Section 2509(a) of the Food, Agriculture, Conservation, and Trade (FACT) Act of 1990 (21 U.S.C. 136a) authorizes the Animal and Plant Health Inspection Service (APHIS) to prescribe and collect user fees for agricultural quarantine and inspection (AQI) services. Congress amended the FACT Act on April 4, 1996, and May 13, 2002.

The FACT Act, as amended, authorizes APHIS to prescribe and collect user fees for AQI services provided in connection with the arrival, at a port in the customs territory of the United States, of certain commercial vessels, commercial trucks, commercial railroad cars, commercial aircraft, and international passengers. According to the FACT Act, as amended, these user fees should be “sufficient” “to cover the cost of”:

• Providing AQI services “in connection with the arrival at a port in the customs territory of the United States” of the conveyances and the passengers listed above;

• Providing “preclearance or preinspection at a site outside the customs territory of the United States” to the conveyances and the passengers listed above; and

• Administering 21 U.S.C. 136a, concerning the collection of fees for inspection services. In addition, the FACT Act, as amended, contains the following requirements:

• The amount of the fees shall be “commensurate with the costs of [AQI] services with respect to the class of persons or entities paying the fees.”

• The cost of AQI services “with respect to passengers as a class” shall include “the costs of related inspections of the aircraft or other vehicle.”

The user fees for the AQI activities described above are contained in 7 CFR 354.3, “User fees for certain international services.” APHIS' regulations regarding user fees relating to imports and exports, as well as overtime services, are found in 7 CFR part 354.

On May 7, 2024, we published a final rule in the Federal Register , (89 FR 38596-38644, Docket No. APHIS-2022-0023), 1 amending the user fee regulations associated with the AQI program. The final rule went into effect and was applied on October 1, 2024, with the exception of the removal of 7 CFR 354.3(e)(2)(iv), which contains an exemption from paying the AQI user fee for commercial aircraft with 64 or fewer seats meeting certain conditions. Because small commercial passenger aircraft have not previously been subject to the fee, we delayed implementation of the commercial aircraft fee for passenger aircraft with 64 or fewer seats until April 1, 2025 (89 FR 38621).

Since the final rule was published, some operators of small commercial passenger aircraft stated that their aircraft do not pose a sanitary or phytosanitary risk because they do not have cargo holds and, therefore, do not carry cargo that requires AQI services. These same small commercial passenger aircraft operators further stated that they should continue to be exempt from the AQI user fees for commercial aircraft. Other small commercial passenger aircraft operators stated that they were not of an equivalent risk profile to larger commercial carriers and should pay a lower fee that correlates to this lower risk.

In accordance with the Presidential Memorandum titled “Regulatory Freeze Pending Review” issued January 20, 2025, which orders all agencies to consider postponing for 60 days the effective date of any rule that has not taken effect, for the purpose of reviewing any question of fact, law, or policy that the rule may raise, 2 on March 21, 2025 we published a notice in the Federal Register (90 FR 13272-13273, Docket No. APHIS-2022-0023)  3 delaying the effective date until June 2, 2025 of the removal of the exemption from paying the AQI user fee for small commercial passenger aircraft, and requesting information.

In that document, we solicited public information about small commercial passenger aircraft operations; in particular, whether small commercial passenger aircraft operators have additional data regarding the nature of their activities and whether those activities result in a lower sanitary and phytosanitary risk profile that would merit less intensive AQI services and a lower corresponding user fee. Specifically, we requested information about whether:

• Small commercial passenger aircraft predominately operate (and seldom depart from) a distinct geographical or environmental area;

• Aircraft departures and arrivals are often more frequent than those of larger commercial aircraft;

• There is information that indicates that these small commercial passenger aircraft take the same or substantially similar routes per flight;

• There is information that indicates that these small commercial passenger aircraft carry the same or substantially similar cargo per shipment and that the cargo carried does not present a significant sanitary or phytosanitary risk;

• There are any other considerations that could help us differentiate aircraft into categories based on sanitary and phytosanitary risk; and

• There are other ways that the fee could be structured differently, in a manner commensurate with the services being provided, and evidence to support any alternate fee structures.

We solicited comments for 30 days ending April 21, 2025. We received 92 comments by that date. They were from aviation industry associations, operators of small commercial passenger aircraft, operators of regional airports, representatives of foreign governments, and private citizens. Some of these commenters presented information supporting their contention that in certain circumstances, some small commercial passenger aircraft may not present significant sanitary and phytosanitary risk, or engage in activities that result in a lower sanitary and phytosanitary risk profile that would merit less intensive AQI services and a lower corresponding user fee than other types of commercial aircraft operators. For example, several aircraft operators presented data that they operated solely over the Great Lakes region during temperate months carrying passengers to and from cottages on Pelee Island, Ontario, lack cargo holds, and allow only non-agricultural carry-on passenger baggage.

For this reason, and because an editorial error inadvertently resulted in the Office of the Federal Register removing the exemption on October 1, 2024, we have decided to restore to the regulations the exemption from paying the AQI user fee for commercial aircraft with 64 or fewer seats meeting certain conditions. We will address the specific circumstances and potential fee structures for small commercial passenger aircraft within the context of future rulemaking.

Specifically, small commercial passenger aircraft do not need to pay the user fee provided that:

• They have 64 seats or fewer;

• They do not carry the following cargo: Fresh fruits, fresh vegetables, plants, unprocessed plant products, cotton or covers, sugarcane, or fresh or processed meats; and

• They do not offer meal service other than beverages and prepackaged snacks that do not contain meats derived from ruminants, swine, or poultry or fresh fruits and fresh vegetables.

As discussed in the preamble, APHIS is amending 7 CFR part 354 as follows:

The Certificate of Compliance (CoC or certificate) is the NRC approved design for each dry cask storage system. Title 10 of the Code of Federal Regulations (10 CFR) 72.48, “Changes, tests, and experiments,” establishes the conditions under which a general or specific licensee, and a spent fuel storage cask certificate holder may make changes to their independent spent fuel storage installation (ISFSI) or monitored retrievable storage installation facility (MRS), spent fuel storage cask design, or procedures, and under which they may conduct tests or experiments, without prior NRC approval. In addition to the 10 CFR 72.48 change review process, paragraph (b)(7) of 10 CFR 72.212, “Conditions of general license issued under 10 CFR 72.210,” also requires the general licensee to evaluate any changes to written evaluations required by paragraphs (b)(5) and (6) of 10 CFR 72.212, using the requirements of 10 CFR 72.48(c). Moreover, there are various provisions in 10 CFR 72.212, such as paragraphs (a)(2), (b)(3), (b)(5)(i), and (b)(11), that require general licensees to ensure they use casks that conform to the terms, conditions and specifications of a CoC listed in 10 CFR 72.214, “List of approved spent fuel storage casks.”

Therefore, if a general licensee wishes to adopt a change initiated by the CoC holder under the CoC holder's 10 CFR 72.48 change authority, the general licensee must perform a separate 10 CFR 72.48 review as required by the regulations. Additionally, if a general licensee adopts a CoC holder's change made under 10 CFR 72.48 and that change is later determined to be noncompliant, the general licensee would also be in noncompliance with provisions of 10 CFR 72.48 and 10 CFR 72.212.

The NRC is implementing a more efficient process in which the staff addresses CoC holders' apparent violations of the 10 CFR 72.48 change control process without pursuing an enforcement action against the general licensee for an apparent violation that is strictly due to the general licensee's adoption of a noncompliant change made under § 72.48 by the CoC holder. The NRC is also implementing a more efficient process for general licensees to review and adopt changes made by a CoC holder, pursuant to the CoC holder's § 72.48 change authority, as long as the general licensee does not need to make any site-specific technical changes. Accordingly, the staff is considering rulemaking, including potential interpretation of the applicable regulations, and revision of the implementation guidance.

The NRC published a final rule on October 4, 1999 (64 FR 53582) that revised 10 CFR 72.48 to clarify the specific types of changes, tests, and experiments conducted at a licensed facility or by a certificate holder that require evaluation, and revised the criteria that licensees and certificate holders must use to determine when NRC approval is needed before such changes, tests, or experiments can be implemented. The Commission approved the publication of the final rule in SECY-99-130, “Final Rule—Revisions to Requirements of 10 CFR parts 50 and 72 Concerning Changes, Tests, and Experiments.”

The preamble to the final rule for 10 CFR 50.59 and 10 CFR 72.48 stated the following in Section O.1, “Part 72 Changes,” provided on page 53601: “The Commission envisioned that a general licensee who wants to adopt a change to the design of a spent fuel storage cask it possesses—which change was previously made to the generic design by the certificate holder under the provisions of § 72.48—would be required to perform a separate evaluation under the provisions of § 72.48 to determine the suitability of the change for itself.” As indicated by the rule and supported by the preamble, both the CoC holder and general licensee are required to perform an evaluation when implementing a change made by a CoC holder pursuant to § 72.48.

The NRC staff may request that the Commission revise its regulations or interpretation of existing regulations to establish that CoC holders and general licensees have different obligations. The NRC staff may seek this change because both entities have separate quality assurance programs, and the NRC staff performs inspections of each change control process on a regular basis, which would provide reasonable assurance of safety and increase regulatory efficiency. Specifically, the efficiency will be realized by streamlining the inspections associated with the evaluation of the changes to focus (1) on CoC holders and (2) on general licensees only to the extent the general licensees make site-specific, technical changes.

This IEP allows staff to exercise enforcement discretion for certain general licensee violations of 10 CFR 72.48 and 10 CFR 72.212 related to the general licensee's adoption of a CoC holder-generated modification. This IEP also allows for better efficiency and reliability of spent fuel storage cask inspection oversight, while still providing adequate protection of public health and safety. The NRC is issuing this IEP due to the NRC's operational experience with its inspection and oversight of general licensees' adoption of CoC holders' § 72.48 changes. Certificate holders are NRC-regulated entities that are required to (1) ensure their storage casks meet NRC requirements and the Certificate of Compliance and (2) perform design changes in accordance with § 72.48; the NRC inspects their processes. In addition, the NRC recognizes that a general licensee who wants to adopt a change to the design of a spent fuel storage cask it possesses—where the change was previously made by the certificate holder under the provisions of § 72.48—must perform a review of that change for their site under a variety of other processes other than § 72.48, including those set forth in paragraphs (b)(5) and (6) of § 72.212, and in the general licensee quality assurance program. The combination of these review and oversight processes, together with other existing inspection and oversight processes, provide confidence that the general licensee has appropriately considered changes made by CoC holders and appropriately evaluated the potential safety implications of implementing those

The substance of these special conditions has been published in the Federal Register for public comment in several prior instances with no substantive comments received. Therefore, the FAA finds, pursuant to 14 CFR 11.38(b), that new comments are unlikely, and notice and comment prior to this publication are unnecessary.

Except for Confidential Business Information (CBI) as described in the following paragraph, and other information as described in title 14, Code of Federal Regulations (14 CFR) 11.35, the FAA will post all comments received without change to www.regulations.gov, including any personal information you provide. The FAA will also post a report summarizing each substantive verbal contact received about these special conditions.

Confidential Business Information (CBI) is commercial or financial information that is both customarily and actually treated as private by its owner. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public disclosure. If your comments responsive to these special conditions contain commercial or financial information that is customarily treated as private, that you actually treat as private, and that is relevant or responsive to these special conditions, it is important that you clearly designate the submitted comments as CBI. Please mark each page of your submission containing CBI as “PROPIN.” The FAA will treat such marked submissions as confidential under the FOIA, and the indicated comments will not be placed in the public docket of these proposed special conditions. Send submissions containing CBI to the individual listed in the For Further Information Contact section above. Comments the FAA receives, which are not specifically designated as CBI, will be placed in the public docket for these proposed special conditions.

The FAA invites interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.

The FAA will consider all comments received by the closing date for comments. The FAA may change these special conditions based on the comments received.

On July 9, 2024, Jet Aviation AG applied for a supplemental type certificate for the installation of therapeutic oxygen systems on the Model GVI airplane. The Gulfstream Model GVI airplane, currently approved under Type Certificate No. T00015AT, is a twin-engine transport-category, business jet, with a maximum seating for 19 passengers, and a maximum take-off weight of 99,600 pounds.

Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Jet Aviation AG must show that the changes to the Gulfstream Model GVI airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. T00015AT or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.

If the Administrator finds that the applicable airworthiness regulations ( e.g., 14 CFR part 25) do not contain adequate or appropriate safety standards for the Gulfstream Model GVI airplane because of a novel or unusual design feature, special conditions are prescribed under the provisions of § 21.16.

Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.

In addition to the applicable airworthiness regulations and special conditions, the Gulfstream Model GVI airplane must comply with the exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.

The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.

The Gulfstream Model GVI airplane will incorporate the following novel or unusual design feature:

An oxygen distribution system that provides a shared source of oxygen between the flightcrew and passengers to provide supplemental and therapeutic oxygen.

There are no specific regulations that address the design and installation of required passenger or crew oxygen systems that share a supply source with an optional oxygen system used specifically for therapeutic applications. Therapeutic oxygen systems have been previously certified and were generally considered an extension of the passenger oxygen system for the purpose of defining the applicable regulations. As a result, existing requirements, such as 14 CFR 25.1309, 25.1441(b) and (c), 25.1451, and 25.1453, in the Gulfstream GVI airplane's certification basis applicable to this project, provide some design standards appropriate for oxygen system installations. In addition, § 25.1445 includes standards for oxygen distribution systems when oxygen is supplied to crew and passengers. If a common source of supply is used, § 25.1445(a)(2) requires a means to separately reserve the minimum supply required by the flight crew.

Section 25.1445 is intended to protect the flightcrew by ensuring that an adequate supply of oxygen is available to complete a descent and landing following a loss of cabin pressure. When the regulation was written, the only passenger oxygen system designs were supplemental oxygen systems intended to protect passengers from hypoxia in the event of a decompression. Existing passenger oxygen systems did not include design features that would allow the flightcrew to control oxygen to passengers during flight. There are no similar requirements in § 25.1445 when oxygen is supplied from the same source to passengers for use during a decompression, and for discretionary or first-aid use any time during the flight. In the design, the crew, passenger, and therapeutic oxygen systems use the same source of oxygen. These special conditions contain additional design requirements for the equipment involved in this dual therapeutic oxygen plus supplemental gaseous oxygen installation.

These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

As discussed above, these special conditions are applicable to the Gulfstream Model GVI airplane. Should Jet Aviation AG apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. T00015AT to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.

This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability and affects only the applicant who applied to the FAA for approval of these features on the airplane.

The authority citation for these special conditions is as follows:

Accordingly, pursuant to the authority delegated to me by the Administrator, the following special conditions are issued as part of the type certification basis for Gulfstream Aerospace Corporation Model GVI airplanes, as modified by Jet Aviation AG.

The distribution system for the passenger therapeutic oxygen system must be designed and installed to meet the following requirements:

(1) When oxygen is supplied to passengers for both supplemental and therapeutic purposes, the distribution system must be designed for either—

(a) A source of supplemental oxygen for protection following a loss of cabin pressure, and a separate source for therapeutic purposes; or

(b) A common source of supply with means to separately reserve the minimum supply required by the passengers for supplemental use following a loss of cabin pressure.

The Drug Enforcement Administration (DEA) issues a temporary scheduling order  1 (in the form of a temporary amendment) to add the following two synthetic benzimidazole-opioid substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, to schedule I under the Controlled Substances Act (CSA):

• 2-(4-methoxybenzyl)-5-nitro-1-(2-(pyrrolidin-1-yl)ethyl)-1 H -benzimidazole (commonly known as, N -pyrrolidino metonitazene or metonitazepyne), and

• 5-nitro-2-(4-propoxybenzyl)-1-(2-(pyrrolidin-1-yl)ethyl)-1 H -benzimidazole (commonly known as, N- pyrrolidino protonitazene or protonitazepyne).

Under 21 U.S.C. 811(h)(1), the CSA provides the Attorney General (as delegated to the Administrator of DEA (Administrator) pursuant to 28 CFR 0.100) with the authority to temporarily place a substance in schedule I of the CSA for two years without regard to the evaluation requirements of 21 U.S.C. 811(b), if she finds that such action is necessary to avoid an imminent hazard to the public safety. 2 In addition, if proceedings to control a substance are initiated under 21 U.S.C. 811(a)(1) while the substance is temporarily controlled under section 811(h), the Attorney General may extend the temporary scheduling for up to one year. 3

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

The CSA requires the Administrator to notify the Secretary of the Department of Health and Human Services (HHS) of an intent to temporarily place a substance in schedule I of the CSA ( i.e., to issue a temporary scheduling order). 5 By letter dated March 24, 2025, the then-Acting Administrator transmitted the required notice to place N -pyrrolidino metonitazene and N -pyrrolidino protonitazene in schedule I on a temporary basis to the Acting Assistant Secretary for Health of HHS (Assistant Secretary). 6 On June 11, 2025, the Acting Assistant Secretary responded to this notice and advised DEA that based on a review by the Food and Drug Administration (FDA), there are currently no investigational new drug applications (IND) or approved new drug applications (NDA) for N -pyrrolidino metonitazene or N -pyrrolidino protonitazene. The Acting Assistant Secretary also stated that HHS had no objection to the temporary placement of these substances in schedule I of the CSA. N -Pyrrolidino metonitazene and N -pyrrolidino protonitazene currently are not listed in any schedule under the CSA, and no exemptions or approvals under 21 U.S.C. 355 are in effect for these substances. 7

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

As required by 21 U.S.C. 811(h)(1)(A), DEA published a notice of intent (NOI) to temporarily schedule N -pyrrolidino metonitazene and N -pyrrolidino protonitazene on September 17, 2024. 8 That NOI discussed findings from DEA's three-factor analysis dated August 2024, which DEA made available on www.regulations.gov.

To find that temporarily placing a substance in schedule I of the CSA is necessary to avoid an imminent hazard to the public safety, the Administrator must consider three of the eight factors set forth in 21 U.S.C. 811(c): the substance's history and current pattern of abuse; the scope, duration, and significance of abuse; and what, if any, risk there is to the public health. 9 Considerations of these factors includes any information indicating actual abuse, diversion from legitimate channels, and clandestine importation, manufacture, or distribution of N -pyrrolidino metonitazene and N -pyrrolidino protonitazene. 10 Substances meeting the statutory requirements for temporary scheduling may only be placed in schedule I. 11 Substances in schedule I have high potential for abuse, no currently accepted medical use in treatment in the United States, 12 and a lack of accepted safety for use under medical supervision. 13

This final rule makes miscellaneous technical corrections, clarifications, updates, and improvements to several of the Pension Benefit Guaranty Corporation's (PBGC's) regulations. These changes are based on PBGC's ongoing retrospective review of the effectiveness and clarity of its rules and on statutory changes to the Employee Retirement Income Security Act of 1974 (ERISA).

PBGC's legal authority for this rulemaking comes from section 4002(b)(3) of ERISA which authorizes PBGC to issue regulations to carry out the purposes of title IV of ERISA. It also comes from section 4006 of ERISA (Premium Rates), section 4007 of ERISA (Payment of Premiums), section 4010 of ERISA (Authority to Require Certain Information), section 4041 of ERISA (Termination of Single-Employer Plans), section 4041A of ERISA (Termination of Multiemployer Plans), section 4043 of ERISA (Reportable Events), section 4044 of ERISA (Allocation of Assets), section 4065 of ERISA (Annual Report of Plan Administrator), section 4203 of ERISA (Complete Withdrawal), section 4204 of ERISA (Sale of Assets), section 4207 of ERISA (Reduction or Waiver of Complete Withdrawal Liability), section 4211 of ERISA (Methods for Computing Withdrawal Liability), section 4219 of ERISA (Notice, Collection, Etc., of Withdrawal Liability), section 4220 of ERISA (Approval of Amendments), section 4233 of ERISA (Partitions of Eligible Multiemployer Plans), section 4245 of ERISA (Insolvent Plans), section 4262 of ERISA (Special Financial Assistance by the Corporation), and section 4281 of ERISA (Benefits Under Certain Terminated Plans).

The major provisions of this rulemaking amend PBGC's regulations on:

• Premium Rates, by codifying the changes of the Setting Every Community Up for Retirement Enhancement Act of 2019 (SECURE Act) (Pub. L. 116-94, Division O) applicable to cooperative and small employer charity (CSEC) plans  1 and certain community newspaper plans;  2

• Payment of Premiums, by revising the due date for the final premium for terminating plans to be the earlier of the normal premium due date or 45 days after the date the post-distribution certification is filed;

• Termination of Single-Employer Plans, by setting due dates for the standard termination notice and notice of intent to terminate where the plan administrator has not provided a proposed termination date, and by adding additional criteria majority owners must meet to waive their benefits if they are owners through constructive ownership; and

• Termination of Multiemployer Plans, by eliminating a requirement for terminated and insolvent multiemployer plans to file withdrawal liability information.

PBGC administers two insurance programs for private-sector defined benefit pension plans under title IV of ERISA: a single-employer plan termination insurance program and a multiemployer plan insolvency insurance program. In addition, PBGC administers a special financial assistance program for certain financially distressed multiemployer plans. The amendments in this rulemaking apply primarily to the single-employer plan termination insurance program.

On January 21, 2025, PBGC published a proposed rule  3 to make miscellaneous technical corrections, clarifications, updates, and improvements to several of PBGC's regulations. PBGC provided a 60-day comment period. In response, PBGC received one comment letter, but the comment does not appear to be related to any of the provisions in the proposed rule. Except for amendments to eliminate certain multiemployer plan withdrawal liability reporting requirements and to revise the expense loading charge provided in § 4044.52(d) of the benefits valuation regulation to correct the rounding methodology, the final rule is substantially the same as the proposed rule. The final rule also includes some technical and editorial changes.

The provisions of this final rule are discussed with respect to each of the regulations as identified below.

Sponsors of plans covered under PBGC's single-employer program are subject to rules requiring the calculation and payment of annual premiums to PBGC under section 4006 of ERISA and PBGC's regulation on Premium Rates (29 CFR part 4006), “premium rates regulation.” The SECURE Act modified the calculation of premiums under section 4006 of ERISA for a CSEC plan and the funding requirements for a community newspaper plan under section 303(m) of ERISA and section 430(m) of the Internal Revenue Code (the Code). The SECURE Act also modified section 401 of the Code to allow an employer to adopt a new pension plan and elect to treat the plan as if it had been adopted during the prior taxable year.

PBGC is amending its premium rates regulation to account for these SECURE Act modifications.

The SECURE Act modified flat and variable rate premiums and changed the way the variable rate premium is calculated for CSEC plans first effective for 2019. 4 Under section 4006(a)(3)(A) of ERISA, as amended by the SECURE Act, CSEC plans calculate the variable rate premiums that they owe to PBGC based on alternative minimum funding standards. CSEC plans now apply an alternate definition of unfunded vested benefits (UVBs). This definition refers to the funding liability of the CSEC plan as determined under section 306(j)(5)(C) of ERISA and section 433(j)(5)(C) of the Code. PBGC issued guidance  5 on these changes and incorporated the special premium rules for CSEC plans into the premium filing instructions starting with the 2021 filing instructions.

Although the rules have been in place for several years, PBGC is now amending its premium rates regulation to conform the regulation with changes made by the SECURE Act regarding how CSEC plans determine UVBs for the purpose of calculating variable rate premiums. First, new § 4006.5(h) provides the rules to calculate a CSEC plan's “premium funding target” using the alternate definition of UVBs as provided in section 306(j)(5)(C) of ERISA and section 433(j)(5)(C) of the Code. In addition, PBGC is making conforming amendments to §§ 4006.2, 4006.4(b)(1) and 4006.4(f)(2) to further conform to changes under the SECURE Act for CSEC plans.

The SECURE Act amended section 430 of the Code and section 303 of ERISA, providing that community newspaper plans may elect to use alternative minimum funding standards. 6 Section 4006 of ERISA was not similarly amended, however, so community newspaper plans are not permitted to use these alternative standards to calculate the premiums that they owe to PBGC. PBGC is adding a reference to community newspaper plans in § 4006.4(f) to denote them as plans subject to special funding rules, which are disregarded for purposes of determining UVBs.

Under PBGC's premium rates regulation and its regulation on Payment of Premiums (29 CFR part 4007), “payment of premiums regulation,” plans that are newly adopted are subject to special rules concerning calculations and payment of premiums. Before the SECURE Act, a “new plan” meant a plan that did not exist before the premium payment year. Following the SECURE Act, which allows employers to elect to treat newly adopted plans as having been adopted during the prior tax year, this definition must be changed. The current definition does not account for newly adopted plans that employers have elected to treat as having a retroactive effective date. Accordingly, PBGC is changing the definition of “New plan” in § 4006.2 to mean a plan with an effective date during the premium payment year.

The final step in a plan's standard termination is the filing of the post-distribution certification under § 4041.29 of PBGC's regulation on Termination of Single-Employer Plans (29 CFR part 4041). The plan administrator of the terminating plan must file the certification (on PBGC Form 501) within 30 days of the final benefits distribution date, or within 60 days of the final benefits distribution date if it certifies to PBGC within 30 days after the final benefits distribution date that the plan assets have been distributed as required. Before 2014, the final premium filing for a terminating plan was due on the same date it would have been due if the plan had not terminated ( i.e., the 15th day of the 10th month after the plan year began). There were instances in which plan administrators of terminating plans neglected to file the final premium filing by the time it was due, however, because the due date was several months after the Form 501 was filed. PBGC found that in some of these cases, especially when the plan sponsor was no longer in business by the final premium due date, it was difficult for the plan administrator to go back or even reconstruct records to calculate and pay premiums, as well as pay the late payment interest and penalties that PBGC assessed.

In 2014, PBGC amended its payment of premiums regulation by revising the premium due date rules for terminating plans. 7 This was intended to facilitate the timely payment of these final year premiums for terminating plans and to relieve them of the burden of calculating premiums long after the final distributions were made. This rule set the due date for the final premium filing for a terminating plan as the earlier of (1) the normal premium due date found in § 4007.11(a), or (2) the date when the post-distribution certification is filed. Therefore, a plan that closes out in the first eight-and-a-half months of its final plan year faces an accelerated premium filing due date. 8

As explained in the proposal, practitioners have informed PBGC that in some cases, it is challenging to prepare and submit both the post-distribution certification ( i.e., PBGC Form 501) and the final premium filing on the same day. As a result of these challenges, some plan administrators have missed filing due dates and have been assessed late premium payment charges.

For the reasons described in the 2014 rule and above, PBGC still believes it is important to have an accelerated premium due date for plans that complete a standard termination long before the “normal” premium due date. However, to reduce the administrative difficulties and related possibility of late or missed filings, PBGC is amending § 4007.11(d)(2) to revise the due date for the final premium filing to be the earlier of (1) the normal premium due date, or (2) 45 days after the date the post-distribution certification is filed.

Under section 4041 of ERISA, a single-employer plan can terminate in either a standard termination or a distress termination. A plan administrator of a single-employer plan covered by PBGC's termination insurance program that has sufficient assets to provide all plan benefits may voluntarily terminate the plan in a standard termination. The rules governing standard terminations are in section 4041 of ERISA and subpart B of PBGC's regulation on Termination of Single-Employer Plans (29 CFR part 4041), “termination regulation.” Within specified timeframes, a plan administrator must notify participants of the proposed termination; provide participants detailed information on their plan benefits; file certain information with PBGC; and, absent the issuance of a notice of noncompliance by PBGC, distribute plan assets to satisfy all plan benefits under the plan.

A single-employer plan insured by PBGC that does not have sufficient assets to pay all plan benefits owed to participants and beneficiaries but does have sufficient assets to pay benefits guaranteed by PBGC, may terminate voluntarily in a distress termination only if the employer and the members of the employer's “controlled group” of affiliated companies meet certain statutory requirements.

Under PBGC's termination regulation, in the event that a plan lacks sufficient funds to pay required plan benefits, a majority owner may forgo receipt of their plan benefits (1) to enable the plan to satisfy all other plan benefits in a standard termination, 9 or (2) in connection with a distress termination. 10 In a standard termination, the election to waive payment of benefits is permitted only to facilitate the standard termination. This alternative treatment of a majority owner's plan benefit is valid only if the election is in writing; requisite spousal consent criteria is met, if applicable; and the majority owner's election and the spouse's consent does not violate a qualified domestic relations order. 11 A majority owner electing to forgo receipt of their plan benefits in a distress termination must meet these same criteria as a majority owner in a standard termination, but in addition, must receive PBGC approval if such election is made after the termination date and would result in PBGC determining that the plan is sufficient for guaranteed benefits under paragraph (c) of § 4041.47. 12

The term “majority owner” is defined under § 4041.2 of the termination regulation as a person who owns, directly or indirectly, 50 percent or more, taking into account the constructive ownership rules of sections 414(b) and (c) of the Code, of an unincorporated trade or business; the capital interest or profits interest in a partnership; or either the voting stock of a corporation or the value of all of the stock of a corporation. One way in which a person can become a majority owner is through an option agreement to acquire stock. If a person has an option to acquire stock, that stock is considered as owned by the person who holds the option. 13

PBGC is concerned that the rules in the current regulation do not effectively eliminate the risk of participants being coerced to waive their benefits as “majority owners” when they are given ownership options by the plan sponsor in anticipation of plan termination. To avoid such potential coercion, PBGC is amending the criteria individuals must meet to waive their benefits by modifying its application of the constructive ownership rules. Under the rule, if the majority owner has an option to acquire any outstanding interest in an organization, such interest will be considered as owned by such person by an option agreement under 26 CFR 1.414(c)-4(b)(1) if the person directly owns 5 percent or more of the unincorporated business or trade, capital interest or the profits interest in a partnership, or either 5 percent or more of the voting stock of a corporation or the value of all the stock of a corporation. 14 Alternatively, if the person does not have a 5 percent or more direct ownership interest, the person would be able to qualify as a majority owner under an option agreement if the person has been a member of the board of directors or officer of the plan sponsor, or a fiduciary of the plan for each of the 3 years immediately preceding the date of plan termination. These exceptions to the ownership rules are intended to minimize the potential misuse of option agreements and protect the benefits of participants who are not direct owners or who have not participated in the management of the plan sponsor.

To complete a standard termination, the plan administrator must: (1) issue notices of intent to terminate and notices of plan benefits to participants, beneficiaries, and other affected parties; (2) file a standard termination notice and post-distribution certification with PBGC; and (3) distribute the plan's assets in satisfaction of the plan's benefit liabilities. Under § 4041.25(a), the standard termination notice is due on or before the 180th day after the proposed termination date. Under § 4041.25(b), a plan's date of termination is the later of the date specified in the standard termination notice or the date specified in the notice of intent to terminate (but not later than 90 days after the earliest date a notice of intent to terminate was provided to any party). However, if the plan administrator fails to specify such date in the notice of intent to terminate and/or fails to file a standard termination notice (thus failing to declare a proposed termination date), then the due date for the standard termination notice is unclear. The final rule clarifies this ambiguity in such cases by clearly establishing a due date for the standard termination notice that does not depend on the declaration of a proposed termination date. Under this rule, § 4041.25(a) is modified such that the due date for a standard termination notice is the earlier of: (1) 180 days after the plan's proposed termination date as specified in the standard termination notice; or (2) 60 days before making any distribution governed by section 4041(b) of ERISA. Thus, the due date for a standard termination notice, where the notice is not filed with PBGC, will be 60 days before distributions begin, and PBGC may assess penalties for the missed filing from that point going forward.

PBGC is also making a corresponding change to § 4041.29(b), which provides to plan administrators who timely filed a standard termination notice a 90-day grace period for the assessment of penalties for an untimely post-distribution certification. This section is modified such that the grace period continues to be available but only if the plan administrator filed a standard termination notice within 180 days of the proposed termination date.

PBGC's regulations on Termination of Multiemployer Plans (29 CFR part 4041A) and Duties of Plan Sponsor of an Insolvent Plan (29 CFR part 4245) require that plans terminated by mass withdrawal, plans terminated by amendment that are expected to become insolvent, and insolvent plans receiving financial assistance from PBGC (whether terminated or not terminated) file withdrawal liability information. PBGC's instructions specify the information to be filed, including information about withdrawal liability payments and settlements, and whether employers have withdrawn from the plan but have not yet been assessed withdrawal liability. This information was used by PBGC to estimate PBGC's multiemployer liabilities for its financial statements. PBGC determined that this reporting requirement is no longer needed for this purpose. On March 10, 2025, 15 PBGC published a notice that informed the public that PBGC was eliminating this reporting requirement. PBGC did not receive any comments in response to its notice. Accordingly, in this final rule, PBGC is removing § 4041A.23(b) and § 4245.8(b)(1), each of which require the filing of withdrawal liability information.

PBGC is amending its regulation on Filing, Issuance, Computation of Time, and Record Retention (29 CFR part 4000) to require electronic filing by plans of standard termination filings, missing participant filings, and coverage determination forms. These filings are made by plans and practitioners representing plans, and not by individual participants. Filing this information electronically (by email or, if available, through PBGC's e-Filing Portal) is currently optional. However, because electronic filing is more efficient for both PBGC and filers and has become the standard method of filing for PBGC's regulated community, PBGC is amending § 4000.3(b) to require electronic filing by plans for standard termination filings under subpart B of 29 CFR part 4041, missing participant filings under 29 CFR part 4050, and coverage determination forms under section 4021 of ERISA, in accordance with instructions on PBGC's website at www.pbgc.gov.

The rule also makes other clarifying and editorial changes to part 4000.

Under PBGC's regulation on Annual Financial and Actuarial Information Reporting (29 CFR part 4010), certain underfunded plans  16 must annually report identifying, financial, and actuarial information to PBGC. Section 4010.8(a)(12) provides that the actuarial information must be certified, in writing, by an enrolled actuary. The final rule amends this paragraph so that the filing instructions, not the regulation, provide the method for certification ( i.e., what information must be contained in the certification and how to complete the certification). This amendment is intended to give PBGC greater flexibility to consider methods other than written certifications, such as e-certifications, in the future.

Plan administrators and contributing sponsors are responsible for notifying PBGC of a reportable event under section 4043 of ERISA or a failure to make certain required contributions under section 303(k)(4) of ERISA or section 430(k)(4) of the Code. PBGC's regulation on Reportable Events and Certain Other Notification Requirements (29 CFR part 4043), “reportable events regulation,” prescribes the requirements for notifying PBGC of one of these circumstances. Filers must submit these notices using PBGC's e-Filing Portal. The e-Filing Portal, available for submitting notices of reportable events since 2016, offers a secure application for submitting reportable events information. Currently, under § 4043.3(a)(3), if notices are required for two or more events, the notices can be combined into one filing. This provision was originally intended to make filing paper notices easier by allowing filers to combine paper notices into one filing. However, this provision is obsolete as under PBGC's e-Filing Portal, the filer is prompted to enter information for only one reportable event per filing. This method is not burdensome for filers as information about the filer is saved in the e-Filing Portal and does not need to be re-entered for each filing. Therefore, PBGC is removing the obsolete language in § 4043.3(a)(3).

PBGC is also modifying § 4043.62 of the reportable events regulation. In 2020, § 4043.29 was amended to clarify that PBGC does not need notice of a change in the contributing sponsor to a plan if the change does not result in a contributing sponsor ceasing to be a member of the plan's controlled group. 17 Therefore, the heading of § 4043.29 was revised to remove “contributing sponsor,” and the description of reportable event was revised to provide that a reportable event occurs for a plan when there is a transaction that results, or will result, in one or more persons (including any person who is or was a contributing sponsor) ceasing to be a member of the plan's controlled group (other than by merger involving members of the same controlled group). The advance notice requirement in § 4043.62 refers to the description of the event that must be reported under § 4043.29. To conform with changes made to § 4043.29 in 2020, PBGC, in this final rule, amends the heading of § 4043.62 by removing “contributing sponsor or,” and amends paragraph (a) of § 4043.62 to remove “contributing sponsor or.” These amendments clarify and minimize confusion as to the advance notice requirement for a change in controlled group.

On June 6, 2024, PBGC published its final rule, Valuation Assumptions and Methods, 18 to amend its regulation on Allocation of Assets in a Single-Employer Plans (29 CFR part 4044), “benefits valuation regulation.” The rule updated the interest, mortality, and expense assumptions used to determine the present value of benefits for single-employer pension plans terminating in a distress or involuntary termination. The assumptions are also used for certain multiemployer withdrawal liability calculations, 4010 reporting, and other purposes.

Under the June 6, 2024, final rule, the expense load assumption begins with the sum of $400 per participant for the first 100 participants and $250 for each participant over 100. That sum is then adjusted for inflation and rounded to the nearest dollar.

Practitioners have asked why PBGC did not post the indexed per-participant amounts on its website, www.pbgc.gov, as it does for other indexed amounts ( e.g., premium rates). The reason is because doing so is not possible given the way § 4044.52(d) of the benefits valuation regulation was amended in 2024. Specifically, as drafted, the indexing applies to the total expense loading charge, not the individual per-participant amounts. This was not PBGC's intent when the expense loading charge was modernized in the June 6, 2024, final rule. After reviewing this issue, PBGC is revising § 4044.52(d) of the benefits valuation regulation to correct the rounding methodology so that PBGC can post the indexed amounts each year on its website. The corrected methodology is consistent with how other pension-related numbers are indexed and will have only a negligible impact on the resulting liabilities ( i.e., generally less than 1/1000 of a percentage).

As revised, the inflation adjustment is applied to the unindexed per-participant amounts ( i.e., $400 or $250, whichever is applicable) and then rounded to the nearest whole dollar amount before the overall expense load is determined for the plan. The indexed $400 amount is used for the first 100 participants, and the indexed $250 amount is used for each participant over 100.

Modifying the methodology for determining the expense loading charge will enable PBGC to post the indexed amounts on its website for practitioners to use, which will simplify the calculation with only an inconsequential impact to the total liability under the benefits valuation regulation.

This change to § 4044.52(d) of the benefits valuation regulation applies to calculations where the valuation date is on or after January 31, 2026.

Under PBGC's regulation on Allocating Unfunded Vested Benefits to Withdrawing Employers (29 CFR part 4211), a plan is responsible for determining the amount of unfunded vested benefits to be allocated to a withdrawing employer and uses one of four methods to do so. Under § 4211.23, PBGC can approve an alternative allocation method or modification to an allocation method if such change or modification would not significantly increase the risk of loss to plan participants and beneficiaries or to PBGC.

PBGC, in the final rule, amends paragraph (c) of § 4211.23 by removing language that implies that reconsideration of PBGC's decision on an alternative allocation method or modification to an allocation method is a right of a plan sponsor. Per PBGC's regulations on Rules for Administrative Review of Agency Decision (29 CFR part 4003), decisions made by PBGC under 29 CFR part 4211 are not subject to either appeal or reconsideration. Instead, PBGC has the authority to review, upon request or its own initiative, determinations when it is deemed to be appropriate. This change clarifies that a plan sponsor may request review of PBGC's decision regarding an alternative allocation method or modification.

A multiemployer plan that is seeking partition must comply with the requirements set forth under PBGC's regulation on Partitions of Eligible Multiemployer Plans (29 CFR part 4233). The specific filing requirements are outlined in § 4233.3 and include a statement under penalties of perjury that the plan sponsor must submit with the signed and dated application for partition.

PBGC is amending paragraph (b) of § 4233.3 to better comply with the affidavit requirements prescribed by the Department of Justice for perjury cases under 28 U.S.C. 1746. The new language for the affidavit must include language specifically referring to the penalty of perjury “under the laws of the United States of America” to adhere to the sample form outlined in paragraph (1) of 28 U.S.C. 1746.

Under the Special Financial Assistance by PBGC regulation (29 CFR part 4262), PBGC is amending paragraph (h)(3)(iv)(B) of § 4262.16 by changing the reference from “section 4291(b)(1)(A) of ERISA,” which was erroneous, to “section 4219(b)(1)(A) of ERISA.”

As discussed earlier in this preamble, the assumptions in PBGC's benefits valuation regulation are used in certain multiemployer plan calculations. For instance, the assumptions are used to value liabilities for determining withdrawn employers' reallocation liability in the event of a mass withdrawal from a multiemployer plan. Thus, § 4281.13 of PBGC's regulation on Duties of Plan Sponsor Following Mass Withdrawal (29 CFR part 4281) was amended by the June 6, 2024, final rule  19 to include references to the amended benefits valuation regulation (29 CFR 4044.52). However, in the amended benefits valuation regulation, the expense loading charge provisions stopped using the term “benefit liabilities,” but the references in 29 CFR part 4281 were not updated to reflect that change. Accordingly, PBGC is making a conforming change to remove the parenthetical in § 4281.13(e) that requires the substitution of “benefits” for “benefit liabilities.”

PBGC is adding § 4909 and a table to display, per the requirements of 5 CFR 1320.5(b)(2)(ii)(C), the Office of Management and Budget control numbers of PBGC information collections for which there is no corresponding paper or electronic form. This change is intended for better organization and clarity. In addition, PBGC is removing outdated or duplicative OMB control numbers from the following sections: 4007.12, 4010.15, 4041A.11, 4065.3, 4203.6, 4204.11, 4204.21, 4207.10, 4211.22, 4219.20, 4220.3, and 4281.4.

The Office of Management and Budget (OMB) has determined that this rule is not a “significant regulatory action” under Executive Order 12866. Accordingly, OMB has not reviewed the final rule under Executive Order 12866.

Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity).

Although this final rule is not a significant regulatory action under Executive Order 12866, PBGC has examined its economic and policy implications. Most of the amendments, including those to parts 4006, 4007, 4010, and 4041, clarify regulations or conform regulations to statutory changes, or are otherwise cost-neutral in their impact.

The changes to parts 4041A and 4245 that eliminate withdrawal liability reporting requirements reduce burden for plan sponsors. 20 While those changes were not included in the January 21, 2025, proposed rule, on March 10, 2025, and May 15, 2025, PBGC published notices  21 that informed the public of its intent to eliminate the reporting requirements and provided comment periods as required under the Paperwork Reduction Act (PRA). PBGC did not receive any comments in responses to these notices. The Administrative Procedure Act (APA) provides at 5 U.S.C. 553(b)(4)(B) that notice and comment requirements do not apply when an agency, for good cause, finds that they are impracticable, unnecessary, or contrary to the public interest. PBGC has determined that because the changes reduce reporting burden and because PBGC did not receive comments in response to the published PRA notices, that additional opportunity for notice and comment is impracticable and unnecessary, and that the public interest is best served by issuing these changes as part of the final rule.

Similarly, PBGC has determined that the amendments to §§ 4044.52 and 4281.13 also fall under the “good cause” exemption and that the public interest is best served by issuing these changes as part of the final rule. As explained earlier in the preamble, these are minor technical amendments to update and correct PBGC's regulations governing the calculation method of the expense load assumption, which will simplify the calculation, and therefore, notice and comment are unnecessary.

Section 6 of Executive Order 13563 requires agencies to rethink existing regulations by periodically reviewing their regulatory program for rules that “may be outmoded, ineffective, insufficient, or excessively burdensome.” Such rules should be modified, streamlined, expanded, or repealed as appropriate. PBGC identified technical corrections, clarifications, and improvements to some of its regulations and has included those amendments in this final rulemaking.

The Regulatory Flexibility Act  22 (RFA) imposes certain requirements respecting rules that are subject to the notice-and-comment requirements of section 553(b) of the Administrative Procedure Act, or any other law, 23 and that are likely to have a significant economic impact on a substantial number of small entities. Unless an agency certifies that a final rule will not, if promulgated, have a significant economic impact on a substantial number of small entities, section 603 of the RFA requires that the agency present an initial regulatory flexibility analysis at the time of the publication of the final rule describing the impact of the rule on small entities and seek public comment on such impact. Small entities include small businesses, organizations, and governmental jurisdictions. 24

For purposes of the RFA requirements with respect to this final rule, PBGC considers a small entity to be a plan with fewer than 100 participants. 25 This is substantially the same criterion PBGC uses in other regulations  26 and is consistent with certain requirements in title I of ERISA  27 and the Code, 28 as well as the definition of a small entity that PBGC and the Department of Labor (DOL) have used for purposes of the RFA. 29

Further, while some large employers operate small plans along with larger ones, in general, most small plans are maintained by small employers. PBGC believes that assessing the impact of the final rule on small plans is an appropriate substitute for evaluating the effect on small entities. The definition of small entity considered appropriate for this purpose differs, however, from a definition of small business based on size standards promulgated by the Small Business Administration (13 CFR 121.201) pursuant to the Small Business Act. PBGC therefore requested comments on the appropriateness of the size standard used in evaluating the impact on small entities of this rule. PBGC received no comments on this point.

Based on its definition of small entity, PBGC certifies under section 605(b) of the RFA that the amendments in this final rule will not have a significant economic impact on a substantial number of small entities. As explained above under “Executive Orders 12866 and 13563,” most of the amendments offer clarifications or conform the regulation to statutory changes and thus are neutral in their impact. For instance, the clarification of deadlines of standard termination filings under part 4041 does not impose any new requirements but rather clarifies existing ones. While it is possible that individual small plans may be impacted by this change, the overall effect on small plans will not be significant. Accordingly, as provided in section 605 of the Regulatory Flexibility Act, sections 603 and 604 do not apply.

This final rule contains collections of information that PBGC is submitting to OMB for review and approval under the Paperwork Reduction Act (PRA). OMB's decision regarding these information collection requests will be available at http://www.reginfo.gov. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Most of the changes PBGC is making are revisions to filing instructions, where necessary or helpful, to incorporate the clarifications in the final rule. Therefore, except as described below, PBGC estimates that the final rule will have no impact on the hour and cost burden of reporting.

The collection of information under part 4041 is approved under OMB control number 1212-0036 (expires March 31, 2026). Under the current information collection requirements, PBGC estimated it would receive 1,647 standard termination requests, with an estimated annual hour burden of 41,175 hours and a cost burden of $8,399,700, and 7 distress termination cases, with an annual hourly burden of 560 hours and a cost burden of $110,040. Therefore, PBGC estimated that the annual burden for complying with this collection of information was 41,735 hours and $8,509,740.

Under the final rule, there will be an increase in the total estimated burden solely due to a change in the number of standard termination requests expected. PBGC estimates for calendar years 2026-2028 it will receive an average of 1,868 standard termination requests per year, resulting in an estimated annual hour burden of 46,700 hours and a cost burden of $9,526,800, and it will open an average of 2 cases per year that will conclude in a distress termination, with an estimated annual hour burden of 160 hours and a cost burden of $31,440. Therefore, the total annual burden of complying with this collection of information for standard terminations and distress terminations is estimated to be 46,860 hours and $9,558,240. PBGC's Standard Termination Filing Instructions under OMB control number 1212-0036 will be updated to reflect the changes in this final rule to eliminate the current option of filing paper forms and to make clear that such filings must be submitted electronically. In addition, PBGC is making other editorial changes to both the standard termination and distress termination instructions. The clarifications incorporated into the instructions will replace or augment existing language but will not create additional filing burden.

The collection of information under part 4010 is approved under OMB control number 1212-0049 (expires February 28, 2026). Under the current information collection requirements, PBGC estimated it would receive 400 filings, with an estimated annual hour burden of 800 hours and a cost burden of $11,080,000.

Under the final rule, PBGC's ERISA 4010 Filing Instructions will be updated to provide the method for certification of actuarial information submitted by certain underfunded plans. The information does not create additional filing burden. Accordingly, there is no change in the estimated burden for calendar years 2026-2028.

The collection of information under part 4050 is approved under OMB control number 1212-0069 (expires November 30, 2026). Under the current information collection requirements, PBGC estimated it would receive 345 missing participant filings, with an estimated annual hour burden of 70 hours and a cost burden of $497,835.

Under the final rule, there will be a decrease in the estimated burden due to a change in the number of missing participant filings expected. PBGC estimates for calendar years 2026-2028 it will receive an average of 340 filings (270 MP-100s, 62 MP-200S, 8 MP-300s, 0 MP-400s) each year, resulting in an estimated annual hour burden of 68 hours and a cost burden of $490,620. PBGC's Missing Participants Instructions under OMB control number 1212-0069 will be updated to reflect the changes in this final rule to eliminate the current option of filing paper forms and to make clear that the forms must be submitted electronically. PBGC is also making editorial changes to the sets of instructions. The clarifications incorporated into the instructions will replace or augment existing language but will not create additional filing burden.

The collection of information under part 4007 is approved under OMB control number 1212-0009 (expires December 31, 2026). Under the current information collection requirements PBGC estimated it would receive 31,303 premium filings, with an estimated annual hour burden of 13,565 hours and a cost burden of $21,661,676.

Under the final rule, there will be a decrease in the estimated burden solely due to a change in the number of premium filings expected. PBGC estimates for calendar years 2026-2028 it will receive an average of 29,288 filings each year, resulting in an estimated annual hour burden of 12,691 hours and a cost burden of $20,267,296. PBGC's Comprehensive Premium Filing Instructions will be updated to reflect the changes in this final rule to change the options for the final premium filing due date. This change is applicable to plan years beginning on or after January 1, 2026.

In addition, PBGC is making other non-material changes to the Comprehensive Premium Filing Instructions for plan years beginning in 2026. These include updating the premium rates with rates applicable for 2026 and updating the premium filing due dates and other dates to those relevant for 2026. The premium filing due dates for 2025 were generally a month earlier than usual because of a provision in the Bipartisan Budget Act of 2015 that superseded the premium filing due date rules provided in § 4007.11 of PBGC's payment of premiums regulation. 30 PBGC is re-incorporating the premium filing rules that apply under § 4007.11 in the instructions. PBGC is also making other editorial changes to the instructions. The changes incorporated into the instructions will replace or augment existing language but will not create additional filing burden.

For the reasons stated in the preamble, PBGC amends 29 CFR chapter XL as follows.

As an organized water event of limited duration which is conducted according to a prearranged schedule is a “Regatta or marine parade,” as defined at 33 CFR 100.05. An individual or organization planning to hold a regatta or marine parade which, by its nature, circumstances or location, will introduce extra or unusual hazards to the safety of life on the navigable waters of the United States, must submit an application to hold it. 33 CFR 100.15. On May 16, 2025, the event sponsor of the “Flotilla to Fight Cancer Benefit Concert” submitted an application under 33 CFR 100.15 to conduct the Fight Cancer Benefit Concert for approximately five hours on August 16, 2025, with a rain date of August 17, 2025. The offshore concert will take place in Casco Bay, on the Falmouth side of Cow Island, in the Town of Long Island, ME.

After approving plans for the holding of a regatta or marine parade within his or her district or zone, a Captain of the Port (COTP) is authorized to promulgate such special local regulations (SLR) as he or she deems necessary to ensure safety of life on the navigable waters immediately prior to, during, and immediately after the approved regatta or marine parade. 33 CFR 100.35. Due to the high-profile nature of this event, spectator vessels and support craft that will be present and they will have the potential to cause vessel congestion in Casco Bay on the Falmouth side of Cow Island, in Long Island, ME. The COTP, Sector Northern New England has determined that potential hazards associated with the offshore concert and offshore concert location would be a safety concern for anyone within the concert area and adjacent navigable waters and is therefore establishing these SLRs.

The Coast Guard is issuing this temporary rule under the authority in 5 U.S.C. 553(b)(B). This statutory provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because it is impractical to do so due to insufficient time to publish a final rule by August 16, 2025.

Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the Federal Register . Delaying the effective date of this rule would be impracticable because the rule must be in effect by August 16, 2025, to serve its intended purpose.

The Coast Guard is issuing this rule under authority in 46 U.S.C. 70041. The COTP has determined that this rule is needed to protect personnel, vessels, and the marine environment from the hazards associated with the offshore concert event.

The Coast Guard is establishing a temporary SLR for a one-day event from 12:30 p.m. through 5:30 p.m. on Saturday, August 16, 2025, unless the event is delayed because of weather conditions in which case it will be subject to enforcement of those same hours on August 17, 2025. The regulated area, as shown below, in figure 1, starts at the point in position at 43°41′26″ N, 070°11′28″ W; then East along the coast of the Falmouth side of Cow Island to a point in position of 43°41′45″ N, 070°11′04″ W; then Northwest to a point in position of 43°41′53″ N, 070°11′18″ W; then Southeast to a point in position of 43°41′34″ N, 070°11′41″ W; and then to point of origin 43°41′26″ N, 070°11′28″ W expressed in Degrees (°) Minutes (′) Seconds (″) (DMS) based on North American Datum 1983 (NAD 83).

The regulated area will mainly serve as a spectator zone but will also include two transit areas where stopping, fishing, mooring, anchoring, or loitering is prohibited at all times. The first transit area will run parallel to the concert stage barge, extending the entire length of the spectator zone, with a width of 240 feet. The second transit area will run down the center of the spectator area, perpendicular to the concert stage barge, with a width of 240 feet. These transit areas will allow vessels to enter and exit the spectator zone from all sides and provide access for emergency vessels.

The temporary SLR will prohibit swimming in the entire regulated area. Additionally, all vessels must follow a “Slow-No Wake” speed limit, meaning they cannot create a wake and cannot exceed speeds of five (5) knots unless a higher speed is needed to maintain control. This regulation is in place to ensure the safety of vessels and people before, during, and after the concert.

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.

Executive Orders 12866 (Regulatory Planning and Review) and 13563 (Improving Regulation and Regulatory Review) direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility.

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

This regulatory action determination is based on size, location, and duration and time-of-day of the event. This rule involves a special local regulation lasting approximately 5 hours (12:30 p.m.-5:30 p.m.) and impacting a certain area of Casco Bay, Cow Island, ME. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the regulated area.

The regulatory flexibility analysis provisions of the Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, do not apply to rules not subject to notice and comment. As 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), we want to assist small entities in understanding this rule. If the rule will affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please call or email the person listed in the FOR FURTHER INFORMATION CONTACT section.

Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 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).

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

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.

The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

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 involves This proposed rule involves establishing a special local regulation lasting for 5 hours on a day in August that will restrict movement in a certain area of Casco Bay, Cow Island, ME for the duration of the marine event. It is categorically excluded from further review under paragraph L61 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 instructions on locating the docket, see the ADDRESSES section of this preamble.

For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:

Table 1—Summary of Docket ID Nos., Public Hearing Dates, and Comment Period Closing Dates Rule Docket ID No. Public hearing date Comment period

Participation in virtual public hearing. The public hearings will be held via virtual platform on September 2, 2025, for Oil and Natural Gas; September 3, 2025, for Integrated Iron and Steel Manufacturing; and on September 4, 2025, for Coke Ovens. The EPA will announce additional details on the virtual public hearings at the EPA website for the respective interim final rule. The EPA may close a session 15 minutes after the last pre-registered speaker has testified if there are no additional speakers.

The EPA will begin pre-registering speakers for each hearing no later than 1 business day following publication of this document in the Federal Register . The EPA will accept registrations on an individual basis. To register to speak at any virtual hearing, please use the online registration form available at each of the interim final rule websites mentioned above, or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov. The last day to pre-register to speak at a hearing will be 3 business days before the public hearing. Prior to the hearings, the EPA will post a general agenda that will list pre-registered speakers at each of the interim final rule websites mentioned above.

The EPA will make every effort to follow the schedule as closely as possible on the days of the hearings; however, please plan for the hearings to run either ahead of schedule or behind schedule.

Each commenter will have 4 minutes to provide oral testimony. The EPA encourages commenters to submit a copy of their oral testimony as written comments electronically to the rulemaking docket.

The EPA may ask clarifying questions during the oral presentations but will not respond to the presentations at that time. Written statements and supporting information submitted during the comment period will be considered with the same weight as oral testimony and supporting information presented at the public hearings.

Please note that any updates made to any aspect of the hearings will be posted online at each of the interim final rule websites mentioned above. While the EPA expects the hearings to go forward as set forth above, please monitor our websites or contact the public hearing team at (888) 372-8699 or by email at SPPDpublichearing@epa.gov to determine if there are any updates. The EPA does not intend to publish a notice in the Federal Register announcing updates.

If you require a special accommodation such as audio description, please pre-register for the hearing with the public hearing team and describe your needs by 8 business days before each public hearing. The EPA may not be able to arrange accommodations without advance notice.

Docket. The EPA has established separate dockets for each of these rulemakings under Docket ID Nos. EPA-HQ-OAR-2025-0162 (Oil and Natural Gas), EPA-HQ-OAR-2002-0083 (Integrated Iron and Steel, EPA-HQ-OAR-2002-0085 (Coke Ovens: Pushing, Quenching, and Battery Stacks source category), EPA-HQ-OAR-2003-0051 (Coke Ovens Batteries source category). All documents in the docket are listed in https://www.regulations.gov/. Although listed, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the internet and will be publicly available only in hard copy. Except for such material, publicly available docket materials are available electronically in Regulations.gov.

Instructions. Direct your comments to Docket ID Nos. EPA-HQ-OAR-2025-0162 (Oil and Natural Gas), EPA-HQ-OAR-2002-0083 (Integrated Iron and Steel), EPA-HQ-OAR-2002-0085 (Coke Ovens: Pushing, Quenching, and Battery Stacks source category), EPA-HQ-OAR-2003-0051 (Coke Ovens Batteries source category), or as appropriate. The EPA's policy is that all comments received will be included in the public docket without change and may be made available online at https://www.regulations.gov/, including any personal information provided, unless the comment includes information claimed to be CBI or other information whose disclosure is restricted by statute. Do not submit electronically to https://www.regulations.gov/ any information that you consider to be CBI or other information whose disclosure is restricted by statute. This type of information should be submitted as discussed in the Submitting CBI section of this document.

The EPA may publish any comment received to its public docket. Multimedia submissions (audio, video, etc.) must be accompanied by a written comment. The written comment is considered the official comment and should include discussion of all points you wish to make. The EPA will generally not consider comments or comment contents located outside of the primary submission ( i.e., on the web, cloud, or other file sharing system). For additional submission methods, the full EPA public comment policy, information about CBI or multimedia submissions, and general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

The https://www.regulations.gov/ website allows you to submit your comment anonymously, which means the EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an email comment directly to the EPA without going through https://www.regulations.gov/, your email address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the internet. If you submit an electronic comment, the EPA recommends that you include your name and other contact information in the body of your comment and with any digital storage media you submit. If the EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, the EPA may not be able to consider your comment. Electronic files should not include special characters or any form of encryption and should be free of any defects or viruses. For additional information about the EPA's public docket, visit the EPA Docket Center homepage at https://www.epa.gov/dockets.

Submitting CBI. Do not submit information containing CBI to the EPA through https://www.regulations.gov/. Clearly mark the part or all the information that you claim to be CBI. For CBI information on any digital storage media that you mail to the EPA, note the Docket ID No., mark the outside of the digital storage media as CBI, and identify electronically within the digital storage media the specific information that is claimed as CBI. In addition to one complete version of the comments that includes information claimed as CBI, you must submit a copy of the comments that does not contain the information claimed as CBI directly to the public docket through the procedures outlined in the Instructions section of this document. If you submit any digital storage media that does not contain CBI, mark the outside of the digital storage media clearly that it does not contain CBI and note the Docket ID No. Information not marked as CBI will be included in the public docket and the EPA's electronic public docket without prior notice. Information marked as CBI will not be disclosed except in accordance with procedures set forth in 40 Code of Federal Regulations (CFR) part 2.

Our preferred method to receive CBI is for it to be transmitted electronically using email attachments, File Transfer Protocol (FTP), or other online file sharing services ( e.g., Dropbox, OneDrive, Google Drive). Electronic submissions must be transmitted directly to the Office of Air Quality Planning and Standards (OAQPS) CBI Office at the email address oaqps_cbi@epa.gov and, as described above, should include clear CBI markings and note the Docket ID No. If assistance is needed with submitting large electronic files that exceed the file size limit for email attachments, or if you do not have your own file sharing service, please email oaqps_cbi@epa.gov to request a file transfer link. If sending CBI information through the U.S. Postal Service, please send it to the following address: U.S. EPA, Attn: OAQPS Document Control Officer, Mail Drop: C404-02, 109 T.W. Alexander Drive, P.O. Box 12055, Research Triangle Park, North Carolina 27711, Attention Docket ID Nos. EPA-HQ-OAR-2025-0162 (Oil and Natural Gas), EPA-HQ-OAR-2002-0083 (Integrated Iron and Steel), EPA-HQ-OAR-2002-0085 (Coke Ovens: Pushing, Quenching, and Battery Stacks source category), EPA-HQ-OAR-2003-0051 (Coke Ovens Batteries source category). The mailed CBI material should be double wrapped and clearly marked. Any CBI markings should not show through the outer envelope.

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document might apply to them. Potentially affected entities may include:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Federal Register 's e-CFR site at https://www.ecfr.gov/current/title-40.

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify the docket ID number EPA-HQ-OPP-2023-0407 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before October 14, 2025. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

The EPA's Office of Administrative Law Judges (OALJ), in which the Hearing Clerk is housed, urges parties to file and serve documents by electronic means only, notwithstanding any other particular requirements set forth in other procedural rules governing those proceedings. See “Revised Order Urging Electronic Filing and Service,” dated June 22, 2023, which can be found at https://www.epa.gov/system/files/documents/2023-06/2023-06-22%20-%20revised%20order%20urging%20electronic%20filing%20and%20service.pdf. Although the EPA's regulations require submission via U.S. Mail or hand delivery, the EPA intends to treat submissions filed via electronic means as properly filed submissions; therefore, the EPA believes the preference for submission via electronic means will not be prejudicial. When submitting documents to the OALJ electronically, a person should utilize the OALJ e-filing system at https://yosemite.epa.gov/OA/EAB/EAB-ALJ_Upload.nsf/HomePage?ReadForm.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2023-0407, by one of the following methods:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute.

• Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001.

• Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions at https://www.epa.gov/dockets/where-send-comments-epa-dockets.

Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

In the Federal Register of September 19, 2023 (88 FR 64398 (FRL-10579-08-OCSPP)), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 3E9047) by Syngenta Crop Protection, LLC (P.O. Box 18300, Greensboro, NC 27419). The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide mandipropamid in or on; papaya, whole fruit at 0.8 part per million (ppm); papaya, peel at 3 ppm; and papaya, pulp at 0.015 ppm. That document referenced a summary of the petition that was prepared by Syngenta, the registrant, which is available in the docket, https://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is establishing the tolerance on Papaya at 0.9 ppm. The reason for this change is explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”

Consistent with FFDCA section 408(b)(2)(D), and the factors specified therein, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for mandipropamid including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with mandipropamid follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections that repeat what has been previously published for tolerance rulemakings of the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemaking, and EPA considers referral back to those sections as sufficient to provide an explanation of the information EPA considered in making its safety determination for the new rulemaking.

EPA has previously published several tolerance rulemakings for mandipropamid in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to mandipropamid and established tolerances for residues of that chemical. EPA is incorporating previously published sections from these rulemakings as described further in this rulemaking, as they remain unchanged. “ Mandipropamid. Human Health Risk Assessment for Proposed Label Amendments for the Tuberous and Corm Vegetable Crop Subgroup (1C) and Tobacco, a Tolerance Without U.S. Registration for Papaya, and Non-Food Status for Non-Bearing Strawberries and Non-Bearing Members of the Tree Nut Crop Group 14-12, ” which is available in the docket for this action at https://www.regulations.gov.

For a discussion of the Toxicological Profile of mandipropamid, see Unit III.A. of the rulemaking published in the Federal Register of March 22, 2019 (84 FR 10695) (FRL-9987-25). In 2020 the Agency published a draft risk assessment for the registration review of mandipropamid, but this assessment did not result in any changes to the conclusions from the 2019 rulemaking.

A summary of the toxicological endpoints for mandipropamid used for human health risk assessment is discussed in Unit III.B of the March 22, 2019 final rule.

In evaluating dietary exposure to mandipropamid, EPA considered exposure under the petitioned-for tolerances as well as all existing tolerances in 40 CFR 180.637. An acute dietary risk assessment was not performed since no endpoint attributable to a single exposure (dose) was identified from the available oral toxicity database. In conducting the chronic dietary exposure assessment, EPA used the Dietary Exposure Evaluation Model software using the Food Commodity Intake Database (DEEM-FCID), Version 4.02, which uses the 2005-2010 food consumption data from the United States Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America (NHANES/WWEIA). The chronic dietary exposure assessment is unrefined, assuming tolerance level residues and 100 percent crop treated (PCT). Based on the lack of evidence of carcinogenicity or genotoxicity, the Agency has classified mandipropamid as “Not Likely to be Carcinogenic to Humans” and therefore, there is no concern for cancer risk.

Since this request is for a tolerance without U.S. registration the action will not impact drinking water exposure estimates. The estimated drinking water concentrations (EDWCs) included all residues of concern in drinking water: mandipropamid, SYN504851, and SYN500003. EPA used the Pesticide in Water Calculator (PWC) to determine both the groundwater and surface water EDWCs. For the chronic dietary risk assessment, the mandipropamid EDWCs are 21.9 ppb in surface water and 62.8 ppb in groundwater. The groundwater value was based on the Wisconsin corn scenario. Because the groundwater value is higher than the surface water value, it was used in the chronic dietary exposure assessment. It was incorporated into the DEEM-FCID model in the food categories “water, direct, all sources” and “water, indirect, all sources.”

There are no residential (non-occupational) uses proposed or currently registered for mandipropamid. Therefore, residential exposures were not assessed.

Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to mandipropamid and any other substances and mandipropamid does not appear to produce a toxic metabolite produced by other substances. Therefore, for the purposes of this action, EPA has not assumed that mandipropamid has a common mechanism of toxicity with other substances.

FFDCA section 408(b)(2)(C) provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor from 10X to 1X. See Unit III.D. of the March 22, 2019, rulemaking for a discussion of the Agency's rationale for that determination.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing dietary exposure estimates to the acute population adjusted dose (aPAD) and the chronic population adjusted dose (cPAD). Short-, intermediate-, and chronic term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate points of departure to ensure that an adequate margin of exposure (MOE) exists.

An acute dietary exposure assessment was not performed as there were no indications of an adverse effect attributable to a single dose. Chronic dietary risks (food and water) are below the Agency's level of concern of 100% of the cPAD; they are 44% of the cPAD for children 1 to less than 2 years old, the population subgroup receiving the highest exposure. As there are no residential uses for mandipropamid, the short-term and chronic aggregate risk estimates are equivalent to the chronic dietary risk estimates, which are not of concern.

Cancer risk was not assessed for mandipropamid because it is classified as “Not Likely to be Carcinogenic to Humans.”

Therefore, based on the risk assessments and information described above, EPA concludes there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to mandipropamid residues, including its metabolites and degradates. More detailed information about the Agency's analysis can be found at https://www.regulations.gov in the document titled “Mandipropamid. Human Health Risk Assessment for Proposed Label Amendments for the Tuberous and Corm Vegetable Crop Subgroup (1C) and Tobacco, a Tolerance Without U.S. Registration for Papaya, and Non-Food Status for Non-Bearing Strawberries and Non-Bearing Members of the Tree Nut Crop Group 14-12” in docket ID number EPA-HQ-OPP-2023-0407.

Under a previous action, Syngenta submitted an updated version of Method 415/01. HED reviewed the updated method, Method 415/02 (W. Drew, D428278, 2/23/2016). This method is essentially the same as Method RAM 415/01, with the exception that it was modified by the addition of a second ion transition for determination of mandipropamid, inclusion of specific LC/MS/MS conditions, and modification to include analysis of hops. Method 415/02 underwent a successful independent laboratory validation, has a validated LOQ of 0.010 ppm, and is adequate for enforcement of mandipropamid tolerances.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. The Codex does not have established MRLs for mandipropamid on papaya.

Based upon review of the data supporting the petition and in accordance with its authority under FFDCA section 408(d)(4)(A)(i), EPA is establishing a tolerance that varies from what was requested. The petitioner proposed a tolerance of 0.8 ppm for Papaya, Whole Fruit; 3 ppm for Papaya, Peel; and 0.015 ppm for Papaya, Pulp. Although the proposed tolerances are for Papaya, Whole Fruit; Papaya, Peel; and Papaya, Pulp, EPA has determined that a tolerance for Papaya only is appropriate because papaya is the only commodity of the three petitioned-for commodities for which the U.S. establishes tolerances, based on the OCSPP residue chemistry guideline 860.1000. Using papaya only, the OECD MRL calculation procedures generated a value of 0.9 ppm as the appropriate tolerance. As a result, the EPA-recommended tolerance for papaya is higher than the tolerance proposed by the petitioner.

Therefore, a tolerance is established for residues of mandipropamid (4-chloro-N-[2-[3-methoxy-4-(2-propyn-1-yloxy)phenyl]ethyl]-α-(2-propyn-1-yloxy)benzeneacetamide) in or on Papaya at 0.9 ppm.

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

This action is exempt from review under Executive Order 12866 (58 FR 51735, October 4, 1993), because it establishes or modifies a pesticide tolerance or a tolerance exemption under FFDCA section 408 in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866.

Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because actions that establish a tolerance under FFDCA section 408 are exempted from review under Executive Order 12866.

This action does not impose an information collection burden under the PRA 44 U.S.C. 3501 et seq., because it does not contain any information collection activities.

Since tolerance actions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the RFA, 5 U.S.C. 601 et seq., do not apply to this action.

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars and adjusted annually for inflation) as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or on the private sector.

This action does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.

This action does not have tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it will not have substantial direct effects on tribal governments, on the relationship between the Federal government and the Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because tolerance actions like this one are exempt from review under Executive Order 12866.

This action is not subject to Executive Order 13211 (66 FR 28355) (May 22, 2001) because it is not a significant regulatory action under Executive Order 12866.

This action does not involve technical standards that would require Agency consideration under NTTAA section 12(d), 15 U.S.C. 272.

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).

For the reasons set forth in the preamble, EPA is amending 40 CFR chapter I as follows:

In FR Doc. 2025-13238 appearing on page 31800 in the Federal Register of Tuesday, July 15, 2025, the following corrections are made: