On November 5, 2021, the Office of Personnel Management (OPM) published an interim rule with request for comments in the Federal Register at 86 FR 61043 to implement the provisions of 5 U.S.C. 3115 for appointing college graduates into positions at specified grades in the competitive service.

During the 60-day comment period between November 5, 2021, and January 4, 2022, OPM received seven sets of written comments. The comments received were from one federal agency, five members of the public, and one labor union representing federal employees. At the end of the public comment period, OPM reviewed and analyzed the comments. Many of the comments received expressed general support for the rule.

OPM determined two comments were beyond the scope of the regulations. OPM is not addressing these comments:

• One comment expressed concern that, if the motivation for the rule was to improve recruitment to the federal civil service, then OPM should advocate for, and Congress should enact, legislation for improved salaries. (Comment 7)  1

• Another comment referenced a statute (Pub. L. 114-328) that is not at issue in this rulemaking. (Comment 8)

One comment expressed concern about the two-year eligibility period and questioned the rationale behind its prescribed length. (Comment 4) The two-year period of eligibility found in the regulations is specified in the authorizing statute, 5 U.S.C. 3115(c). The same commentor also expressed the idea that the provisions in § 315.614(b) are read to mean that a college graduate had to wait two years after completing a degree before applying for positions filled under the authority. This idea is incorrect. College graduates may apply at any time between completion of degree requirements and up to two years after the degree has been completed. Additionally, agencies may choose to accept applications from individuals who anticipate completing their degree in the near future.

One comment suggested OPM should provide additional clarification on the phrase `obligated service in a uniformed service' used in § 315.614(b)(1)(iii). (Comment 8) Specifically, this commenter wanted to know if “obligated service” means “active duty,” and whether “uniformed service” includes service in the National Guard. Obligated service means an obligation or requirement to complete a period of full-time active-duty uniformed service. For example, some students who receive certain Reserve Officer Training Corps (ROTC) scholarships are required to serve full time in the armed forces for four or five years after completing a degree as a condition of receiving the scholarship. In such cases this obligated full-time service would prevent the applicant from applying for positions under the authority during the two years immediately following completion of a degree. The provision in 5 U.S.C. 3115(C)(2)(B) and § 315.614(b)(1)(iii) allows the applicant's eligibility window to begin after their service obligation ends. National Guard service may be part-time or full-time. An applicant who has a service obligation to serve part-time in the National Guard would not meet the criteria in § 315.614(b)(1)(iii) because the part-time National Guard service obligation will not prevent the applicant from applying for civilian positions in the two years immediately following the completion of a degree. An applicant who completes a service obligation to serve for a period of at least four years of full-time active duty with the National Guard or Reserves may have an eligibility period that begins after completing the service obligation. The period of eligibility may not be delayed if the period of full-time active duty is less than four years. We have modified the text of § 315.614(b)(1)(iii) to reflect that the period of eligibility may be delayed until after the completion of an intervening period of at least four years of full-time active-duty uniformed service.

Another comment asked if transcripts are needed to verify completion of a degree. (Comment 8) When determining whether an applicant is eligible for appointment under this authority, an agency must use appropriate documentation such as transcripts or diplomas to verify that an applicant has completed a bachelor's or graduate degree.

One commenter questioned whether the provisions for qualifications in § 315.614(c) were an agency-specific requirement or a requirement across all agencies. (Comment 4) Agencies must use the OPM-prescribed qualification standard, or an OPM-approved agency- specific qualification standard, when evaluating eligible college graduates for the position being filled. This is because positions filled under this authority are in the competitive service and the governing statute did not exempt the use of OPM-administered governmentwide qualification standards.

A Federal agency requested OPM allow recent graduate appointments in the excepted service to be included when calculating the 15 percent limitation on appointments under this authority. The agency suggested this would benefit agencies that hire through mechanisms other than delegated examining (DE) procedures. (Comment 8) OPM cannot adopt this suggestion. The types of appointments that may be used when calculating the numerical limitation are specified in the 5 U.S.C. 3115(e)(1). Under the statute, the total number of employees the head of an agency may appoint during a fiscal year using this authority may not exceed 15 percent of the number of individuals the agency head appointed under a competitive examining procedure during the previous fiscal year to a position in the competitive service classified in a professional or administrative occupational category at or below the GS-11, or equivalent, level. OPM interprets the phrase “under a competitive examining procedure” to mean OPM DE procedures pursuant to an OPM-approved delegated examining agreement (DEA), agency-specific DE procedures authorized by Congress, or any OPM-approved modifications to DE procedures such as those formally approved pursuant to a demonstration project.

One comment encouraged OPM to monitor the effectiveness of the program and emphasized the need to capture data on the number of appointments made, demographic breakdown of the appointments, and recruitment sources. Additionally, the commenter also suggested that OPM should use any applicable and appropriate data to ensure that agencies adhere to merit system principles and do not use this rule in ways that abuse veterans' preference or disguise nepotism. (Comment 7) OPM reminds readers that 5 U.S.C. 3115(b)(1) allows agencies to make appointments without regard to any provision of sections 3309 through 3319 of title 5. This means an agency may select any eligible and qualified individual without regard to the application of veterans' preference.

OPM notes the authorizing statute required specific reporting requirements for the first 3 years after enactment of the statute (August 2018 through August 2020). Because the dates for required reporting have passed, we have removed the reporting requirement from the regulatory text of this final rulemaking. OPM continues to conduct oversight of all hiring activities including agency use of this hiring authority.

OPM simplifies and updates the language in § 315.614(j) to reflect that Section 1116 of Public Law 118-31 extended the DOD direct hire authority for post-secondary students until September 30, 2030, and that subpart I does not apply to DOD during that time.

OPM is issuing this rule to implement the provisions of 5 U.S.C. 3115. This statute establishes a hiring authority for college graduates into certain positions at specified grades in the competitive service. The statute and this implementing regulation will allow agencies to make appointments of college graduates directly into competitive service positions, without regard to rating, ranking and veterans' preference provisions in 5 U.S.C. 3309-3319 and 3330. The final rule also supports section I.C.1 (Early Career Recruitment) of the OPM-Executive Office of the President (EOP) joint memorandum “Merit Hiring Plan” issued May 29, 2025. This authority, when combined with agencies' strategic recruitment and Merit Hiring Plan actions pertaining to early career talent, may help agencies better recruit and fill mission critical occupations.

OPM expects the impact of this final rule will be a streamlined hiring flexibility for recruiting early career talent. This rule provides agencies with the necessary information to create policies and procedures for using the authority to hire college graduates as a part of an agency's overall strategy to implement strategic workforce and recruitment plans. It may also help agencies address hiring and recruiting gaps for filling early career talent positions.

OPM's implementing regulations are required by statute and cannot be avoided. The statute prescribes eligibility requirements; types of positions that can be filled using the authority; public notice requirements; and a numerical limit for the number of appointments made. The statute also initially required reporting requirements.

The strict wording of the eligibility requirements in the statute does not allow the regulations to offer any alternatives. For this reason, the eligibility requirements in the rule match those specifically prescribed by the statute. At the request of commenters, the final rule provides clarifying information on the eligibility of veterans who are unable to apply within two years of completing a degree due to an intervening period of full-time uniformed service of at least four years.

Regarding the types of positions filled, the statute allows the authority to be used for professional and administrative positions. The statute did not include a specific definition of this term. At first, OPM considered including a specific definition with a list of specific occupations. However, we believe that OPM classification standards and other guidance on classifying positions provide ample information to allow agencies to designate the types of positions that are professional or administrative. This approach offers agencies maximum flexibility in choosing positions that can be filled using the authority.

For the public notice requirement created in the statute, OPM provided agencies the flexibility to use a variety of ways to tell the public about opportunities. While the regulations specify the information required to be included in the public notice, they also allow the agency the discretion to determine the format of the notice when the agency is not using OPM's USAJOBS platform.

The numerical limit on the use of the authority is prescribed in statute. The precise wording does not allow OPM to prescribe a limit higher than 15 percent or a waiver of the limit. Our approach in writing the implementing regulations for this issue is to provide instructions and clarifying information on how an agency must calculate the statutorily prescribed limit.

This final rule will affect the operations of over 80 Federal agencies—ranging from cabinet-level departments to small independent agencies. We estimate that this rule will require individuals employed by these agencies to modify policies and procedures to implement the rule and perform outreach and recruitment activities when using the authority. For the purpose of this cost analysis, OPM assumed an average salary rate of Federal employees performing this work will be the rate in 2026 for GS-14, step 5, from the Washington, DC, locality pay table ($163,104 annual locality rate and $78.15 hourly locality rate). We assume that the total dollar value of labor, which includes wages, benefits, and overhead, is equal to 200 percent of the wage rate, resulting in an assumed labor cost of $156.30 per hour.

In order to comply with the regulatory changes in this final rule, affected agencies may need to review and update their policies and procedures. We estimate that, in the first year following publication of the final rule, this will require an average of 100 hours of work by employees with an average hourly cost of $156.30. This would result in estimated costs in that first year of implementation of about $15,630 per agency, and about $1,250,400 in total Governmentwide. We do not believe this rule will substantially increase the ongoing administrative costs to agencies (including the administrative costs of administering the program and hiring and training new staff).

OPM did not receive any comments on the estimated costs in the interim rule.

This regulation will support the Administration's priority to advance hiring of early career talent by allowing agencies to use strategic recruiting to hire recent college graduates to fill professional and administrative positions at the GS-11 level and below. When using the authority agencies will have additional flexibility in how college graduates are hired. Federal agencies will determine recruitment sources and processes for the solicitation of applications and will be held responsible for merit-based selections and in accordance with the joint OPM-Executive Office of the President Merit Hiring Plan guidance. This authority, when combined with agencies' strategic recruitment plans, may help agencies better recruit to fill mission critical occupations.

If any of the provisions of this final rule is held to be invalid or unenforceable by its terms, or as applied to any person or circumstance, it shall be severable from its respective section(s) and shall not affect the remainder thereof or the application of the provision to other persons not similarly situated or to other dissimilar circumstances, unless such holding is that the provision is invalid and unenforceable in all circumstances, in which event the provision shall be severable from the remainder of this part and shall not affect the remainder thereof. Should provisions related to one of the sections be held to be invalid we believe that the other sections should be severable and would not be impacted. Similarly, many of the operational requirements have no bearing on other provisions and are severable. For example, a holding that a hiring provision is invalid should not impact provisions related to conversion. In enforcing the provisions of this rule, OPM will comply with all applicable legal requirements. OPM did not receive any comments on severability in the proposed rule.

OPM has examined the impact of this rule as required by Executive Orders 12866 and 13563, which direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public, health, and safety effects, distributive impacts, and equity). A regulatory impact analysis must be prepared for rules that have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities. This final rule is not a “significant regulatory action” under section 3(f) of Executive Order 12866. For the reasons discussed in the Expected Impact section, this rule is considered deregulatory under Executive Order 14192.

The Director of the Office of Personnel Management certifies that this regulation will not have a significant impact on a substantial number of small entities because it applies only to Federal agencies and employees.

This rule will not have substantial direct effects on the States, on the relationship between the National Government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant preparation of a Federalism Assessment.

This rule meets the applicable standard set forth in section 3(a) and (b)(2) of Executive Order 12988.

Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) requires that agencies assess anticipated costs and benefits before issuing any rule that would impose spending costs on State, local, or tribal governments in the aggregate, or on the private sector, in any 1 year of $100 million in 1995 dollars, updated annually for inflation. That threshold is currently approximately $206 million. This rulemaking will not result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, in excess of the threshold. Thus, no written assessment of unfunded mandates is required.

OMB's Office of Information and Regulatory Affairs has determined this rule does not satisfy the criteria listed in 5 U.S.C. 804(2).

Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ) (PRA), unless that collection of information displays a currently valid Office of Management and Budget (OMB) Control Number. This rule involves the following OMB-approved collections of information subject to the PRA: USAJOBS 3.0 (OMB Control Number 3206-0219).

OPM believes any additional burden associated with this final rule falls within the existing estimates currently associated with this control number. OPM does not anticipate that the implementation of this final rule will increase the cost burden to members of the public. Additional information regarding this collection of information—including all background materials—can be found at https://www.reginfo.gov/public/do/PRAMain by using the search function to enter either the title of the collection or the OMB Control Number.

This action amends the Census Bureau's regulations at 15 CFR part 50, which govern requests and establish fee structures for special census services and studies. The regulations at part 50 purport to implement 15 U.S.C. 1525, which generally authorizes the Secretary of Commerce to perform special services and furnish special records “upon the payment of the actual or estimated cost of such special work,” and 13 U.S.C. 8, which similarly authorizes the Secretary to furnish transcripts or copies of reports in connection with surveys and censuses “upon payment of the actual or estimated cost of searching the records and furnishing such transcripts or copies.” The regulatory framework established by part 50 was first promulgated by final rule on January 4, 1963 (28 FR 120), and was subsequently amended several times between then and 2004 (January 20, 1971, 36 FR 905; February 1, 1984, 49 FR 3980; July 29, 1991, 56 FR 35815; July 18, 2003, 68 FR 42586; July 30, 2004, 69 FR 45580). This action amends part 50 again in three ways.

First, this action removes § 50.1(a). That subsection currently reads as follows: “Fee structure for age search and citizenship service, special population censuses, and for foreign trade and shipping statistics.” Upon review, the Department has determined that this incomplete introductory sentence creates a risk of confusion and also is unnecessary, given the sufficiently explanatory contents of § 50.1(b) and other subsequent sections.

Second, this action removes § 50.30. That section established a fee structure for foreign trade and shipping statistics. However, that section is now obsolete, as the Census Bureau no longer charges fees for such services. The removal of § 50.30 will therefore ensure that the Census Bureau's regulations are accurate and up-to-date.

Third, this action removes § 50.40. That section established a fee structure for statistics for city blocks for the 1980 census of population and housing. That section is now plainly obsolete and no longer serves any meaningful purpose. The removal of § 50.40 will simplify part 50 and reduce the possibility of unnecessary confusion and/or distraction.

Overall, these three changes will simplify and streamline part 50 and reduce the possibility of public confusion—thereby promoting efficiency—without substantively altering any obligations of the Census Bureau or public rights.

Pursuant to 5 U.S.C. 553(b)(B), the Department finds good cause to waive the prior notice and opportunity for public participation requirements of the Administrative Procedure Act for this final rule. The Department has determined that prior notice and opportunity for public participation is unnecessary because this rule only removes regulatory language that is not required by statute and that is plainly obsolete and/or clearly poses an unnecessary risk of public confusion; the obsolete and unnecessary nature of the regulatory language at issue will not be cured by any public comment. The Department has also determined that delaying the removal of this regulatory language for the sake of carrying out the notice and comment process would be contrary to the public interest, as the language being removed no longer serves any meaningful function but does pose a risk of confusion and distraction. The Department therefore finds good cause to waive the public notice and comment period under 553(b)(B) and, for the same reason, to waive the 30-day delay in effectiveness under 553(d).

The Office of Management and Budget has determined this rule is not significant pursuant to Executive Order (E.O.) 12866. This rule is an E.O. 14192 deregulatory action. This rule does not contain policies having federalism implications as the term is defined in E.O. 13132.

Because a notice of proposed rulemaking and an opportunity for public participation are not required to be given for this rule by 5 U.S.C. 553(b)(B), the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ) are not applicable. Accordingly, no regulatory flexibility analysis is required, and none has been prepared.

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

George M. Cook, Chief of Staff to the Under Secretary for Economic Affairs, performing the non-exclusive functions and duties of the Director of the Census Bureau, approved the publication of this notice in the Federal Register .

For the reasons set forth in the preamble, the Census Bureau amends 15 CFR part 50 to read as follows:

This document corrects two of the final rules published in the Federal Register on January 17, 2025, 90 FR 5610. In 29 CFR 2700.5(e)(6), a typographical error is corrected to change the word “sealing” to “unsealing.” In 29 CFR 2700.8(e)(1), a day of the week set forth is changed to correctly correspond with a date.

Accordingly, 29 CFR part 2700 is corrected by making the following correcting amendments:

Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of the criteria outlined in Section 503(a) of SMCRA, the Secretary of the Interior conditionally approved the West Virginia program on January 21, 1981. Background information on the West Virginia program, including the Secretary's findings, the disposition of comments, and conditions of approval, is found in the January 21, 1981, Federal Register (46 FR 5915). Later actions concerning the West Virginia program and program amendments can be found at 30 CFR 948.10 (State regulatory program approval), 948.12 (State statutory, regulatory, and proposed program amendment provisions not approved), 948.13 (State statutory and regulatory provisions set aside), 948.15 (Approval of West Virginia's regulatory program amendments), and 948.16 (Required regulatory program amendments).

Section 523(c) of the Act permits a State with a permanent regulatory program to enter into a cooperative agreement with the Department for the regulation of surface coal mining and reclamation operations on Federal lands within the State. 30 U.S.C. 1273(c). West Virginia sent a request, received by us on August 26, 1981, proposing to enter into a Federal Lands Cooperative Agreement (herein referred to as the existing cooperative agreement) between the Department and the State of West Virginia to grant West Virginia the ability to administer its approved regulatory program on Federal lands within West Virginia. West Virginia's existing cooperative agreement was approved on February 24, 1984, and the final rule notice was published in the March 9, 1984, Federal Register (49 FR 8913). Several years have passed since the original agreement was adopted, and West Virginia proposed to amend the existing cooperative agreement to reflect the operative statutes and regulations, and agency responsibilities associated with the regulation of coal mining and reclamation activities on Federal lands covered by the agreement. The revised cooperative agreement will also grant the State the additional authority to regulate all coal exploration activities on Federal lands, except for those subject to 43 CFR part 3400, and the primary responsibility to review and approve coal mining permits involving leased Federal coal.

On August 5, 2014, the West Virginia Department of Environmental Protection (WVDEP) submitted a proposed, revised cooperative agreement (herein referred to as the revised cooperative agreement) to address several changes that have occurred since the existing cooperative agreement was adopted. (Administrative Record No. WV-1599). Before submitting its draft revised cooperative agreement, WVDEP collaborated with OSMRE's Charleston Field Office (CHFO).

The regulatory provision authorizing the amendment of cooperative agreements is found in 30 CFR 745.14. This provision provides that a cooperative agreement, which has been approved pursuant to 30 CFR 745.11, may be amended by mutual agreement of the Secretary and the Governor of a State.

Amendments to a cooperative agreement must be adopted by the Federal rulemaking process in accordance with 30 CFR 745.11. Section 745.11(b)(1) requires information sufficient for OSMRE to make findings in accordance with paragraph (f) that the State has: (1) an approved program; (2) sufficient budget, equipment, and personnel to enforce its program on Federal lands in the state; and (3) legal authority to enter into the cooperative agreement. Section 745.11(b)(2) requires a cooperative agreement, consistent with the requirements of 30 CFR part 745, and § 745.11(b)(3) requires a certification from the State Attorney General or the chief legal officer of the State regulatory authority that no state statutory, regulatory, or legal constraints exist that would preclude the state from fully carrying out the cooperative agreement. The information relating to the budget, staffing, organization, and duties of the State regulatory authority, WVDEP, was submitted when West Virginia requested its existing cooperative agreement. We have determined that the information provided at that time satisfies the requirements for the proposed amendments to the cooperative agreement, and no additional information is needed. See 49 FR 8913.

A written certification from the West Virginia Attorney General was included in the State's request for its existing cooperative agreement. The Attorney General concluded that no State statutory, regulatory, or other legal constraint exists that would limit the capability of the State to fully comply with section 523(c) of the Act, as implemented by 30 CFR part 745. By letter dated July 7, 2014, WVDEP's General Counsel certified the same about the agency's August 5, 2014, proposed, revised cooperative agreement. WVDEP included this letter with its submission.

By mutual agreement between the Governor of West Virginia and the Secretary, with the Secretary's understandings and limitations provided herein, the proposed amendments to the cooperative agreement, published in the Federal Register on July 20, 2020 (85 FR 43761), are being adopted as final with certain revisions described below and minor non-substantive revisions. A discussion of the terms of the cooperative agreement follows. The full text of the cooperative agreement will be published as an appendix to 30 CFR 948.30.

Sets forth the parties to the Cooperative Agreement.

Paragraph A. Authority is amended to clarify that surface coal mining and reclamation operations include “surface operations and surface impacts incident to underground mining operations.” Paragraph A is further amended to provide (1) reference to activities reserved for the Bureau of Land Management (BLM), such as the ability to lease Federal coal subject to 43 CFR parts 3400 through 3480 and activities reserved for OSMRE through the mining plan approval process at 30 CFR part 746; (2) explains that the State regulation will be conducted in a manner consistent with SMCRA, the Federal lands program pursuant to 30 CFR parts 740, 745, and 746, and the approved West Virginia program; and (3) delegates authority to the State to review and approve coal exploration activities on Federal lands within West Virginia except those activities reserved for BLM under 43 CFR part 3400. We made several minor revisions in this section and throughout the revised cooperative agreement to clarify and emphasize that coal exploration activities subject to BLM's authority under 43 CFR part 3400 are not covered by this agreement.

Paragraph B. Purposes is amended for clarity and to account for coal exploration not subject to BLM authority.

Paragraph C. Responsible Administrative Agencies indicates that the WVDEP is authorized to regulate coal mining in West Virginia subject to oversight from OSMRE, as provided in SMCRA; WVDEP is authorized to administer this cooperative agreement on behalf of the Governor; and that OSMRE will administer this cooperative agreement on behalf of the Secretary, in accordance with the regulations in 30 CFR chapter VII.

Article II: Effective Date provides that, after the cooperative agreement has been signed by the Secretary and the Governor, it will become effective 30 days after publication in the Federal Register . This cooperative agreement will remain in effect until terminated, as provided in Article XI, or superseded by amendment, in accordance with Article XIII, which cites the process under 30 CFR 745.14. We revised this section to clarify that its effective date is 30 days from publication in the Federal Register , consistent with section 553(d) of the Administrative Procedure Act (APA), 5 U.S.C. 553(d), and that amendment exists as an alternative to termination.

Article III: Definitions expands the list of definition sources, originally listing 30 CFR parts 700, 701, and 740, and the State program, to incorporate SMCRA, 30 CFR 700.5, 701.5 and 740.5, the West Virginia Surface Coal Mining and Reclamation Act (WVSCMRA), the Office of Explosives and Blasting, and the rules and regulations promulgated pursuant to those Acts. Moreover, it resolves instances where a conflict occurs between State and Federal definitions, stating that the definitions used in the approved State program will apply, except for instances where a term conflicts with the Secretary's remaining responsibilities under SMCRA and other laws, and the definition of “valid existing rights,” for which WVDEP will use the Federal definition. We revised Article III from the version West Virginia submitted to account for terms that may conflict with the Secretary's remaining responsibilities under SMCRA and other laws, and to emphasize that the term “coal exploration operation(s)” used in this agreement excludes those operations subject to BLM's authority under 43 CFR part 3400.

Article IV: Applicability provides clarity that although the laws, regulations, terms and conditions of the West Virginia program are applicable to Federal lands in the State through the cooperative agreement, certain authority or responsibilities are reserved and cannot be delegated to the State as the regulatory authority. Further, it includes current statutory and regulatory references that are relevant but not presently included. This Article further states that WVDEP would be primarily responsible for regulating coal mine sites that may involve Federal coal, which is discussed further below.

This Article further provides that the State Surface Mine Board is the appropriate entity to receive appeals of orders and decisions issued by WVDEP and that the Department of the Interior's Office of Hearings and Appeals is the appropriate entity to receive appeals of orders and decisions issued by the Secretary or OSMRE.

Article V: General Requirements .

Paragraph A. Authority of State Agency provides that WVDEP has, and will continue to have, the authority to carry out the terms of this cooperative agreement.

Paragraph B. Funding states that WVDEP will be provided with the necessary funds to cover the full cost incurred by the State in carrying out its responsibilities under this cooperative agreement, subject to the availability of appropriations and provided that such cost does not exceed the estimated cost that the Federal government would have expended on such responsibilities in the absence of this cooperative agreement. Further, it includes current references to Federal regulations and guidance that are relevant, but not presently included, and provides that if sufficient funds are not appropriated to OSMRE, OSMRE and WVDEP will meet to decide on appropriate measures to ensure that coal operations subject to regulation under the cooperative agreement remain regulated in accordance with the State program.

Paragraph C. Reports and Records requires the State, pursuant to 30 CFR 745.12(d), to report its compliance with the cooperative agreement to us on a regular basis. Further, the provision provides that OSMRE will provide WVDEP a copy of any final evaluation report concerning the State's administration and enforcement of this cooperative agreement and is amended to acknowledge WVDEP's ability to provide comments on such reports.

Paragraph D. Personnel requires the State to provide the necessary personnel and access to facilities to implement this cooperative agreement. However, the revised cooperative agreement would make the existing personnel requirements contingent upon adequate appropriations and grant awards.

Paragraph E. Equipment and Facilities provides that WVDEP will ensure it has access to equipment, laboratories, and facilities to perform all necessary inspections, investigations, studies, tests, and analyses. However, the revised cooperative agreement would make the existing equipment and facilities requirements contingent upon adequate appropriations and grant awards.

Paragraph F. Permit Application Fees and Civil and Criminal Penalties is amended to incorporate coal exploration application fees. It requires civil and criminal penalties and fines collected by the State from operations on Federal lands to be deposited in the State's Special Reclamation Fund and Special Reclamation Water Trust Fund and allows the State to consider all permit application fees collected as program income to be retained by the State and deposited within WVDEP's Mining and Reclamation Operation Fund. We made a minor revision to specify that civil penalty money collected by the State gets deposited in this way to distinguish from civil penalty money collected by OSMRE in its oversight capacity, which is subject to the uses specified in 30 CFR 845.21. Additionally, a requirement to submit a financial status report pursuant to 30 CFR 735.26 requires that the State report the permit fee, penalty, and fine amounts collected from operations on Federal lands covered by this agreement during the prior grant year. This amendment also deletes a provision from Paragraph F that required that the funds “be disposed of in accordance with Federal regulations, and OMB Circular No. A-102, Attachment E.” Attachment E (Program Income) of OMB Circular No. A-102, in effect at the time of the original cooperative agreement, has since been replaced by provisions addressing program income in the Office of Management and Budget's Common Rule for Uniform Administration Requirements for Grants and Cooperative Agreements to State and Local Governments (2 CFR part 200). The reference to the Common Rule was moved to Article V, Paragraph B (Funding) above.

Article VI: Review of Permit Application updates the procedures, responsibilities of each agency, and agency coordination associated with permitting on Federal lands covered by this agreement. WVDEP is primarily responsible for reviewing and approving coal mining permits involving Federal and privately owned coal as well as the authority to regulate all surface coal mining and reclamation operations on Federal lands covered by this agreement. This article provides a more thorough outline of the specific duties assigned to the State or Federal agency for permitting actions, including the agency responsibilities and review procedures for operations involving Federal surface and leased Federal coal.

Paragraph A. Responsibilities establishes that WVDEP would continue to hold the primary responsibility for reviewing and approving a permit application package. BLM is the agency responsible for matters concerning Federal coal leases issued under mineral leasing laws, as well as the regulation of exploration operations involving Federal coal, both of which fall under 43 CFR part 3400 of the Federal regulations. In instances where the operation involves leased Federal coal, OSMRE is required to prepare a mining plan decision document and make a recommendation to the Secretary to approve, disapprove, or approve with conditions the mining plan (30 CFR part 746). OSMRE is also required to consult with and seek concurrence from BLM, any Federal land management agency, and other relevant Federal agencies, in order to determine the appropriate mining plan recommendation for the Secretary.

Paragraph A sets forth the Secretary's reserved right to carry out certain responsibilities, and act independently of WVDEP, pursuant to laws other than SMCRA. The cooperative agreement provides a clear depiction of the Secretary's responsibilities, outlined in 30 CFR 740.4(a), that cannot be delegated to the State under the Federal lands program, the Mineral Leasing Act of 1920 (MLA), National Environmental Policy Act of 1969 (NEPA), this cooperative agreement, and other applicable Federal laws. However, Paragraph A explains that the Secretary's authority to make certain determinations under SMCRA that cannot be delegated to WVDEP may be delegated to OSMRE. Although the Department of the Interior retains responsibilities under NEPA, the Department of the Interior may request the State's assistance in preparing documents for NEPA compliance. The cooperative agreement enables us and the State, with the concurrence of other Federal agencies involved, to delegate additional responsibilities to WVDEP under other applicable Federal laws by establishing a working cooperative agreement.

Paragraph B. Submission of Permit Application continues to set forth similar permit application submission procedures as those provided under Paragraph A. Contents of Permit Application Package of the existing cooperative agreement and incorporates coal exploration operations on Federal lands. Paragraph B additionally requires applicants to satisfy the 30 CFR 740.13(b) requirements, which set forth the information required for a permit application package, submission procedures, and other permit requirements.

Paragraph C. Review Procedures provides a more extensive description of agency responsibilities during permit review. Paragraph C requires OSMRE and WVDEP to develop a work plan and permit application review schedule, incorporating the timeframes established by the approved State program. In addition to agency coordination procedures, it provides that OSMRE will provide the State with comments on the application, as well as any requirements for additional data, within 45 days of receiving the administratively complete permit application. In the event that OSMRE is unable to provide comments in that timeframe, we revised the proposed version of this provision to provide WVDEP a mechanism to elevate the matter to the OSMRE Regional Director for prompt resolution. This revision reflects that, while we intend to provide comments or request additional information within 45 days of receiving an application, we cannot through nonaction waive or abrogate any statutory and regulatory obligations set out in the authorities expressly reserved to the Secretary under 30 CFR 745.13. Paragraph C also requires OSMRE to send WVDEP copies of all non-privileged external correspondence that may have a bearing on the permit application unless the correspondence is otherwise protected by Federal law. We revised the proposed version of this provision, which referenced copies of all correspondence, to reflect that some correspondence may be privileged or otherwise protected by law from unnecessary disclosure. See 51 FR 45082, 45083 (Dec. 16, 1986) (adding a similar limitation to Wyoming's cooperative agreement and referencing as an example a request for confidentiality by citizen complainant pursuant to 30 CFR 842.12(b)). We will coordinate the resolution of any conflicts between WVDEP and other Federal agencies to assist the State in carrying out its responsibilities. Finally, we revised the proposed agreement by removing two references to a “Federal lands liaison,” a term which has no statutory or regulatory origin, using instead simply “primary point of contact.”

Paragraph D. Review Procedures Where There is Federal Surface, but No Leased Federal Coal Involved clarifies that WVDEP will be responsible for reviewing permit applications for operations on Federal lands that do not involve leased Federal coal and do not require a mining plan.

Paragraph E. Review Procedures Where Federal Surface and Leased Federal Coal Is Involved allows us to delegate our obligations under 30 CFR 740.4(c)(1), (2), (3), (4), (6), and (7), thereby authorizing WVDEP to issue permitting decisions for operations on Federal land, review coal exploration operations not subject to 43 CFR part 3400 and assist us in the preparation of NEPA documents. After consulting with the appropriate agency, the revised cooperative agreement would also enable the State to approve and release bonds and determine the postmining land use. Paragraph E provides that BLM will notify WVDEP of its leasing actions and provide a copy of the decision.

Paragraph F. [WV]DEP, OSMRE, and Other Federal Agency Coordination reiterates the agency coordination required when Federal leased coal is involved. In addition to discussing WVDEP's responsibility to consult with BLM and any Federal land management agency when the proposed permit application involves leased Federal coal, Paragraph F provides that WVDEP is responsible for seeking comments from other agencies with jurisdiction over Federal lands affected by the proposed operation. Further, the State will request that Federal agencies provide their comments and findings to WVDEP within 45 calendar days after receipt of the permit application. Pursuant to Paragraph F, WVDEP is also responsible for providing us with written findings that each permit application involving lands containing leased Federal coal is in compliance with the State program.

Paragraph F sets forth the State, OSMRE, and BLM's responsibility to coordinate with other agencies in instances where the proposed permit area includes leased Federal coal. The State is required to provide OSMRE with written findings demonstrating that each permit application complies with the West Virginia program and to perform a technical analysis of each application. To make the recommendation for the Secretary's decision on the mining plan, OSMRE will be required to consult with and obtain concurrence from BLM, any Federal land management agency, and any other agency with jurisdiction over Federal lands affected by the proposed operations. Lastly, Paragraph F of Article VI establishes a five-day timeframe for BLM to notify the State of actions taken pursuant to 43 CFR part 3400 and provide documentation on all leasing decisions.

Paragraph G. Permit Application Decision and Permit Issuance authorizes the State to approve, disapprove, or conditionally approve permits for surface coal mining operations and coal exploration activities on Federal lands covered by this agreement. It requires certain terms or conditions to be incorporated into State-issued permits, including but not limited to, lease requirements pursuant to the MLA and postmining land use conditions imposed by any Federal land management agency.

Additionally, Paragraph G allows the State to approve a surface mining permit involving leased Federal coal before the Secretary has issued a decision on the mining plan. However, it clarifies that the State will be responsible for informing the operator that permit issuance is contingent upon the Secretary's approval of the mining plan or surface mining cannot commence unless the mining plan has been approved. Further, Paragraph G authorizes the State to reserve the right to withdraw permit approval or modify the permit requirements to conform with any terms or conditions imposed by the Secretary in the approval of the mining plan. We removed references to coal exploration activities from this section because those activities would be subject to BLM's authority under 43 CFR part 3400.

Paragraph H. Review Procedures for Permit Revisions; Renewals; and Transfer, Assignment or Sale of Permit Rights, incorporates the procedures for the above-listed permit actions. For applications involving permit revisions or renewals on Federal lands covered by this agreement, WVDEP is responsible, under the revised cooperative agreement, for reviewing and approving the proposed permit revision or renewal. However, the cooperative agreement requires the State to consult with OSMRE beforehand so that we may determine whether the proposed permitting action would require a mining plan modification. Paragraph H requires OSMRE to notify the State, within 15 days of receiving a copy, if the proposed permit revision or renewal constitutes a mining plan modification. In the event that OSMRE is unable to provide its determination in that timeframe, we revised the proposed version of this provision to provide WVDEP a mechanism to elevate the matter to the OSMRE Regional Director for prompt resolution. This revision reflects that while we intend to provide our determination with the 15 days, we cannot through inaction waive or abrogate our obligation to make the determination. When a mining plan modification requiring Secretarial approval is necessary, Paragraph H directs OSMRE and the State to follow the procedures outlined in Paragraph E. Review Procedures Where Federal Surface and Leased Federal Coal Is Involved of the revised cooperative agreement.

We have removed proposed revisions to Paragraph H stating that we may establish criteria, consistent with the mining plan modification criteria set forth in 30 CFR 746.18, to identify those permit revisions or renewals that clearly do not constitute mining plan modifications. We began accepting this provision in various state cooperative agreements beginning in 1985, and most recently in 1999. See 50 FR 30916, 30919, 30923 (July 30, 1985) (approving Alabama cooperative agreement) and 64 FR 70578, 70582 (Dec. 17, 1999) (approving Indiana cooperative agreement). In the 40 years since we began approving this provision, we have not promulgated any such criteria. As we acknowledged in our approval of the Wyoming cooperative agreement in 1986, “[s]uch permit revisions and renewals also may not affect the non-delegable responsibility of OSMRE and other Federal agencies.” 51 FR 45082, 45087 (Dec. 16, 1986). Because our non-delegable responsibilities under various Federal statutes have not remained static, promulgation of this type of criteria has been and remains imprudent. Should we decide in the future that promulgation of these criteria is warranted, we will assess their impact on our cooperative agreements at that time. If we determine that the renewal or revision does not require a mining plan modification, the cooperative agreement under Paragraph H directs the State to review the proposed revision or renewal according to the procedures set forth in the proposed Paragraph D. Review Procedures Where There is Federal Surface, but No Leased Federal Coal Involved, the West Virginia Program, and the regulations at 30 CFR 740.13(d), if applicable.

Paragraph H also requires transfer, assignment, or sale of permit rights on Federal lands to be processed in accordance with the West Virginia program and the regulations at 30 CFR 740.13(e). Similar to the permit revisions or renewals procedures, applications for transfer, assignment, or sale of permit rights must be evaluated to determine whether the application requires a mining plan modification. Those applications that are determined by us to require a mining plan modification will be processed according to the procedures provided in Paragraph E. Otherwise, applications that do not require a mining plan modification will be evaluated by the State according to the procedures set forth in the proposed Paragraph D of the revised cooperative agreement.

Article VII: Inspections continues to require WVDEP to perform inspections on Federal land pursuant to 30 CFR 740.4(c)(5) and provide OSMRE with a copy of the completed State inspection report. However, Article VII requires WVDEP to provide OSMRE with access to a copy of the completed State inspection report after the State conducts an inspection on Federal lands, on a “timely basis”, rather than the 15-day deadline previously required by the cooperative agreement. The cooperative agreement specifically refers to 30 CFR parts 842 and 843 to clarify that the authority for Federal inspection and monitoring and Federal enforcement is retained by OSMRE. We made a minor revision to the proposed provision to clarify that all citizen complaints that do not involve an imminent danger or significant, imminent environmental harm will be handled consistent with OSMRE's procedures under section 521 of SMCRA, 30 U.S.C. 1271, and the corresponding regulations under 30 CFR part 842. We removed language that the complaint will be “referred” to DEP, language that we first accepted in our approval of Colorado's cooperative agreement in 1982. See 47 FR 44208 (Oct. 6, 1982). In our approval, we provided, “[We] have decided to adopt this comment. However, it should be understood that pursuant to section 521 of [SMCRA], if the State regulatory authority fails within ten days after notification to take appropriate action to cause such violation to be corrected or to show good cause for such failure and transmit notification of its action to the Secretary, the Secretary shall immediately order Federal inspection of the surface coal mining operation at which the alleged violation is occurring.” Id. (internal quotations omitted). We make this revision here to simply cite to the established ten-day notice process. Lastly, a provision in the existing cooperative agreement about State and Department of the Interior witness availability is moved to Article VIII: Enforcement.

Article VIII: Enforcement clarifies that WVDEP's enforcement actions include the assessment of civil or criminal penalties in addition to issuing orders of cessation or notices of violation. Although the cooperative agreement requires the State to take appropriate enforcement action, it also requires WVDEP to notify us and any Federal land management agency of decisions to suspend or revoke a permit on Federal lands before issuing such decision.

In instances where inspections are conducted solely by us, or during a joint inspection where WVDEP and OSMRE do not agree on a particular enforcement action, Article VIII provides that OSMRE may take any enforcement action necessary to comply with 30 CFR parts 843, 845, and 846. The existing cooperative agreement was amended to add 30 CFR part 846, which relates to individual civil penalties.

Article VIII also provides that permits to conduct coal exploration or surface coal mining and reclamation operations covered by this agreement may be suspended or revoked by WVDEP pursuant to the State program, but issuance of any decision to suspend or revoke a permit on Federal land requires that WVDEP must first inform us and the Federal land management agency before its decision is issued. The State will be required to notify BLM of its decision to revoke or suspend a permit that is on lands containing leased Federal coal, so BLM may assess whether cancellation of the Federal lease is necessary. Article VIII also now contains the provision from Article VII of the existing cooperative agreement that WVDEP and Department of the Interior personnel will be mutually available to serve as litigation witnesses taken by the other agency.

Finally, Article VIII specifies that the cooperative agreement does not affect or limit the Secretary's authority to enforce violations of Federal authorities other than SMCRA or the State's authority under other State laws. For reference, a current list of the most relevant other authorities is found in Appendix A to the cooperative agreement; however, this list is not intended to be exhaustive.

Article IX: Bonds incorporates coal exploration activities covered by this agreement, use of penal bonds, the conversion to a full-cost reclamation bond in the event the cooperative agreement is suspended or terminated, and the agency coordination and procedures associated with bond release and forfeiture. The State and the Secretary will require operators conducting coal exploration or surface coal mining and reclamation activities on Federal lands covered by this agreement to submit a performance and/or penal bond. The Article specifies that these requirements include those established by SMCRA, the State program, other State or Federal laws and regulations, along with any other requirements imposed by the Secretary or any Federal land management agency. In order for the State to release the bond, the State will be required to obtain our concurrence on the bond release, which, in turn, would require us to consult with any Federal land management agency and any other agency with jurisdiction or responsibility over Federal lands affected by the operation. This Article also requires the State to advise us of any annual adjustments to the bonds made pursuant to the West Virginia program.

The Article continues to require bonds to be made payable to the United States in the event the cooperative agreement is terminated. However, it additionally requires the bond to provide that the portion covering Federal lands be converted into a full-cost reclamation bond upon the termination, as well as suspension, of the cooperative agreement. Further, this Article requires WVDEP, before termination of the cooperative agreement, to assist us in obtaining the full-cost reclamation bond from the operator for the areas only covering Federal lands.

Moreover, the list of funds available to the State in the event of bond forfeiture will be revised to include the Special Reclamation Water Trust Fund. Additional language clarifies that reclamation by the State is to be completed consistent with the West Virginia program, the reclamation plan, and the current mining plan that were in existence before the permit was revoked or modified.

Further, this Article includes additional bonding requirements and would identify the responsible agencies for collection and maintenance of such bonds. The cooperative agreement provides that we or the appropriate Federal agency will be responsible for the collection and maintenance of Federal lease bonds or lessee protection bonds, if such bonds are required. The cooperative agreement provides that the Federal agency that holds a Federal lease bond is responsible for compliance with 43 CFR part 3400 requirements before releasing a Federal lease bond after concurrence with BLM, if necessary.

Article X is newly added; thus, remaining articles are renumbered accordingly.

Article X: Designating Land Areas Unsuitable for all or Certain Types of Surface Mining and Reclamation Operations and Activities and Valid Existing Rights (VER) and Compatibility Determinations provides a more extensive outline of the procedures and agency responsibilities associated with the following determinations.

Paragraph A. Unsuitability Petitions sets forth the Secretary's reserved authority to designate Federal lands as unsuitable for mining as provided by 30 CFR 745.13(a). Paragraph A discusses OSMRE's responsibilities in processing requests for designating Federal lands as unsuitable for mining and the termination of previous designations in accordance with 30 CFR part 769. The cooperative agreement provides the required procedures for State and Federal agency coordination after a petition to designate lands unsuitable for mining is received. Following comments from WVDEP, we revised the proposed provision to include a 5 day timeframe for the agency that receives a petition to notify the other agency of its receipt.

Paragraph B. Valid Existing Rights Determinations provides the procedures and appropriate actions to be taken by the applicable State or Federal agency when requests for determinations of valid existing rights (VER), pursuant to section 522(e) of SMCRA and the Federal regulations at 30 CFR 761.11, are received. For private in-holdings within areas protected under 30 CFR 761.11(a) and SMCRA section 522(e)(1), WVDEP is to process the VER request in accordance with the State program but use the Federal VER definition at 30 CFR 761.5 when making VER determinations. The framework in this paragraph is outlined in 30 CFR 761.16(a).

Paragraph C. Compatibility Determinations outlines the procedures for compatibility determinations and indicates that the Secretary is responsible for issuing findings determining whether there are significant recreational, timber, economic, or other values that may be incompatible with surface coal mining operations incident to underground mining on Federal lands within the boundaries of a national forest protected pursuant to section 522(e)(2) of SMCRA and 30 CFR 761.11(b). Paragraph C lists OSMRE as the responsible agency to process requests for compatibility determinations in accordance with the procedures outlined in 30 CFR 761.13.

Article XI: Termination of Cooperative Agreement specifies that this Cooperative Agreement may be terminated by the Governor or the Secretary under the provision of 30 CFR 745.15.

Article XII: Reinstatement of Cooperative Agreement provides that if this Cooperative Agreement is terminated in whole or in part, it may be reinstated under the provisions of 30 CFR 745.16.

Article XIII: Amendment of Cooperative Agreement provides that this Cooperative Agreement may be amended by mutual agreement of the Governor and the Secretary in accordance with 30 CFR 745.14.

Article XIV: Changes in State or Federal Standards, in addition to renumbering, contains non-substantive wording changes.

Article XV: Changes in Personnel and Organization, in addition to renumbering, contains non-substantive wording changes.

Article XVI: Reservation of Rights states that this Cooperative Agreement will not be construed as waiving or preventing the assertion of any rights in this Cooperative Agreement that the State or the Secretary may have under laws other than SMCRA and the State program, including, but not limited to, those listed in Appendix A.

We received only one anonymous comment during the specified comment period, but it was not germane to the amendment, and, therefore, we have not provided a response.

This rule would not result in a taking of private property or otherwise have taking implications that would result in private property being taken for government use without just compensation under the law. This rule revises a cooperative agreement at the request of the State of West Virginia and will result in the delegation of additional authority to the State that would otherwise be exercised by the Department through OSMRE. Therefore, a takings implication assessment is not required.

Executive Order 12866 provides that the Office of Information and Regulatory Affairs in the office of Management and Budget (OMB) will review all significant rules. Pursuant to OMB guidance, dated October 12, 1993 (OMB Memo M-94-3), entering into an amended State-Federal Cooperative Agreement under SMCRA is exempted from OMB review under Executive Order 12866. Executive Order 13563, which affirms and supplements Executive Order 12866, retains this exemption.

The Department of the Interior has reviewed this rule, as required by Section 3 of Executive Order 12988. The Department determined that this Federal Register document meets the criteria of Section 3 of Executive Order 12988, which is intended to ensure that the agency review its legislation and proposed regulations to eliminate drafting errors and ambiguity; that the agency write its legislation and regulations to minimize litigation; and that the agency's legislation and regulations provide a clear legal standard for affected conduct rather than a general standard, and promote simplification and burden reduction. Because Section 3 focuses on the quality of Federal legislation and regulations, the Department limited its review under this Executive Order to the quality of this Federal Register document and to changes to the Federal regulations. The review under this Executive Order did not extend to any language of the State regulatory program or the Federal lands program, neither of which is affected by this amended State-Federal Cooperative Agreement.

This rule has no potential Federalism implications, as defined under Section 1(a) of Executive Order 13132. Executive Order 13132 directs agencies to “grant the States the maximum administrative discretion possible” with respect to Federal statutes and regulations administered by the States. West Virginia, through its approved regulatory program, implements and administers SMCRA and its implementing regulations at the state level. This rule approves an amended State-Federal Cooperative Agreement for the regulation of Federal lands under SMCRA and is consistent with the direction to provide maximum administrative discretion to States.

The Department of the Interior strives to strengthen its government-to-government relationship with Tribes through a commitment to consultation with Tribes and recognition of their right to self-governance and Tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in Executive Order 13175 and have determined that it has no substantial direct effects on the distribution of power and responsibilities between the Federal government and Tribes. The basis for this determination is that this amended State-Federal Cooperative Agreement in this rule is only applicable to Federal lands and not Indian lands, as those terms are defined by SMCRA, or other Tribal lands. Indian lands under SMCRA are regulated independently under the applicable Federal Indian program. The Department's consultation policy also acknowledges that our rules may have Tribal implications where the Federal lands covered by this Agreement encompass ancestral lands in areas with mineable coal. Moreover, Department agencies responsible for Federal lands subject to this Agreement must still comply with the Department's consultation policy in fulfilling their responsibilities outlined in this Agreement.

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

State program and/or plan amendments are not regulatory actions under Executive Order 14192 because they are exempt from review under Executive Order 12866 (OMB Memo M-94-3).

This rule does not constitute a major Federal action significantly affecting the quality of the human environment. We are not required to provide a detailed statement under the National Environmental Policy Act of 1969 (NEPA) because this rule qualifies for categorical exclusion under the U.S. Department of the Interior Departmental Manual, part 516, appendix 2, section 13.5(B)(21).

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

This rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). The amended State-Federal Cooperative Agreement submitted by West Virginia, which is the subject of this rule, does not impose any new substantive requirements on the coal industry. Rather, the amended State-Federal Cooperative Agreement grants West Virginia the additional authority to regulate all coal exploration activities on Federal lands and would delegate the primary responsibility to review and approve coal mining permits involving leased Federal coal, among other updates, that are responsibilities that would otherwise be undertaken by the Department through OSMRE.

This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule: (a) does not have an annual effect on the economy of $100 million; (b) will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; and (c) does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises. This rule only affects the State of West Virginia. The costs to West Virginia of carrying out the responsibilities under the State-Federal Cooperative Agreement are offset by grants from the Federal government.

This rule does not impose an unfunded mandate on State, local, or Tribal governments, or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or Tribal governments or the private sector. This rule amends an existing cooperative agreement at the request of the State of West Virginia and will result in additional delegation of federal authority to the State. Therefore, a statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531 et seq. ) is not required.

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

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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

EPA is finalizing several tolerance actions that the Agency proposed in the Federal Register of May 22, 2025 (90 FR 21878) (FRL-12748-01-OCSPP), because EPA previously determined these tolerance actions were necessary or appropriate during registration review of the pesticide active ingredients identified in Unit III. of the proposed rule. The tolerance actions for each pesticide active ingredient are described in detail in Unit III. of the proposed rule. This rulemaking finalizes the previously proposed actions with no changes.

The Agency received one comment on the proposed rule from one contributor. The public comment did not initiate changes to the regulatory text of this final rulemaking. For a detailed summary of the comment received and Agency's response, see Unit III.

FFDCA section 408(e), 21 U.S.C. 346a(e), authorizes EPA to establish, modify, or revoke tolerances or exemptions from the requirement of a tolerance on its own initiative. After providing a 60-day public comment period, EPA may finalize the rule. EPA provided a 60-day comment period and is now finalizing the rule.

FFDCA section 408(b)(2)(A)(i) 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.” FFDCA section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. FFDCA section 408(b)(2)(C) 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 . . .”

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number of this final rule (EPA-HQ-OPP-2025-0153), and the chemical-specific docket ID number as provided in Unit III of the proposed rule (90 FR 21878) (FRL-12748-01-OCSPP) 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 April 21, 2026.

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.

In the proposed rule, EPA proposed several tolerance actions that the Agency previously determined were necessary or appropriate during registration review for the following pesticide active ingredients: diphenylamine, diflubenzuron, flutolanil, isoxaflutole, famoxadone, aminopyralid, fenazaquin, and tembotrione. The specific tolerance actions proposed for these pesticide active ingredients were identified in Unit III. of the proposed rule (90 FR 21878) (FRL-12748-01-OCSPP). This final rule serves to implement the previously proposed actions without any changes.

During the public comment period for the changes in the proposed rule, which closed on July 21, 2025, EPA received 1 comment, from 1 source. The following is a summary of the comment received and the Agency's response to the comment.

Comment: The commentor expressed a general concern about the risk associated with the use of pesticides.

EPA's Response: Since the commenter did not provide any information specific to the proposed tolerance changes, the Agency is not making any revisions to the previously proposed tolerance changes.

EPA is finalizing the tolerance actions it proposed in the May 22, 2025, proposed rule. The comment received did not warrant any changes in what was proposed, nor has EPA identified any other changes (see Unit III). As a result, EPA is finalizing the tolerance actions as proposed in Unit III. of the proposed rule.

As noted in Unit II.D. of the proposed rule and the supporting registration review documents, EPA has assessed the individual risks from exposure to the pesticide active ingredients identified in Unit II. of this final rule. EPA is finalizing the proposed safety findings contained in the proposed rule for each of the pesticide active ingredients contained in this rule.

For further detail about pesticide-specific registration review safety findings, see the public docket that has been opened for each pesticide, which is available online at https://www.regulations.gov using the docket ID number listed in Unit III. of the proposed rule.

Adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expressions for the tolerances subject to this final rule.

Therefore, EPA is finalizing the tolerance actions identified in Unit III. of the proposed rule. All tolerance values expressed in the regulatory text of this rule, updated or otherwise, reflect current OECD rounding class practice.

These tolerance actions are effective on the date of publication of the final rule in the Federal Register . For actions in the final rule that lower or revoke existing tolerances, EPA has set an expiration date for the existing tolerance of six months after the date of publication of the final rule in the Federal Register , to allow a reasonable interval for producers in exporting members of the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures Agreement to adapt to the requirements.

Additional information about these statutes and Executive Orders can be found at https://www.epa.gov/regulations/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. This exemption also applies to tolerance revocations for which extraordinary circumstances do not exist. As such, this exemption applies to the tolerance revocations in this final rule because the Agency knows of no extraordinary circumstances that warrant reconsideration of this exemption for those tolerance revocations.

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.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, EPA concludes that the impact of concern for this action is any significant adverse economic impact on small entities and that the Agency is certifying that this action will not have a significant economic impact on a substantial number of small entities because the action has no net burden on small entities subject to this rulemaking. As discussed in the proposed rule, this determination takes into account several EPA analyses of potential small entity impacts for tolerance actions. EPA did not receive any comments about the Agency's determination for this rulemaking.

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

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

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

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866 (See Unit VI.A.), and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.

However, EPA's 2021 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is documented in the pesticide-specific registration review documents located in each chemical docket at https://www.regulations.gov.

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

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

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action 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:

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

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(b)(2)(A)(i) 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.” FFDCA section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. FFDCA section 408(b)(2)(C) 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 . . .”

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify the docket ID number EPA-HQ-OPP-2024-0502 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 April 21, 2026.

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

In the Federal Register of January 13, 2025 (90 FR 2662) (FRL-11682-11-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 3F9095) 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 pydiflumetofen, (3-(difluoromethyl)-Nmethoxy-1-methyl-N-[1-methyl-2-(2,4,6-trichlorophenyl)ethyl]-1H-pyrazole-4-carboxamide), in or on coffee, green bean at 0.2 part per million (ppm), and dragon fruit at 0.9 ppm. That document referenced a summary of the petition prepared by Syngenta Crop Protection, LLC, the registrant, which is available in the docket, http://www.regulations.gov, docket ID number EPA-HQ-OPP-2024-0502.

EPA received one comment in response to the April 3, 2025, Notice of Filing, which summarized the agency's tolerance petition process. EPA has determined that the pydiflumetofen tolerances are safe. The commenter has provided no information indicating that a safety determination cannot be supported.

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 in FFDCA section 408(b)(2)(D), 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 pydiflumetofen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with pydiflumetofen 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 pydiflumetofen in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to pydiflumetofen 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. These sections include toxicological profile, toxicological points of departure (POD)/levels of concern, exposure assessment, cancer, dietary exposure of drinking water, safety factor for infants and children, aggregate risk and determination of safety, chronic risk, and analytical enforcement methodology. The risk assessment published in support of this rulemaking is “ Pydiflumetofen. Human Health Risk Assessment to Support Tolerance without U.S. Registrations for Coffee, Green Bean, and Dragon Fruit” which is available in the docket for this action at https://www.regulations.gov.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by pydiflumetofen as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in the Federal Register of August 19, 2019 (84 FR 155) (FRL-9997-09). The Hazard and Science Policy Council (HASPOC) (M. Lewis, TXR 0057659, 12/22/2017) recommended a waiver for the requirement for the subchronic neurotoxicity (SCN) and immunotoxicity studies. Based on a weight of evidence approach considering all the available hazard and exposure information, the HASPOC later also recommended a subchronic inhalation study be waived (Z. Staley, TXR 0058378, 10/05/2022).

Once a pesticide's toxicological profile is determined, EPA identifies toxicological PODs and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the NOAEL dose and the LOAEL dose. Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level, generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD), and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for pydiflumetofen used for human risk assessment is discussed in Unit III.B. of the final rule published in the Federal Register of May 24, 2018 (83 FR 101) (FRL-9976-66). All endpoints remain unchanged from the referenced Federal Register except for the dermal absorption factor (DAF), which now equals 5%.

In evaluating dietary exposure to pydiflumetofen, EPA considered exposure under the petitioned-for tolerances as well as all existing pydiflumetofen tolerances in 40 CFR 180.699. EPA assessed dietary exposures from pydiflumetofen in food as follows:

1. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. The exposure assessment remains the same. For a description of the EPA approach to, and assumptions for, the exposure assessment, please reference Unit III.C of the August 12, 2019, rulemaking.

2. Dietary exposure from food and feed uses. EPA's dietary exposure assessments have been updated to include the additional exposure from the new use on coffee, green bean and dragon fruit. The chronic and acute dietary (food and drinking water) exposure and risk assessment were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02, which uses the 2005-2010 food consumption data from the U.S. Department of Agriculture's (USDA) National Health and Nutrition Examination Survey, What We Eat in America. The chronic and acute dietary risk assessments were partially refined, assuming tolerance-level residue values, 100% crop treated (PCT) for all commodities, and default processing factors, when empirical processing factors were not available. The assessment is considered partially refined due to the use of empirical processing factors.

3. Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight of the evidence from cancer studies and other relevant data. If quantitative cancer risk assessment is appropriate, Cancer risk may be quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or nonlinear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determine a mutagenic mode of action, a default linear cancer slope factor approach is utilized. As discussed in Unit III.A. of the 2019 Final Rule, EPA has concluded that pydiflumetofen should be classified as “Not Likely to be Carcinogenic to Humans” at doses that do not induce a proliferative response in the liver. This determination has remained unchanged.

4. Dietary exposure from drinking water. The new use on coffee, green bean and dragon fruit does not result in an increase in the estimated residue levels in drinking water, so EPA used the same estimated drinking water concentrations identified in Unit IV. C of the 2019 rulemaking.

5. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). For this action there is no occupational or residential exposures anticipated. As such, there is no quantitative residential post-application exposure assessment associated specifically with this action. There are, however, recommended residential post-application scenarios for use in the aggregate assessment based on a previous quantitative assessment of all registered residential uses.

Pydiflumetofen is currently registered for uses on golf course turf and ornamentals that could result in residential exposures. Residential handler exposures are not expected since the turf and ornamental use labels indicate that the product is intended for use by professional applicators, and the crop use labels include the statement “Not for residential use.” There is the potential for residential short-term post-application exposures as a result of being in an environment that had been previously treated with pydiflumetofen.

The quantitative exposure/risk assessment for residential post-application exposures is based on the short-term dermal exposure from activities in gardens for adults and children 6 to less than 11 years old, and short-term dermal exposure from post-application activities for children 11 to less than 16 years old golfing on treated golf course turf. Intermediate-term exposures are not expected.

Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found at http://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/standard-operating-procedures-residential-pesticide.

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

Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines, based on reliable data, that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X or uses a different additional SF 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 FQPA SF from 10X to 1X. See Unit III.D. of the August 12, 2019, rulemaking for a discussion on the Agency's rationale for that determination.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. Using the exposure assumptions discussed in unit III.C. for acute exposure, the acute dietary exposure from food and water to pydiflumetofen will occupy 9.1% of the aPAD for children 3-5 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to pydiflumetofen from food and water will utilize 29% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of pydiflumetofen is not expected.

3. Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Pydiflumetofen is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to pydiflumetofen.

Using the exposure assumptions described in unit III.C. for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs of 350 for adults, 550 for children 6 to less than 11 years old, and 2400 for children 11 to less than 16 years old. Because EPA's level of concern for pydiflumetofen is a MOE of 100 or below, these MOEs are not of concern.

4. Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Because no intermediate-term adverse effect was identified, pydiflumetofen is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, pydiflumetofen is not expected to pose a cancer risk to humans.

6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pydiflumetofen residues, including its metabolites and degradates. More detailed information about the Agency's analysis can be found at https://www.regulations.gov in docket ID number EPA-HQ-OPP-2024-0502, in the document titled “ Pydiflumetofen. Human Health Risk Assessment to Support Tolerances without U.S. Registrations for Coffee, Green Bean, and Dragon Fruit”.

For a discussion of the available analytical enforcement method, see Unit IV.A. of the August 12, 2019, rulemaking (90 FR 2662) (FRL-11682-11-OCSPP).

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 (MRL) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex 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 has not established a MRL for uses of pydiflumetofen on coffee, green bean or dragon fruit.

Therefore, tolerances are established for residues of pydiflumetofen, in or on coffee, green bean at 0.2 ppm and dragon fruit at 0.9 ppm.

Additional information about these statutes and Executive orders can be found at https://www.epa.gov/regulations/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. However, EPA's 2021 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in Unit III.E.

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. However, EPA's 2021 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in Unit III.E.

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:

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:

• 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 .

EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(b)(2)(A)(i) 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.” FFDCA section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. FFDCA section 408(b)(2)(C) 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 . . .”

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2024-0217 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 April 21, 2026.

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.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. If you wish to include CBI in your request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.

In the Federal Register of July 3, 2025 (90 FR 29515 (FRL-12474-05-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 4F-9155) by the American Spice Trade Association. The petition requested that 40 CFR part 180 be amended by establishing tolerances for residues of the insecticide imidacloprid in or on black pepper at 0.05 ppm. That document referenced a summary of the petition that was prepared by the petitioner and is included in the docket.

One comment was received in response to that notice of filing. The comment expressed disdain for “chemicals”, without reference to imidacloprid, or the current tolerance petition. While the Agency recognizes that some people do not like pesticides, it nevertheless has a statutory obligation to review pesticide applications and determine whether use of a pesticide meets the FIFRA and FFDCA/FQPA safety standards of causing no unreasonable adverse effects to people or the environment, and to ensure a reasonable certainty of no harm from potential dietary exposure (including drinking water), respectively. Here, the Agency has evaluated the aggregate risk of imidacloprid and has determined that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to imidacloprid residues. The commentor has offered no relevant information that would warrant a reconsideration of the Agency's determination.

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 imidacloprid, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with imidacloprid is summarized in this unit.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The primary target system for toxicity following oral administration of imidacloprid in mammalian systems is the nervous system. The most sensitive species tested was the dog. Evidence of neurotoxicity was reported in the subchronic dog study and consisted of trembling and tremors. Evidence of neurotoxicity was also reported in the rat acute and developmental neurotoxicity studies (DNT) and consisted of decreased motor and locomotor activities, tremors, gait abnormalities, increased righting reflex impairments and body temperature, decreased number of rears and response to stimuli, and decreases in forelimb and hindlimb grip strength. These effects were seen at doses seven-fold higher than in the subchronic dog study. Only body-weight decrements were observed in mice following chronic exposure. Imidacloprid showed no signs of toxicity through the dermal and inhalation routes. There was no evidence of carcinogenic potential in either the rat chronic/carcinogenicity or mouse carcinogenicity studies, and imidacloprid was not genotoxic in a variety of assays.

There is no evidence of increased prenatal susceptibility in the developmental toxicity studies in rats or rabbits; however, there is evidence of increased quantitative susceptibility in the rat DNT. There were no maternal effects when imidacloprid was administered to pregnant/lactating dams, however, decreases in offspring motor activity measurements were observed at the highest dose tested (55 mg/kg/day). The apparent increased quantitative susceptibility in the DNT is well-characterized in the context of the entire hazard database with a clear NOAEL, and the doses and endpoints selected for regulatory purposes are protective of the pup effects noted at these higher doses in the DNT study. There was no evidence of susceptibility observed in the rat two-generation reproductive study, where decreases in pup body weights (reported in both litters of each generation) were observed at the same dose level as parental effects consisting of decreased premating and gestational absolute body weights. Therefore, the Food Quality Protection Act Safety Factor (FQPA SF) was reduced to 1X.

Imidacloprid was categorized as having high acute lethality through the oral route (Toxicity Category II), but low lethality through the dermal and inhalation routes (Toxicity Category IV). Imidacloprid was not an eye or skin irritant, or a dermal sensitizer.

All of the exposure scenarios and points of departure (POD) for imidacloprid are based upon an increased incidence of tremors/trembling occurring within one week of dosing observed in the 90-day dog study at the lowest-observed adverse-effect level (LOAEL) of 22 mg/kg/day. The no-observed adverse-effect level (NOAEL) is 8 mg/kg/day. The standard combined UF of 100X was applied to account for interspecies (10X) and intraspecies (10X) extrapolation, as well as the 1X FQPA SF to generate an acute population-adjusted dose (aPAD) and chronic population-adjusted dose (cPAD) of 0.08 mg/kg/day. The level of concern (LOC) for short-, intermediate- and long-term incidental oral, dermal and inhalation exposure scenarios is 100 based on interspecies (10X) and intraspecies (10X) extrapolation, and an FQPA SF (1X) when applicable. EPA has classified Imidacloprid as a Group E chemical, “Evidence of non-carcinogenicity for humans”.

Specific information on the risk assessment conducted in support of this action, including on the studies received and the nature of the adverse effects caused by imidacloprid, can be found in the document titled “Imidacloprid. Proposed Tolerance for Residues in/on Imported Black Pepper ” (hereinafter “Imidacloprid Human Health Risk Assessment”), which is available in the docket for this action.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological PODs and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level, generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD), and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www2.epa.gov/pesticide-science-and-assessing-pesticide-risks/assessing-human-health-risk-pesticides.

More detailed information on the toxicological endpoints for imidacloprid used for human health risk assessment can be found in the Imidacloprid Human Health Risk Assessment, available in the docket for this action.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to imidacloprid, EPA considered exposure under the petitioned-for tolerances as well as all existing imidacloprid tolerances in 40 CFR 180.472. The assessments were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02. EPA with 2005-2010 food consumption information from the United States Department of Agriculture's (USDA's) National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). The acute and chronic assessments used tolerance-level residues for most commodities, and 100 PCT for all commodities. For both the acute and chronic assessment, ARs and empirical processing factors were calculated for some commodities based on the results of previously submitted crop field trial and processing data. Default HED processing factors were used for all other relevant processed commodities. For more detail, see the “Imidacloprid. Acute and Chronic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessment for a New Tolerance for Residues in/on Importer Black Pepper” document available in the docket for this action. EPA assessed dietary exposures from imidacloprid as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. Such effects were identified for imidacloprid. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA conducted a partially refined, acute dietary exposure assessment using tolerance-level residues for most commodities, with refined values based upon ARs and empirical processing factors for some commodities. EPA assumed 100 percent crop treated (PCT) for all commodities for the acute dietary assessment.

ii. Chronic exposure. In estimating chronic dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 2005-2010 National Health and Nutrition Examination Survey, What We Eat in America, (NHANES/WWEIA). As to residue levels in food, EPA conducted a partially refined, chronic dietary exposure assessment using tolerance-level residues for most commodities, with refined values based upon ARs and empirical processing factors for some commodities. EPA assumed 100 percent crop treated (PCT) for all commodities for the chronic dietary assessment.

iii. Cancer. Imidacloprid has been classified as a Group E chemical, “Evidence of non-carcinogenicity for humans,” and therefore a cancer dietary assessment was not conducted.

iv. Anticipated residue and PCT information. FFDCA section 408(b)(2)(E) authorizes EPA to use available data and information on the anticipated residue (AR) levels of pesticide residues in food and the actual levels of pesticide residues that have been measured in food. If EPA relies on such information, EPA must require pursuant to FFDCA section 408(f)(1) that data be provided 5 years after the tolerance is established, modified, or left in effect, demonstrating that the levels in food are not above the levels anticipated. EPA assumed 100 PCT for both the acute and chronic dietary assessments for this action.

2. Dietary exposure from drinking water. Based on the Pesticide in Water Calculator's (PWC) version 1.52, the estimated drinking water concentrations (EDWCs) of imidacloprid in groundwater are 92 parts per billion (ppb) for acute exposures and 84.9 ppb for chronic exposures. Groundwater EDWCs were used in the dietary assessment for all sources of drinking water. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found at https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-assessment.

3. From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). There are no new proposed residential uses for imidacloprid at this time. However, imidacloprid is currently registered for uses that could result in residential handler and post-application exposures, which have been assessed previously, and are not of concern.

4. Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.” In 2016, EPA's Office of Pesticide Programs released a guidance document entitled “Pesticide Cumulative Risk Assessment: Framework for Screening Analysis.” The Agency has utilized this framework for imidacloprid and determined that imidacloprid along with clothianidin, acetamiprid, dinotefuran, nithiazine, and thiacloprid form a candidate common mechanism group (CMG). This group of pesticides, referred to as neonicotinoids, is considered a candidate CMG because they share characteristics to support a testable hypothesis for a common mechanism of action for neonicotinoids.

Following this determination, the Agency conducted a screening-level cumulative risk assessment consistent with the 2016 guidance document. The current screening assessment indicates that cumulative risk estimates for neonicotinoids are below the Agency's levels of concern. No further cumulative evaluation is necessary for imidacloprid.

1. In general. 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 10X Food Quality Protection Act (FQPA) safety factor to 1X. See section 4.4 of the Imidacloprid Human Health Risk Assessment for more detail on this 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 MOE exists.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, EPA has concluded that acute exposure to imidacloprid from food and water is 86% of the aPAD for children 1-2 years old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to imidacloprid from food and water is 32% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

3. Short- and intermediate-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Imidacloprid is currently registered for uses that could result in short-term residential exposure, and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to imidacloprid. Using the exposure assumptions described in this unit for short-term exposures, the children and adult MOEs are greater than their respective LOCs of 100. As a result, the short-term aggregate risk estimates are not of concern for the general U.S. population or any population subgroup.

Intermediate- and long-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). For imidacloprid, though there is potential for intermediate-term residential exposure from the registered pet collar and spot-on uses, an intermediate-term aggregate assessmen is not required. The short- and intermediate-term toxicological endpoints are the same, and the exposures assessed in the short-term aggregate (adults- combined dermal post-application exposures from contacting treated lawns and gardens; and children—combined dermal and hand-to-mouth from contacting treated turf) are greater than intermediate-term exposure estimates. Therefore, the estimates of risk for short-term duration exposures are protective of those for intermediate-term duration exposures.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, cancer aggregate risk assessments were not performed. Imidacloprid is classified as a Group E chemical, “Evidence of non-carcinogenicity for humans”.

5. Determination of safety. Based on these risk assessments, and information described above, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children, from aggregate exposure to imidacloprid residues. More detailed information on this action can be found in the, “Imidacloprid. Proposed Tolerance for Residues in/on Imported Black Pepper” Human Health Risk Assessment in the docket ID EPA-HQ-OPP-2024-0630.

An adequate enforcement methodology as described in the supporting documents is available to enforce the tolerance expressions. Methodoloy is available to determine imidacloprid residues of concern in plant [Bayer gas chromatography/mass spectrometry (GC/MS) Method 00200] and livestock commodities (Bayer GC/MS Method 00191). These methods have undergone successful EPA petition method validations (PMV), and the registrant has fulfilled the remaining requirements for additional raw data, method validation, independent laboratory validation (ILV), and an acceptable confirmatory method [high-performance liquid chromatography/ultraviolet (HPLC/UV) Method 00357].

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address: residuemethods@epa.gov.

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 (MRL) 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.

Neither Codex nor Canada's Pest Management Regulatory Agency (PMRA) have established a MRL for imidacloprid in/on black pepper. Therefore, there are no harmonization issues regarding the establishment of a tolerance without a U.S. registration on black pepper.

In general, a tolerance action is effective on the date of publication of the final rule in the Federal Register . For actions in the final rule that lower or revoke existing tolerances, EPA will set an expiration date for the existing tolerance of six months after the date of publication of the final rule in the Federal Register , in order to allow a reasonable interval for producers in exporting members of the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures Agreement to adapt to the requirements.

Therefore, a tolerance is established for residues of imidacloprid (CASRN 138261-41-3), in or the food and feed commodities of black pepper at 0.05 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 tolerances 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. However, EPA's 2021 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in Unit III.

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:

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:

• Crop production (NAICS code 111).

• Animal production (NAICS code 112).

• Food manufacturing (NAICS code 311).

• Pesticide manufacturing (NAICS code 32532).

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

EPA is finalizing several tolerance actions that the Agency proposed in the Federal Register of July 22, 2024 (89 FR 59012) (FRL-11773-01-OCSPP), because EPA previously determined these tolerance actions were necessary or appropriate during registration review of the pesticide active ingredients identified in Unit III. of this final rule. The tolerance actions for each pesticide active ingredient are described in detail in Unit III. of the proposed rule and are not repeated in this final rule. This final rulemaking addresses the previously proposed changes, and where applicable, addresses additional changes initiated by public comments.

The Agency received five comments on the proposed rule from five contributors. The public comments did initiate changes to the regulatory text of this final rulemaking. For a detailed summary of the comments received and Agency responses, see Unit II.

FFDCA section 408(e), 21 U.S.C. 346a(e), authorizes EPA to establish, modify, or revoke tolerances or exemptions from the requirement of a tolerance on its own initiative. After providing a 60-day public comment period, EPA may finalize the rule. EPA provided a 60-day comment period, which closed on September 20, 2024, and is now finalizing the actions previously proposed in the proposed rule.

FFDCA section 408(b)(2)(A)(i) 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.” FFDCA section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. FFDCA section 408(b)(2)(C) 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. . . .”

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify the docket ID number of this final rule, and the chemical specific docket ID number as provided in Unit III. 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 April 21, 2026.

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.

In the proposed rule, EPA proposed several tolerance actions that the Agency previously determined were necessary or appropriate during registration review of the pesticide active ingredients identified in Unit III. of the proposed rule. This final rule serves to implement the previously proposed changes and, where noted, incorporates any necessary changes initiated by public comment.

During the public comment period for the changes in the proposed rule, which closed on September 20, 2024, EPA received five comments from five sources. The following is a summary of the comments received and the Agency's responses to those comments.

Comment: EPA received one comment from Syngenta Crop Protection, LLC requesting revisions based on current OECD rounding class practice for the tolerances for cyproconazole on cattle, goat, horse, and sheep livers that were not included in the proposed rule. The comment also requested clarification on the Agency's rationale for the proposal to revise new tolerances for pinoxaden on animal fat, meat, and meat byproducts and whether the revision was proposed for aligning with Canadian maximum reside limits (MRLs).

EPA's Response: In response to the comment on revisions to cattle, goat, horse, and sheep liver tolerances for cyproconazole to be consistent with OECD rounding class practices, EPA is including in this final rule rounded values for the cattle, goat, horse, and sheep liver tolerances in 40 CFR 180.485 paragraph (a)(3) at 0.5 ppm by removing trailing zeroes, which is also supported by the human health risk assessment.

The proposed rule included the establishment of animal fat, meat, and meat byproduct tolerances for pinoxaden at 0.04 ppm. EPA proposed establishing these tolerances because, during registration review, it was determined that the tolerances were needed to cover potential residues on treated feed items at the same level as the current tolerances for cattle based on evaluation of available cattle feeding studies, calculated dietary burdens, and livestock metabolism studies. The Canadian MRLs for animal fat, meat, and meat byproduct tolerances for pinoxaden are equivalent to the tolerance levels of 0.04 ppm and are considered harmonized.

Comment: Four individual commenters submitted comments on the proposed rule generally supporting updates to pesticide tolerances. Individual comments generally questioned the value of updating commodity definitions and requested additional public comment opportunities. One commenter referenced potential impacts on growers and stakeholders, specifically about increased costs for small-scale farmers from compliance with the updated tolerance requirements.

EPA's Response: EPA appreciates the comments on the proposed rule. Since the commenters did not request specific changes from the proposal, the Agency is not making specific changes in this final rule in response to these comments. Regarding potential impacts to growers from increased costs with the updated tolerance requirements, the commenter did not provide a specific tolerance or commodity expected to impose this cost. Since the commenter did not suggest any specific changes, the Agency is not changing its determination that the actions in this final rule have no net burden on small entities subject to this rulemaking. As discussed in the proposed rule, the Agency's determination takes into account analyses published in the Federal Register in May 4, 1981 (46 FR 24950) (FRL-1809-5) and December 17, 1997 (62 FR 66020) (FRL-5753-1). The potential for increased costs for small-scale farmers from compliance with the updated tolerance requirements is also discussed in Unit V.D of this final rule.

As noted in Unit II.D. of the proposed rule, and the supporting registration review documents, EPA has assessed the individual risks from exposure to the pesticide active ingredients identified and discussed in Unit III. of this final rulemaking. After fully considering comments on the proposed rule, EPA is confirming the proposed safety findings contained in Unit III. of the proposed rule.

For further detail about pesticide-specific registration review safety findings, see the public docket that has been opened for each pesticide, which is available online at https://www.regulations.gov using the docket ID number listed in Unit III. of this final rulemaking.

Adequate enforcement methodology, as described in the supporting documents, is available to enforce the tolerance expressions for the pesticide active ingredients identified in Unit III.

Therefore, EPA is finalizing the tolerance actions proposed in the proposed rule. For Cyproconazole, EPA is also updating tolerance values for cattle, goat, horse, and sheep liver to remove trailing zeroes to reflect current OECD rounding class practice.

EPA is finalizing the tolerance actions identified in this unit. All tolerance values expressed in the regulatory text of this rule, modified or otherwise, reflect current OECD rounding class practice.

EPA is finalizing its proposals to revise the current tolerance expression, revise commodity definitions to the updated “Peppermint, fresh leaves” and “Spearmint, fresh leaves”, and modify tolerance values to reflect OECD's rounding class practices.

EPA is finalizing its proposals to revise the current tolerance expression and the commodity definition to the updated “Fruit, citrus, group 10-10”.

EPA is finalizing its proposal to revise the commodity definitions to the updated “Beet, sugar, leaves”, “Cilantro, fresh leaves”, “Berry, low growing, subgroup 13-07G, except cranberry”, “Grass, forage, fodder and hay, group 17, forage”, “Grass, forage, fodder and hay, group 17, hay”, and “Vegetable, brassica, head and stem, group 5-16”.

EPA is also finalizing its proposals to add the chemical name to the title in 40 CFR 180.368 and to modify tolerance values to reflect OECD's rounding class practices.

EPA is finalizing its proposals to revise the current tolerance expression, revising the chemical name to the title in 40 CFR 180.370, and modify the tolerance level for tomatoes from 0.15 ppm to 0.1 ppm. EPA is modifying the tolerance level for etridiazole on tomatoes due to new data submitted by the registrant that shows no measurable residues and the Agency is not able to set a tolerance level below the limit of quantitation (LOQ) of 0.1 ppm. Since the tolerance level is being lowered, EPA is establishing an expiration date of August 19, 2026 for the tolerance at 0.15 ppm for “Tomato”.

EPA is finalizing its proposals to revise the commodity definitions to the updated “Fish, freshwater, finfish”, “Fish, shellfish, mollusc”, “Fish, shellfish, crustacean”, “Grass, forage, fodder and hay, group 17, forage”, “Grass, forage, fodder and hay, group 17, hay” and modifying tolerance levels to reflect OECD's rounding practices. EPA is also finalizing its proposals to establish a new paragraph for the fish and shellfish commodities in (a)(1) and revise the tolerance expression.

EPA is finalizing its proposal to modify the tolerances for “Grain, cereal, group 15, except sweet corn” and “Tomato” to harmonize with Codex MRLs.

To correct typographical errors, EPA is revising the entries in this rule for “Vegetable, root, except sugar beet, Subgroup IB” to “Vegetable, root, except sugar beet, subgroup 1B” and “Vegetable, tuberous and corm, Subgroup IC” to “Vegetable, tuberous and corm, subgroup 1C”.

EPA is finalizing its proposals to revise the current tolerance expression and convert crop group tolerances to the updated crop groups “ Brassica, leafy greens, subgroup 4-16B”; “Fruit, citrus, group 10-10”; “Fruit, pome, group 11-10”; “Fruit, stone, group 12-12”; “Leaf petiole vegetable subgroup 22B”; “Leafy greens subgroup 4-16A”; “Nut, tree, group 14-12”; “Vegetable, brassica, head and stem, group 5-16”; “Vegetable, fruiting, group 8-10”, to establish tolerances for the commodities “Celtuce” and “Fennel, florence, fresh leaves and stalk” and “Kohlrabi”, and remove the tolerances for “Lettuce, head”; “Lettuce, leaf”; “Mustard greens”; “Pepper”; “Pistachio”; “Tomato”; and “Turnip, greens”.

EPA is also finalizing its proposal to modify the tolerances for “Hog, meat byproducts” and “Fruit, citrus, group 10-10” to harmonize with Codex MRLs.

EPA is finalizing its proposals to revise commodity definitions to the updated “Coffee, green bean”, “Cattle, meat byproducts, except liver”, “Goat, meat byproducts, except liver”, “Grain, aspirated fractions”, “Horse, meat byproducts, except liver”, “Sheep, meat byproducts, except liver”, and “Wheat, milled byproducts”.

EPA is also finalizing its proposal to modify the tolerance for “Wheat, grain” to harmonize with Codex MRLs.

In response to public comments, EPA is also in this final rule modifying values for cattle, goat, horse, and sheep liver tolerances in paragraph (a)(3) from 0.50 ppm to 0.5 ppm to be consistent with OECD rounding class practices, which was discussed in the supporting registration review documents.

EPA is finalizing its proposals to revise the current tolerance expression and to revise the commodity definitions to the updated “Grass, forage, fodder and hay, group 17, forage” and “Grass, forage, fodder and hay, group 17, hay”.

EPA is also finalizing its proposal to remove the tolerance for “Barley, hay” and adding a tolerance for “Barley, forage” that was erroneously removed in a September 30, 1998 rulemaking (63 FR 5216) (FRL-6033-49).

EPA is finalizing its proposals to redesignate paragraph (a) as (a)(1) and establishing a new paragraph (a)(2) under paragraph (a) for livestock commodities and revise the current tolerance expression.

EPA is also finalizing its proposal to revise the current commodity definitions and modified value for “Grass, forage, group 17” and “Grass, hay, group 17” to the updated “Grass, forage, fodder and hay, group 17”.

EPA is finalizing its proposals to revise commodity definitions to the updated “Peppermint, fresh leaves” and “Spearmint, fresh leaves” and to modify tolerances for “Almond, hulls”, “Peppermint, fresh leaves”, and “Spearmint, fresh leaves” to harmonize with Codex MRLs.

EPA is finalizing its proposal to revise the commodity definition from “Citrus, oil” to “Fruit, citrus, group 10-10, oil.”

EPA is finalizing its proposals to revise the current tolerance expression in (a)(1) and (a)(2) and to modify tolerances for “Barley, hay”, “Barley, straw”, “Wheat, hay”, and “Wheat, straw”, to harmonize with Codex MRLs.

EPA is also finalizing its proposal to establish new tolerances in paragraph (a)(2) for livestock commodities “Goat, fat”; “Goat, meat”; “Goat, meat byproducts”; “Hog, fat”; “Hog, meat”; “Hog, meat byproducts”; “Horse, fat”; “Horse, meat”; “Horse, meat byproducts”; “Sheep, fat”; “Sheep, meat”; and “Sheep, meat byproducts” since during registration review it was determined that the tolerances were needed to cover potential residues on treated feed items at the same level as the current tolerances for cattle.

EPA is finalizing its proposal to revise commodity definitions to the updated “Fennel, florence, fresh leaves and stalk”, “Peppermint, fresh leaves”, and “Spearmint, fresh leaves”.

EPA is finalizing its proposal to revise the current tolerance expression to describe more clearly the coverage of the tolerances and the method for measuring compliance.

These tolerance actions are effective on the date of publication of the final rule in the Federal Register . For actions in the final rule that lower or revoke existing tolerances, EPA has set an expiration date for the existing tolerance of 180 days after the date of publication of the final rule in the Federal Register , to allow a reasonable interval for producers in exporting members of the World Trade Organization's (WTO's) Sanitary and Phytosanitary (SPS) Measures Agreement to adapt to the requirements.

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. This exemption also applies to tolerance revocations for which extraordinary circumstances do not exist. As such, this exemption applies to the tolerance revocations in this final rule because the Agency knows of no extraordinary circumstances that warrant reconsideration of this exemption for those tolerance revocations.

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.

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C. 601 et seq. In making this determination, EPA concludes that the impact of concern for this action is any significant adverse economic impact on small entities and that the Agency is certifying that this action will not have a significant economic impact on a substantial number of small entities because the action has no net burden on small entities subject to this rulemaking. As discussed in the proposed rule, this determination takes into account several EPA analyses of potential small entity impacts for tolerance actions. EPA received a comment on the proposed rule concerning the potential for increased costs for small-scale farmers from compliance with the updated tolerance requirements, however the commenter did not provide a specific tolerance or commodity that would impose this cost. Since the commenter did not identify specific changes to the proposed rule or proposed actions or specific extraordinary circumstances that exist that would change EPA's previous analyses, the Agency is not changing this determination.

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

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

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

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not a significant regulatory action under section 3(f)(1) of Executive Order 12866 (See Unit V.A.), and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. However, EPA's 2021 Policy on Children's Health applies to this action.

This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is documented in the pesticide-specific registration review documents, located in each chemical docket at https://www.regulations.gov.

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

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

This action is subject to the CRA, 5 U.S.C. 801 et seq., and EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action 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:

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

• 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 .

EPA is issuing this rulemaking under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. FFDCA section 408(b)(2)(A)(i) 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.” FFDCA section 408(b)(2)(A)(ii) defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. FFDCA section 408(b)(2)(C) 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 . . .”

Under FFDCA section 408(g), 21 U.S.C. 346a(g), any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. If you fail to file an objection to the final rule within the time period specified in the final rule, you will have waived the right to raise any issues resolved in the final rule. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2021-0433 or EPA-HQ-OPP-2021-0833 in the subject line on the first page of your submission. This document addresses two related petitions for inpyrfluxam tolerance that were received by the Agency at different times and are docketed under EPA-HQ-OPP-2021-0433 and EPA-HQ-OPP-2021-0833. This final rule and all supporting documents will be uploaded to both dockets, EPA-HQ-OPP-2021-0433 and EPA-HQ-OPP-2021-0833. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before April 21, 2026.

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.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be CBI or other information whose disclosure is restricted by statute. If you wish to include CBI in your request, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice.

In the Federal Register of June 22, 2022 (87 FR 37287) (FRL-9410-02-OCSPP), EPA issued a document pursuant to FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), announcing the filing of pesticide petitions (PP 1F8922, PP 1F8924, and PP 1F8942) by Valent U.S.A. LLC, 4600 Norris Canyon Road, San Ramon, CA 94583. The petitions requested that 40 CFR part 180 be amended by establishing tolerances for residues of the fungicide inpyrfluxam, (3-(difluoromethyl)-N-[(3R)-2,3-dihydro-1,1,3-trimethyl-1H-inden-4-yl]-1-methyl-1H-pyrazole-4-carboxamide), in or on cotton, undelinted seed, at 0.01 parts per million (ppm) (PP 1F8922); cotton, gin byproducts (gin trash) at 0.02 ppm (PP 1F8922); wheat, forage at 0.01 ppm (PP 1F8924); wheat, grain at 0.01 ppm (PP 1F8924); wheat, hay at 1.5 ppm (PP 1F8924); wheat, straw at 0.3 ppm (PP 1F8924); and rapeseed, seed (crop subgroup 20A) at 0.01 ppm (PP 1F8942). That document referenced a summary of the three petitions prepared by Valent U.S.A. LLC, the registrant, which is available in the docket http://www.regulations.gov (docket ID numbers EPA-HQ-OPP-2021-0433 and EPA-HQ-OPP-2021-0833). There were no comments received in response to the June 22, 2022, notice of filing.

In the Federal Register of May 22, 2024 (89 FR 44954) (FRL-11682-04-OCSPP), EPA issued a notice that supersedes the June 22, 2022, notice of filing for PP 1F8942. This amended petition requests tolerances for residues of inpyrfluxam in or on rapeseed subgroup 20A at 0.01 ppm and “rapeseed, forage” at 0.02 ppm. One comment was received in response to the May 22, 2024, notice but was not germane to the petition.

EPA is not establishing a tolerance on “rapeseed, forage” as requested in PP 1F8942. The reason for this change is explained in Unit IV.D.

Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), 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 inpyrfluxam, including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with inpyrfluxam follows.

In an effort to streamline its publications in the Federal Register , EPA is not reprinting sections of the rule that repeat what has been previously published in tolerance rulemakings for the same pesticide chemical. Where scientific information concerning a particular chemical remains unchanged, the content of those sections would not vary between tolerance rulemakings, 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 a tolerance rulemaking for inpyrfluxam in which EPA concluded, based on the available information, that there is a reasonable certainty that no harm would result from aggregate exposure to inpyrfluxam and established tolerances for residues of that chemical. EPA is incorporating previously published sections from that rulemaking as described further in this rule, as they remain unchanged.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Specific information on the studies received and the nature of the adverse effects caused by inpyrfluxam as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in Unit III.A. of the Federal Register of August 26, 2020 (85 FR 52483) (FRL-10011-32).

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level, generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD), and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/human-health-risk-pesticides.

A summary of the toxicological endpoints for inpyrfluxam used for human risk assessment can be found at http://www.regulations.gov in the document “Inpyrfluxam. Human Health Risk Assessment for the Proposed New Use of Inpyrfluxam as a Seed Treatment on Canola and Rate Increase for Rapeseed Subgroup 20A.” and “Inpyrfluxam. Human Health Risk Assessment for New Uses of Inpyrfluxam on Cottonseed and Wheat.” (hereinafter “Inpyrfluxam Human Health Risk Assessment”) on pages 16 and 18, respectively, in Docket ID numbers EPA-HQ-OPP-2021-0433 and EPA-HQ-OPP-2021-0833.

1. Dietary exposure from food and feed uses.

In evaluating dietary exposure to inpyrfluxam, EPA considered exposure under the petitioned-for tolerances as well as all existing inpyrfluxam tolerances in 40 CFR 180.712. EPA assessed dietary exposures from inpyrfluxam in food as follows:

i. Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

The acute and chronic dietary assessment were conducted using the Dietary Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM-FCID) Version 4.02. This software uses 2005-2010 food consumption data from the U.S. Department of Agriculture (USDA) National Health and Nutrition Examination Survey, What We Eat in America. As to residue levels in food, the acute and chronic analyses incorporated anticipated residues to account for the metabolites of concern, 100 percent crop treated (PCT) estimates, default processing factors for processed commodities and empirical processing factors when available.

ii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that inpyrfluxam does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

2. Dietary exposure from drinking water.

The proposed uses do not result in an increase in the estimated residue levels in drinking water, so the estimated drinking water concentrations used in the August 26, 2020, final rule (85 FR 52483) (FRL-10011-32) are the same as those used in this assessment.

3. From non-dietary exposure.

The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure ( e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Inpyrfluxam is not registered for any specific use patterns that would result in residential exposure.

4. Cumulative effects from substances with a common mechanism of toxicity.

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

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

EPA continues to conclude that there are reliable data to support the reduction of the Food Quality Protection Act (FQPA) safety factor. See Unit III.D. of the August 26, 2020, rulemaking (85 FR 52483) (FRL-10011-32) 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 PAD (aPAD) and chronic PAD (cPAD). Short-, intermediate-, and chronic-term aggregate risks are evaluated by comparing the estimated total food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1. Acute risk. An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to inpyrfluxam will occupy 6.8% of the aPAD for all infants less than one year old, the population group receiving the greatest exposure.

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to inpyrfluxam from food and water will utilize 2.4% of the cPAD for all infants less than one year old, the population group receiving the greatest exposure. There are no residential uses for inpyrfluxam.

3. Short- and intermediate-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Short-term risk is assessed based on short-term residential exposure plus chronic dietary exposure. Because there is no short-term or intermediate residential exposure and chronic dietary exposure has already been assessed under the appropriately protective cPAD (which is at least as protective as the POD used to assess short-term risk), no further assessment of short-term or intermediate-term risk is necessary, and EPA relies on the chronic dietary risk assessment for evaluating the aggregate risk for inpyrfluxam.

4. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, inpyrfluxam is not expected to pose a cancer risk to humans.

5. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to inpyrfluxam residues.

For a discussion of the available enforcement analytical methods, see Unit IV.A. of the August 26, 2020, rulemaking (85 FR 52483) (FRL-10011-32).

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 (MRL) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex 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.

Codex has not established MRLs for inpyrfluxam in/on cottonseed, rapeseed, or wheat.

Although the petition requested a tolerance for “rapeseed, forage”, EPA has determined that the “rapeseed, forage” tolerance is not needed because the proposed pesticide product label prohibits livestock feeding and grazing of rapeseed forage (canola varieties only) treated with inpyrfluxam. The commodity definition for cotton, gin byproducts (gin trash) was also revised in conformity with EPA guidelines.

Therefore, tolerances are established for residues of inpyrfluxam, (3-(difluoromethyl)-N-[(3R)-2,3-dihydro-1,1,3-trimethyl-1H-inden-4-yl]-1-methyl-1H-pyrazole-4-carboxamide), in or on cotton, gin byproducts at 0.02 ppm; cotton, undelinted seed at 0.01 ppm; rapeseed subgroup 20A at 0.01 ppm; wheat, forage at 0.01 ppm; wheat, grain at 0.01 ppm; wheat, hay at 1.5 ppm; and wheat, straw at 0.3 ppm.

Additional information about these statutes and Executive orders can be found at https://www.epa.gov/regulations/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. However, EPA's 2021 Policy on Children's Health applies to this action. This rule finalizes tolerance actions under the FFDCA, which requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue . . .” (FFDCA 408(b)(2)(C)). The Agency's consideration is summarized in Unit III.E.

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, 40 CFR chapter I is amended as follows:

The MMPA prohibits the “take” of marine mammals, with certain exceptions. Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361 et seq. ) direct the Secretary of Commerce (as delegated to NMFS) to allow, upon request, the incidental, but not intentional, taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region if certain findings are made and either regulations are promulgated and a LOA is issued or an incidental harassment authorization (IHA) is issued.

The statute also requires that authorization for incidental takings be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s) and will not have an unmitigable adverse impact on the availability of the species or stock(s) for taking for subsistence uses (where relevant). If such findings are made, NMFS must prescribe the permissible methods of taking and other “means of effecting the least practicable adverse impact” on the affected species or stocks and their habitat, paying particular attention to rookeries, mating grounds, and areas of similar significance, and on the availability of the species or stocks for taking for certain subsistence uses (referred to in shorthand as “mitigation”); and set forth requirements pertaining to the monitoring and reporting of the takings. The definitions of applicable MMPA statutory terms are provided directly below or included in the relevant sections of this rule.

• U.S. citizen —individual U.S. citizens or any corporation or similar entity if it is organized under the laws of the United States or any governmental unit defined in 16 U.S.C. 1362(13); 50 CFR 216.103);

• Take —to harass, hunt, capture, or kill, or attempt to harass, hunt, capture, or kill any marine mammal (16 U.S.C. 1362(13);

• Incidental harassment, incidental taking, and incidental, but not intentional, taking —an accidental taking. This does not mean that the taking is unexpected, but rather it includes those takings that are infrequent, unavoidable or accidental (50 CFR 216.103);

• Level A harassment —any act of pursuit, torment, or annoyance which has the potential to injure a marine mammal or marine mammal stock in the wild (16 U.S.C. 1362(18); 50 CFR 216.3); and

• Level B harassment —any act of pursuit, torment, or annoyance which has the potential to disturb a marine mammal or marine mammal stock in the wild by causing disruption of behavioral patterns, including, but not limited to, migration, breathing, nursing, breeding, feeding, or sheltering (16 U.S.C. 1362(18); 50 CFR 216.3).

NMFS received an application from Hilcorp requesting 5-year regulations and a LOA that would authorize the take of 12 marine mammal species, comprising 15 stocks, by Level B harassment, and take by Level A harassment of 9 of those 12 species, comprising 12 stocks, incidental to activities conducted by Hilcorp in support of oil and gas exploration, development, production, and decommissioning. No serious injury or mortality is anticipated or authorized.

The regulations provide a framework for authorizing the take of marine mammals incidental to specified activities associated with Hilcorp's oil and gas exploration, development, production, and decommissioning activities in Cook Inlet, Alaska. NMFS has, in accordance with the MMPA, issued the associated LOA.

Section 101(a)(5)(A) of the MMPA (16 U.S.C. 1371(a)(5)(A)) directs the Secretary of Commerce, as delegated to NMFS, to allow, upon request, the incidental, but not intentional taking of small numbers of marine mammals by U.S. citizens who engage in a specified activity (other than commercial fishing) within a specified geographical region for up to 5 years if, after notice and public comment, the agency makes certain findings and promulgates regulations that set forth permissible methods of taking pursuant to that activity and other means of effecting the “least practicable adverse impact” on the affected species or stocks and their habitat (see the discussion below in the Mitigation section), as well as monitoring and reporting requirements. Section 101(a)(5)(A) of the MMPA and the implementing regulations at 50 CFR part 216, subpart I provide the legal basis for issuing this rule containing 5-year regulations and the LOA.

The major provisions of this rule are:

• Authorizing, through the issuance of the LOA, the take of small numbers of marine mammals by Level A harassment and/or Level B harassment incidental to Hilcorp's specified activities (no mortality or serious injury of any marine mammal is authorized);

• Requiring operating project vessels to maintain a distance of 2.4 km (1.5 miles) from the mean lower low water (MLLW) line of the Susitna Delta (MLLW line between the Little Susitna River and Beluga River) between April 15 and November 15 and restrict pile driving to November 15 through April 15 to avoid and minimize impacts when Cook Inlet beluga whales (CIBWs) are more likely engaging in foraging behavior;

• Requiring NMFS-approved protected species observers (PSOs) on board vessels associated with the specified activities and delaying commencement of or shutting down certain activities should a marine mammal be detected within identified clearance or shutdown zones to minimize the amount and severity of take;

• Requiring a soft start for impact pile driving to allow marine mammals the opportunity to leave the area prior to being exposed to higher noise levels; and

• Requiring submission of monitoring reports including, but not limited to, a summary of marine mammal species and behavioral observations, construction shutdowns or delays, and construction work completed.

On October 30, 2024, NMFS received an application from Hilcorp requesting authorization to take marine mammals incidental to oil and gas exploration, development, production, and decommissioning activities in Cook Inlet, Alaska. Specifically, Hilcorp plans to conduct necessary work, including use of tugs towing, holding, or positioning a jack-up rig; pile driving; and pipeline replacement/installation activities. The exposure of marine mammals occurring in the vicinity to underwater noise generated by the activities could result in incidental take of marine mammals by Level A and/or Level B harassment. Therefore, Hilcorp requested authorization to incidentally take marine mammals. NMFS requested additional information from Hilcorp regarding their request on November 19, 2024, which Hilcorp provided on January 2, 2025. A final request from NMFS for information was sent to Hilcorp on January 22, 2025. Hilcorp provided all necessary information on February 10, 2025, and NMFS deemed Hilcorp's application, which includes a Marine Mammal Monitoring and Mitigation Plan in Appendix A, adequate and complete on February 18, 2025 (note that NMFS' Notice of Receipt (NOR) of Hilcorp's application erroneously described this date as being February 10, 2025). On March 13, 2025, NMFS published a NOR of Hilcorp's adequate and complete application in the Federal Register (90 FR 11951), requesting comments and soliciting information related to Hilcorp's request during a 30-day public comment period. NMFS did not receive any public comments. Subsequently, on March 14, 2025, Hilcorp submitted a revised application that corrected minor details but did not substantively modify the description of the specified activities or the type or amount of take requested incidental to those activities. This revised application is available at: https://www.fisheries.noaa.gov/action/incidental-take-authorization-hilcorp-alaska-llcs-oil-and-gas-activities-cook-inlet-alaska.

On July 24, 2025, NMFS published a proposed rule in the Federal Register (90 FR 34974). The public comment period on the proposed rule was open for 30 days from July 24, 2025 through August 25, 2025. A summary of public comments received during this 30-day period are described in the Comments and Responses section of this final rule; full public comments may be viewed on https://Regulations.gov.

A history of previous incidental take authorizations that NMFS has issued to Hilcorp for identical or similar specified activities can be found in the proposed rule (90 FR at 34975). Hilcorp complied with all the requirements ( e.g., mitigation, monitoring, and reporting) of the previous LOAs and IHAs, and information regarding their monitoring results may be found in the Potential Effects of Specified Activities on Marine Mammals and their Habitat section of the proposed rule.

Hilcorp plans to continue oil and gas exploration, development, production, and decommissioning activities in Cook Inlet, Alaska, for the reasonably foreseeable future. Over the course of the 5-year effective period of the regulations, this work includes up to 54 days of tugs towing, holding, or positioning a jack-up rig in support of production drilling at existing platforms in middle Cook Inlet and Trading Bay; up to 70 days of pile driving in support of production well development at the Tyonek Platform in middle Cook Inlet; up to 6 days of tugs towing, holding, or positioning a jack-up rig; up to 18 days of pile driving in support of exploration drilling at two locations in the Middle Ground Shoal Unit in middle Cook Inlet and one location between the Anna and Bruce platforms on the northern border of Trading Bay; and up to 22 days of pipeline replacement/installation, involving either pipe pulling or anchor handling or a combination of both, at up to two locations in middle Cook Inlet and/or Trading Bay. Hilcorp requested authorization of take by Level B harassment for 12 marine mammal species and additionally by Level A harassment for a subset of 9 of these species.

Table 1 provides a summary of the anticipated timings and durations for Hilcorp's planned activities; however, the schedule may shift such that actual activities occur in different years than specified below.