedural advantages they have over the Government with additional opportunities to necessarily bring meritless appeals with attendant delays.

The Department recognizes that this IFR represents a notable procedural change to how the Board has operated; however, in recognition of that point, this change will apply only prospectively and not to appeals pending when the rule becomes effective. Instead, it will apply only to decisions otherwise subject to appeal that are issued by either an Immigration Judge or DHS on or after the rule's effective date. Because there is no right to a merits adjudication of any appeal in the first instance, and because the rule does not change the process for aliens who submitted an appeal with the expectation of receiving a different process, this change will not undermine any reliance interests of either an alien or DHS. Indeed, there is no evidence that DHS initiates a case in immigration proceedings or an alien brings a claim for relief or protection from removal based on the availability of an appeal to the Board if they lose, nor is there any logical reason that either party would do so. And, to be clear, the change applies equally to appeals filed by both DHS and aliens, so neither side will be procedurally advantaged or disadvantaged by the change. 14

FHFA adopted part 1293 in May 2024  1 to codify the Agency's fair housing and fair lending oversight of the regulated entities, the Enterprise Equitable Housing Finance Plan (EHFP or Plan) program, 2 and requirements for the Enterprise to collect a borrower's language preference and housing counseling and homeownership education information. After setting forth the purpose of part 1293, definitions, and FHFA enforcement authority in subpart A, subpart B requires the Federal National Mortgage Association (Fannie Mae), the Federal Home Loan Mortgage Corporation (Freddie Mac), and the Federal Home Loan Banks (Banks) (Fannie Mae and Freddie Mac collectively, the “Enterprises”; the Enterprises and the Banks collectively, the “regulated entities”) to comply with fair housing and fair lending laws and with federal prohibitions against unfair or deceptive acts or practices; imposes on the board of directors of each regulated entity a duty to direct operations in conformity with such requirements and prohibitions by appropriately considering compliance with such requirements and prohibitions; reserves FHFA's right to require reports from each regulated entity; and imposes a certification obligation on the reporting regulated entity. Subpart C requires each Enterprise to adopt a triennial EHFP; addresses the contents of such Plans (including actions the Enterprise plans to take to address barriers to sustainable housing opportunities faced by one or more underserved communities), optional Enterprise annual Plan updates, and publication of Plans and updates on an Enterprise's website; addresses FHFA review of Plans once submitted; requires each Enterprise to develop and publish annual performance reports and sets forth the contents of such reports; addresses public engagement on Enterprise Plans and performance assessments; provides for FHFA publication of its annual evaluation assessing Enterprise performance; and imposes obligations related to developing and implementing Plans on Enterprise boards of directors. Subpart D obligates the Banks, beginning in February 2026, to report to FHFA on activities voluntarily undertaken to support underserved communities, and to publicly report if they had taken no such activities and do not plan to take such activities in the future. Subpart E establishes requirements for Enterprise collection of applicant and borrower language preference and whether applicants and borrowers have completed housing counseling or homeownership education and related information. FHFA was not statutorily required to adopt any provision of part 1293.

FHFA published a Notice of Proposed Rulemaking (proposed rule) in July 2025 to repeal part 1293  3 after reviewing it in accordance with Executive Order (“Executive Order” or “E.O.”) 14219. 4 That E.O. directed federal agencies to rescind, as appropriate, regulations determined to be inconsistent with law or certain Administration policies on how statutory authority should be administered. 5 As FHFA stated in its proposed rule, Administration policy as expressed in various EOs includes “the policy to be `prudent and financially responsible in the expenditure of funds, from both public and private sources, and to alleviate unnecessary regulatory burdens;' ”  6 protect the civil rights of all Americans;  7 terminate discriminatory and illegal preferences, programs, and activities and combat illegal private-sector diversity, equity, and inclusion preferences, policies, programs, and activities;  8 terminate to the maximum extent allowed by law, all equity programs or action plans;  9 and “focus enforcement resources on regulations that are squarely authorized by constitutional Federal statutes and . . . reduce regulatory burden.”  10 Administration priorities also include “lowering the cost of housing and expanding housing supply.”  11

Congress provided express authorities and duties for FHFA, the Banks, and the Enterprises to fulfill their public purposes in promoting access to credit throughout the nation. These include the statutory requirement to meet housing goals to serve low-income and very low-income families at 12 U.S.C. 4561 to 4564 for the Enterprises and 12 U.S.C. 1430c (implemented at 12 CFR 1281.11) for the Banks (affordable housing goals), a statutory duty imposed on the Enterprises to serve underserved markets at 12 U.S.C. 4565, and statutorily required Enterprise financial support for the Housing Trust Fund and Capital Magnet Fund at 12 U.S.C. 4567 to 4569. Upon review, FHFA believes that the regulated entities' public purpose to support access to credit in underserved markets can be accomplished effectively through administration of these statutory mandates. 12 As a result, FHFA determined that part 1293 is not legally necessary.

FHFA also determined that, as a matter of policy, part 1293 could be inconsistent with Administration policies and, further, repeal would enhance the prudent and financially responsible expenditure of funds from both public and private sources; alleviate unnecessary regulatory burdens; avoid confusion about roles and responsibilities relative to other agencies with primary statutory jurisdiction; avoid redundant statements about FHFA authority; and align with Administration policy. On the bases that part 1293 is unnecessary and could be inconsistent with Administration policies, and that repeal of part 1293 would further Administration policies, FHFA published the proposed rule to repeal part 1293. 13

The FAA issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all Textron Aviation, Inc., Model 525B airplanes. The NPRM was published in the Federal Register on November 28, 2025 (90 FR 54599). The NPRM was prompted by notification to the FAA by Textron Aviation that the existing Model 525B AMM contained incorrect inspection intervals for airworthiness limitation tasks for Chapter 54—Nacelle/Pylons and Chapter 55—Stabilizers. The incorrect inspection intervals were introduced during a technical manual update. In the NPRM, the FAA proposed to require revising the ALS of the existing AMM or ICA and the existing approved maintenance or inspection program, as applicable. The FAA is issuing this AD to prevent undetected cracks in the engine mount and vertical stabilizer front and rear spar caps. The unsafe condition, if not addressed, could result in reduced structural integrity and consequent reduced controllability of the airplane.

The FAA received a comment from Capital City Jet Center. The commenter had no objection to the NPRM.

The FAA reviewed the relevant data, considered any comments received, and determined that air safety requires adopting this AD as proposed. Accordingly, the FAA is issuing this AD to address the unsafe conditions on these products. Except for minor editorial corrections, this AD is adopted as proposed in the NPRM.

The FAA estimates that this AD affects 601 airplanes of U.S. registry. The FAA estimates the following costs to comply with this AD:

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

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

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

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

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

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

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

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

The FAA'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 and amends the Class E airspace at the affected airports to support IFR operations.

The FAA published an NPRM for Docket No. FAA-2025-5136 in the Federal Register (90 FR 55819; December 4, 2025) proposing to establish and amend the Class E airspace at South Bend, IN. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraphs 6002, 6003, 6004, and 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the 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 amends 14 CFR part 71 by modifying the Class E surface airspace; establishing a Class E extension to Class C airspace; establishing a Class E extension to a Class E surface area; and modifying the Class E airspace extending upward from 700 ft. above the surface at South Bend, Indiana, due to airspace reviews conducted as part of the decommissioning of the Keeler VOR as part of the VOR MON Program.

For the South Bend International Airport, South Bend, IN, Class E surface area, this action: (1) updates the name of the airport from Michiana Regional Transportation Center Airport to South Bend International Airport and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database; (2) removes the city associated with the airport from the airspace legal description header to comply with changes to FAA Order JO 7400.2R, Procedures for Handling Airspace Matters; (3) adds the Chain-O-Lakes Airport to the airspace legal description header as it was previously omitted; and (4) updates the outdated term “Airport/Facility Directory” to “Chart Supplement.”

This action establishes a Class E extension to Class C airspace at South Bend International Airport extending upward from the surface within 2 miles each side of the 179° bearing from the airport extending from the 5-mile radius of the airport to 9.7 miles south of the airport.

This action establishes a Class E extension to a Class E surface area at South Bend International Airport extending upward from the surface within 2 miles each side of the 179° bearing from the airport extending from the 5-mile radius of the airport to 9.7 miles south of the airport.

For the South Bend International Airport Class E airspace extending upward from 700 ft. above the surface, this action: (1) decreases the radius from 8 miles to 7.5 miles; (2) amends the east extension to within 4 miles (decreased from 4.4 miles) south and 8 miles (increased from 7 miles) north of the 089° bearing from the South Bend INTL: RWY 27L-LOC (previously South Bend ILS Localizer East Course) extending from the 7.5-mile radius of the airport (previously South Bend Regional Airport) to 10 miles (decreased from 10.5 miles) east of the airport (previously Misha outer marker); (3) adds an extension within 2 miles each side of the 179° bearing from the airport extending from the 7.5-mile radius to 10.7 miles south of the airport; (4) removes the Gipper VORTAC and associated extensions as they are no longer required; (5) updates the name of the localizer from South Bend ILS Localizer to South Bend INTL: RWY 27L-LOC to coincide with the FAA's aeronautical database; and (6) removes the Misha Outer Marker from the airspace legal description header as it is no longer required.

And for the Jerry Tyler Memorial Airport, Niles, MI, Class E airspace extending upward from 700 ft. above the surface, contained within the South Bend, IN, airspace legal description, this action: (1) increases the radius from 6.4 miles to 6.9 miles; and (2) removes the city associated with the airport in the airspace legal description header to comply with changes to FAA Order JO 7400.2R.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

The FAA published a final rule in the Federal Register (91 FR 19; January 2, 2026), establishing RNAV Routes Q-190 and T-497, and amending domestic VOR Federal Airways V-1, V-70, and V-194, in the eastern United States. Subsequent to publication of the final rule the FAA determined that, with respect to RNAV Route Q-190, the route segment between Carleton, MI (CRL), VOR/Distance Measuring Equipment (VOR/DME) and the WIGGZ, PA, waypoint (WP) failed to exclude the portion of the route within Canadian airspace as required.

This action corrects this error by amending the route description of RNAV Route Q-190 to include two new route points where the route intersects the United States/Canadian border. Specifically, the FAA adds the RONZY, MI, WP and the PRANI, OH, WP to the route description of RNAV Route Q-190, thereby excluding Canadian airspace. The addition of these two route points does not substantively alter the route but rather excludes Canadian airspace, as originally intended.

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace at the affected airports to support IFR operations.

The FAA published an NPRM for Docket No. FAA-2025-5367 in the Federal Register (90 FR 56711; December 8, 2025) proposing to amend the Class E airspace at Benton Harbor, MI. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. No comments were received.

Class E airspace designations are published in paragraphs 6002 and 6005 of FAA Order JO 7400.11, Airspace Designations and Reporting Points, which is incorporated by reference in 14 CFR 71.1 on an annual basis. This document amends the 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 amends 14 CFR part 71 by modifying the Class E surface airspace and the Class E airspace extending upward from 700 ft. above the surface at Benton Harbor, Michigan, due to an airspace review conducted as part of the decommissioning of the Keeler VOR as part of the VOR MON Program.

For the Southwest Michigan Regional Airport, Benton Harbor, MI, Class E surface area, this action: (1) increases the radius from 4.2 miles to 4.5 miles; (2) updates the name of the airport from Ross-Field-Twin Cities Airport to Southwest Michigan Regional Airport and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database; (3) removes the city associated with the airport from the airspace legal description header to comply with changes to FAA Order JO 7400.2R, Procedures for Handling Airspace Matters; and (4) updates the outdated term “Airport/Facility Directory” to “Chart Supplement.”

For the Southwest Michigan Regional Airport Class E airspace extending upward from 700 ft. above the surface, this action: (1) increases the radius from 6.5 miles to 7 miles; (2) adds an extension within 3.7 miles each side of the 090° bearing from the Southwest Michigan RGNL: RWY 28-LOC extending from the 7-mile radius of the airport to 9.3 miles east of the airport; (3) adds an extension within 2 miles each side of the 090° bearing from the airport extending from the 7-mile radius to 11.5 miles east of the airport; (4) updates the name of the airport from Ross-Field-Twin Cities Airport to Southwest Michigan Regional Airport and updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database; and (5) removes the city associated with the airport from the airspace legal description header to comply with changes to FAA Order JO 7400.2R.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class E airspace at the affected airport to support IFR operations.

The FAA published an NPRM for Docket No. FAA-2025-5106 in the Federal Register (90 FR 52580; November 21, 2025) proposing to amend the Class E airspace at Beeville, TX. Interested parties were invited to participate in this rulemaking effort by submitting written comments on the proposal to the FAA. One comment was received from the Citizens Rulemaking Alliance.

Overall, the comment and accompanying petition are not applicable to the proposed airspace action; however, the following explanations are provided.

The comment and accompanying petition requested that the final rule be withdrawn, an NPRM or direct final rule be issued, and the effective date delayed for an applicable comment period. The comment was written as if the FAA had already issued a final rule without any opportunity for comment, but in fact, the FAA had only issued an NPRM. The FAA provided a 45-day comment period for the NPRM, during which the commenter submitted its comment and petition. The commenter's request had already been satisfied at the time it submitted its comment and petition. The comment, therefore, appears to be unrelated and inapplicable to the instant action.

The petition also seems to allege that, because the FAA employs standardized language in its routine airspace action rulemakings, it has not performed the requisite analyses, specifically with respect to the Regulatory Flexibility Act and Executive Order (E.O.) 12866. Indeed, the FAA has developed standardized language for use in these routine actions to ensure consistency and streamline drafting of rulemaking documents in one of its most prolific regulatory portfolios. However, each action is individually assessed and tailored as appropriate in compliance with applicable law and agency guidance, including the Administrative Procedures Act; the Regulatory Flexibility Act; E.O. 12866; FAA Order JO 7400.2R, Procedures for Handling Airspace Matters; and FAA Order 1050.1G, FAA National Environmental Policy Act Implementing Procedures. Ironically, the commenter appears to utilize boilerplate language in its comment and petition that is not relevant to the instant action.

Substantively, the petition also makes an assumption that the expansion of the Class E airspace extending upward from 700 ft. above the surface at Beeville, TX, “can foreclose or constrain marginal VFR operations,” which is unsubstantiated. This Class E airspace is established as transitional airspace to/from terminal or enroute environments around airports with instrument procedures as required by FAA Order JO 7400.2R. No air traffic control services are provided, and there are no communications requirements, so there is little to no impact on VFR traffic. In fact, this Class E airspace advises the VFR pilots that there are instrument procedures and potential IFR traffic in the area which increases the pilot's situational awareness.

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 amends 14 CFR part 71 by modifying the Class E airspace extending upward from 700 ft. above the surface at Beeville, Texas, due to an airspace review conducted as part of the decommissioning of the Three Rivers VOR as part of the VOR MON Program.

For the Beeville Municipal Airport, Beeville, TX, Class E airspace extending upward from 700 ft. above the surface, this action: (1) increases the radius from 6.6 miles to 7.1 miles from the airport; (2) removes the Beeville NDB and associated extension as they are no longer required; and (3) updates the geographic coordinates of the airport to coincide with the FAA's aeronautical database.

The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore: (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

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

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

In FR Doc. 2025-19607 (193 FERC ¶ 61,002) (90 FR 48397, October 21, 2025), FERC added a conditional sunset date to § 157.202 at paragraph (b)(2)(ii)(H) in error. FERC is removing paragraph (b)(2)(ii)(H).

Accordingly, 18 CFR part 157 is corrected by making the following correcting amendment:

I. Introduction

In the Federal Register of August 5, 2024 (89 FR 63330), FDA announced that we filed a color additive petition (CAP 4C0334) submitted on behalf of GNT by Exponent, 1150 Connecticut Ave. NW, Suite 1100, Washington, DC 20036. The petition proposed that FDA amend the color additive regulations in part 73 (21 CFR 73.530), “Listing of Color Additives Exempt from Certification,” to provide for the expanded safe use of spirulina extract as a color additive at levels consistent with GMP in human foods generally, excluding infant formula and certain foods subject to regulation by the U.S. Department of Agriculture (USDA).

Spirulina extract is approved under § 73.530 for coloring confections (including candy and chewing gum), frostings, ice cream and frozen desserts (including non-dairy frozen dessert), dessert coatings and toppings, beverage mixes and powders, yogurts (including non-dairy yogurt alternatives), custards, puddings (including non-dairy puddings), cottage cheese, gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded cereals), alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, seasoning mixes (unheated), salad dressings, condiments and sauces, dips, coating formulations applied to dietary supplement tablets and capsules, at levels consistent with GMP, and to seasonally color the shells of hard-boiled eggs, except that it may not be used to color foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 341), unless the use of the added color is authorized by such standards. Spirulina extract is exempt from certification under section 721(c) of the FD&C Act (21 U.S.C. 379e(c)) because we previously determined that certification was not necessary for the protection of public health (78 FR 49117 at 49119, August 13, 2013).

The spirulina extract that is the subject of this final order is a blue-colored powder or liquid prepared by the water extraction and filtration of the dried biomass of A. platensis (also known as Spirulina platensis ), an edible blue-green cyanobacterium. The extraction and filtration remove oil, oil soluble substances, and fibers. The color additive contains phycocyanins as the principal coloring components, and consists of proteins, carbohydrates, and minerals. Based on data and information provided in the petition on the identity, physical and chemical properties, manufacturing process, and composition of the color additive, we have determined that the color additive meets the current specifications for spirulina extract in § 73.530 (Refs. 1 and 2). During the review of the petition, FDA noted that the specifications for heavy metals could be lowered based on the results of the petitioner's batch analyses, and a specification for cadmium should be added. These modifications to the heavy metal specifications would align with FDA's work to reduce dietary exposure to contaminants. Therefore, in addition to expanding the use of spirulina extract, the petitioner proposed to lower the heavy metal specifications for lead (≤0.2 mg/kg), arsenic (≤0.3 mg/kg), and mercury (≤0.1 mg/kg) that are currently in the regulation, and to add a specification for cadmium (≤0.3 mg/kg).

There is no generally recognized as safe (GRAS) exception in the definition of a color additive in section 201(t) of the FD&C Act (21 U.S.C. 321(t)), and, therefore, the intended use of a color additive requires our approval. However, we note that spirulina-based ingredients have been the subject of several GRAS notices (GRNs) reviewed by FDA (discussed in 78 FR 49117 at 49118). (Under section 201(s) of the FD&C Act, a substance is GRAS, and excepted from the definition of a food additive, if it is generally recognized, among experts qualified by scientific training and experience to evaluate its safety, to be safe under the conditions of its intended use.) In particular, the spirulina substance that was the subject of GRN 000424 is similar in chemical composition to the subject color additive, with phycocyanin content ranging from 42 to 47 percent ( id. ). If a substance imparts color to a food, it may be subject to regulation as a color additive even if its use is also considered GRAS.

Under section 721(b) of the FD&C Act (21 U.S.C. 379e(b)), a color additive may not be listed for a proposed use unless the data and other information available to FDA establish that the color additive is safe for that use. Our color additive regulations at 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive.

To determine whether a color additive is safe under the general safety clause, the FD&C Act requires FDA to conduct a fair evaluation of the available data and consider, among other relevant factors: (1) probable consumption of, or other relevant exposure from, the additive and of any substance formed in or on food, drugs, devices, or cosmetics because of the use of the additive; (2) cumulative effect, if any, of such additive in the diet of man or animals, taking into account chemically or pharmacologically related substance or substances in such diet; and (3) safety factors recognized by experts as appropriate for the use of animal experimentation data (see section 721(b)(5)(A)(i) through (iii) of the FD&C Act).

As part of our safety evaluation to establish with reasonable certainty that a color additive is not harmful under its intended conditions of use, we consider the additive's manufacturing and stability, the projected human dietary exposure to the additive and any impurities resulting from the petitioned use of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us. We compare the estimated dietary exposure to the color additive from all sources to an acceptable daily intake (ADI) level established by toxicological data. The dietary exposure is estimated based on the amount of the color additive proposed for use in particular foods or drugs and on data regarding the amount consumed from all sources of the color additive. We commonly use the dietary exposure for the 90th percentile consumer of a color additive as a measure of high chronic dietary exposure.

During our safety review of this petition (CAP 4C0334), we considered the estimated dietary exposure to spirulina extract and c-phycocyanin (the main coloring component) from the petitioned uses of the subject color additive. Specifically, the petition sought to expand the intended uses of this color additive to include all foods, except infant formula and certain foods subject to regulation by the USDA ( i.e., products subject to regulation by the USDA under the Federal Meat Inspection Act (21 U.S.C. 601 et seq. ), the Poultry Products Inspection Act (21 U.S.C. 451 et seq. ), or the Egg Products Inspection Act (21 U.S.C. 1031 et seq. )). C-phycocyanin is the predominant phycocyanin present in spirulina, although low levels of allophycocyanin are also present; due to the predominance of c-phycocyanin, the concentration of c-phycocyanin in spirulina extract is assumed to represent all “phycocyanins” in spirulina. The petitioner provided the eaters-only 90th percentile dietary exposure to spirulina extract and c-phycocyanin from the petitioned uses for the U.S. population aged 2 years and older, and various subpopulations.

The petitioner provided information on the proposed expanded food uses of spirulina extract, including food categories in which spirulina extract is intended to be used and the corresponding maximum use levels that represent GMP for the petitioned uses (Ref. 2). The petitioner used food consumption data from the combined 2015-2016 and 2017-2018 National Health and Nutrition Examination Survey (NHANES) to estimate the dietary exposure to spirulina extract from the petitioned uses. The petitioner estimated the eaters-only ( i.e., only those individuals in the population that consume the foods of interest) dietary exposure to spirulina extract from the petitioned uses to be 6.3 grams/person/day (g/p/d) at the mean and 14.1 g/p/d at the 90th percentile for the U.S. population aged 2 years and older; and 5.1 g/p/d at the mean and 10.7 g/p/d at the 90th percentile for children aged 2-5 years (Ref. 2). We independently confirmed the petitioner's dietary exposure using food consumption data from the combined 2015-2016 and 2017-2018 NHANES and concur with the petitioner's dietary exposure to spirulina extract (Ref. 2).

The petitioner also estimated the eaters-only dietary exposure to c-phycocyanin from the petitioned uses of spirulina extract to be 0.13 g/p/d at the mean and 0.28 g/p/d at the 90th percentile for the U.S. population aged 2 years and older; and 0.1 g/p/d at the mean and 0.21 g/p/d at the 90th percentile for children aged 2-5 years (Ref. 2).

The petitioner did not provide an updated cumulative dietary exposure estimate for c-phycocyanin in this petition. However, the petitioner indicated that: (1) the overall maximum GMP use level in the current petition is comparable to that in GRN 000424 on a c-phycocyanin basis; GRN 000424 pertains to the use of a spirulina-based substance similar in chemical composition to the subject color additive, but with a higher phycocyanin content; GRN 000424 pertains to the intended use in all foods (except infant formula and foods under the USDA's jurisdiction) ( i.e., products subject to regulation by the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act) at levels consistent with GMP; (2) the petitioner's spirulina extract would not be added to foods already containing other sources of spirulina; (3) the number of servings in the daily diet that could be colored with spirulina extract would reasonably be well below the assumption of 50% of the daily servings in the current cumulative dietary exposure of 1.14 g/p/d from the notified GRAS uses of spirulina; and (4) the current cumulative dietary exposure for c-phycocyanin is inclusive of the dietary exposure to c-phycocyanin from the approved uses of spirulina extract as a color additive under § 73.530 as well as the expanded uses in the current petition. As such, the petitioner concluded that the intended uses of spirulina extract in this petition would be substitutional to other sources of spirulina in foods (on a c-phycocyanin basis), and the dietary exposure to c-phycocyanin from the petitioned uses would be subsumed by the dietary exposure to c-phycocyanin from the uses in GRN 000424. Therefore, the petitioned uses would not increase the current upper-bound cumulative dietary exposure to c-phycocyanin of 1.14 g/p/d in GRN 000424. We concur with the petitioner's statement regarding the cumulative dietary exposure to c-phycocyanin (Ref. 2).

To support the safety of the petitioned use of spirulina extract, the petitioner referenced the safety determinations made by FDA for spirulina extract in CAPs 2C0293 (78 FR 49117, August 13, 2013), 2C0297 (79 FR 20095, April 11, 2014), 4C0300 (80 FR 50762, August 21, 2015), 6C0306 (82 FR 30731, July 3, 2017), and 0C0316 (87 FR 67785, November 10, 2022). The petitioner also conducted an updated search of the peer-reviewed scientific literature on spirulina and submitted the published studies that they identified as being relevant to their petition. The petitioner concluded that these publications did not reveal any significant new toxicological effects and should not alter the conclusion of FDA's previous reviews on spirulina.

FDA's most recent evaluation of the use of spirulina extract as a color additive in alcoholic beverages with less than 20 percent alcohol-by-volume content, non-alcoholic beverages, condiments and sauces, dips, dairy product alternatives (non-dairy yogurt alternatives, non-dairy frozen desserts, and non-dairy puddings), salad dressings, and unheated seasoning mixes (87 FR 67785, November 10, 2022), included a comprehensive review of studies submitted by the petitioner and a review of all available literature. From our evaluation, we did not have any concerns regarding the safety of the use of spirulina extract and its principal coloring components, phycocyanins.

Of the publications submitted by the petitioner, some studies had been previously reviewed by FDA (Ref. 3), including a chronic toxicity study which identified a NOAEL (“No Observed Adverse Effect Level”) of 15,000 mg/kg bw/d of spirulina powder. Our review of the new information submitted by the petitioner, the information submitted in previously reviewed publications, as well as our own independent literature search and review of spirulina and phycocyanins, did not reveal any safety concerns relating to spirulina or phycocyanins, nor did it identify any information or data that would change the ADI of 1.8 g/p/d for phycocyanins (Ref. 3).

We discussed the potential allergenicity of spirulina phycocyanins in our final rule for the use of spirulina extract as a color additive in candy and chewing gum (78 FR 49117 at 49119, August 13, 2013). We stated that, based on our review of a comparison of the known amino acid sequences of c-phycocyanin, which is the predominant phycocyanin present in spirulina (Ref. 2), with the sequences of known protein allergens, there is a low probability that the spirulina c-phycocyanin is a protein allergen. Additionally, while allophycocyanin is present at very low levels in spirulina, we consider these levels and any allergenicity risk to be negligible. Therefore, we concluded that spirulina phycocyanins present an insignificant allergy risk to consumers of the color additive. In addition, after a review of all available literature relevant to the potential allergenicity of spirulina, we have determined that while spirulina extract and specifically c-phycocyanin are possible allergens for certain individuals, reactivity is not widespread and spirulina sensitization appears to be rare (Ref. 3). Therefore, we continue to conclude that spirulina extract as a color additive presents an insignificant allergy risk for the general population (Ref. 3). We are not aware of any new information that would cause us to change this conclusion.

Our review considered the safety data provided by the petitioner, including our independent review of the current published literature, which did not present evidence of safety concerns for spirulina extract at the expected dietary exposures. Given that the upper-bound cumulative dietary exposure estimate for c-phycocyanin of 1.14 g/p/d is not expected to increase with the new petitioned uses, exposure remains below the previously determined ADI for phycocyanins of 1.8 g/p/d. Therefore, we conclude that spirulina extract is safe for the petitioned uses (Refs. 2 and 3).

Based on the data and information in the petition and other available relevant information, we conclude that the petitioned use of spirulina extract as a color additive at levels consistent with GMP (in human foods generally except for infant formula and products subject to regulation by the USDA under the Federal Meat Inspection Act, the Poultry Products Inspection Act, or the Egg Products Inspection Act) is safe.

We further conclude that this color additive will achieve its intended technical effect and is suitable for the petitioned use. Therefore, we are amending the color additive regulations in 21 CFR part 73 to provide for the safe use of this color additive as set forth in this document. In addition, based on the factors in 21 CFR 71.20(b) and consistent with our conclusions in our earlier published approvals of spirulina extract for petitioned uses, we continue to conclude that batch certification of spirulina extract is not necessary to protect the public health.

In accordance with § 71.15 (21 CFR 71.15), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT ). As provided in § 71.15, we will delete from the documents any materials that are not available for public disclosure.

We previously considered the environmental effects of this order, as stated in the August 5, 2024, Federal Register notification of petition for CAP 4C0334 (89 FR 63330 at 63331). The petitioner claimed that this action is categorically excluded under § 25.32(k) (21 CFR 25.32(k)) because the substance is intended to be added directly to food, remain in food through ingestion by consumers, and is not intended to replace macronutrients in food. We have not received any new information or comments regarding this claim of categorical exclusion. We considered the petitioner's claim of categorical exclusion and determined that this action is categorically excluded under § 25.32(k) (Ref. 4). Therefore, neither an environmental assessment nor an environmental impact statement is required.

This order contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Our review of this petition was limited to section 721 of the FD&C Act (21 U.S.C. 379e). This order is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this color additive. Accordingly, this order should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all color additive final orders that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

This order is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES ) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register .

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://www.regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows:

In the Federal Register of March 12, 2024 (89 FR 17789), we announced that we filed a color additive petition (CAP 4C0326) submitted by Phytolon, Ltd., Ha-Tsmikha St, Yokne'am Illit, Israel. The petition proposed to amend the color additive regulations in part 73 (21 CFR part 73), “Listing of Color Additives Exempt From Certification,” to provide for the safe use of beetroot red for the coloring of foods generally, in amounts consistent with current good manufacturing practice, except in products under the jurisdiction of the USDA, in infant formula, and foods for which standards of identity have been promulgated under section 401 of the FD&C Act unless added color is authorized by such standards.

Beetroot red is a reddish-purple liquid or powder produced by fermentation using a modified strain of the yeast, Saccharomyces cerevisiae ( S. cerevisiae ), expressing the genes for betanin biosynthesis from red beets ( Beta vulgaris L. var. rubra). The principal coloring component in beetroot red is betanin (CAS Reg. No. 7659-95-2). Betanin is a type of betacyanin, which in turn is a type of betalain. Betalains are a class of water-soluble pigments present primarily in red beets and in plants belonging to the order, Caryophyllales ( e.g., quinoa, spinach, amaranths, and others). Betalains are divided into two subclasses: betacyanins (reddish to violet, including betanin) and betaxanthins (yellow to orange). Beetroot red contains a similar betacyanin pigment composition to dehydrated beets (21 CFR 73.40).

The color additive is manufactured by the following steps: (1) construction of the S. cerevisiae production strain that is genetically engineered to express the genes involved in the biosynthesis of betanin; (2) expression of betanin product via controlled fermentation by the S. cerevisiae production strain; (3) removal of the production organism from the fermentation broth; and (4) water evaporation to produce the liquid form of the product and optional drying to produce a powder form of the product.

The petitioner proposed the following specifications for beetroot red: total betacyanin, not less than 0.6 percent by weight; betanin purity, not less than 75 percent of the total betacyanin; total betacyanin other than betanin, not more than 20 percent; lead, not more than 0.15 milligram per kilogram (mg/kg); arsenic, not more than 0.05 mg/kg; mercury, not more than 0.01 mg/kg; cadmium, not more than 0.05 mg/kg. FDA concluded that the petitioner's proposed specifications for total betacyanin, betanin purity, and total betacyanin other than betanin are not needed in the codified regulation (Ref. 1).

Under section 721(b)(4) of the FD&C Act (21 U.S.C. 379e(b)(4)), a color additive may not be listed for a particular use unless the data and other information available to FDA establish that the color additive is safe for that use. Our color additive regulations at 21 CFR 70.3(i) define “safe” to mean that there is convincing evidence establishing with reasonable certainty that no harm will result from the intended use of the color additive.

As part of our safety evaluation to establish with reasonable certainty that a color additive is not harmful under its intended conditions of use, we consider the additive's manufacturing and stability, the projected dietary exposure to the additive and any impurities resulting from the petitioned use of the additive, the additive's toxicological data, and other relevant information (such as published literature) available to us.

The petitioner requested that beetroot red be permitted at levels consistent with current good manufacturing practice and provided the representative maximum use levels for the proposed uses of the color additive. The petitioner used food consumption data from the 2017-2018 National Health and Nutrition Examination Survey (NHANES) to estimate the dietary exposure to betanin from the proposed use of beetroot red. The petitioner stated that the use of the color additive would be substitutional for current food uses of beetroot powder (21 CFR 73.40), and therefore, the proposed use of the color additive will not increase the current dietary exposure to betanin in the diet.

The petitioner estimated the eaters-only (that is, only those individuals in the population who consume the foods of interest) dietary exposure to betanin, the principal coloring component, from the intended uses of beetroot red (Ref. 2). However, FDA noted that the petitioner did not provide an estimate of dietary exposure to the powder or liquid forms of beetroot red. Therefore, we conducted our own estimate of dietary exposure to betanin and beetroot red. In addition, the petitioner included food codes for meat and poultry in the dietary exposure estimate and indicated that removal of these food codes would not impact the dietary exposure estimate because beetroot red is proposed for uses in plant-based meat analog products, and due to the limited availability of plant-based meat codes, the petitioner used the comminuted meat and poultry product food codes as surrogates. We noted that NHANES contains food codes for meat substitutes and, therefore, including the surrogate food codes is not necessary.

We estimated the dietary exposure to betanin from the use of beetroot red using 2-day food consumption data from the 2015-2020 NHANES for food and dietary supplements to be 27 mg/person/day (mg/p/d) at the mean and 53 mg/p/d at the 90th percentile for the U.S. population aged 2 years and older and 19 mg/p/d at the mean and 37 mg/p/d at the 90th percentile for children aged 2 to 5 years. Additionally, using the average total betacyanin and percent betanin from betacyanins, we estimated the dietary exposure to beetroot red powder and liquid forms to be 1.8 gram (g)/p/d and 4.4 g/p/d at the mean, respectively and 3.7 g/p/d and 8.9 g/p/d at the 90th percentile, respectively, for the U.S. population aged 2 years and older and 1.3 g/p/d and 3.2 g/p/d at the mean, respectively and 2.5 g/p/d and 6.1 g/p/d at the 90th percentile, respectively, for children aged 2-5 years (Ref. 2).

To establish that beetroot red is safe for use as a color additive, the petitioner used a weight-of-evidence approach based on the following: (1) the history of widespread and safe consumption of betalains, including the betacyanin, betanin; (2) the results of safety studies conducted with beetroot red as the test article; and (3) an allergenicity assessment of protein sequences introduced into the production strain.

Betanin, as part of beetroot red, is a natural dietary constituent, and FDA acknowledges the long history of safe consumption of betanin from existing dietary sources, including red beetroot and purple dragon fruit (Ref. 3). In 1967, FDA published a regulation authorizing the use of dehydrated beets (beet powder) (21 CFR 73.40), which contains betanin, but we did not specify a maximum daily intake because no significant safety concerns existed. Furthermore, FDA acknowledges that S. cerevisiae has a prior history of safe use in a variety of food applications, and we conclude the S. cerevisiae strain developed by the petitioner for the production of beetroot red is non-toxicogenic and non-pathogenic (Ref. 3).

We reviewed the mutagenicity and genotoxicity studies (a bacterial reverse mutation assay, an in vitro mammalian chromosome aberration assay, an in vitro mammalian cell micronucleus assay, an in vivo mammalian erythrocyte Pig-a gene mutation assay, and an in vivo mutagenicity assessment using duplex sequencing in liver, stomach, and intestine tissues collected from a Pig-a gene mutation assay) using beetroot red as a test article (id.). We agree with the petitioner that beetroot red is not mutagenic or genotoxic under the experimental procedures and conditions applied.

We reviewed the subchronic (90-day) toxicity study in rats using beetroot red as a test article (id.). The no-observed-adverse-effect-levels (NOAELs) established in this study are 3,581 mg beetroot red/kg body weight (bw)/d in male rats and 4,055 mg beetroot red/kg bw/d in female rats, the highest dose tested (id.).

We consider the subchronic toxicity study on betanin-enriched beetroot red in rats to provide an important new set of data that corroborates the existing safety information for beetroot red (see id.). The petitioner states that the beetroot color test article used in the subchronic toxicity study was specifically manufactured to include pigment at the highest concentration possible (approximately 4.5% of betanin) to maximize the margin of exposure for the safety assessment (see id.).

In its assessment of the allergenicity of beetroot red, the petitioner examined the incidence of beetroot allergy in consumers and conducted bioinformatic analyses to determine if protein sequences introduced into the production strain share significant identity with the protein sequences of known allergens (see id.). The petitioner identified several reports of allergic reactions associated with consumption of beetroot but concluded there is no evidence that betalains are associated with these cases of allergic reactions (see id.). The petitioner did not identify known allergens sharing significant sequence identity with the introduced protein sequences, and we independently verified the results of the allergenicity assessment (see id.). We agree with the petitioner that there is no evidence of allergenic potential of the introduced protein sequences.

Based on the weight of evidence, such as the long history of consumption of beetroot and its color components, including betanin, the safety of orally administered betanin-enriched beetroot red in the subchronic rat study, and the lack of evidence of allergenic potential of introduced protein sequences, we conclude that beetroot red is safe for the petitioned uses (id.).

We received one comment in response to FDA's filing of the beetroot red color additive petition. The commenter requested that we decline to name the color additive “beetroot red” or any similar name using the term “beetroot” because the color additive is not derived from beetroot. The commenter further requested that the color additive be named “betanin.” After consideration of the comment, we are listing this color additive as “beetroot red” because (1) the color additive is expressed by genes from red beets ( Beta vulgaris L. var. rubra), and we consider the phrase “beetroot red” appropriately descriptive of the identity of the color additive; and (2) while the color additive contains betanin as its principal coloring component, the color additive is composed of other pigments and non-pigment constituents (as discussed previously in II. Background), and therefore the color additive would not accurately be identified solely as “betanin.”

Based on the data and information in the petition and other available relevant information, we conclude that the petitioned use of beetroot red is safe for use as a color additive in foods generally and at levels consistent with current good manufacturing practices, except that it may not be used to color products under the jurisdiction of the USDA, infant formula, and foods for which standards of identity have been promulgated under section 401 of the FD&C Act unless added color is authorized by such standards.

We further conclude that this color additive will achieve its intended technical effect and is suitable for the petitioned use. Therefore, we are amending the color additive regulations in part 73 to provide for the safe use of beetroot red as set forth in this document. In addition, based on the factors in 21 CFR 71.20(b), we conclude that batch certification of beetroot red is not necessary to protect the public health.

In accordance with § 71.15(a) (21 CFR 71.15(a)), the petition and the documents that we considered and relied upon in reaching our decision to approve the petition will be made available for public disclosure (see FOR FURTHER INFORMATION CONTACT ). As provided in § 71.15(b), we will delete from the documents any materials that are not available for public disclosure.

As stated in the March 12, 2024, Federal Register notification of petition for CAP 4C0326, the petitioner claimed that this action is categorically excluded under 21 CFR 25.32(r) because it applies to an action for substances which occur naturally in the environment, and for which the action does not alter significantly the concentration or distribution of the substance, its metabolites, or degradation products in the environment. We stated that, if FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. We did not receive any new information or comments regarding this claim of categorical exclusion. We considered the petitioner's claim of categorical exclusion and determined that this action is categorically excluded under 21 CFR 25.32(r) (Ref. 4). Therefore, neither an environmental assessment nor an environmental impact statement is required.

This order contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.

Our review of this petition was limited to section 721 of the FD&C Act. This order is not a statement regarding compliance with other sections of the FD&C Act. For example, section 301(ll) of the FD&C Act (21 U.S.C. 331(ll)) prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act (21 U.S.C. 355), a biological product licensed under section 351 of the Public Health Service Act (42 U.S.C. 262), or a drug or biological product for which substantial clinical investigations have been instituted and their existence has been made public, unless one of the exemptions in section 301(ll)(1) to (4) of the FD&C Act applies. In our review of this petition, we did not consider whether section 301(ll) of the FD&C Act or any of its exemptions apply to food containing this color additive. Accordingly, this order should not be construed to be a statement that a food containing this color additive, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll) of the FD&C Act. Furthermore, this language is included in all color additive orders that pertain to food and therefore should not be construed to be a statement of the likelihood that section 301(ll) of the FD&C Act applies.

This order is effective as shown in the DATES section, except as to any provisions that may be stayed by the filing of proper objections. If you will be adversely affected by one or more provisions of this regulation, you may file with the Dockets Management Staff (see ADDRESSES ) either electronic or written objections. You must separately number each objection, and within each numbered objection you must specify with particularity the provision(s) to which you object, and the grounds for your objection. Within each numbered objection, you must specifically state whether you are requesting a hearing on the particular provision that you specify in that numbered objection. If you do not request a hearing for any particular objection, you waive the right to a hearing on that objection. If you request a hearing, your objection must include a detailed description and analysis of the specific factual information you intend to present in support of the objection in the event that a hearing is held. If you do not include such a description and analysis for any particular objection, you waive the right to a hearing on the objection.

Any objections received in response to the regulation may be seen in the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov. We will publish notice of the objections that we have received or lack thereof in the Federal Register .

The following references are on display at the Dockets Management Staff (see ADDRESSES ) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at https://regulations.gov.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under the authority delegated to the Commissioner of Food and Drugs, 21 CFR part 73 is amended as follows:

FDA is amending the animal drug regulations to reflect approval actions for NADAs, ANADAs, and CNADAs during July, August, and September 2025, as listed in table 1. Documentation of environmental review required under the National Environmental Policy Act, summaries of the basis of approval under the Freedom of Information Act (FOIA summaries), and marketing exclusivity and patent information are available at Animal Drugs @FDA: https://animaldrugsatfda.fda.gov/adafda/views/#/search .

Elanco US Inc., 450 Elanco Circle, Indianapolis, IN 46211 (drug labeler code 058198) requested that FDA withdraw approval of the NADA listed in table 2 because the product information has been combined with NADA 010-918. No change to the regulatory text is required.

The sponsor of the approved applications listed in table 3 has informed FDA that they have transferred ownership of, and all rights and interest in, these applications to another sponsor. The regulations cited in table 3 are amended to reflect these actions.

This final rule is issued under section 512(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b(i)). Although deemed a rule under the FD&C Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability” and is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 516, 520, 522, 529, 556, and 558 are amended as follows:

The NDAA-23 also grants the Director of DHA discretionary authority to waive assessment of medical fees of non-beneficiaries when the healthcare provided enhances the knowledge, skills, and abilities (KSAs) of healthcare providers, as determined by the Director of DHA. The DHA is implementing the amendments to 10 U.S.C. 1079b enacted through the NDAA-23. By statute (Pub. L. 117-263, div. A, title VII, § 716(c), Dec. 23, 2022, 136 Stat. 2661), the sliding fee scale and/or catastrophic fee waivers apply to bills for healthcare services provided at MTFs on or after June 21, 2023.

Title 10, United States Code (U.S.C.), section 1073d requires the DoD to maintain MTFs for the purposes of supporting the medical readiness of the armed forces and the readiness of deployable medical personnel. To maintain medical currency and bolster the KSAs of DoD healthcare providers, the DoD renders emergency, trauma, and other medical services to beneficiaries of the MHS which consist of service members and former service members, and their dependents. The MHS may provide healthcare services to other individuals who are not eligible beneficiaries, in certain circumstances, as authorized by law, and typically on a reimbursable basis (Pub. L. 114-328, 717(c), Dec. 23, 2016, as amended (10 U.S.C. 1071 note); and § 1074(c)).

Regulations implementing DoD's authority under 10 U.S.C. 1095 and related provisions of law to compute reasonable charges for inpatient and ambulatory (outpatient) care provided by MTFs, including charges for pharmaceuticals, durable medical equipment, supplies, immunizations, injections, or other medications, are at 32 CFR part 220, last updated on August 20, 2020 (55 FR 21742-21750). Medical billing is structured under three existing healthcare cost recovery programs: Third Party Collections (10 U.S.C. 1095); Medical Services Account (10 U.S.C. 1079b, 1085, and 1104); and Medical Affirmative Claims (42 U.S.C. 2651-2653). The rates used for billing are modeled after the rates published by the Centers for Medicare & Medicaid Services. The rates are approved annually by the Assistant Secretary of Defense for Health Affairs (ASD(HA)) and published on the DoD Comptroller's website at https://comptroller.defense.gov/Financial-Management/Reports/rates2023/. Funds collected through the healthcare cost recovery programs are used to enhance healthcare delivery at MTFs.

In carrying out the DoD's healthcare cost recovery programs, charges and fees for care provided are assessed, as applicable, to civilian non-beneficiary patients who receive treatment at MTFs. When medical care is provided, such individuals become indebted to the United States. The DoD has authority under the Debt Collection Improvement Act of 1996 (DCIA) (Pub. L. 104-134) to compromise, or terminate the collection of, claims involving monetary indebtedness to the United States. The Federal Claims Collection Standards (FCCS) promulgated at 31 CFR parts 900 through 904, which implement the DCIA, require that Federal agencies aggressively collect all debts arising out of activities of that agency. Collection activities must be undertaken promptly with follow-up action taken as necessary. Although an individual's financial circumstances may be considered in applying the FCCS, the relevance of such information in determinations concerning debt compromise or termination concerns the likelihood of repayment or successful enforced collection within a reasonable period of time, rather than the impact on or financial harm to an individual that is consequential to being indebted.

Title 10 U.S.C. 1079b, as amended by section 716 of NDAA-23, implements financial protections for certain individual civilian non-beneficiaries.

Due to the high cost of healthcare in the United States and the mandate for Federal agencies to aggressively pursue collection of debts under FCCS, civilian non-beneficiaries who were provided emergency or trauma healthcare services in DoD MTFs have experienced financial harm after receiving substantial medical bills from MTFs. The DoD does not have authority to forgive or waive indebtedness for MTF charges outside of the FCCS and has not had authority to discount charges and fees for medical care, in contrast to for-profit and non-profit hospitals that offer various financial assistance policies. As a result, Congress wholly amended 10 U.S.C. 1079b via section 716 of NDAA-23 providing DoD with significant authority to protect patients from financial harm under the existing billing and collection laws. Section 716 directs DoD to apply a sliding fee and/or a catastrophic fee waiver when assessing fees and charges to non-beneficiaries. For non-beneficiaries with health insurance, Section 716 directs DoD to accept payments from health insurers as full payment and to not balance bill non-beneficiaries except for copays, coinsurance, deductibles, nominal fees, and non-covered services. It also provides the Director of DHA conditional, discretionary authority to waive the assessment of fees that otherwise would be charged to non-beneficiaries when the healthcare provided enhances the KSAs of healthcare providers, as determined by the Director of DHA. The NDAA for FY 2017 (NDAA-17) authorizes provision of such care on a reimbursable basis to civilians who are not covered beneficiaries. Public Law 114-328, 717(c), Dec. 23, 2016, as amended, 10 U.S.C. 1071 note.

The proposed rule titled “Medical Billing for Healthcare Services Provided by Department of Defense Military Medical Treatment Facilities to Civilian Non-Beneficiaries” was published in the Federal Register on October 1, 2024 (89 FR 79804-79815). Comments were accepted for 60 days until December 2, 2024. A total of 12 comments were received of which eight indicated general support for the rule and four expressed various concerns. Please see a synopsis of the comments received, our responses to those comments, and clarifications being made to the regulations at 32 CFR part 220 as a result of the public comments.

Comment: The Department received eight public comments expressing support for the proposed rule and four expressing various concerns.

Response: The Department values public input as an essential component of the rulemaking process. We extend our sincere thanks to everyone who submitted comments on the proposed rule. We are particularly grateful for the support expressed by the eight commenters who affirmed the rule's goals. We believe this rule represents a collaborative effort to strengthen financial protections for patients accessing the exceptional healthcare services offered within the MHS.

Comment: Four commenters expressed concern that the application process seemed too burdensome, specifically that there are too many forms to fill out and too much paperwork to gather as part of the application process. Some pointed out that it could be particularly difficult for people who are homeless, do not speak English well, or are dealing with other challenges. Commenters advocated that patients be protected from aggressive debt collection while they are trying to get their application processed. Recommendations included simplifying forms, streamlining income verification (including exploring Internal Revenue Service (IRS) collaboration and accepting alternative documentation), limiting supporting documents, providing clearer instructions and dedicated support staff, and translating materials into multiple languages.

Response: We acknowledge the need for a simplified and accessible MHS MPWP process:

• Clearer Communication: Section 220.12(e) of the final rule requires standardized language on all invoices, explaining the MHS MPWP in plain terms and directing patients to a dedicated website with detailed program information, frequently asked questions, and a fee calculator to help them estimate their potential savings.

• Easier Income Verification: Section 220.12(k)(2)(iii) of the final rule clarifies that patients can use documents other than tax returns and pay stubs to prove their income, such as bank statements or Social Security benefit letters. While we appreciate the suggestion of accessing income data directly from the IRS, this may result in evaluating a patient's income based on outdated information. We will continue to assess the feasibility of this option in the future.

• Protection During Application: Section 220.12(m) of the final rule states that DoD will suspend DoD collection actions against the patient (excluding processing of insurance claims) during the application review period.

• Fresh Start After Approval: Section 220.12(j)(1) clarifies that we are also resetting the delinquency clock after a decision is made on the application. This means that approved applicants will have a new opportunity to manage their payments without the pressure of past delinquency.

• Recalling Debt from Treasury: To prevent unnecessary hardship, the final rule mandates the recall of debts from the Department of the Treasury's Cross-Servicing Program upon approval of a discount or waiver, stopping further collection actions.

• Flexible Payment Plans: We recognize the need for affordable payment options. The final rule guarantees flexible installment plans for up to 72 months, allowing patients to spread out their payments over a manageable timeframe.

• Tax Implications of Waivers: We understand the concerns regarding the potential tax implications of debt waivers. However, tax matters fall outside the jurisdiction of the Department.

Comment: We heard strong support from four commenters for prioritizing the use of waivers to provide greater financial relief, including the use of preemptive waivers, especially for those with injuries similar to those seen in combat. Commenters also advocated for adjustments to the sliding scale and catastrophic cap fees; and one commenter requested that we not transfer delinquent accounts to Treasury, but rather that we hold onto them for an additional eight-month period past delinquency.

Response: We carefully considered this feedback:

• Waiver Authority: While we will maintain the DHA Director's discretion to determine when a waiver is appropriate, the final rule makes it clear at § 220.12(o) that after receiving a discount, patients may further apply for a potential waiver. The final rule clarifies at § 220.12(o)(iv) that waivers will be considered in all cases where there is confirmation by a competent medical authority at the treating MTF that the care provided to the applicant enhanced the clinical readiness of military medical personnel. Additionally, we have clarified that waivers may be partial or full and are applicable to a remaining balance that has already been discounted by a sliding fee in order to minimize any tax implications for the patient. The phrase “used sparingly” has been deleted from the final rule.

• Preemptive Waivers: Two commenters advocated for automatic or presumptive waivers for specific types of injuries, such as gunshot wounds or car accidents. We will not implement these because the training value of each case depends heavily on its unique circumstances, the experience level of the medical team, and the specific learning objectives. For example, a common fracture might provide valuable training for a new medic, while a complex, multi-system trauma case could offer a significant learning opportunity for even the most experienced surgeons. Assessing whether a case adds KSAs in the context of battlefield equivalency value will be done on a case-by-case basis by the treating facility's competent medical authority as stated at § 220.12(o).

• Sliding Scale: Four commenters recommended that we expand the income thresholds for the sliding scale discount. We carefully reviewed the recommendations and determined that the current structure strikes a reasonable balance between providing meaningful relief and ensuring the program's financial sustainability, allowing us to help as many patients as possible. However, we clarify at § 220.12(l)(2) that applicants whose income is between 401 percent through 600 percent of the Federal Poverty Guidelines (FPGs) are eligible for catastrophic fee waivers. We are committed to closely monitoring the program's impact and will consider adjustments to the sliding scale in the future if data indicates that it is not adequately meeting the needs of our patients.

• Withholding Delinquent Accounts From Transferring to Treasury: Four commenters requested that delinquent accounts not be transferred to the Treasury. However, per the Federal Claims Collection Standards, we are mandated to transfer debts that become delinquent more than 180 days. As stated at § 220.12(r), individuals may still submit an application for the MHS MPWP after their account has been transferred to the Cross-Servicing Program (“Cross-Servicing”) of the Department of the Treasury, Bureau of the Fiscal Service.

Comment: Three commenters suggested that we clarify our processes for billing insurance and two commenters suggested automatically adjusting Medicaid civilians' fees to their copays or to zero under the sliding scale and abstaining from charging Medicare patients.

Response: We have carefully considered the comments:

• Streamlined Insurance Processes and Denials: We have clarified at § 220.12(h) of the final rule that MTFs will engage in standard denials management practices, including providing supporting documentation and participating in appeal processes, to facilitate the resolution of disputed claims.

• Medicaid and Medicare Billing: DHA does not intentionally seek out Medicare or Medicaid patients. However, because some MTFs have arrangements with specific localities to accept trauma patients injured in close proximity to the MTF, sometimes Medicare and Medicaid beneficiaries are brought to the MTF for treatment. The DHA has an election agreement with Medicare as a non-participating provider. Medicare patients treated in MTFs are stabilized and transferred to a Medicare participating hospital. Medicare will pay the MTF for the costs associated with stabilization and transfer. Medicare patients are never balanced billed for care received in an MTF. Because MTFs, as Federal entities, are not licensed by the states, at present all MTFs, except one in Texas, are not allowed to participate in Medicaid. We did not make any changes to the rule, as Medicaid and Medicare billing are beyond the scope of what is needed to implement 10 U.S.C. 1079b. The sliding scale provides substantial reductions based on an individual's income inclusive of discounting a patient's bill to zero should their household income be below 100 percent of the FPGs.

Comments: Three commenters advocated for relief of debts incurred prior to June 21, 2023, including those currently subject to Treasury offsets.

Response: We recognize the financial challenges these debts may pose. While we are sympathetic to individuals with outstanding medical debt incurred prior to June 21, 2023, the statutory language included at section 716(c) of the NDAA-23 is clearly prospective. Although we cannot retroactively apply the MHS MPWP, patients can work with the DHA Debt Adjudication Office for debts that have not become delinquent. The DHA has limited authority to compromise debts under $100,000 if an applicant demonstrates an inability to pay under the FCCS. Once a debt has become delinquent, the FCCS requires that we transfer the debt to the Department of Treasury for collection. For delinquent debt, patients can work with debt management at the Department of Treasury to request that their debt be lowered (compromised). Patients should contact the Treasury's Cross-Servicing Program to discuss available options for financial relief.

Section 717 of NDAA-17 conditionally authorizes DoD to evaluate and treat civilian non-beneficiaries at MTFs if the evaluation and treatment is necessary to maintain medical readiness skills and competencies of healthcare providers. Section 717(c) mandates that DoD bill such individuals for the costs of such healthcare services provided. By amending 10 U.S.C. 1079b, section 716 of NDAA-23 has provided discretionary authority to waive an individual's responsibility to pay those statutorily mandated charges if the provision of care enhances the KSAs of healthcare providers, as determined by the DHA. If, under 10 U.S.C. 1079b(b), DoD elects to waive charges it is otherwise statutorily required to collect from an individual, any resulting discharge of indebtedness may need to be reported to the IRS in accordance with the reporting requirements at 26 U.S.C. 6050P. DoD may also be required to issue a Form 1099-C, “Cancellation of Debt” (Office of Management and Budget (OMB) Control Number 1545-1424), available at https://www.irs.gov/pub/irs-pdf/f1099c.pdf, to the patient in accordance with the same reporting requirements. This discharge of indebtedness could result in gross income being attributed to the patient under 26 U.S.C. 61. Authority provided by § 1079b(c) to adjust or waive assessment of fees and charges for medical care will be exercised by applying criteria applicable to civilian non-beneficiaries, rather than by exercising discretion to discharge indebtedness with respect to non-beneficiaries. Consequently, to reduce avoidable gross income to a patient under 26 U.S.C. 61, DoD will consider a waiver under 10 U.S.C. 1079b(b) of an individual's responsibility to pay charges only after any sliding scale discounts and catastrophic cap on charges have been applied.

For non-beneficiary medical encounters occurring prior to June 21, 2023, an MTF processes a bill to either the patient, the patient's third-party insurance, or to another guarantor. The current legal framework to process non-beneficiary bills is established under 10 U.S.C. 1079b (Procedures for Charging Fees to Civilians). Collection of medical debt resulting from medical bills is subject to the DCIA.

Title 10 U.S.C. 1079b directs the Secretary of Defense to implement procedures by which a non-beneficiary will be billed. The ASD(HA) publishes medical rates packages that are updated annually. The ASD(HA) rates reflect the full cost to the Government of providing care to a non-beneficiary patient; the rates generally reflect the same amounts that DoD reimburses to civilian healthcare providers when care is rendered outside of an MTF to a beneficiary patient, and they are also the same rates that DoD uses to bill third-party health insurers (under 10 U.S.C. 1095) when a beneficiary patient receives care in an MTF.

A bill generated for care at an MTF must be paid in full, whether by the patient, medical insurer, or other guarantor. The full amount is pursued against the patient and/or the patient's guarantor. If the debt is not paid within 180 days of the due date (or an installment plan due date), the debt is transferred to the Cross-Servicing Program (“Cross-Servicing”) of the Department of the Treasury, Bureau of the Fiscal Service, for collection. Agencies may also refer eligible debts that are less than 180 days delinquent to the Cross-Servicing program.

Under the current legal framework there is no authority to reduce the amount of a debt owed by a patient who received care at an MTF. There is an ability to compromise a balance that cannot be paid by the non-beneficiary. However, the FCCS, which governs compromises of debt, requires that a debtor reasonably demonstrate the inability to pay the debt balance, which entails evaluation of a debtor's current financial condition, and obtaining a credit report or other financial information in order to evaluate the debtor's assets, liabilities, income, and expenses.

Under 10 U.S.C. 1079b, as amended by NDAA-23, the DoD is required to apply a sliding scale and/or catastrophic fee waivers to medical invoices generated by MTFs in certain instances. The statute also gives the Director of DHA discretionary authority to waive charges mandated by section 717 of NDAA-17, when the care provided enhances the medical KSAs of MHS healthcare providers, as determined by the Director of DHA. Consequently, the DoD is implementing § 1079b authorities with the objective of mitigating financial harm to civilian non-beneficiaries. The MHS MPWP will be applied uniformly to all civilian non-beneficiary patients who apply to the program. Applicable discounts will be based only on household income and family size. All patients will be eligible to apply for the MHS MPWP in order to mitigate financial harm. Applicants to the MHS MPWP whose income is less than 100 percent of the FPGs will automatically receive a 100 percent discount of their medical bill. Applicants with income between 101 and 400 percent of the FPGs will be eligible for a sliding scale discount; and applicants whose income is between 400 through 600 percent of the FPGs will be eligible for a catastrophic fee waiver.

The MHS MPWP will involve a cascading, sequential process that begins with collecting health insurance information from all patients. For patients with health insurance, the patient must agree to allow DoD to file medical claims on the patient's behalf. Patients with health insurance who do not consent to allowing DoD to file insurance claims on their behalf will not be eligible for the MHS MPWP. By allowing DoD to file insurance claims on the patient's behalf, the DoD will be assured that insurance remittances and Explanation of Benefits (EOB) documents are properly sent to the DoD. This will enable the DoD to adjust balances on the patient's account inclusive of the amount paid by the insurance carrier, amounts disallowed, and amounts that are the patient's responsibility as determined by the insurance carrier ( i.e., copays, coinsurance, deductibles, nominal fees and non-covered services). DoD MTFs will participate in claims disputes through standard denials management practices. Once the patient's account is properly adjusted in accordance with the EOB, the DoD will bill insured patients only for portions of the bill that are their responsibility. For patients without health insurance, DoD will bill the patient.

Patients who are uninsured, underinsured and/or who have a remaining balance for copay, coinsurance, deductible, nominal fee, or non-covered services may apply to the MHS MPWP for application of the sliding scale discounts and catastrophic fee waivers.

Patients unable to pay the remaining balance after the application of the sliding scale and catastrophic fee waivers may also apply for a waiver of their medical fees under 10 U.S.C. 1079b(b), by submitting a completed DD Form 3201-1, “Request for Medical Debt Waiver, Military Health System Modified Payment and Waiver Program” ( https://www.esd.whs.mil/Directives/forms/dd3000_3499/ ). Waivers may be approved at the discretion of the DHA Director when the care rendered to the patient enhanced the KSAs of the healthcare providers as confirmed by competent medical authority at the treating MTFs on the DD Form 3201-1A. Waivers may be partial or full and applied to already waivered fees. KSAs are a set of clinical skill requirements a provider needs in order to provide medical care/treatment in the deployed environment. Waivers may result in financial reporting to the IRS and issuance of an IRS Form 1099-C to the patient. Generally, waivers may be granted if: (a) The patient has completed a DD Form 2569, “Third Party Collection Program/Medical Services Account/Other Health Insurance” (OMB Control Number 0720-0055), available at https://www.esd.whs.mil/Directives/forms/dd2500_2999/;

(b) the patient has submitted a completed application for the MHS MPWP via the DD Form 3201 and any and all appropriate discounts have been applied; and

(c) DHA competent medical authority confirms in writing on the DD Form 3201-1A that the care provided to the patient enhanced the KSAs of the DoD healthcare provider.

(d) If the above conditions are met, the Director of DHA may exercise discretionary authority to waive the medical invoice.

All patients receiving healthcare services at a DoD MTF are asked to complete a DD Form 2569 to collect health insurance information along with the patients' consent for the DoD to file a claim on their behalf. The form advises patients that their “records may be disclosed outside of DoD to healthcare clearinghouses, commercial insurance providers, and other third parties in order to collect amounts owed to the Department of Defense.”

For non-beneficiaries with health insurance who complete the DD Form 2569, the DHA will bill the non-beneficiary's health insurance and accept remittances. When payment or an EOB is received from the insurance company, the DoD will not bill the patient except for copays, coinsurance, deductibles, nominal fees, and amounts for non-covered services. The DoD will suspend collection against the patient for up to 120 days to allow the patient's insurance to process the claim. The DoD will not bill the patient until a determination on payment and/or an EOB is received from the insurance company, or 120 days has lapsed, whichever comes first. If the DoD receives an insurance remittance after 120 days have elapsed, the DoD will deposit the check, adjust the patient's account in accordance with the EOB, and issue the patient a refund for overpayments, if any have been received. The DoD will ensure that medical invoices sent to the patient reflect information about the MHS MPWP, including instructions for applying to the program. The DHA will support claims appeals through standard MTF denials management processes.

Delinquent accounts will be processed in accordance with the DCIA as implemented by the FCCS.

Individuals may still submit an application for the MHS MPWP even if their account has been transferred to Cross-Servicing; however, any reductions to the medical invoice from the MHS MPWP may be subject to interest, penalties, and costs. For patients who apply and are eligible for a reduction under the MHS MPWP, the DoD will recall the debt from Cross-Servicing. For patients who apply and are ineligible for a reduction under the MHS MPWP, the debt will remain at Cross-Servicing. Patients may request reconsideration for the MHS MPWP when their financial circumstances appear to have significantly changed.

Required MHS MPWP application documentation. Patients who desire to apply for the MHS MPWP must do so by completing a DD Form 3201, “Application for Military Health System Modified Payment and Waiver Program” (OMB Control Number PENDING), available at https://www.esd.whs.mil/Directives/forms/dd3000_3499/, and submitting the requisite documents. All DoD patient invoices will include a description of the documents that patients must submit together with DD Form 3201 in order to demonstrate their eligibility for the MHS MPWP. To demonstrate eligibility for a sliding fee/catastrophic fee waiver, the patient must first complete a DD Form 2569 (even in cases where the patient possesses no health insurance). Patients must also attach a copy of their most recent filed Federal income tax return and the patient's (or guarantor's if the patient is a minor) last two pay stubs. Patients who did not file a Federal income tax return for the preceding year must certify that they did not file an income tax return on the DD Form 3201 (a section is provided directly on the application form). Additionally, when the patient has no verifiable income, the patient must provide a certification to that effect on the DD Form 3201. For this purpose, a section is provided directly on the application form. The last two pay stubs or disability check stubs may be used if no Federal income tax return is provided in conjunction with the patient's certification of annual income on the DD Form 3201 to determine the patient's income. Finally, when the patient has certified to having no verifiable income and has neither a tax return nor pay stubs, other information may be used to validate the patient's lack of income including, but not limited to, the last two bank statements (savings and checking), or a Social Security benefits letter.

For patients with health insurance, the patient must agree to allow DoD to file medical claims on the patient's behalf.

Consideration for sliding scale and catastrophic fee waivers requires evaluation of the patient's household income. To receive consideration for the sliding fee discount or catastrophic fee waiver, or to be considered for a full waiver of fees under 10 U.S.C. 1079b(b), the patient must apply to the MHS MPWP after receiving the MTF medical invoice by completing and submitting the DD Form 3201 (OMB Control Number PENDING). Applications can be made by: (1) patients with a remaining balance after insurance has been billed by the DoD and the insurance remittance and/or EOB has been received by the DoD; (2) by patients without insurance who have a balance; and (3) by patients with a remaining balance after recovery from tortfeasors is made. Application instructions will be printed on the DoD invoice. Applicants to the MHS MPWP will be notified of the status of their application via the following methods: (1) For approved applications, the DoD will issue to the patient a modified medical invoice reflecting the balance due after applying the sliding fee and/or catastrophic fee waiver; (2) for disapproved applications, the DoD will issue a letter reflecting the reason why the application was disapproved. The letter will inform the patient of the right to reapply should the patient's financial circumstances change.

Applicants to the MHS MPWP will first be considered for a sliding fee discount, and then for a catastrophic fee waiver. The threshold for the sliding fee discount will be set to a 100 percent medical bill discount and no nominal fee for applicants whose annual household income is at or below 100 percent of the applicable year's FPGs; and a 100 percent medical bill discount plus a stratified nominal fee for applicants whose annual household income is greater than 100 percent and up to 400 percent of the applicable year's FPGs. The ASD(HA) may periodically adjust the threshold limits by issuing policy to be published on the DoD Reimbursement Rates website (available at https://comptroller.defense.gov/Financial-Management/Reports/ ). Stratified nominal fees are generally established in a manner that is equitable with what military retirees enrolled in the TRICARE program would be required to pay in the private sector for comparable services. The ASD(HA) will annually set the stratified nominal fees for outpatient and inpatient care and may periodically adjust the nominal fee by issuing policy to be published on the DoD Reimbursement Rates website. The initial nominal stratified fees are as follows:

Applicants with annual household income of greater than 400 percent of the applicable year's FPGs will not be eligible for a sliding fee discount but may be eligible for a catastrophic fee waiver if their household income does not exceed 600 percent.

The catastrophic fee waiver applies to applicants whose household income is between 401 percent and 600 percent of the FPGs and is based on a formula for adjusting the medical invoice over a 36-month period. The catastrophic fee waiver consists of limiting the patient's medical bill to a maximum percentage of the patient's monthly household income multiplied by 36 months and waiving the balance of the medical bill that exceeds the calculation. If the calculation yields an amount greater than the original medical bill, then the catastrophic fee waiver will not be applicable. The maximum percentage will be set to 5 percent of the patient's monthly household income multiplied by 36 months. The ASD(HA) will annually set the catastrophic fee thresholds by issuing policy to be published on the DoD Reimbursement Rates website.

As part of the implementation of the sliding fee and catastrophic fee protections to prevent severe financial harm, patients eligible for the MHS MPWP may have amounts collected in installments for a term not to exceed 72 months. Additionally, patients may request to pay their balance by lump sum. The minimum amount that may be paid by installment per month is $25.

In accordance with 10 U.S.C. 1079b(b), the Director of DHA may issue a partial or full waiver of already discounted fees for care provided to civilian non-beneficiaries if determined by the Director of DHA to be appropriate. Accordingly, consideration of a waiver of medical fees will occur on a case-by-case basis and only after application approval for the MHS MPWP has occurred and competent medical authority at the MTF that treated the patient confirms (on the DD Form 3201-1A) that the care provided to the patient enhanced provider KSAs. The DD Form 3201-1A is strictly for internal use and is not subject to the Paperwork Reduction Act (PRA). A waiver under 10 U.S.C. 1079b(b) of $600 or more will result in reporting to the IRS and issuance of a Form 1099-C to the non-beneficiary for the amount waived. All patient invoices will include a statement that the patient may apply for a waiver based on 10 U.S.C. 1079b(b) and § 220.12(n) and include information on how to submit a waiver request.

No discount or waiver of fees under 10 U.S.C. 1079b shall be interpreted to be applicable to tortfeasors under the Federal Medical Care Recovery Act (FMCRA), 42 U.S.C. 2651 or to third-party payers under 10 U.S.C. 1095. Patients treated at DoD MTFs are responsible to identify on the DD Form 3201 whether their injury/disease was caused by a third party. To be eligible to obtain any discounts or waivers under the MHS MPWP, the patient must consent and agree to cooperate with the United States to recover the cost of care against any liable tortfeasor or insurance under the FMCRA. Patients who have a remaining balance after recoveries from third-party tortfeasors or their insurers, may apply for relief of any remaining medical debt or may be refunded amounts already paid toward their medical debt if no balance is owed.

DoD anticipates that section 716 of the NDAA-23 will substantially mitigate serious financial harm to non-beneficiaries through application of a sliding fee and/or a catastrophic fee waiver to medical invoices generated by MTFs. DoD anticipates that the Director of DHA's discretionary authority to waive fees for non-beneficiaries will also contribute to reducing severe financial harm. The anticipated costs for the MHS MPWP include only the time required for a patient's application to be completed (see Paperwork Reduction Act section of this preamble) and reviewed. This includes time required for civilian non-beneficiary patients to complete the associated DD Form 3201 declaring their income, DoD to receive and assess the application, followed by the determination of the eligibility for a sliding scale discount, catastrophic fee waiver, or waiver under 10 U.S.C. 1079b(b) by the Director of DHA, and the response time for the decision. The total estimated time is less than 90 calendar days. In addition, costs may be incurred for patients who desire to apply for a waiver of their medical debt (via a DD Form 3201-1) after they have been approved for the MHS MPWP. Lastly, costs may be incurred by DHA staff who will be responsible for completing and processing the DD Form 3201-1A, which will be used by competent medical authority to confirm that care provided to civilian non-beneficiaries enhanced provider KSAs.

(1) Government Burden Related to the DD Form 3201, “Application for Military Health System Modified Payment and Waiver Program”:

(2) Government Burden Related to the DD Form 3201-1, “Request for a Medical Debt Waiver, Military Health System Modified Payment and Waiver Program”:

(3) Government Burden Related to the DD Form 3201-1A, “MHS Modified Payment and Waiver Program (MPWP) Medical Skills Sustainment Scoring Worksheet”:

(4) Note: The DD Form 3201-1A is strictly for internal use and is not subject to the PRA.

The Union Pacific Railroad vertical lift drawbridge crosses the San Bernard River, mile 20.7, near Brazoria, TX. The bridge is currently operated by a bridge tender at the site of the drawbridge and opens on signal; except that, from 10 a.m. to 2 p.m. and 10 p.m. to 2 a.m., the draw opens on signal if at least three hours-notice is given. This bridge at mean high water has a vertical clearance of 22 feet in the closed to boat position, a vertical clearance of 56 feet in the open to boat position and a 52 foot horizontal clearance. The bridge operates according to 33 CFR 117.984. The San Bernard River is used primarily by small recreational and fishing boats. Boats can and do pass beneath the bridge when the draw is in the closed to vessel position, and it currently opens about 1 time per day.

UPRR has requested to operate this drawbridge from their railroad dispatch center located in Spring, TX. UPRR has installed a remote operation system at the bridge and at the remote control center in Spring, TX. Eight cameras have been installed at the bridge; one per tower at each corner of the bridge approaches as well as 4 cameras that look under the bridge as well as up and down stream. The cameras are equipped with thermal imaging to assist with visibility during inclement weather. There are two sets of microwave type send-receive sensors that are installed to detect vessels under the bridge. The microwave boat detections sensors are connected to the UPRR signal system with input provided from the signal system to the bridge control system. The remote control station monitors the cameras, microwave system and communicates to boats with VHF radio and telephone.

During this test, the bridge will be operated by a bridge tender located in the UPRR Train Dispatch Center. A bridge tender will also be stationed at the bridge site to open and close the bridge if needed.

Boats and vessels will contact the remote bridge operator to open the draw on VHF-FM channel 9 or at the phone number posted on the bridge.

The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2025-0070 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

View material in the docket. To view documents mentioned in this deviation as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. Also, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted, or a final rule is published of any posting or updates to the docket.

We review all comments received, but we will only post comments that address the topic of this deviation. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

The Union Pacific Railroad vertical lift drawbridge crosses the Old Brazos River, mile 5.3, near Freeport, TX. The bridge is maintained in the open-to-boat position and is lowered to allow trains to pass. This bridge at mean high water has a vertical clearance of 10 feet in the closed to boat position, a vertical clearance of 71 feet in the open to boat position and a 228 foot horizontal clearance. The bridge operates according to 33 CFR 117.975. The Old Brazos River is used primarily by small recreational. The bridge lowers about 12 times per day to allow trains to pass.

UPRR has requested to operate this drawbridge from their railroad yard located next to the bridge. UPRR has installed a remote operation system at the bridge and at the railroad yard. Six cameras have been installed at the bridge; one per tower at each corner of the bridge that can be moved to look upriver, downriver and beneath the bridge and 2 cameras that look at the east and west rail tracks. The cameras are equipped with thermal imaging to assist with visibility during inclement weather. There are two sets of sensors that are installed to detect vessels under the bridge: 1 microwave sensor and 1 light detecting and ranging sensor. The remote control station monitors the cameras, sensor systems and communicates to boats with VHF radio and telephone.

During this test, the bridge will be operated by a bridge tender located in the UPRR Train Dispatch Center. A bridge tender will also be stationed at the bridge site to open and close the bridge if needed.

Boats and vessels will contact the remote bridge operator to open the draw on VHF-FM channel 9 or at the phone number posted on the bridge.

The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.

In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.

We view public participation as essential to effective rulemaking and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.

Submitting comments. We encourage you to submit comments through the Federal Decision Making Portal at https://www.regulations.gov. To do so, go to https://www.regulations.gov, type USCG-2025-0309 in the search box and click “Search.” Next, look for this document in the Search Results column, and click on it. Then click on the Comment option. If your material cannot be submitted using https://www.regulations.gov, contact the person in the FOR FURTHER INFORMATION CONTACT section of this document for alternate instructions.

View material in the docket. To view documents mentioned in this deviation as being available in the docket, find the docket as described in the previous paragraph, and then select “Supporting & Related Material” in the Document Type column. Public comments will also be placed in our online docket and can be viewed by following instructions on the https://www.regulations.gov Frequently Asked Questions web page. Also, if you go to the online docket and sign up for email alerts, you will be notified when comments are posted, or a final rule is published of any posting or updates to the docket.

We review all comments received, but we will only post comments that address the topic of this deviation. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.

We accept anonymous comments. Comments we post to https://www.regulations.gov will include any personal information you have provided. For more about privacy and submissions in response to this document, see DHS's eRulemaking System of Records notice (85 FR 14226, March 11, 2020).

The Coast Guard will enforce a safety zone for the Riverwalk Marketplace/Lundi Gras Fireworks Display from 6 p.m. through 7 p.m. on February 16, 2026. This action is being taken to provide for the safety of life on the navigable waterways during this one-day event. Our regulation for Annual fireworks displays and other events in the USCG Heartland District requiring safety zones, in 33 CFR 165.801, Table 5, Line 1 specifies the location of the safety zone on the Lower Mississippi River, from Mile Marker 93.0 to 96.0. During the enforcement period, as reflected in § 165.801 (a)-(c), entry into this zone is prohibited unless authorized by the Captain of the Port or a designated representative. A designated representative means any Coast Guard commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of Sector New Orleans; to include a Federal, State, and/or local officer designated by or assisting the COTP in the enforcement of the safety zone.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period and any changes in the planned schedule via Broadcast Notice to Mariners and actual notice via VHF-FM Channels 16 and 22A.

During winter months, the Saginaw River becomes a popular area for recreational users, particularly for ice fishing, snowmobiling, and other activities conducted on the ice. At the same time, critical bridge construction and maintenance projects often take place during this period, requiring the use of heavy equipment and tug/barges. Specifically, construction crews are working to construct the Lafayette Bridge over the Saginaw River. This construction presents hazards to recreational users and the public at large, as tug and barge traffic will be breaking the ice in the area surrounding the Lafayette Bridge while cranes and heavy equipment work in the area. This activity, especially the frequent icebreaking operations, present hazards to recreational users, particularly those ice fishing, snowmobiling, or conducting other activities on the ice.

Therefore, the COTP is issuing this rule under the authority in 46 U.S.C. 70034, which is needed to protect personnel 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. The final decision to implement this safety zone was reached only recently, following comprehensive consultations with state and local law enforcement authorities to find an alternative route around the safety zone, and we must establish this safety zone by February 7, 2026, to protect personnel and the marine environment. Therefore, we do not have enough time to solicit and respond to comments.

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

This rule is effective from 8 a.m. on February 7, 2026 until 8 a.m. on April 1, 2026. The safety zone covers all U.S. navigable waters of the Saginaw River within 400 yards upriver and 600 yards downriver of the Lafayette Bridge, along the main shipping channel. No recreational vehicles or persons on foot are 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. 4321-4370f), 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 will enforce a safety zone regulation in 33 CFR 165.930 for fish barrier testing from February 7 through February 22, 2026, each day from 7:00 a.m. to 11:00 a.m., and from 1:00 p.m. to 5:00 p.m. The regulated area—the Chicago Sanitary and Ship Canal, Mile Marker 295.5 to Mile Marker 297.5—is a 2-mile portion of the area specified in § 165.930(a)(2). All vessels must obtain permission from the Captain of the Port (COTP) Lake Michigan, or designated on-scene representative to enter, move within, or exit this safety zone during the enforcement time listed in this notice of enforcement. Vessels and persons granted permission to enter the safety zone must obey all lawful orders or directions of the COTP Lake Michigan or designated representative. Upon being hailed by siren, radio, flashing light or other means, the operator of a vessel must proceed as directed.

In addition to this notification of enforcement in the Federal Register , the Coast Guard will provide the maritime community with notification of this enforcement period via Broadcast Notice to Mariners. Lieutenant Kyle Goetz may be reached via telephone at 630-986-2155 for any inquiries.

An on-scene Safety Vessel may be reached during operating hours via VHF-FM Channel 16.

The Coast Guard will enforce a security zone in 33 CFR 165.846 for events related to Mardi Gras Celebrations from February 14, 2026, through February 17, 2026. This action is being taken to provide security and protection for visiting personnel during the events related to Mardi Gras. The security zone will cover all navigable waters within 350 yards of the Left Descending Bank on the Lower Mississippi River from MM 94.4 to MM 95.7 AHP, New Orleans, LA. No person or vessel may enter this security zone unless authorized by the Captain of the Port New Orleans (COTP) or a designated representative. A designated representative means any Coast Guard commissioned, warrant, or petty officer of the U.S. Coast Guard assigned to units under the operational control of Sector New Orleans; to include a Federal, State, and/or local officer designated by or assisting the COTP in the enforcement of the security zone. To seek permission to enter, contact the COTP or a designated representative by telephone at (504) 365-2209 or VHF-FM Channel 16 and 67. Those in the security zone must transit at their slowest speed and comply with all lawful orders or directions given to them by the COTP or a designated representative.

In addition to this notification of enforcement in the Federal Register , the Coast Guard plans to provide notification of this enforcement period and any changes in the planned schedule via Broadcast Notice to Mariners and actual notice via VHF-FM Channels 16 and 22A.

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

On August 12, 2022, NDEP submitted the 2022 Nevada Regional Haze Plan, titled “Nevada Regional Haze State Implementation Plan for the Second Planning Period” as a revision to the Nevada SIP to address regional haze for the second implementation period. NDEP made this SIP submission to satisfy the requirements of the CAA's regional haze program pursuant to CAA sections 169A and 169B and 40 CFR 51.308. The EPA found this submission complete on August 16, 2022. On July 27, 2023, NDEP withdrew the reasonable progress determinations for Tracy Generating Station's Piñon Pine Unit (also known variously as Tracy Unit 4 and Tracy Unit 7) and North Valmy Generating Station's Unit 1 and Unit 2. On May 28, 2025, NDEP submitted the 2025 SIP Supplement, titled “Nevada Regional Haze Revision to the State Implementation Plan for the Second Planning Period,” which includes revised reasonable progress determinations for those two sources. The 2025 Supplement also includes updated permits for three sources, replacing those submitted as part of the 2022 Nevada Regional Haze Plan. On October 23, 2025, the EPA proposed to approve the 2022 Nevada Regional Haze Plan (excluding the portions withdrawn on July 27, 2023) and appendix A (“Air Quality Permits Incorporated by Reference”) of the 2025 Supplement (collectively “the Plan”) into the Nevada SIP. 1 The October 23, 2025 proposal provided background on the requirements of the CAA and RHR, summarized the Plan, and explained the rationale for our proposed action. That background and rationale will not be restated in full here.

The EPA's October 23, 2025 proposal provided a 30-day public comment period that ended on November 24, 2025. The EPA received nine comments during the comment period: three anonymous comments; one comment from a private individual; a comment from Mid-Atlantic/Northeast Visibility Union (MANEVU); a comment from Citizens Rulemaking Alliance; a comment from Idaho Power Company; a comment from NV Energy; and a joint comment letter signed by the National Parks Conservation Association (NPCA), Sierra Club, Center for Biological Diversity, and Coalition to Protect America's National Parks. After reviewing the anonymous comments and the comment from the private individual, the EPA has determined that they fail to raise issues germane to the approval of the Plan, which is based on the criteria set forth in the CAA, the RHR and relevant policy documents. Therefore, we have determined that these comments do not necessitate a response, and the EPA will not provide specific responses to these comments. The comments from Idaho Power Company and NV Energy supported the EPA's proposed action. The EPA acknowledges these supportive comments, which are included in the docket for this action. We respond to the issues raised in the three remaining comment letters received on our proposed rulemaking in this document and the associated response to comments (RTC) Document, which is included in the docket for this rulemaking.

We briefly address in this section the following topics that were raised by commenters: (1) whether the EPA's new policy is consistent with the CAA and RHR; (2) whether the EPA sufficiently justified its basis for the new policy; (3) whether the action is nationally applicable or based on a determination of nationwide scope and effect; (4) whether the action departs from national policy without complying with the EPA's consistency regulations at 40 CFR part 56; and (5) whether the Plan meets the applicable statutory and regulatory requirements in accordance with the new policy.

As stated in the proposal, it is now the EPA's policy that, where visibility conditions for a Class I Federal area impacted by a state are below the Uniform Rate of Progress (URP) and the state has considered the four statutory factors, the state will have presumptively demonstrated reasonable progress for the second planning period for that area. 2 As detailed at length in the RTC Document section III., the EPA's new policy is consistent with the CAA. Pursuant to CAA 169A(a)(4), Congress explicitly delegated to the EPA the authority to promulgate regulations regarding reasonable progress towards meeting the national goal. As some commenters note, to determine the measures necessary to make reasonable progress towards the national visibility goal under 169A(a)(1), Congress mandated “tak[ing] into consideration the cost of compliance, the time necessary for compliance, and the energy and nonair quality environmental impacts of compliance, and the remaining useful life of any existing source subject to such requirement.”  3

The EPA emphasizes that just because a Class I area is below the URP does not mean that a state is relieved of its obligations under the CAA and the RHR to make reasonable progress. In other words, the URP is not a “safe harbor,” as that phrase has sometimes been used, because the EPA still must review a state's determination whether additional control measures are necessary to make reasonable progress, determine whether the state submitted those measures for incorporation into the SIP, and evaluate whether the measures are consistent with other provisions in the CAA.

Regarding the basis for the new policy, under FCC v. Fox Television, 556 U.S. 502 (2009), an agency's change in policy is permissible if the agency acknowledges the change, believes it to be better, and “show[s] that there are good reasons for the new policy.”  4 In section IV.E.7. of our proposal for this rulemaking, we referred to previous actions, in which we stated our reasons for implementing this new policy. 5

The decision in FCC v. Fox turned primarily on whether the FCC's change in policy would lead to the FCC “arbitrarily punishing parties without notice of the potential consequences of their action.”  6 In this instance, the changed policy is prospective, which addresses the primary concern in FCC v. Fox. Additionally, the new policy “aligns with the purpose of the statute and RHR, which is achieving `reasonable' progress, not maximal progress, toward Congress' natural visibility goal.”  7 Furthermore, we note that the legislative history of CAA section 169A is consistent with our change in policy. The reconciliation report for the 1977 CAA amendments indicates that the term “maximum feasible progress” in section 169A was changed to “reasonable progress” in the final version of the legislation passed by both chambers. 8

Some commenters also state that this action is incompatible with the EPA's consistency regulations. As discussed in the West Virginia final action  9 and the RTC Document for this action in response section III.D.1., the EPA's Regional Consistency regulations at 40 CFR part 56, and in particular 40 CFR 56.5(b), are not relevant to this action. 40 CFR 56.5(b) requires that a “responsible official in a Regional office shall seek concurrence from the appropriate EPA Headquarters office on any interpretation of the Act, or rule, regulation, or program directive when such interpretation may result in application of the act or rule, regulation, or program directive that is inconsistent with Agency policy.” (emphasis added). As we expressly indicated in the proposal, the approval is consistent with the change in agency policy, first announced in Air Plan Approval; West Virginia; Regional Haze State Implementation Plan for the Second Implementation Period. Therefore, there is no obligation under the plain language of the EPA's Regional Consistency regulations for anyone in the Region to seek concurrence from EPA Headquarters to take action consistent with EPA policy. Because these regulations are not relevant to this action, the docket for this rulemaking does not include materials related to compliance with the Regional Consistency process. In addition, this action is not a significant regulatory action subject to a review by the Office of Management and Budget under Executive Order (E.O.) 12866, because it is a SIP approval, which is a category of regulations that has been exempted from review under section 3(d)(4) of E.O. 12866.

This action is “locally or regionally applicable” under CAA section 307(b)(1) because it applies only to a SIP submission from a single state, Nevada. 10 To determine whether an action is “nationally applicable” or “locally or regionally applicable,” “court[s] need look only to the face of the agency action, not its practical effects . . . .”. 11 As discussed in the West Virginia final action  12 and the RTC Document for this action in response III.D.4, comments that claim that the EPA “must” publish a finding that this action is “based on a determination of nationwide scope [or] effect” are also unsupported and incorrect. The Supreme Court has recognized that “[b]ecause the `nationwide scope or effect' exception can apply only when `EPA so finds and publishes' that it does, EPA can decide whether the exception is even potentially relevant.”  13 As the D.C. Circuit has also stated, the “EPA's decision whether to make and publish a finding of nationwide scope or effect is committed to the agency's discretion and thus is unreviewable.”  14 The Administrator has not made and published a finding that this action is based on a determination of nationwide scope or effect. Accordingly, any petition for review of this action must be filed in the United States Court of Appeals for the appropriate regional circuit.

Finally, as detailed in section III.B. of the RTC Document, the Plan meets the applicable statutory and regulatory requirements. As required by the statute, Nevada took into consideration the four statutory factors in CAA section 169A(g)(1) and determined that several existing and new controls for stationary sources were necessary to make reasonable progress.

In addition, the RHR requires states to submit a long-term strategy that addresses regional haze visibility impairment for each mandatory Class I Federal area within the State and for each mandatory Class I Federal area located outside the State that may be affected by emissions from the State, 15 and the statute refers to “a State the emissions from which may reasonably be anticipated to cause or contribute to any impairment of visibility in any such area.”  16 However, there is no specific statutory or regulatory requirement to identify the precise set of Class I areas that are affected by emissions from Nevada, and there is no requirement to establish a source contribution threshold in identifying those areas. In this case, NDEP appropriately identified affected out-of-state Class I areas, as we explain in section IV.A.3. of the RTC Document. The EPA believes NDEP has reasonably documented its out-of-state Class I area contributions, and that, with one possible exception discussed in the RTC at response section IV.B., emissions from Nevada do not impact any Class I area whose 2028 RPG for the most impaired days is above the URP.

In conclusion, as discussed in more detail in the responses at section III.B. of the RTC Document, Nevada took into consideration the four statutory factors in CAA section 169A(g)(1) and selected several control measures as necessary for reasonable progress.

The full text of comments received is included in the publicly posted docket associated with this action at https://www.regulations.gov. The RTC Document, which is also included in the docket associated with this action, provides detailed responses to all significant comments received. The RTC Document is organized by topic. Therefore, if additional information is desired concerning how the EPA addressed a particular comment, the reader should refer to the appropriate section in the RTC Document.

For the reasons set forth in the October 23, 2025 proposal, the RTC Document, and in this final rule, the EPA is approving the Plan as satisfying the regional haze requirements for the second planning period contained in 40 CFR 51.308(f), (g), and (i). Specifically, we are proposing to approve the 2022 Nevada Regional Haze Plan (excluding the portions withdrawn on July 27, 2023) and appendix A of the 2025 SIP Supplement into the Nevada SIP. Thus, we are incorporating by reference in 40 CFR 52.1470(d) (“EPA-approved State source-specific permits”), the following source-specific requirements:

• NDEP Permit No. AP4911-0194.04 (for Tracy Generating Station), Conditions IV.B.1.a, IV.B.3.f, IV.D.1.a, IV.D.3.f, IV.F.1, IV.L.1.a, IV.L.3.g, IV.M.1.a, IV.M.3.g, V.A, and V.C.

• Clark County DES Authority to Construct Permit for a Major Part 70 Source, Source ID: 3 (for Lhoist North America Apex Plant), Conditions 2.1.1, 2.2.1, 2.2.2, 2.2.3, 3.2.1, 3.2.2, 4.1, 4.3, 4.4.7, 4.4.8, 4.4.15, and 4.4.16.

• NDEP Permit No. AP3274-1329.03 (for Graymont Pilot Peak Plant), Conditions IV.K.1.a, IV.K.3.b, IV.K.4.q, IV.K.4.u, IV.N.1.a, IV.N.3.b, IV.N.4.q, IV.N.4.u, V.S.1.a, IV.S.3.b, IV.S.4.q, IV.S.4.u, and V.B-C.

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 incorporating by reference the regulatory and source-specific provisions described in section III. of this preamble and set forth in the amendments to 40 CFR part 52 in this document. Therefore, these materials have been approved by the EPA for inclusion in the SIP, have been incorporated by reference by the EPA into that plan, are fully federally enforceable under sections 110 and 113 of the CAA as of the effective date of the final rulemaking of the EPA's approval, and will be incorporated by reference in the next update to the SIP compilation. 17 The EPA has made, and will continue to make, these documents available through https://www.regulations.gov and at the EPA Region IX Office (please contact the person identified in the FOR FURTHER INFORMATION CONTACT section of this preamble for more information).

Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 18 Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the 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 Orders 12866 (58 FR 51735, October 4, 1993);

• Is not subject to Executive Order 14192 (90 FR 9065, February 6, 2025) because SIP actions are exempt from review under Executive Order 12866;

• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501 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 proposes to approve a state program;

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

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

In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian Tribe has demonstrated that a Tribe has jurisdiction. In those areas of Indian country, the 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 (CRA), and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by April 7, 2026. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements (see section 307(b)(2)).

For the reasons stated in the preamble, the EPA amends chapter I, title 40 of the Code of Federal Regulations as follows:

Throughout this document, the use of “Agency,” “we,” “us,” or “our” refers to the EPA. We use multiple acronyms and terms in this preamble. While this list may not be exhaustive, to ease the reading of this preamble and for reference purposes, the EPA defines the following terms and acronyms here:

Under the CAA, the EPA establishes national ambient air quality standards (NAAQS) to protect public health and welfare. The EPA has established NAAQS for certain pervasive air pollutants including ozone, carbon monoxide, nitrogen dioxide, sulfur dioxide, lead, and particulate matter. Under CAA section 110(a)(1), States must submit plans that provide for the implementation, maintenance, and enforcement of the NAAQS within each State. Such plans are referred to as SIPs, and revisions to those plans are referred to as “SIP revisions.” CAA section 110(a)(2) sets forth the content requirements for SIPs. Among the various requirements, SIPs must include enforceable emissions limitations and other control measures, means, or techniques as may be necessary or appropriate to meet the applicable requirements of the CAA. 1 SIP revisions may be submitted to address specific CAA requirements (such as the elements and demonstrations required within an attainment plan), or, as with the State submittal addressed in this action, may be provided to demonstrate emissions reductions to support attainment.

Upon receiving a SIP that meets the completeness criteria in CAA section 110(k)(1)(A), the EPA must determine whether the submission meets all applicable CAA requirements. 2 The EPA must either approve, conditionally approve, approve in part and disapprove in part, or disapprove a complete State submission within twelve months. 3 In addition to the limitations described above, CAA section 110(a)(2)(E) provides that a SIP must include “necessary assurances” that the State “is not prohibited by any Federal or State law from carrying out such implementation plan or portion thereof” and that the State or applicable State entity has adequate authority, personnel, and funding to carry out adequate implementation of the SIP.

Under California law, the California Air Resources Board (CARB) is the State agency responsible for adopting and submitting SIP revisions to the EPA for review. These include both local rules adopted by county and regional air districts (typically regulating stationary source emissions) and statewide regulations adopted by CARB and other State agencies. If approved into the SIP, submitted regulations become federally enforceable pursuant to CAA section 110(a)(2)(A).

CARB submitted the “Heavy-Duty Inspection and Maintenance Regulation”  4 (“HD I/M Regulation”) as a revision to the California SIP on December 14, 2022. 5 Table 1 identifies the regulatory sections included in the HD I/M Regulation and addressed by this action with the dates that they were adopted by CARB and submitted to the EPA.

The HD I/M Regulation incorporates by reference the “California Standards for Heavy-Duty Remote On-Board Diagnostic Devices” (“OBD Standards”). CARB approved the HD I/M Regulation on December 9, 2021, through Resolution 21-29. Following minor, non-substantive edits by CARB staff, 6 CARB formally adopted the final HD I/M Regulation and OBD Standards on August 22, 2022, through CARB Executive Order R-22-002. For more information on the HD I/M Regulation, including the EPA's prior actions on precursor SIP submittals, see section II of the preamble to the proposed action. 7

Based on ambient data collected at numerous sites throughout the State, the EPA designated certain areas within California as nonattainment for the ozone NAAQS and the particulate matter (PM) NAAQS, which includes both coarse and fine particulate matter ( i.e., PM 10 and PM 2.5 ). 8 The EPA redesignated to attainment several areas in California previously designated as nonattainment for the carbon monoxide NAAQS because these areas attained the standard and are subject to an approved maintenance plan demonstrating how the State will maintain the carbon monoxide standard into the future.

Mobile source emissions constitute a large portion of overall emissions of ozone precursors, including volatile organic compounds (VOC) and oxides of nitrogen (NO X ), as well as direct PM and PM precursors, including NO X , sulfur dioxide (SO 2 ), and carbon monoxide in the various air quality planning areas within California. 9 According to CARB, heavy-duty vehicles constitute 52 percent of the on-road NO X emissions and 54 percent of on-road PM 2.5 emissions. 10 In addition, according to CARB, out-of-state or out-of-country heavy-duty vehicles constitute approximately half of the total number of heavy-duty vehicles travelling in the State and approximately 30 percent of heavy-duty vehicle NO X emissions. 11 According to CARB, the HD I/M Regulation is intended to reduce PM 2.5 and NO X emissions from heavy-duty non-gasoline combustion vehicles operating in California to further ozone and PM attainment by areas within the State. 12

The HD I/M Regulation establishes a comprehensive I/M program for heavy-duty vehicles that is intended to ensure that vehicle emissions control systems on these vehicles are operating as designed and repaired quickly. CARB asserted that this regulatory revision builds on CARB's current heavy-duty inspection programs, including building on and replacing the Heavy-Duty Vehicle Inspection Program and Periodic Smoke Inspection regulations for heavy-duty vehicles. 13

The HD I/M Regulation applies to all non-gasoline combustion vehicles above 14,000 gross vehicle weight rating (GVWR) that operate in California. Unlike virtually all prior CARB regulations and similar regulations adopted by other States, the HD I/M Regulation would also apply to vehicles registered out-of-state and out-of-country that operate within the State of California for almost any length of time. 14 Some vehicle categories are exempted, including zero-emission vehicles ( i.e., electric vehicles), emergency and military tactical vehicles, and other classes defined by use or purpose. There is a limited 5-day pass-through exception permitting program which contemplates that a “vehicle owner may obtain written approval from the Executive Officer to operate a vehicle for up to five consecutive calendar days without being subject to” 13 CCR 2196.1(a)(1) and (2), which govern the owner operator requirements. 15 The 5-day exemption is available once per calendar year to vehicles with no outstanding enforcement actions. The five days must run consecutively after approval and the application must be sent at least seven business days “prior to the vehicle's planned travel or entry in California.”  16 Vehicle owners must request the exemption in advance through CARB's compliance platform by providing a variety of information, including the vehicle's registration information, vehicle identification number (VIN), relevant dates, and origin and destination information. If granted, the owner must keep the pass document in the vehicle and provide it to CARB inspectors upon request.

The HD I/M Regulation requires owners of heavy-duty vehicles operating in California (including out-of-state and out-of-country vehicles) to report owner and vehicle information to CARB. It also requires owners of heavy-duty vehicles to demonstrate that their vehicle emissions control systems are properly functioning through vehicle compliance tests completed by CARB-approved testers and to periodically submit vehicle compliance test results to CARB. Vehicles equipped with on-board diagnostic (OBD) systems can be tested using OBD data, while older non-OBD vehicles are subject to smoke opacity and visual inspections. Vehicle owners are also required to have a valid HD I/M compliance certificate with the vehicle while operating in California, which they must present to a CARB inspector and/or California Highway Patrol officer upon request.

The HD I/M Regulation also establishes a referee testing network to provide independent evaluations of heavy-duty vehicles and services for vehicles with inspection incompatibilities or compliance issues. Finally, the HD I/M Regulation describes procedures for HD I/M roadside inspections, including roadside monitoring and field inspections.

On August 26, 2025, the EPA proposed to partially approve and partially disapprove, or, in the alternative, to fully approve, the HD I/M Regulation into the California SIP. 17 While the Agency proposed to find that the submission generally meets applicable requirements of the CAA and implementing regulations, the EPA proposed to partially disapprove because of substantial concerns with allowing provisions in the HD I/M Regulation that purport to regulate vehicles registered out-of-state and out-of-country to become federally enforceable.

Specifically, the EPA proposed that California had not provided necessary assurances that the State is not prohibited by any provision of Federal or State law from implementing the SIP, as required by CAA section 110(a)(2)(E)(i). The Agency proposed that the Commerce Clause of the U.S. Constitution appears to prohibit implementing the HD I/M Regulation because its extraterritorial reach burdens core instrumentalities of interstate commerce, that is, heavy-duty vehicles used in interstate shipping. The Agency noted that the HD I/M Regulation effectively outsources the costs of emissions reductions within California to other States and regulated entities in those States by requiring compliance with California's inspection and maintenance (“I/M”) regime even when the vehicles are not within California. The Agency also noted that under the structure of CAA section 110, a full approval of the HD I/M Regulation would effectively force regulated entities in other States to comply with California's HD I/M requirements, rather than the applicable requirements in their respective States, including requirements approved by the EPA pursuant to the CAA. Finally, we proposed that the extraterritorial reach of the HD I/M Regulation appears to abrogate the foreign relation powers vested exclusively in the Federal Government by the U.S. Constitution.

The EPA further proposed that the extraterritorial reach of the HD I/M Regulation is inconsistent with CAA section 110. The Agency observed that CAA section 110 requires the submission of SIPs by each State and that full approval of the submission would, by making the HD I/M Regulation federally enforceable, potentially result in multiple conflicting sources of obligations. The Agency also noted that the HD I/M Regulation was unusual in this respect and requested comment on all aspects of the proposal, including whether a full approval of the State's submission would raise additional concerns under any other Federal or State law.

After reviewing California's submission and all comments received during the public comment period, the EPA is finalizing a partial approval and partial disapproval that will allow the HD I/M Regulation to go into effect for CAA purposes except to the extent it applies to vehicles registered outside the State. As previously noted, the CAA expressly requires that a SIP submittal “shall” provide “necessary assurances” that the State “is not prohibited by any provision of Federal or State law from carrying out such implementation plan or portion thereof.”  18 The EPA cannot approve a SIP submission, thereby making it effective for CAA purposes and federally enforceable, unless “it meets all of the applicable requirements of this chapter.”  19

The EPA determines that California has not provided necessary assurances that the State is not prohibited by Federal law—specifically, the Clean Air Act and the Commerce Clause of the U.S. Constitution—from implementing the HD I/M Regulation to the extent it purports to regulate vehicles registered out-of-state or out-of-country based solely on whether such vehicles traverse California for virtually any length of time. As discussed at proposal and reinforced by several commenters, the State's submission externalizes the cost of additional emissions reductions (out-of-state vehicles that must comply with California's I/M regime on an ongoing basis) to achieve localized benefits (additional emissions reductions that assist California in demonstrating attainment of the NAAQS for the benefit of California residents).

The Supreme Court has explained that the “dormant” Commerce Clause prohibits “even nondiscriminatory burdens on commerce” when “those burdens clearly outweigh the benefits of a state or local practice.” Nat'l Pork Producers Council v. Ross, 598 U.S. 356, 392 (2023) (Roberts, C.J., concurring in part and dissenting in part). 20 Such burdens are of particular concern when they impose costs on interstate trade, see, e.g., Kassel v. Consol. Freightways Corp., 450 U.S. 662, 674 (1981) (plurality op.); Raymond Motor Transp., Inc. v. Rice, 434 U.S. 429, 445 & n.21 (1978), where “the nature of” the market means that a State regulation generates costs whether or not participants sell into the regulating State, Nat'l Pork Producers, 598 U.S. at 400 (Roberts, C.J., concurring in part and dissenting in part), and where a State regulation targets “instrumentalities of interstate transportation—trucks, trains, and the like,” id. at 379-80 & n.2 (majority op.); accord id. at 392 (Sotomayor, J., concurring in part).

In this context, Congress has exercised its exclusive regulatory authority over interstate commerce by enacting CAA section 110 and related provisions specifying States' obligations to attain the NAAQS. Under CAA section 110, “ each State” must develop and submit a plan for implementing, maintaining, and enforcing the NAAQS “ within such State.”  21 As a general matter, the Clean Air Act assigns national regulation, including the regulation of interstate air pollution and standards-setting for mobile sources, to the EPA. For example, title II of the Act authorizes the EPA to set mobile source standards when certain conditions are met and expressly preempts the adoption or attempted enforcement of State standards (including certification, inspection, and approval requirements for sale, titling, or registration) except through the preemption waiver and waiver adoption processes in CAA sections 177 and 209. 22 Similarly, the Act generally does not permit States to outsource the costs of emissions reductions within their borders onto other States except where expressly authorized. 23 Under CAA section 110(a)(2)(D)(i)(I), for example, States must submit plans to restrict certain emissions within their borders if such emissions contribute significantly to nonattainment in other States.

Here, California's SIP submission seeks to remedy local nonattainment by extending the State's regulatory reach to vehicles registered in other States, and even other countries, that happen to traverse the State. As explained at proposal and confirmed in this final action, out-of-state vehicle owners and operators effectively must comply with the HD I/M Regulation given the volume of interstate trucking that passes through California, the uncertainties regarding whether and when a route will cross through California over the course of a year, and the significant penalties associated with failure to comply. This result is not contemplated or authorized by CAA section 110, which requires “each State” to implement the NAAQS “within such State,” and does not fall within any of the exceptional provisions of the Act that contemplate one State reaching into another State in pursuit of air quality improvements within its own borders. This is not a lawful use of the CAA's SIP provisions, which instruct each State to adopt appropriate controls for that State and prohibit the approval of SIPs not supported by “necessary assurances” of legality under Federal and State law. California may adopt and seek approval of a broad range of strategies to promote NAAQS attainment within the State, including by adopting additional controls for vehicles registered within the State. But it cannot (at minimum, without providing necessary assurances) outsource the costs of local attainment to out-of-state and out-of-country vehicle owners and operators through a regulation that would, if approved, become federally enforceable throughout the country in lieu of adopting additional controls for vehicles registered within the State. Nothing in California's submission provides necessary assurances that implementing the HD I/M Regulation in full would not contravene Federal law, and California continues to maintain that its submission not only can, but must, be approved and made federally enforceable under the CAA.

While not necessary to the EPA's determination that the SIP submission fails to provide necessary assurances, the HD I/M Regulation also arguably discriminates against out-of-state vehicle owners and operators by externalizing the costs of achieving the local benefits of NAAQS attainment. Nothing about the regulatory goals of the HD I/M Regulation required California to extend compliance requirements to out-of-state vehicles or to make that extension federally enforceable by seeking approval in the State's SIP. Rather than taking this novel approach, California could have limited its application to vehicles registered within the State and adopted additional controls for vehicles registered within the State (or for other sources that emit the relevant pollutants), thereby achieving significant progress toward NAAQS attainment without raising interstate commerce concerns. Indeed, the HD I/M Regulation includes provisions specific to out-of-state vehicles, and CARB separately estimated emissions reductions attributable to in-state and out-of-state vehicles. 24 The choice to extend the regulation to out-of-state and out-of-country vehicles was deliberate and unnecessary to the operation of the regulatory scheme with respect to vehicles registered within the State. In this way, the SIP submittal arguably discriminates against out-of-state vehicles by subjecting them to additional regulatory requirements that apply year-round and regardless of location in exchange for localized benefits. California's legitimate objective, reducing emissions to comply with its NAAQS obligations under Federal law, does not require regulation of all trucks nationwide that may traverse the State, particularly in a manner in which the burdens of compliance fall disproportionately on out-of-state owners and operators as compared to vehicles registered within the State. 25 Put another way, extending the regulation to out-of-state vehicles serves the illegitimate objective of outsourcing the costs of attaining the NAAQS within California to other States and vehicle owners and operators in those States, rather than identifying additional emissions reduction strategies within the traditional ambit of purely in-state sources encompassed within and creditable to the State of California.

The discrimination at issue here is different in kind from the indirect impacts to interstate commerce permitted by the Supreme Court's Commerce Clause jurisprudence. In National Pork Producers, the Court rejected an “almost per se” Commerce Clause challenge to a California law that sought to promote the humane treatment of animals by barring California merchants from selling non-compliant pork within California. 598 U.S. at 367 (majority op.); see also id. at 384 (plurality op.) (emphasizing that the law regulated sales within California and that non-compliant producers remained free to “withdraw from that State's market”). In contrast here, the HD I/M Regulation would, if approved into the SIP, apply directly to and be federally enforceable against out-of-state and out-of-country vehicle owners and operators even if they conduct no business in California. Trucks shipping apples from Washington to Arizona, or export goods from Texas to ports on the Pacific Ocean, would be obligated to comply merely because they passed through California. As already discussed, proactive compliance by many out-of-state interstate shippers would be the only practicable option to avoid noncompliance and significant fines. This extraterritorial scope exceeds the localized scope of California's interest. Nor is California's goal of demonstrating compliance with its statutory obligations, thereby avoiding potential bump-ups in nonattainment level by operation of the statute, directly related to the health, safety, or other interests the Court has recognized as grounds for permissible in-state regulation imposing indirect out-of-state burdens. Id. at 374-75 (majority op.). Rather, the out-of-state reach of the SIP submission is explicitly tied to more effectively meeting California's obligations under the CAA's NAAQS implementation provisions, including deadlines for attainment and reclassification. And the SIP submission's out-of-state reach pursues that goal by imposing costs on interstate trucking, a function the Court specifically noted warrants a more exacting analysis. Id. at 379 n.2 (majority op.) (“[T]his Court [has] refused to enforce certain state regulations on instrumentalities of interstate transportation—trucks, trains, and the like. . . . Nothing like that exists here. We do not face a law that impedes the flow of commerce. Pigs are not trucks or trains.”). 26

Regardless of whether the regulation at issue here is discriminatory, a showing of discrimination is not required under Pike v. Bruce Church, Inc., 397 U.S. 137 (1970), or related cases. In National Pork Producers, a majority of the Supreme Court “le[ft] the courtroom door open to plaintiffs invoking the rule in Pike, that even nondiscriminatory burdens on commerce may be struck down on a showing that those burdens clearly outweigh the benefits of a state or local practice.”  27 And the Court has long recognized special considerations for instrumentalities of commerce (including interstate trucking). 28 This line of cases is directly on-point and demonstrates that the HD I/M Regulation at issue here warrants careful consideration. The SIP submittal's intended applicability to interstate trucking beyond the borders of California (and that which passes through California, at least on occasion, owing to the nature of the market) appears to contravene case law evaluating State laws which impose undue burdens upon the instrumentalities of interstate commerce. California provided no assurances to the contrary in its SIP submission and continues to maintain its entitlement to impose such burdens under the CAA. As articulated in greater detail in our responses to comments in section III of this preamble, the EPA views the burdens of a fully approved SIP submission on interstate commerce as significant. Such significant burdens outweigh the proposed local compliance benefits of the regulation and therefore run afoul of the Commerce Clause. As one commenter explained: “The program's overreach will result in the potential for de facto regulation of out-of-state rented or leased trucks across the country even though renting and leasing companies have no control [over] whether their trucks' routes include traveling into California. . . . CARB's HD I/M program disproportionately affects out-of-state rental and leasing company operations and finances . . . in clear violation of the Dormant Commerce Clause.”  29

Unlike virtually all prior CARB regulations and similar regulations adopted by other States, the HD I/M Regulation would apply to vehicles registered out-of-state and out-of-country that operate within the State of California for almost any length of time. Because approval of a SIP makes its requirements federally enforceable, 30 the regulation would, in effect, become a Federal regulation enforceable by the EPA (and citizen-suit plaintiffs)  31 against any owner or operator in all fifty States of any heavy-duty vehicle that may pass through California. 32

As addressed in section III of this preamble, Response to Comments, this would in effect lead to additional compliance costs for heavy-duty vehicle operators in all jurisdictions. Some States have HD I/M provisions that differ from California's in material respects, but none of these have been approved into SIPs. 33 If approved into the SIP in all respects, California's HD I/M Regulation would be federally enforceable to the same extent as other State I/M regulations, including any that may be approved by the EPA in the future pursuant to CAA section 110. The result would be multiple conflicting sources of obligations that are enforceable both within the respective States and federally under the CAA.

Additionally, the SIP would require owners of heavy-duty vehicles to demonstrate that their vehicle emissions control systems are properly functioning through vehicle compliance tests completed by CARB-approved testers and require such owners to periodically submit vehicle compliance test results to CARB to show compliance with the HD I/M Regulation. Vehicles equipped with OBD systems would have to be tested using OBD data, while older non-OBD vehicles would be subject to smoke opacity and visual inspections. Lastly, vehicle owners would be required to have a valid HD I/M compliance certificate with the vehicle while operating in California presentable to a California Highway Patrol officer upon request. As CAA section 202(m) authorizes the EPA to regulate and require such OBD systems for heavy-duty vehicles, the imposition of a State program which would be national in character also risks intrusion into an area reserved to Federal authority. 34 The CAA's requirements and procedures for California to seek and obtain a preemption waiver, and for other States to adopt California standards for which preemption has been waived, do not apply to this submission, and nothing in CAA section 110 suggests that the statute's provisions for SIP development and submission can function as a workaround for the requirements of CAA sections 177 and 209.

The impact of California's HD I/M Regulation on vehicles registered out-of-state (and out-of-country) and on interstate shipping is significant. The HD I/M Regulation adds significant costs to operation of heavy-duty vehicles even within California. According to the CARB Staff Report, the HD I/M Regulation will cost $4.12 billion between 2023-2050, with a maximum annual cost of $350 million in 2024. Many of these costs relate to heavy-duty vehicle testing, repair, and compliance fees. 35 But this analysis, which seeks to balance these costs against the benefits of promoting local NAAQS compliance, improperly weighs the benefits to California against costs imposed nationwide. As commenters point out, overcompliance costs and unknowing violations risk fines and burdens imposed outside the borders of California. The EPA notes that many heavy-duty vehicles covered by the regulations at issue are used for purposes of interstate shipping, and that maintenance of those vehicles could occur in any number of States, meaning the burdens of compliance could be felt across the country and even in other countries. The outsourcing of costs and burdens to other States in pursuit of local benefits via the SIP misunderstands the ambit of State regulation and the Commerce Clause limits on the State's powers. The regulatory regime imposed by the SIP, which reports in-state benefits against conservative estimates of out-of-state burdens, calls into question the entirety of the State's cost-benefit analysis as addressed more fully in section III of this preamble. 36

Contrary to claims made by some adverse commenters, the EPA need not specify a less discriminatory approach for California to follow that would comply with the Commerce Clause and therefore render the SIP approvable under the CAA. 37 Under the Pike analysis, the availability of a less discriminatory approach to achieve a regulatory goal is but one of many factors a reviewing court may consider in evaluating whether a State regulation infringes on Federal authority reserved to Congress by the Commerce Clause. 38 When relevant, courts generally place the burden on the regulating State to explain why alternatives that are less burdensome on interstate commerce and out-of-state economic activity were not considered and adopted. 39 The EPA is not required to identify alternatives in this context, including because the CAA's requirement for necessary assurances is a mandatory element of a fully approvable SIP submission. In any event, a less discriminatory alternative is both apparent and reflected in the Agency's proposal: California may achieve significant emissions reductions creditable to NAAQS attainment by implementing the HD I/M Regulation to vehicles registered within the State and, as necessary and appropriate, developing additional controls for in-state registered vehicles and potentially other categories of in-state sources. This final action approves the SIP submittal to that extent while, at the same time, disapproving the submittal to the extent that it purports to infringe on interstate commerce by regulating and burdening interstate trucking.

California's submission does not contain necessary assurances to demonstrate that the HD I/M Regulation can be implemented if approved as to out-of-state and out-of-country vehicles without running afoul of Commerce Clause principles, as required by CAA section 110(a)(2)(E). The SIP rests on a misunderstanding of the reach of the State's regulatory authority and the division of authority between the EPA and the States under the CAA, including CAA section 110. California may regulate I/M activities for vehicles registered within the State consistent with Federal law and may submit such regulation for approval to satisfy the State's NAAQS attainment obligations under Federal law. But the EPA cannot authorize California to become a de facto Federal regulator by making the State's HD I/M Regulation federally enforceable through approval into the SIP. Under the circumstances presented here, approval of the SIP would not be consistent with CAA section 110(a)(2)(E). 40