Title: Report Forms under Federal Milk Orders (From Milk Handlers and Milk Marketing Cooperatives).

OMB Number: 0581-0032.

Expiration Date of Approval: February 29, 2024.

Type of Request: Extension and revision of a currently approved information collection.

Abstract: Federal milk marketing order regulations (7 CFR parts 1000-1199) authorized under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), require milk handlers to report in detail the receipts and utilization of milk and milk products handled at each of their plants that are regulated by a Federal order. The data are needed to administer the classified pricing system and related requirements of each Federal order.

A Federal milk marketing order (hereinafter, Order) is a regulation issued by the Secretary of Agriculture that places certain requirements on the handling of milk in the area it covers. Each order is established under the authority of the Act. The Order requires that handlers of milk for a marketing area pay not less than certain minimum class prices according to how the milk is used. These prices are established under each Order after a public hearing at which evidence is received on the supply and demand conditions for milk in the market. An Order requires that payments for milk be pooled and paid to individual farmers or cooperative associations of farmers on the basis of a uniform or average price. Thus, all eligible farmers (producers) share in the market wide use-values of milk by regulated handlers.

Milk Orders help ensure adequate supplies of milk and dairy products for consumers and adequate returns to producers.

The Orders also provide for the public dissemination of market statistics and other information for the benefit of producers, handlers, and consumers.

Formal rulemaking amendments to the Orders must be approved in referenda conducted by the Secretary.

During 2022, 23,108 dairy farmers delivered over 151.6 billion pounds of milk to handlers regulated under the milk orders. This volume represents 67 percent of all milk marketed in the U.S. and 68 percent of the milk of bottling quality (Grade A) sold in the country. The value of this milk delivered to Federal milk order handlers at minimum order blend prices was over $35.9 billion. Producer deliveries of milk used in Class I products (mainly fluid milk products) totaled 41.0 billion pounds, 27 percent of total producer deliveries.

Each Order is administered by a USDA market administrator. The market administrator is authorized to levy assessments on regulated handlers to carry out the market administrator's duties and responsibilities under the Orders. Additional duties of the market administrators are to prescribe reports required of each handler, to assure that handlers pay producers and associations of producers according to the provisions of the Order. The market administrator employs a staff that verifies handlers' reports by examining records to determine that the required payments are made to producers. Most reports required from handlers are submitted monthly to the market administrator.

The forms used by the market administrators are required by the respective Orders that are authorized by the Act. The forms are used to establish the quantity of milk received by handlers, the pooling status of the handlers, the class-use of the milk used by the handler, and the butterfat content and amounts of other components of the milk.

The forms covered under this information collection require the minimum information necessary to effectively carry out the requirements of the Orders, and their use is necessary to fulfill the intent of the Act as expressed in the Orders and in the rules and regulations issued under the Orders. The information collected is used only by authorized employees of the market administrator and authorized representatives of the USDA, including AMS Dairy Programs' headquarters staff.

Estimated of Burden: Public reporting burden for this collection of information is estimated to average 0.50 hours per response.

Respondents: Milk handlers and milk marketing cooperatives.

Estimated Number of Respondents: 679.

Estimated Total Annual Responses: 15,980.

Estimated Number of Responses per Respondent: 186.

Estimated Total Annual Burden on Respondents: 18,050 (rounded).

Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.

All comments received on this information collection will be summarized and included in the final request for OMB approval. All comments will become a matter of public record, including any personal information provided.

Title of collection: Corn and Soybean Grower Survey.

OMB Control Number: 0536-NEW.

Type of Request: A new information collection.

Abstract:

The proposed data collection will survey corn and soybean farmers in the Midwestern United States to study farmers' preferences for participating in programs that support cover cropping and gather new information about current cover cropping practices. This survey sample will be drawn from Midwestern states as they represent a large majority corn and soy acreage, similar policy contexts, and potential for growth in cover crop adoption. USDA agencies are interested in supporting voluntary long-run adoption of climate smart conservation practices such as cover crops through technical assistance and financial incentives. There are multiple Federal, state, and private programs that support planting cover crops. This study is interested in Federal programs, the two largest of which are the Environmental Quality Incentive Program (EQIP) and the Conservation Stewardship Program (CSP).

The survey will use questions on contract enrollment to examine how contract flexibility, ease of applying, payments, and other aspects of cover crop contracts affect farmers' willingness to enroll their corn and soybean fields in cover crop programs. Results will be compared between farmers with no history of cover cropping in Federal programs and those who have cover cropped in Federal Programs.

Participation in the survey will be voluntary, and subjects will be recruited by mail with options to participate either online or by mail. Data will be analyzed using discrete choice models to estimate farmer preferences for cover crop contracts. Results from the survey will be used in academic and Federal research publications to provide information to stakeholders and the public regarding farmer preferences for planting cover crops and participating in cover crop programs. This work will also inform future studies on adoption of cover crops and other conservation practices.

This committee meeting is available to the public through the registration link above. Any interested member of the public may listen to the meeting. An open comment period will be provided to allow members of the public to make a statement as time allows. Per the Federal Advisory Committee Act, public minutes of the meeting will include a list of persons who are present at the meeting. If joining via phone, callers can expect to incur regular charges for calls they initiate over wireless lines, according to their wireless plan. The Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free telephone number. Closed captioning will be available for individuals who are deaf, hard of hearing, or who have certain cognitive or learning impairments. To request additional accommodations, please email Liliana Schiller, Support Services Specialist, at lschiller@usccr.gov at least 10 business days prior to the meeting.

Members of the public are entitled to submit written comments; the comments must be received in the regional office within 30 days following the meeting. Written comments may be emailed to David Barreras at dbarreras@usccr.gov. Persons who desire additional information may contact the Regional Programs Coordination Unit at (312) 353-8311.

Records generated from this meeting may be inspected and reproduced at the Regional Programs Coordination Unit Office, as they become available, both before and after the meeting. Records of the meetings will be available via www.facadatabase.gov under the Commission on Civil Rights, Utah Advisory Committee link. Persons interested in the work of this Committee are directed to the Commission's website, http://www.usccr.gov, or may contact the Regional Programs Coordination Unit at lschiller@usccr.gov.

Atlantic HMS fisheries (tunas, billfish, swordfish, and sharks) are managed under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1801 et seq. ) and the Atlantic Tunas Convention Act (16 U.S.C. 971 et seq. ). The 2006 Consolidated Atlantic HMS Fishery Management Plan (FMP) and its amendments are implemented by regulations at 50 CFR part 635. Specifics regarding the commercial shark quotas and the shark research fishery can be found at §§ 635.27(b) and 635.32(f).

The shark research fishery was established, in part, to maintain time series data for stock assessments and to meet NMFS' research objectives. Since the shark research fishery was established in 2008, it has allowed for: the collection of fishery-dependent data for current and future stock assessments; the operation of cooperative research to meet NMFS' ongoing research objectives; the collection of updated life-history information used in the sandbar shark (and other species) stock assessment; the collection of data on habitat preferences that might help reduce fishery interactions through bycatch mitigation; evaluation of the utility of the mid-Atlantic closed area on the recovery of dusky sharks and collection of hook-timer and pop-up satellite archival tag information to determine at-vessel and post-release mortality of dusky sharks; and collection of sharks to determine the weight conversion factor from dressed weight to whole weight.

The shark research fishery allows selected commercial fishermen the opportunity to earn revenue from selling additional sharks, including sandbar sharks. Only the commercial shark fishermen selected to participate in the shark research fishery are authorized to land sandbar sharks subject to the sandbar quota available each year. The base quota for sandbar sharks is 90.7 metric tons (mt) dressed weight (dw) per year, although this number may be reduced in the event of overharvests. The selected shark research fishery permittees will also be allowed to land other LCS, SCS, smoothhound, and pelagic sharks consistent with any restrictions established on their shark research fishery permit. Generally, the shark research fishery permits are valid only for the calendar year for which they are issued.

One hundred-percent observer coverage is required on shark research fishery trips. The specific 2024 trip limits and number of trips per month will depend on the availability of funding, number of selected vessels, the availability of observers, the available quota, and the objectives of the research fishery, and will be included in the permit terms at time of issuance. The number of participants in the research fishery changes each year. In 2023, three fishermen were chosen to participate. From 2008 through 2023, there has been an average of 6 participants each year with the range from 3 to 11. Overall, the timing of trips and the number of the trips participants taken has varied year-to-year based on seasonal availability of certain species and available quota. Specifically, the number of trips taken per month are limited by the scientific and research needs of the Agency and the number of NMFS-approved observers available; in the last few years participating vessels on average have been able to take one trip per month. Participants may also be limited in the amount of gear they can deploy on a given set ( e.g., number of hooks and sets, soak times, length of longline). These limits have changed both between years and during the year depending on research goals and bycatch limits.

In 2023, NMFS split 90 percent of the sandbar and LCS research fishery quotas equally among selected participants, with 16.3 mt dw (35,935 pounds (lb) dw) of sandbar shark research fishery quota and 9.0 mt dw (19,841 lb dw) of other LCS research fishery quota available to each vessel. The remaining quota was held in reserve to ensure the overall sandbar and LCS research fishery quotas were not exceeded. NMFS may use this process again for the quotas in 2024 or may consider other methods of distributing the available quotas.

In 2023, NMFS continued to implement a regional dusky bycatch limit, which was first established in 2013, in the shark research fishery, applicable to four regions across the Gulf of Mexico and Atlantic. Under this limit, when four or more dusky sharks have been brought to the vessel dead in a region, shark research fishery permit holders in that region were prohibited from soaking their gear for longer than 3 hours. If, after the change in soak time, three additional dusky shark interactions (alive or dead) were observed, shark research fishery permit holders were prohibited from making a trip in that region for the remainder of the year, unless otherwise permitted by NMFS. Slightly different measures were established for shark research fishery participants in the mid-Atlantic shark closed area in order to allow NMFS observers to place satellite archival tags on dusky sharks and collect other scientific information on dusky sharks while also minimizing any dusky shark mortality.

To participate in the shark research fishery, commercial shark fishermen need to submit a completed Shark Research Fishery Permit Application by the deadline noted above (see DATES ) showing that the vessel and owner(s) meet the specific criteria outlined below.

Each year, the research objectives are developed by a shark board, which is comprised of NMFS representatives from the Southeast Fisheries Science Center (SEFSC) Panama City Laboratory, the Southeast Regional Office Protected Resources Division, and the HMS Management Division. The research objectives for 2024 are based on various documents, including the May 2020 Biological Opinion on the Operation of the Atlantic Highly Migratory Species Fisheries Excluding Pelagic Longline, as well as recent stock assessments for the U.S. South Atlantic blacknose, U.S Gulf of Mexico blacknose, U.S. Gulf of Mexico blacktip, sandbar, and dusky sharks (all these stock assessments can be found at http://sedarweb.org/ ). The 2024 research objectives are:

• Collect reproductive, length, sex, and age data from sandbar and other sharks throughout the calendar year for species-specific stock assessments;

• Monitor the size distribution of sandbar sharks and other species captured in the fishery;

• Collect information regarding depredation events;

• Continue ongoing shark tagging programs for identification of migration corridors and stock structure using dart and/or spaghetti tags;

• Maintain time-series of abundance from previously derived indices for the shark bottom longline observer program;

• Acquire fin-clip samples of all shark and other species for genetic analysis;

• Attach satellite archival tags to endangered smalltooth sawfish to provide information on critical habitat, preferred depth and post-release mortality, consistent with the requirements listed in the take permit issued under section 10 of the Endangered Species Act to the SEFSC Observer Program;

• Attach satellite archival tags to prohibited dusky and other sharks, as needed, to provide information on daily and seasonal movement patterns, and preferred depth;

• Evaluate hooking mortality and post-release survivorship of dusky, hammerhead, blacktip, and other sharks using hook-timers and temperature-depth recorders;

• Evaluate the effects of controlled gear experiments to determine the effects of potential hook changes to prohibited species interactions and fishery yields;

• Examine the size distribution of sandbar and other sharks captured including in the Mid-Atlantic shark time/area closure off the coast of North Carolina from January 1 through July 31;

• Develop allometric and weight relationships of selected species of sharks ( e.g., hammerhead, sandbar, blacktip shark);

• Collect samples such as liver and muscle plugs for stable isotope analysis as a part of a trophic level-based ecosystem study; and

• Examine the feasibility of using electronic monitoring (EM) to accurately measure soak times of bottom longline sets. This specific research objective may require participating vessels to have an EM system sensors installed for the duration of the 2024 research fishery. During each research trip, the EM sensors must be operating. The sensors will be removed after the end of the 2024 research fishery.

Shark Research Fishery Permit Applications will only be accepted from commercial shark fishermen who hold a current directed or incidental shark limited access permit. If a large number of applications are received, NMFS will give priority to directed permit holders to ensure that an appropriate number of sharks are landed to meet the research objectives.

The Shark Research Fishery Permit Application includes, but is not limited to, a request for the following information: type of commercial shark permit possessed; past participation and availability in the commercial shark fishery (not including sharks caught for display); past involvement and compliance with HMS observer programs per § 635.7; past compliance with HMS regulations at 50 CFR part 635; past and present availability to participate in the shark research fishery year-round; ability to fish in the regions and seasons requested; ability to attend necessary meetings regarding the objectives and research protocols of the shark research fishery; and ability to carry out the research objectives of the Agency. Preference will be given to those applicants who are willing and available to fish year-round and who affirmatively state that they intend to do so, to ensure the timely and accurate data collection NMFS needs to meet this year's research objectives. An applicant who has been charged criminally or civilly ( e.g., issued a Notice of Violation and Assessment (NOVA) or Notice of Permit Sanction) for any HMS-related violation will not be considered for participation in the shark research fishery. In addition, applicants who were selected to carry an observer in the previous 2 years for any HMS fishery, but failed to contact NMFS to arrange the placement of an observer as required per § 635.7, will not be considered for participation in the 2024 shark research fishery. Applicants who were selected to carry an observer in the previous 2 years for any HMS fishery and failed to comply with all the observer regulations per § 635.7 will also not be considered. Exceptions will be made for vessels that were selected for HMS observer coverage but did not fish in the quarter when selected and thus did not require an observer. Applicants who do not possess a valid U.S. Coast Guard safety inspection decal when the application is submitted will not be considered. Applicants who have been non-compliant with any of the HMS observer program regulations in the previous 2 years, as described above, may be eligible for future participation in shark research fishery activities by demonstrating 2 subsequent years of compliance with observer regulations at § 635.7.

The HMS Management Division will review all submitted applications and develop a list of qualified applicants from those applications that are deemed complete. A qualified applicant is an applicant that has submitted a complete application by the deadline (see DATES ) and has met the selection criteria listed above. Qualified applicants are eligible to be selected to participate in the 2024 shark research fishery. The HMS Management Division will provide the list of qualified applicants without identifying information to the SEFSC. The SEFSC will then evaluate the list of qualified applicants and, based on the temporal and spatial needs of the research objectives, the availability of observers, the availability of qualified applicants, and the available quota for a given year, will randomly select qualified applicants to conduct the prescribed research. Where there are multiple qualified applicants that meet the criteria, permittees will be randomly selected through a lottery system. If a public meeting is deemed necessary, NMFS will announce details of a public selection meeting in a subsequent Federal Register notice.

Once the selection process is complete, NMFS will notify the selected applicants and issue the shark research fishery permits. The shark research fishery permits will be valid through December 31, 2024, unless otherwise specified. If needed, NMFS will communicate with the shark research fishery permit holders to arrange a captain's meeting to discuss the research objectives and protocols. NMFS usually holds mandatory captain's meetings before observers are placed on vessels and may hold one for the 2024 shark research fishery in early 2024. Once the fishery starts, the shark research fishery permit holders must contact NMFS or the NMFS-designee to arrange the placement of a NMFS-approved observer for each shark research trip, and in the beginning, if required, to arrange the installation of the specific EM sensor. Selected applicants are required to allow observers the opportunity to perform their duties and assist observers as necessary. At the end of the shark fishery, shark research fishery permit holders must contact NMFS or a designee to arrange for the removal of the EM sensors.

A shark research fishery permit will only be valid for the vessel and owner(s) and terms and conditions listed on the permit, and, thus, cannot be transferred to another vessel or owner(s). Shark research fishery permit holders must carry a NMFS-approved observer on shark research fishery trips. Issuance of a shark research permit does not guarantee that the permit holder will be assigned a NMFS-approved observer on any particular trip. Rather, issuance indicates that a vessel may be issued a NMFS-approved observer for a particular trip, and on such trips, may be allowed to harvest Atlantic sharks, including sandbar sharks, in excess of the retention limits described in § 635.24(a). Applicable retention limits will be based on available quota, number of vessels participating in the 2024 shark research fishery, the research objectives set forth by the shark board, the extent of other restrictions placed on the vessel, and may vary by vessel and/or location. When not operating under the auspices of the shark research fishery, the vessel would still be able to land LCS, SCS, and pelagic sharks subject to existing retention limits on trips without a NMFS-approved observer. Additionally, during those times, the vessel would not need to operate the EM sensors.

NMFS annually invites commercial shark permit holders (directed and incidental) to submit an application to participate in the shark research fishery. Permit applications can be found on the HMS Management Division's website at https://www.fisheries.noaa.gov/atlantic-highly-migratory-species/atlantic-highly-migratory-species-exempted-fishing-permits#shark-research-fishery, by calling 301-427-8503, or by emailing NMFS.Research.Fishery@noaa.gov. Final decisions on the issuance of a shark research fishery permit will depend on the submission of all required information by the deadline (see DATES ), and NMFS' review of applicant information as outlined above. The 2024 shark research fishery will start after the opening of the shark fishery and under available quotas as published in a separate Federal Register final rule.

This meeting is being held under the provisions of chapter 10 of title 5, United States Code (U.S.C.) (commonly known as the “Federal Advisory Committee Act” or “FACA”), 5 U.S.C. 552b (commonly known as the “Government in the Sunshine Act”), and 41 CFR 102-3.140 and 102-3.150.

Availability of Materials for the Meeting: Additional information, including the agenda, is available on the DHB website, http://www.health.mil/dhb. A copy of the agenda or any updates to the agenda for the November 29, 2023, meeting will be available on the DHB website. Any other materials presented in the meeting may also be obtained at the meeting.

Purpose of the Meeting: The DHB provides independent advice and recommendations to maximize the safety and quality of, as well as access to, health care for DoD health care beneficiaries. The purpose of the meeting is to provide progress updates on specific tasks before the DHB. In addition, the DHB will receive information briefings on current issues related to military medicine.

Agenda: The DHB anticipates receiving a decision briefing on Eliminating Racial and Ethnic Health Disparities in the Military Health System. The DHB also expects an update from the DHB Public Health Subcommittee's tasking on Effective Public Health Communication Strategies with DoD personnel.

Meeting Accessibility: Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165 and subject to the availability of space, this meeting will be held in-person and virtually and is open to the public from 9 a.m. to 5 p.m. Seating and virtual participation is limited and is on a first-come basis. All members of the public who wish to participate must register by emailing their name, rank/title, and organization/company to dha.dhb@health.mil or by contacting Mr. Rubens Lacerda at (703) 275-6012 no later than Wednesday, November 22, 2023. Additional details will be required from all members of the public attending in-person that do not have Gatehouse building access. Once registered, participant access information will be provided.

Special Accommodations: Individuals requiring special accommodations to access the public meeting should contact Mr. Rubens Lacerda at least five (5) business days prior to the meeting so that appropriate arrangements can be made.

Written Statements: Any member of the public wishing to provide comments to the DHB related to its current taskings or mission may do so at any time in accordance with section 10(a)(3) of the FACA, 41 CFR 102-3.105(j) and 102-3.140, and the procedures described in this notice. Written statements may be submitted to the DHB's Designated Federal Officer (DFO), CAPT Clausen, at shawn.s.clausen.mil@health.mil . Supporting documentation may also be included, to establish the appropriate historical context and to provide any necessary background information. If the written statement is not received at least five (5) business days prior to the meeting, the DFO may choose to postpone consideration of the statement until the next open meeting. The DFO will review all timely submissions with the DHB President and ensure they are provided to members of the DHB before the meeting that is subject to this notice. After reviewing the written comments, the President and the DFO may choose to invite the submitter to orally present their issue during an open portion of this meeting or at a future meeting.

Statutory Authority and Function: The Board is established by 20 U.S.C. 1066f. The Board is also governed by 5 U.S.C. chapter 10 (Federal Advisory Committees), which sets forth standards for the formation and use of advisory committees. The purpose of this Board is to advise the Secretary of Education (Secretary) and the designated bonding authority on the most effective and efficient ways to implement construction financing on the campuses of Historically Black Colleges and Universities (HBCUs). The Board also advises Congress regarding progress made in implementing the HBCU Capital Financing Program.

Meeting Agenda: The meeting agenda will include roll call; an update from the Executive Director of the HBCU Capital Financing Program; a discussion regarding several recommendations from the Board to the Secretary and to Congress; the Board may vote on those recommendations, and a discussion regarding dates and locations for meetings that will be held during calendar year 2024. The public comment period will begin immediately following the discussion of meeting dates and locations.

Individuals can attend the meeting in person at 400 Maryland Ave. SW, 1st Floor, Washington, DC, Lyndon Baines Johnson Auditorium. Individuals attending virtually must register online at https://ed-gov.zoomgov.com/webinar/register/WN_A3GrX6U_QASIFA-yVWC_bQ any time before the meeting begins on November 13, 2023 or join using an H.323/SIP room system:

H.323: 161.199.138.10 (U.S. West) or 161.199.136.10 (U.S. East).

Meeting ID: 160 344 0326.

Passcode: 080503.

SIP: 1603440326@sip.zoomgov.com.

Passcode: 080503.

Public Comment: Members of the public interested in submitting written comments may do so via email to Donald Watson donald.watson@ed.gov no later than 11:59 p.m. Eastern Time (ET) on November 9, 2023. Please note that written comments should pertain to the work of the Board.

Reasonable Accommodations: The meeting is accessible to individuals with disabilities. If you will need an auxiliary aid or service for the meeting ( e.g., interpreting service, assistive listening device, or materials in an alternate format), please notify the contact person listed in this notice no later than two weeks before the meeting date. Although we will attempt to meet a request received after that date, we may not be able to make available the requested auxiliary aid or service because of insufficient time to arrange it.

Access to Records of the Meeting: The Department will post the official minutes of this meeting on the Resources—Historically Black College and University Capital Financing Program website, https://www2.ed.gov/programs/hbcucapfinance/resources.html, no later than 60 days after the meeting. Pursuant to 5 U.S.C. 1009(b), the public may also inspect the meeting materials and other Board records at 400 Maryland Avenue SW, Washington, DC 20202, by emailing Donald Watson at donald.watson@ed.gov, or calling (202) 453-6166 to schedule an appointment.

Electronic Access to This Document: The official version of this document is the document published in the Federal Register . Free internet access to the official edition of the Federal Register and the Code of Federal Regulations is available via the Federal Digital System at: www.gpo.gov/fdsys. At this site you can view this document, as well as all other documents of this Department published in the Federal Register , in text or Adobe Portable Document Format (PDF). To use PDF, you must have Adobe Acrobat Reader, which is available free at the site. You also may access documents of the Department published in the Federal Register by using the article search feature at: www.federalregister.gov. Specifically, through the advanced search feature at this site, you can limit your search to documents published by the Department.

Authority: 20 U.S.C. 1066f.

The Department, in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Department is soliciting comments on the proposed information collection request (ICR) that is described below. The Department is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.

Title of Collection: Regional Educational Laboratory (REL) Southwest Write to Succeed Evaluation.

OMB Control Number: 1850-NEW.

Type of Review: A new ICR.

Respondents/Affected Public: State, Local, and Tribal Governments.

Total Estimated Number of Annual Responses: 2,453.

Total Estimated Number of Annual Burden Hours: 366.

Abstract: The current authorization for the Regional Educational Laboratories (REL) program is under the Education Sciences Reform Act of 2002, part D, section 174, (20 U.S.C. 9564), administered by the Department of Education, Institute of Education Sciences (IES), National Center for Education Evaluation and Regional Assistance (NCEE). The central mission and primary function of the RELs is to support applied research and provide technical assistance to state and local education agencies within their region (ESRA, part D, section 174[f]). The REL program's goal is to partner with educators and policymakers to conduct work that is change-oriented and supports meaningful local, regional, or state decisions about education policies, programs, and practices to improve outcomes for students.

Supporting equitable educational opportunities and achievement for English learner students in New Mexico is a high priority for the New Mexico Public Education Department (NMPED, n.d., 2021). In light of analysis showing English learner students in the state have lower rates of English language arts (ELA) proficiency (Arellano et al., 2018), plus legal rulings in the state that English learner students' rights to a sufficient public education have been violated (NMPED, 2022a), NMPED created a strategic plan that includes supporting the whole child through literacy instruction that is culturally and linguistically responsive (NMPED, 2022b). Improving English learner students' English proficiency and the literacy skills of all students is a top priority of NMPED and the district and regional partners of REL Southwest. To address this problem, REL Southwest is implementing, refining, and building evidence for the Write to Succeed professional learning program. The core focus of the Write to Succeed program is scaffolded writing instruction that can support all students but with embedded opportunities to meet the language needs to English learner students. Prior to this study, the program will be further enhanced with supports for teacher collaboration and culturally and linguistically relevant instructional routines, as prior work with New Mexico partners has indicated these are two elements in need of further support.

This study is designed to measure the efficacy and implementation of the Write to Succeed. The evaluation team plans to conduct an independent evaluation using a school-level, cluster randomized control trial design to assess the program's impact on teachers' practices and beliefs and students' language and literacy outcomes. The evaluation will also assess the implementation of the program and how it may be effectively scaled. The evaluation will take place in 40 schools across an estimated 10 districts in New Mexico and will focus on teachers and students in grades 4-8. The evaluation will produce a report and presentations to study participants, practitioners, policymakers, and researchers, and infographics and blog posts for a wider audience of educators and policymakers. These will be designed to inform district and school leaders and teachers about scaffolded writing practices that could be beneficial for English learner students and all students.

The Idaho National Laboratory (INL) Site, near Arco, Idaho, currently stores solid calcined radioactive waste in stainless-steel bins housed in six reinforced concrete vaults that are below or partially below grade at the CSSF. The CSSF is located at the Idaho Nuclear Technology and Engineering Center (INTEC) at the INL Site. The stored calcined HLW was generated by converting liquid HLW and non-reprocessing waste into a granular solid. The liquid HLW was generated by the prior reprocessing of spent nuclear fuel (SNF). DOE's current mission focuses on the cleanup and remediation of those wastes and ultimate closure of the CSSF.

As part of that mission, DOE plans to retrieve waste from the CSSF for treatment, and disposition out of the State of Idaho. Following waste retrieval, DOE plans to stabilize in grout and pursue closure (disposal in place) of the CSSF bins (including integral equipment), transport lines, and any residual waste remaining therein.

The Draft CSSF 3116 Basis Document concerns the CSSF bins (including integral equipment), transport lines, and any residual waste remaining therein, after waste retrieval, which is anticipated to remove most of the calcine, (approximately 99% or more of the calcine (by volume) and approximately 99% of the radioactivity attributable to highly radioactive radionuclides). A small amount of calcine, less than approximately 1% by volume, is expected to remain in the CSSF at the time of closure. The final CSSF closure configuration is anticipated to include stabilizing (with grout) the bins and transport line piping void spaces. The grout will serve to provide long term structural stability, limit the amount of water infiltration into the bins and transfer lines to mitigate contaminate migration, and provide a barrier for intrusion by burrowing animals, plant roots, or humans.

NDAA Section 3116(a) provides that HLW does not include radioactive waste resulting from the reprocessing of SNF that the Secretary of Energy, in consultation with the NRC, determines:

“(1) does not require permanent isolation in a deep geologic repository for spent fuel or high-level radioactive waste;

(2) has had highly radioactive radionuclides removed to the maximum extent practical; and

(3) (A) does not exceed concentration limits for Class C low-level waste as set out in Section 61.55 of title 10, Code of Federal Regulations, and will be disposed of—

(i) in compliance with the performance objectives set out in subpart C of part 61 of title 10, Code of Federal Regulations; and

(ii) pursuant to a State-approved closure plan or State-issued permit, authority for the approval or issuance of which is conferred on the State outside of this section; or

(B) exceeds concentration limits for Class C low-level waste as set out in section 61.55 of title 10, Code of Federal Regulations, but will be disposed of—

(i) in compliance with the performance objectives set out in subpart C of part 61 of title 10, Code of Federal Regulations;

(ii) pursuant to a State-approved closure plan or State-issued permit, authority for the approval or issuance of which is conferred on the State outside of this section; and

(iii) pursuant to plans developed by the Secretary in consultation with the Commission.”

The Draft CSSF 3116 Basis Document demonstrates that after waste retrieval activities, the CSSF at closure will meet the above criteria. DOE is predicating this Draft CSSF 3116 Basis Document on extensive analysis and scientific rationale, using a risk-informed approach, including analyses presented in the Performance Assessment and Composite Analysis for the INTEC Calcined Solids Storage Facility at the INL Site (CSSF PA/CA).

Specifically, this Draft CSSF 3116 Basis Document shows that the CSSF bins (including integral equipment), transport lines, and any residual waste at the time of closure does not require permanent isolation in a deep geologic repository for spent fuel or HLW, and that the highly radioactive radionuclides (those radionuclides which contribute most significantly to radiological dose to workers, the public, and the environment as well as radionuclides listed in 10 CFR 61.55) will have been removed to the maximum extent practical. As also shown in the Draft CSSF 3116 Basis Document, the stabilized (grouted) CSSF stainless-steel bins (including integral equipment), transport lines, and any residual waste at CSSF closure will not exceed concentration limits for Class C LLW. Based on the analyses in the CSSF PA/CA, this Draft CSSF 3116 Basis Document projects that potential doses to a hypothetical member of the public and hypothetical inadvertent intruder after CSSF closure will be well below the doses specified in the performance objectives for disposal of LLW. Furthermore, the CSSF closure will be performed pursuant to a State-approved closure plan.

DOE is consulting with the NRC on this Draft CSSF 3116 Basis Document and also making the Draft CSSF 3116 Basis Document available for comments from states, Tribal Nations, stakeholders, and the public. After consultation with the NRC, carefully considering comments received, and performing any necessary revisions of analyses and technical documents, DOE plans to issue a Final CSSF 3116 Basis Document. Based on the Final CSSF 3116 Basis Document, the Secretary of Energy, in consultation with the NRC, may determine in the future whether the CSSF bins (including integral equipment), transport lines, and any residual waste therein are non-HLW, and may be disposed in place as LLW.

This document of the Department of Energy was signed on October 20, 2023, by Kristen Ellis, Acting Associate Principal Deputy Assistant Secretary for Regulatory and Policy Affairs, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .

1. In this proposed policy statement, we clarify how the Commission will treat the use of project-area wage standards in calculating the labor cost component of cost-of-service rates, including under Natural Gas Act (NGA) sections 4, 5, and 7, 15 U.S.C. 717c-d, 717f; the Interstate Commerce Act (ICA), 49 U.S.C. app. 1(5)(a); and Federal Power Act (FPA) sections 205 and 206, 16 U.S.C. 824d-e. 1

2. Project-area wage standards are the prevailing wages set by labor markets in the locale where the associated project work ( e.g., construction, capital repairs, decommissioning) is performed. They can be found in data sources that indicate the basic hourly wage rates and fringe benefit rates for labor, direct employees and/or contract personnel that prevail in a predetermined geographic area. For example, under the Davis-Bacon Act, the U.S. Department of Labor issues prevailing wage determinations based on periodic surveys of union and non-union wages paid in a particular location, which serve as the minimum wage that must be paid by contractors and subcontractors performing under certain federally funded or assisted construction contracts. 2 A number of states have enacted their own prevailing wage laws, sometimes referred to as “Little Davis-Bacon” laws. 3

This is a request for approval of a new collection. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. http://www.epa.gov/dockets This notice allows 60 days for public comments. Supporting documents, which explain in detail the information that the EPA will be collecting, are available in the public docket for this ICR. The docket can be viewed online at www.regulations.gov or in person at the EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone number for the Docket Center is 202-566-1744. For additional information about EPA's public docket, visit http://www.epa.gov/dockets.

Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting comments and information to enable it to: (i) evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility; (ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (iii) enhance the quality, utility, and clarity of the information to be collected; and (iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The ICR package will be submitted to OMB for review and approval.

Abstract: This supporting statement is for an Information Collection Request (ICR) for four mobile source related grant programs administered by the Transportation and Climate Division (TCD), within Environmental Protection Agency's (EPA) Office of Transportation and Air Quality (OTAQ). These four programs include: Diesel Emission Reduction Act (DERA) Grant Program, Clean School Bus (CSB) Grant Program, Clean Heavy-Duty (CHD) Grant Program, and Clean Ports Grant Program.

The DERA Grants Program and the Clean School Bus Grant Program currently collect information under an existing ICR, the General Administrative Requirements for Assistance Programs (Renewal), ICR No. 2030-0020. The EPA currently uses ICR No. 2030-0020 to collect information for most major elements of grants administration, but in order to ease the burden for applicants, awardees, and Agency staff, as well as enrich data quality across programs, the Agency needs to be able to collect information via new reporting instruments, specifically program-specific, fillable data templates. This ICR for these four programs is requesting clearance to cover fillable data templates for three phases of the grant lifecycle: initial application, quarterly reporting, and final reporting. Notably, for successful grant applicants, the information in data templates collected during the application phase of the grant lifecycle will flow into the data templates for the quarterly and final reporting periods, enabling these templates to capture data efficiently throughout the life of the entire award.

TCD uses approved procedures and forms to collect necessary information to operate its grant programs and has been providing grants under DERA since 2008. EPA is preparing to launch the 2024 Clean Port Program in late winter 2024, the 2024 Clean Heavy Duty in early spring 2024, as well as the 2024 DERA grant program in summer 2024, and overseeing the 2023 Clean School Bus Grantees, who are expected to begin reporting in mid-2024.

While these programs each have unique statutory requirements, there are key aspects that unite them as mobile source emissions reduction efforts, and by combining them as a cohort of programs under one ICR, EPA aims to enrich data quality across our programs and to ease burden on applicants and awardees considering applying for multiple programs. Additionally, collecting data via program-specific, fillable data templates that supplement the main application document will enhance the Agency's oversight of these projects as directed by Congress. Further, doing so will also provide critical real-world performance data that the Agency would not otherwise be able to procure, which can inform future research and policy decisions related to OTAQ's mission to protect human health and the environment by reducing air pollution and greenhouse gas emissions from mobile sources and advancing clean fuels and technology.

Respondents/affected entities: Entities potentially affected by this action are those interested in applying for grants under EPA's CSB, DERA, Clean Heavy Duty, and Clean Ports programs and include but are not limited to the following NAICS (North American Industry Classification System) codes: 23 Construction; 482 Rail Transportation; 483 Water Transportation; 484 Truck Transportation; 485 Transit and Ground Passenger Transportation; 4854 School and Employee Bus Transportation; 48831 Port and Harbor Operations; 61111 Elementary and Secondary Schools; 61131 Colleges, Universities, and Professional Schools; 9211 Executive, Legislative, and Other Government Support; and 9221 Justice, Public Order, and Safety Activities.

Respondent's obligation to respond: Mandatory for grant recipients.

Estimated number of respondents: 50 CSB, 112 DERA, 100 Clean Ports and 50 Clean Heavy Duty grant recipients annually.

Frequency of response: One initial report, 3 quarterly reports per year the grant is active, and one final report.

Total estimated burden: 19,701 hours (per year). Burden is defined at 5 CFR 1320.03(b).

Total estimated cost: $1,104,668 (per year), which includes $0 annualized capital or operation & maintenance costs.

Changes in the Estimates: This is a new collection.

You may be potentially affected by this action if you produce, manufacture, use, or import pesticide/agricultural chemicals and other chemical substances; or if you are or may otherwise be involved in the testing of chemical substances for potential endocrine effects. Potentially affected entities, identified by the North American Industrial Classification System (NAICS) codes, may include, but are not limited to:

• Chemical manufacturers, importers and processors (NAICS code 325), e.g., persons who manufacture, import or process chemical substances.

• Pesticide, fertilizer, and other agricultural chemical manufacturing (NAICS code 3253), e.g., persons who manufacture, import or process pesticide, fertilizer and agricultural chemicals.

• Scientific research (NAICS code 5417).

FFDCA section 408(p)(1) requires, among other things, that EPA “develop a screening program, using appropriate validated test systems and other scientifically relevant information to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as [EPA] may designate.” (21 U.S.C. 346a(p)). FFDCA sections 408(p)(2) and (p)(7) require EPA to implement the EDSP by August 1999 and report to Congress on the program's progress by August 2000, respectively.

FFDCA section 408(p)(3) requires that EPA “shall provide for the testing of all pesticide chemicals.” FFDCA section 201 defines “pesticide chemical” as “any substance that is a pesticide within the meaning of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), including all active and pesticide inert ingredients of such pesticide.” (21 U.S.C. 231(q)(1)). However, FFDCA section 408(p)(4) authorizes EPA to, by order, exempt a substance from the EDSP if the EPA “determines that the substance is anticipated not to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.” FFDCA section 408(p)(5) identifies the requirements and processes for issuing test orders, requiring testing under the EDSP, and submitting information obtained from the testing to EPA. (21 U.S.C. 346a(p)(5)). Finally, FFDCA section 408(p)(6) requires EPA to “as appropriate, take action under such statutory authority as is available to the Administrator, including consideration under other sections of this chapter, as is necessary to ensure the protection of public health” for “any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on humans.”

The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) precludes the distribution and sale of any pesticide that is not registered under FIFRA. (7 U.S.C. 136a(a)). Applications for registration of a pesticide may be submitted to EPA but must meet the requirements in FIFRA sections 3(c) and 33, which include providing complete data in support of that registration request. (7 U.S.C. 136a and 136w-8). The data required to support these applications are identified in EPA regulations at 40 CFR part 158. EPA may issue Data Call-In (DCI) notices under FIFRA section 3(c)(2)(B) to require additional data during the registration process to address a risk or after registration to maintain a registered pesticide. (7 U.S.C. 136a(c)(2)(B)). To grant a pesticide registration, FIFRA requires EPA to consider whether the pesticide has “unreasonable adverse effects” to human health and the environment. (7 U.S.C. 136a(c)(5)). FIFRA section 2(bb) defines “unreasonable adverse effects on the environment” to mean, among other things, “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” (7 U.S.C. 136(bb)). EPA is required to review each pesticide registration every 15 years to determine whether the pesticide continues to satisfy this FIFRA standard for registration. (7 U.S.C. 136a(g)). EPA regulations at 40 CFR part 155, subpart C apply to the conduct of this registration review process.

This document describes three near-term strategies the Agency is taking to further implement its obligations and commitments under FFDCA section 408(p) relating to the EDSP, which EPA established in 1998 as a two-tier endocrine screening and testing process for pesticides and other chemicals. EPA is pursuing these strategies to generate momentum toward its longer-term goal of timely addressing all its endocrine data needs and decisions.

Under strategy one, EPA will prioritize addressing potential human estrogen, androgen, and thyroid effects for conventional pesticide active ingredients. Although the Agency will continue to address wildlife endocrine effects and endocrine effects from other pesticide chemicals ( e.g., inert ingredients and active ingredients intended solely for biological or antimicrobial uses), updates and activities relating to that work are on a longer-term timeline for the reasons discussed in the strategy. Under strategy two, EPA will use existing data, routinely obtained through FIFRA registration and registration review, to determine whether additional human health-related endocrine data are needed and to make endocrine decisions under FIFRA and FFDCA section 408(p). This strategy also describes the endocrine data that EPA considers sufficient to register a new conventional active ingredient and how EPA will address endocrine data deficiencies for those registration submissions and for registration review cases. Under strategy three, EPA will phase into its registration review processes any new data requirements to address potential human estrogen, androgen, and thyroid effects for conventional pesticide active ingredients, starting with 30 registration review cases (“Group 1” cases) that EPA has identified using a new framework for prioritizing estrogen and androgen data needs. In this notice, EPA is requesting comments and the voluntary submittal of existing information on these 30 cases and, during the comment period, plans to begin preparing DCIs with the goal of issuing those them in spring of 2024 for specified EDSP Tier 1 data for these cases.

To support the strategies described in this document, EPA has posted the following three reference documents in the docket:

1. Use of Existing Mammalian Data to Address Data Needs and Decisions for Endocrine Disruptor Screening Program (EDSP) for Humans under FFDCA Section 408(p) (Ref. 1). This endocrine science paper explains when and how EPA will rely on data it has already received under FIFRA to address the data needs and decisions under FFDCA section 408(p), providing the scientific support for strategies two and three.

2. List of Conventional Registration Review Chemicals for Which an FFDCA Section 408(p)(6) Determination is Needed (Ref. 2). This paper lists each currently registered conventional pesticide active ingredient, and how the types of data EPA has for each active ingredient inform where it fits within EPA's priorities for obtaining any additional endocrine data for those pesticides in registration review. Commenters should use this list to identify the active ingredients for which EPA is seeking information through this document.

3. Status of Endocrine Disruptor Screening Program (EDSP) List 1 Screening Conclusions (Ref. 3). This paper explaining EPA's decisions under FFDCA section 408(p) relating to the human endocrine system (estrogen, androgen, and thyroid endpoints) for all 52 EDSP List 1 chemicals. In 2009, EPA published the List 1 chemicals and issued test orders for them (the original List 1 had 67 chemicals). The Agency later revised the list to 52 chemicals because 15 were canceled or discontinued. The actions to address the remaining List 1 chemicals are unrelated to the development of Group 1 chemicals in this document.

Many aspects of this document overlap with policies described in a notice issued in the Federal Register of August 11, 1998 (63 FR 42852) (FRL-6021-3) (hereinafter referred to as the “1998 Notice”), that established the basic components of the EDSP. EPA views this document as consistent with the policies in the 1998 Notice and thus is not rescinding or modifying those policies. Rather, this document augments the notice with complementary strategies and priorities that reflect advances in science, EPA's experience administering the EDSP, and the Agency's recent efforts to more quickly meet its FFDCA section 408(p) obligations and commitments.

After over two decades of implementing FFDCA section 408(p), EPA has developed the near-term strategies in this document to begin to transparently address the challenges it has encountered and rebuild the EDSP. This document explains how the Agency currently obtains and will obtain data needed to assess a conventional pesticide active ingredient's interaction with the human estrogen, androgen, and thyroid pathways, and when and how EPA intends to make the requisite FFDCA section 408(p)(6) finding that the pesticide use adequately protects human health. This document also addresses the confusion about when and how EPA obtains data in the registration and registration review processes to assess the potential for effects to the endocrine system from use of a conventional pesticide active ingredient. These near-term strategies also help EPA respond to specific recommendations in a 2021 EPA Office of Inspector General (OIG) Report to develop a strategic plan for the EDSP and to a legal complaint filed in the Federal District Court for the Northern District of California raising similar issues.

This document describes EPA's near-term strategies over the next several years to accelerate how the Agency meets its FFDCA section 408(p) obligations and commitments. The requirements in the statutes and any future FIFRA DCIs or FFDCA test orders are binding on EPA and the order recipients, respectively, but this document does not impose any binding requirements on EPA or outside parties. The strategies outlined in this document further the general goals of the program, and EPA may depart from the strategies where circumstances warrant and without prior notice. In general, however, EPA will continue to offer notice and comment on chemical-specific proposed decisions that implement these strategies.

As discussed further in strategy three of this document, EPA encourages the public to submit any relevant estrogen, androgen, and thyroid data for the Group 1 and Group 2 cases of pesticide active ingredients currently in registration review. The public may also submit any explanations for why additional endocrine data are unnecessary to inform the Agency's findings under FIFRA and FFDCA section 408(p) for potential endocrine effects in humans.

Please submit any relevant endocrine data, Other Scientifically Relevant Information (OSRI), or explanations of why the additional data are unnecessary for EPA to make its FIFRA and FFDCA section 408(p) decisions to the “Registration Review” section of EPA's Pesticide Submission Portal (PSP). The PSP can be accessed through EPA's Central Data Exchange (CDX) using the link https://cdx.epa.gov/.

Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the part or all of the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

When preparing and submitting your comments, see the commenting tips at https://www.epa.gov//commenting-epa-dockets.

Endocrine systems, also referred to as hormone systems, are found in all mammals, birds, fish, and many other living organisms. These systems are made up of glands located throughout the body, the hormones synthesized by these glands and released into the bloodstream or the fluid surrounding cells, and the receptors in various organs and tissues that recognize and respond to the hormones.

In 1996, Congress amended the FFDCA with the Food Quality Protection Act, 21 U.S.C. 346a(p), requiring EPA to develop a screening program “to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effects as [EPA] may designate.” In response, EPA established the EDSP, the basic components of which were described in the 1998 Notice (63 FR 42852). Further, when carrying out the EDSP, EPA “shall provide for the testing of all pesticide chemicals,” which includes active and inert ingredients, and “may provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance.” The FFDCA required EPA to implement the EDSP by August 1999 and report to Congress on the program's progress by August 2000. EPA met both requirements on time, as the Agency began implementing the EDSP after issuing the 1998 Federal Register Notice (the statute does not specify when implementation ends nor steps for implementing the EDSP, and thus EPA views implementation as an ongoing activity) and the Agency issued its report to Congress in August 2000.

FFDCA section 408(p) requires EPA to screen only for estrogen effects in humans that are similar to an effect produced by a naturally occurring estrogen. Through the 1998 Federal Register Notice, however, EPA permissibly expanded the scope of the EDSP in two important ways. One is to include screening for androgen and thyroid effects, based on the recommendations of the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), which EPA formed to advise on designing a screening and testing program for chemicals. EPA had explained that it will focus on estrogen, androgen, and thyroid because they are among the most studied of the approximately 50 known vertebrate hormones, with a relatively large body of relevant data and screening tests. EPA also explained that including these three hormone systems will help the Agency understand effects on reproduction, development, and growth. Further, EPA adopted the EDSTAC recommendation to screen for effects in the same endocrine systems in wildlife because adverse effects on wildlife can forewarn of potential risks to humans and because strong evidence existed for endocrine disruption from pesticides in natural wildlife and fish populations. Throughout this document, when EPA refers to section 408(p) “obligations and commitments,” the Agency is describing both the mandatory aspects of this section (obligations) and the discretionary aspects (commitments), as summarized in Table 1.

Through the 1998 Notice, EPA also adopted the EDSTAC recommendation to create a two-tier EDSP screening and testing process. The purpose of the first tier of testing (Tier 1) is to screen chemicals for the potential to interact with the estrogen, androgen, or thyroid systems and inform the need for any additional data ( e.g., Tier 2) to evaluate possible adverse effects in humans or wildlife. The purpose of Tier 2 testing is to identify, characterize, and quantify those adverse effects for risk assessment. The Tier 1 screening battery consists of 11 assays, six of which are in vivo (performed with living organisms) and five of which are in vitro (performed outside of living organisms, with biological material such as cells or tissues).

As described in its January 2023 white paper on new approach methodologies (NAMs; Ref. 4), EPA has now validated two computational models that integrate bioactivity data from multiple in vitro assays, referred to as the ToxCast Pathway Models for estrogen and androgen receptors, which can serve as alternatives to four of the 11 assays. Specifically, the validated estrogen receptor ToxCast Pathway Model can serve as an alternative for three of the Tier 1 assays that detect estrogen activity and the validated androgen receptor ToxCast Pathway Model can serve as an alternative for one of the Tier 1 assays that detect androgen activity. Research is ongoing to develop validated models as alternatives for other Tier 1 and Tier 2 assays.

Under the EDSP two-tier process, analysis of Tier 1 screening data, in conjunction with OSRI on the endocrine system, results in one of two outcomes: a recommendation for additional data ( e.g., through Tier 2 testing of the chemical) to establish a dose-response relationship for any adverse effects that may result from interactions with the endocrine system, or an explanation for why no further testing is needed to assess the chemical for potential impacts to the estrogen, androgen, and thyroid hormone pathways. If more testing is recommended, the Tier 1 analysis also informs which tests may be performed.

FFDCA section 408(p) is not limited to EDSP screening and testing, as paragraph (p)(6) also requires EPA to “as appropriate, take action under such statutory authority as is available to the Administrator, including consideration under other sections of this chapter, as is necessary to ensure the protection of public health” for “any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect on humans.” Because FFDCA section 408(p) does not itself provide legal authority to “ensure the protection of public health,” EPA must rely on authorities in other sections of FFDCA and other laws, such as FIFRA, to satisfy FFDCA section 408(p)(6). In this respect, EPA's implementation of FFDCA section 408(p) and FIFRA are closely linked.

The two are closely linked in another important manner. To meet the FIFRA requirement of ensuring that a pesticide will not cause “unreasonable adverse effects on the environment,” EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. These studies include acute, sub-chronic, and chronic toxicity, including assessments of a wide range of potential toxic effects for carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity, and other effects. These studies include endpoints that may be susceptible to endocrine influence, including effects on endocrine target organ weights and histopathology, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring.

In the past, however, EPA's Office of Pesticide Programs (OPP) has generally focused on endocrine-related activities under FIFRA separate from the EDSP testing strategy. Thus, OPP's FIFRA decisions have not been explicit about how its review of required and submitted data for FIFRA informs EPA's obligations and commitments under FFDCA section 408(p). For instance, OPP amended its FIFRA data requirements at 40 CFR part 158 to incorporate an updated reproductive study, which is the same study identified in EDSP Tier 2 and which allows the Agency to fully evaluate the potential for a conventional pesticide active ingredient to interact with the estrogen and androgen pathways. However, EPA did not explain how that effort informs the obligations and commitments under FFDCA section 408(p).

In addition, while prior FIFRA decisions often referred to the FFDCA section 408(p) screening program, those decisions have not expressly discussed whether or how the data EPA reviews for its FIFRA decisions address FFDCA section 408(p) obligations or commitments. For example, FIFRA actions protect for the most sensitive endpoints in humans, which in many cases are not endocrine endpoints. In these situations, EPA did not take the final step of explaining whether or how the FIFRA decision fully addresses the data needs and decisions under FFDCA section 408(p) and protects the public from potential endocrine effects.

One reason EPA has not completed these FFDCA section 408(p) actions is that it had focused on developing the science and technology to rapidly screen for chemicals that may have the potential to disrupt the estrogen, androgen, and thyroid systems of humans and wildlife. In recent years, for example, the Agency has focused on NAMs, particularly with high-throughput testing approaches, because of their central role in supporting the screening of the thousands of chemicals covered by the EDSP. This includes EPA testing of over 1,800 chemicals using the estrogen receptor and androgen receptor ToxCast Pathway Models, which, as explained in a separate white paper previously released, fulfill the data needs for four separate EDSP Tier 1 assays for those chemicals. Through the strategies in this document, EPA is planning to expand the scope of its EDSP work to emphasize obtaining any additional human endocrine data as part of the Agency's FIFRA decisions and to issue FFDCA section 408(p)(6) decisions where possible.

The issues discussed earlier have led to confusion and criticism about the extent to which EPA has implemented FFDCA section 408(p) for pesticides. These criticisms have included concerns that EPA has been failing to obtain data and assess whether a pesticide active ingredient may cause adverse endocrine effects at the regulated levels and failing to make decisions under FFDCA section 408(p)(6) that consider those data and effects. In addition, EPA understands that some stakeholders have heard different messages over the years about whether EPA would require Tier 1 data when it has adequate Tier 2 data to make FIFRA determinations and FFDCA section 408(p) findings. Through this notice, EPA seeks to transparently address some of these criticisms and concerns.

In July 2021, EPA's OIG issued a report concluding that the Agency has made limited progress in implementing the EDSP (Ref. 5). The report identified several reasons for this limited progress, including delays in testing pesticides for endocrine disruption, and lack of strategic guidance, performance measures, and other actions needed to implement the EDSP. The report offered ten recommendations for OCSPP, which the office generally agreed with and proposed to address. This document represents the Agency's strategic plan for rebuilding the EDSP that OCSPP will augment in the future. OCSPP has also begun implementing several other OIG recommendations, including publishing an EDSP white paper on NAMs, conducting an annual internal program review, and periodically updating the program website.

In December 2022, EPA received a complaint in Alianza Nacional de Campesinas et al. v. EPA, alleging that EPA has violated the FFDCA and Administrative Procedures Act by not implementing the EDSP and not testing all pesticide chemicals for possible endocrine effects. (Ref. 6).

EPA recognizes that its past practice has created questions about whether and how the Agency has been implementing FFDCA section 408(p), and now seeks to address these questions and accelerate progress in further implementing the EDSP, beginning with the three strategies described in this section. Before discussing the strategies, EPA is identifying the two overall approaches for expediting its ability to meet its FFDCA section 408(p) obligations and commitments.

EPA will use the FIFRA registration and registration review processes to obtain data as needed to assess potential human estrogen, androgen, and thyroid effects for its FIFRA and FFDCA section 408(p) decisions. In general, EPA is already receiving some endocrine data through these processes as part of its standard FIFRA processes and regulatory data requirements. For example, for over a decade, EPA has routinely received data on mammalian estrogen and androgen effects for new conventional pesticide registrations through either a two-generation reproductive study (typically performed in the rat (Ref. 7)) or an extended one-generation reproductive toxicity (EOGRT) study (also normally performed in the rat) (Organization for Economic Cooperation and Development (OECD) TG443) (Ref. 8). In these situations, EPA will generally not need to obtain additional data for these endpoints, including Tier 1 data, as explained in strategy three. Further, EPA understands that some registrants may have generated endocrine data to meet registration requirements in other countries but never submitted those data to EPA. EPA will consider those data, if submitted, to assess the need for additional endocrine data and to make the relevant FIFRA and FFDCA section 408(p) decisions, while avoiding unnecessary duplicative testing.

Where EPA has identified outstanding endocrine data needs for a pesticide active ingredient, it will generally obtain the data through the FIFRA registration or registration review process, rather than through the FFDCA section 408(p)(5) process for issuing FFDCA test orders, as EPA already has a well-established process of seeking data through FIFRA. Further, EPA will generally obtain the data based on prioritized lists of pesticide active ingredients that it has begun developing and describes in strategy three.

For conventional pesticide active ingredients, EPA will integrate its FFDCA section 408(p) endocrine data and decisions into its FIFRA decisions, so that the Agency can efficiently use its FIFRA process and timelines to also address its FFDCA obligations and commitments for those chemicals. This approach will significantly increase EPA's consistency and transparency about how and when the Agency is meeting its FFDCA section 408(p) obligations and commitments as part of FIFRA decisions.

Moving forward, when EPA has addressed those obligations and commitments for a pesticide active ingredient, it will clearly indicate that it has sufficient endocrine data and completed taking action under FFDCA section 408(p)(6) to “ensure the protection of public health.” This can occur in one of three scenarios. In scenario one, the most sensitive human endpoint identified in the pesticide's database is not an endocrine endpoint and is protective of endocrine effects at higher doses, if any are present. In scenario two, EPA exempts a pesticide active ingredient from the requirements of FFDCA section 408(p) because the Agency determines that the chemical meets the section 408(p)(4) statutory standard that it “is anticipated not to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.” In its 2023 decision for citric acid, for instance, EPA concluded the acid is not anticipated to produce in humans or other organisms any effect similar to an effect produced by naturally occurring estrogen, androgen, or thyroid hormones, because it has no endocrine activity and no toxic effects at levels that people consume (Ref. 9).

In both scenarios, EPA will issue a determination as part of a FIFRA decision for a pesticide that the Agency has completed taking action under FFDCA section 408(p)(6) to “ensure the protection of public health” by regulating exposure based on the most sensitive endpoint. Although FFDCA section 408(p)(6) does not obligate EPA to issue this determination and explanation, EPA is committing to do so because the Agency recognizes the benefits of more clarity and transparency about how it implements FFDCA section 408(p). This is another example where EPA distinguishes between mandatory obligations and discretionary commitments, as summarized in Table 1.

In scenario three, an endocrine effect is the most sensitive endpoint, so EPA would directly regulate to protect against that effect and issue a determination that it has completed taking action under FFDCA section 408(p)(6) through its FIFRA decision that uses the endocrine endpoint to regulate exposure to that pesticide. For example, the thyroid is a target organ for the insecticide fipronil, and thyroid effects were used as the basis for deriving most of the risk assessment endpoints and points of departure in the most recent human health risk assessment for this chemical (Ref. 10).

Throughout this document, when EPA refers to a FFDCA section 408(p)(6) “decision,” it is referring to one of these three scenarios. Strategies two and three explain when and how EPA will integrate these FFDCA section 408(p) data and decisions into its FIFRA registration and registration review decisions for conventional pesticide active ingredients.

In implementing these strategies, EPA recognizes that it cannot address all past and present challenges simultaneously. For example, EPA is concerned about overwhelming the capacity of testing laboratories if it were to immediately impose testing for the hundreds of pesticide active ingredients in registration review. In addition, EPA does not have the resources to immediately assess each active ingredient case to identify all endocrine data gaps and to begin obtaining all outstanding data immediately. Thus, EPA developed this document to help prioritize how the Agency will implement these strategies. To summarize, the three strategies discussed are as follows:

• EPA will prioritize addressing potential human estrogen, androgen, and thyroid effects for conventional pesticide active ingredients (see strategy one), starting with the use of existing data routinely obtained through FIFRA registration and registration review activities, to determine whether additional endocrine data are needed (see strategy two).

• If existing data are adequate to inform the FFDCA section 408(p)(6) and FIFRA decisions for any of the three endocrine pathways, EPA will make those decisions without obtaining additional endocrine data for that pathway ( e.g., Tier 1), because any additional data would be duplicative and would not alter those decisions (see strategy three).

• EPA will continue to require that all applications for conventional new active ingredient registrations include adequate data to assess potential interaction with the human estrogen, androgen, and thyroid pathways. Those data will inform the FIFRA registration decision, which will include whether or how it addresses FFDCA section 408(p) endocrine data and decisions (see strategy two).

Similarly, to ensure all existing registrations for conventional pesticide active ingredients are supported by adequate human health-related endocrine data, EPA will phase into the registration review process, using the framework discussed in this document (see strategy three), any additional data needs for evaluating potential interaction with human estrogen, androgen, and thyroid pathways. For 30 high priority conventional pesticide active ingredients, however, EPA is seeking any comments, existing endocrine data, and explanations on the need for additional endocrine data for any chemical on this list. During the public comment period, EPA will initiate the process for issuing DCIs in spring 2024 to require specified data for each of these active ingredients to address gaps in the data. EPA expects to include in the DCIs for these chemicals the requirement for the following EDSP Tier 1 studies or equivalent data: steroidogenesis, aromatase, Hershberger, female rat pubertal, and male rat pubertal studies. EPA also expects to include in the DCIs the potential for requiring submission of Tier 2 studies, based on the results of the Tier 1 studies submitted and any OSRI that may inform the weight-of-evidence analyses on those data. In the alternative, EPA expects to accept Tier 2 data in response to the DCIs to assess for potential effects to the estrogen and androgen pathways. Thus, if EPA receives an acceptable two-generation reproductive or EOGRT study, the study would fully satisfy the EDSP Tier 1 DCI for estrogen and androgen endpoints. As discussed in strategy three, EPA has prioritized the 30 chemicals because it lacks sufficient Tier 2 data for the chemicals but does have screening-level data indicating potential activity in the mammalian estrogen and/or androgen system. Further, as with new conventional active ingredient applications, EPA will explain in registration review documents for conventional active ingredients whether or how EPA's assessment or decision addresses FFDCA section 408(p) data and decisions.

EPA's resources for the EDSP are limited, so the Agency must prioritize which aspects of the EDSP to address first. For these near-term strategies, EPA has prioritized the registration of new conventional active ingredients and the registration review of conventional active ingredients, because they comprise the majority of registered active ingredients. The strategies are not intended to apply at this time to pesticide active ingredients that are solely intended for biological and antimicrobial uses or inert ingredients. Those ingredients span a wider range of uses and modes of action and can often present very different chemistries than conventional pesticides. EPA is still evaluating how best to prioritize human endocrine assessments for those active and inert ingredients and to develop strategies for the chemicals.

The FFDCA section 408(p)(1) mandate is limited to developing a screening program to identify potential estrogen effects in humans, but EPA in 1998 expanded the scope of the program to include potential androgen and thyroid effects in humans and potential wildlife estrogen, androgen, and thyroid effects. Because of limited resources, however, EPA will initially focus on ensuring that the potential for human endocrine effects is transparently and sufficiently addressed for conventional pesticide active ingredients.

Meanwhile, EPA will maintain its current approach in its FIFRA decisions of addressing wildlife endocrine effects if it already has adequate endocrine data for a species or group of species, supported by multiple lines of scientific evidence, as part of a new conventional registration or registration review action. EPA will also prioritize resources for research and risk assessment methods development to better understand endocrine effects in wildlife.

There are several reasons for this decision to first address EPA's statutory requirement to more fully assess human endocrine effects before assessing discretionary wildlife effects. First, EPA's scientific understanding of the impacts of chemical interactions on the human endocrine system is generally more developed than for most wildlife. Thus, the data and science currently available to EPA enable the Agency to make progress in evaluating effects on humans using the approaches presented in this document. This is especially true considering the large number of non-mammalian species that are covered by the EDSP ( e.g., birds, fish, amphibians). Second, EPA is already taking unprecedented steps to reduce pesticide exposure to wildlife through its work under FIFRA and the Endangered Species Act (ESA) (16 U.S.C. 1531 et seq. ). Through its ESA-FIFRA Workplan released in April 2022 and subsequent updates, EPA has prioritized mitigating pesticide effects on endangered species earlier in the FIFRA registration and registration review processes (Ref. 11). In addition, EPA has developed and will be implementing FIFRA Interim Ecological Mitigation measures for agricultural crop uses of conventional pesticide active ingredients in registration review. EPA expects that these mitigation measures will reduce pesticide exposures for ESA-listed species. EPA is also pursuing several pilot projects to expedite mitigation for listed species ( e.g., herbicide strategy, Hawaiian species initiative) and continuing to implement the mitigation measures from ESA biological opinions for individual pesticide active ingredients, such as certain organophosphates (Ref. 11). These mitigation measures are also expected to reduce pesticide exposure to wildlife, which will also reduce the potential for endocrine disruption.

EPA will continue to advance the science and develop strategies to consider the potential for endocrine effects on wildlife under the EDSP. For example, as outlined in the EDSP NAMs white paper, EPA is continuing to refine and apply species extrapolation processes and tools, which will help EPA understand how test results on laboratory animals extrapolate to effects on wildlife (Ref. 4). EPA is also involved in international efforts to assess the addition of thyroid endpoints to fish assays and tests that are commonly submitted to support pesticide registrations. Lastly, EPA is building datasets to support the development and validation of models that would allow in vitro to in vivo extrapolation for Tier 1 ecological studies. EPA will further discuss its approach to wildlife under the EDSP in future strategy documents. For the remainder of this document, all discussions are limited to the human endocrine system.

As a key part of rebuilding the EDSP, EPA is committing to transparency when assessing the adequacy of data on whether a conventional pesticide active ingredient has the potential to interact with the estrogen, androgen, and thyroid pathways. EPA is also committing to ensure that when it authorizes a new pesticide through registration and reauthorizes its use through registration review, those decisions adequately protect human health, as required by FFDCA section 408(p)(6). EPA can make these determinations more promptly when they are based on existing data, supplemented by targeted requests for additional data and explanations to address any potential data gaps. In most cases, the existing data will already have been submitted through registration or registration review to inform the FIFRA unreasonable adverse effects finding.

In this strategy, EPA explains the overall status of what data are already typically available to the Agency on conventional pesticide active ingredients as part of its registration and registration review program. If EPA determines that available Tier 2 or other data are sufficient to fully inform the FIFRA registration/registration review and FFDCA section 408(p)(6) decisions for estrogen, androgen, and thyroid pathways, EPA will make the decisions without seeking additional EDSP Tier 1 data. In contrast, if EPA determines that additional data are needed to make the decisions, EPA will base the next steps and timing for those steps on the priority group in which the chemical belongs, as further discussed subsequently in this document.

To inform when and how EPA will use existing FIFRA data or OSRI to determine whether a pesticide has a potential endocrine effect under FFDCA section 408(p), EPA has prepared a science support paper (Ref. 1), which is available in the docket and briefly summarized in this strategy. That paper explains the data typically submitted to EPA that will meet EPA's needs for evaluating potential interaction with human estrogen, androgen, and thyroid pathways. EPA is separating its discussion of estrogen and androgen data from thyroid data because the data on estrogen and androgen are often generated together and separate from thyroid data. As discussed further subsequently in this document, EPA plans to reevaluate its approach to assessing any additional thyroid data needs in the coming years.

EPA created the two-tier EDSP system in 1998 as one way to screen and prioritize testing for the thousands of chemicals that required screening. The goal was to limit the more expensive and lengthier Tier 2 testing by using Tier 1 screening to eliminate Tier 2 testing requirements for chemicals that had no potential to affect the human endocrine system. Since 1998, however, EPA has obtained additional data for many pesticide active ingredients through registration or registration review, because those data are also important to evaluate whether a pesticide meets the FIFRA registration standard. Specifically, in 1998, EPA updated its guidelines for the two-generation reproductive study (OCSPP 850.3800). Soon after this update, EPA required the updated study to be submitted for all new registrations of conventional pesticide active ingredients. In addition, in some cases EPA may have also received the updated study for pesticides registered before the guideline update. The updated reproductive study is the same as what EPA would have required through Tier 2 testing to determine effects on human estrogen and androgen pathways, as explained in the science support paper (Ref. 1). Similarly, for some newer pesticide active ingredients, EPA has received a rodent EOGRT study instead of an updated two-generation reproductive study. The EOGRT study provides the same estrogen and androgen data as the updated reproductive study, and thus EPA also considers the EOGRT study as a validated alternative to satisfy the Tier 2 and FIFRA data needs (Ref. 1). There may also be OSRI (such as a study submitted to meet other countries' regulatory requirements) that might meet the data needs that the Tier 2 mammalian study is designed to fulfill.

Further, if EPA has adequate Tier 2 data, it does not expect that Tier 1 data are needed to inform FFDCA section 408(p)(6) decisions for human estrogen and androgen effects and FIFRA unreasonable adverse effects determinations. EPA recognized this relationship between EDSP Tier 1 and Tier 2 data in the 1998 Federal Register Notice (Ref. 12) with the conceptual framework for the EDSP, which states that “the outcome of Tier 2 is designed to be conclusive in relation to the outcome of Tier 1 and any other prior information. Thus, a negative outcome in Tier 2 will supersede a positive outcome in Tier 1.” Consistent with this statement, when EPA has either an updated two-generation reproductive or EOGRT study, only in exceptional situations would the Agency need to consider OSRI or require more data ( e.g., Tier 1 data) to assess for interaction with the estrogen or androgen pathway. For example, if the outcome of a two-generation reproductive study is ambiguous or inconclusive for one or more endocrine endpoints, EPA may consider whether OSRI addresses the ambiguity or inconclusiveness. This strategy clarifies that when EPA concludes that the two-generation reproductive study, EOGRT study, or OSRI are adequate to assess a conventional pesticide active ingredient for interaction with the estrogen or androgen pathway, it will explicitly make that determination as part of a FIFRA assessment and the accompanying registration or registration review decision. In those situations, EPA will not need or require EDSP Tier 1 data under FIFRA or FFDCA section 408(p)(5).

Based on this analysis, for new pesticide active ingredient registrations, EPA will continue to require the updated two-generation reproductive study, the alternative EOGRT study, or equivalent data. Applications for new conventional pesticide active ingredients that are not accompanied by either study or equivalent data will be deemed incomplete and unacceptable for further review.

For conventional active ingredients in registration review, EPA will first determine whether an updated reproductive or EOGRT study is available and adequate to assess for interaction with the estrogen and androgen pathways. Among the approximately 460 conventional active ingredient cases currently in registration review, EPA has received acceptable updated two-generation reproductive or EOGRT studies for approximately 90 (20%) cases. This is only an estimate based on EPA's initial analysis and will change over time.

For the remaining conventional registration review cases without the updated two-generation reproductive or EOGRT study, EPA's approach will depend on which of three groups the chemical belongs to, as discussed in strategy three. To help implement these next steps, EPA will use its Endocrine Disruptor Science Policy Council (EDSPOC), established in 2022 to review hazard and exposure data and to recommend whether to exempt a pesticide under FFDCA section 408(p)(4). The EDSPOC will recommend whether additional Tier 2 data are needed based on its review of comments and data submitted in response to this document, future DCIs for endocrine data, and all existing data for pesticides for which the Agency lacks either an updated two-generation reproductive or EOGRT study. This issue is discussed in the science support paper (Ref. 1).

Unlike the estrogen and androgen pathways, a Tier 2 assay for thyroid was not established at the time of the EDSP's creation in 1998. At the time, only the Tier 1 rat pubertal assays provided thyroid evaluation in the EDSP battery. In 2005, EPA released its “Guidance for Thyroid Assays in Pregnant Animals, Fetuses and Postnatal Animals, and Adult Animals” (Ref. 13), which was used to develop studies to evaluate lifestage sensitivity to thyroid effects. This includes the EOGRT study that the OECD adopted in 2011 and the comparative thyroid assay (CTA). Both studies evaluate the same endpoints as the Tier 1 rat pubertal assays for adult animals, while providing additional information on thyroid toxicity at various stages of an animal's life. If a registrant has submitted an acceptable EOGRT study with a thyroid evaluation or a CTA, EPA does not expect to need Tier 1 or other data to inform its FFDCA section 408(p)(6) decision for thyroid effects, unless the Agency identifies an issue that warrants additional lifestage information.

EPA recognizes that studies such as the EOGRT and CTA are animal and resource intensive, and certain endpoint data may be difficult to obtain ( e.g., advanced techniques necessary for small blood volumes particularly in young animals, limited number of laboratories capable of properly conducting studies). As a result, EPA does not require either of these studies for all pesticide active ingredients unless data indicate such a need. Currently, EPA evaluates all available thyroid data during registration or registration review to assess whether evidence exists that a chemical may cause adverse thyroid effects and determine whether additional thyroid information is needed. This includes data from several studies required under FIFRA ( e.g., subchronic, chronic, and carcinogenicity) for conventional pesticide active ingredients that evaluate potential thyroid toxicity. Measurements in these studies typically include thyroid organ weights and histopathology ( e.g., colloid amount, follicular cell height and shape) that can detect changes associated with thyroid hormone perturbations. For some of these conventional pesticide active ingredients, registrants also submit optional thyroid hormone data to EPA to provide additional characterization of potential thyroid toxicity. Additionally, EPA may also consider data from EDSP Tier 1 rat pubertal assays or OSRI that provide thyroid evaluation. These data are predominantly obtained from guideline studies in rats, which are recognized as a sensitive animal model for humans, as discussed in the science support paper (Ref. 9). Thus, a lack of thyroid toxicity in these rat studies provides a strong basis for concluding a lack of concern for thyroid toxicity in humans and thus a sufficient basis for FIFRA and FFDCA section 408(p)(6) findings. This strategy clarifies that if EPA finds no evidence of thyroid toxicity, then it will conclude that no further data are needed at that time under FIFRA and FFDCA section 408(p) to assess the conventional pesticide active ingredient for thyroid toxicity. The registration and registration review documents will explain that conclusion.

In contrast, if EPA determines that there is evidence of thyroid toxicity, EPA will refer the case to the Hazard and Science Policy Council (HASPOC), an internal peer review council that addresses whether additional data may be necessary to evaluate the potential of an active ingredient to interact with the thyroid pathway. HASPOC takes a weight-of-evidence approach to determine whether additional thyroid information is needed considering data from multiple lines of evidence, such as physical-chemical properties, toxicity of the chemical and any structurally related chemicals, exposure from the registered use pattern, and estimated risks. HASPOC has predominantly considered the need for a CTA to obtain lifestage specific thyroid measurements, including thyroid hormones. Depending on the available data, however, EPA may seek additional thyroid data for screening the chemical before requiring lifestage information. If the HASPOC concludes that no further data are needed at that time under FIFRA and FFDCA section 408(p) to assess the conventional pesticide active ingredient for thyroid effects, the EPA registration or registration review documents will explain that conclusion. If substantial new information is raised in the future calling into question these FIFRA and FFDCA findings, EPA can address the issue at that time, as appropriate to the circumstances.

EPA believes that there may be existing studies with thyroid measurements, such as EDSP Tier 1 rat pubertal assays or EOGRT studies, that EPA had not yet specifically requested. Additionally, although thyroid hormone and organ weight measures are not required as part of the EPA rat subchronic toxicity test guidelines (OCSPP 870.3050, 870.3100), registrants may submit existing or future studies that follow the OECD guidelines to support pesticide registrations. In 2018, the OECD updated its guidelines for the 28-day and 90-day rat subchronic studies (TGs 407 and 408 (Refs. 14 and 15, respectively)) to measure thyroid hormones and organ weight, in addition to the previously required thyroid histopathology evaluations in those guidelines, to detect perturbations to the thyroid pathway. EPA anticipates that as more pesticide applications are submitted consistent with the OECD guidelines, EPA will receive additional thyroid-related data, which will be consistent with the data obtained from the Tier 1 rat pubertal assays.

As of 2023, most new conventional pesticide active ingredient registration submissions that EPA receives have not followed the voluntary 2018 OECD guidelines for the subchronic rodent oral toxicity studies. One reason is that EPA regulations allow registrants, consistent with the OECD agreement on Mutual Acceptance of Data, to decide whether to follow the EPA or the OECD guidelines for the subchronic rodent oral toxicity studies. A second reason is that registrants typically perform these types of studies many years before they submit a registration application package to EPA. The Agency expects within the next few years to begin receiving more FIFRA new pesticide active ingredient applications with studies that follow the 2018 OECD guidelines for subchronic rodent oral toxicity studies that will contain these additional thyroid-related measures.

EPA is actively considering potential revisions to its current framework for thyroid data needs, including scientific advancements and potential to require additional thyroid measures. As described in the EDSP white paper on NAMs (Ref. 4), EPA has ongoing research to develop high-throughput screening assays for thyroid-relevant targets, and models to predict thyroid-related apical outcomes ( e.g., growth, reproduction). Further, EPA is collaborating in international efforts to advance NAMs for thyroid effects. EPA needs additional research and peer review before it can include these NAMs in the EDSP. Thus, EPA expects to convene a FIFRA Scientific Advisory Panel (SAP) (anticipated in 2025) to obtain external peer review on potential revisions to the thyroid framework and may alter its approach after the FIFRA SAP review.

Strategy two pertains to situations where EPA can clearly use existing endocrine data, but in some situations further analysis of available data will lead EPA to determine that data gaps exist. For example, EPA estimates approximately 317 conventional pesticide cases in registration review that lack an updated, post-1998 two-generation reproductive or EOGRT study. Compared to the updated guideline reproductive study that provides Tier 2 test data (Ref. 7), the pre-1998 study likely did not evaluate all the endocrine-related endpoints that were added to the test guideline in 1998. As a result, for these pesticides, EPA will need to assess the results of the pre-1998 study along with any OSRI to determine the need for additional data on the potential for estrogen and androgen effects. What constitutes additional data will depend on the extent of missing information as described in more detail in strategy three. In general, EPA will seek Tier 1 data or OSRI to augment the data obtained from the pre-1998 reproductive study. Although both FIFRA section 3(c) and FFDCA section 408(p) provide authority for EPA to obtain any additional needed endocrine data, EPA already has an established FIFRA process under section 3(c) to obtain data, so the Agency will generally use this process rather than the FFDCA process.

Thus far, the discussion of Tier 1 data has been limited to whether EPA needs those data when it has adequate Tier 2 data or OSRI to assess potential effects on the human endocrine system. This is a result of the structure of the two-tier EDSP that EPA developed in 1998. More generally, however, the data listed in EDSP Tier 1 may be developed independently of the EDSP and, thus, may also inform aspects of risk assessment unrelated to FFDCA section 408(p). One potential role is to inform the required FFDCA cumulative effects analysis of whether a substance “may have an effect that is cumulative to the effect of a pesticide chemical.” To the extent such Tier 1 data has already been submitted (or is submitted) to EPA for purposes of the EDSP, EPA may find that data useful for informing other aspects of risk assessment. If EPA needs similar data in those or other situations, it can obtain them under FIFRA or provisions of the FFDCA unrelated to the EDSP, although it would not be called “Tier 1 data” per se. Because this document covers only the initial rebuilding of the EDSP, it does not address potential uses of that type of data for non-EDSP uses.

To summarize, the key parts of strategy two are as follows:

• For human estrogen and androgen effects, if EPA has an adequate updated two-generation or EOGRT study to support a new conventional pesticide active ingredient application or a currently registered conventional pesticide active ingredient in registration review, then it will likely conclude that it has sufficient data to inform its FIFRA and its FFDCA section 408(p)(6) decisions for potential human estrogen and androgen effects. In those case, EPA will not seek Tier 1 data to complete those decisions.

• Consistent with current practice, new conventional pesticide active ingredient applications will be deemed incomplete if EPA has neither an adequate updated two-generation or EOGRT study, or equivalent data. Those applications will not proceed through the registration process.

• For currently registered conventional pesticide active ingredients, strategy three explains how EPA will prioritize these pesticides to determine whether and what additional data it needs. In general, EPA will prioritize an active ingredient that lacks an adequate updated two-generation or EOGRT study (which will likely be the case for pesticides registered before 1998), if EPA determines available data are inadequate or insufficient to address interaction on the estrogen and androgen pathway.

• For human thyroid effects, if EPA has an acceptable CTA or EOGRT study with thyroid evaluations, then it will likely have sufficient thyroid toxicity data to inform its FIFRA and FFDCA 408(p)(6) decisions for potential human thyroid effects, and EPA will not seek Tier 1 data to support those decisions. When neither of these studies are available, EPA will continue with its current approach of evaluating the available data for each pesticide active ingredient. If no evidence exists of thyroid-related toxicity or if HASPOC has not recommended requiring additional data ( e.g., CTA) based on the weight-of-the evidence evaluation, then EPA will include in its FIFRA assessments and accompanying registration or registration review decision an explanation for why the available data are sufficient to inform its FIFRA and its FFDCA section 408(p)(6) decisions for thyroid. In these cases, EPA will not need Tier 1 data for thyroid. If HASPOC recommends additional thyroid data, OPP's regulatory divisions will review the recommendation during the registration or registration review process for the pesticide to determine whether or when to issue a DCI for the additional needed thyroid data. EPA may alter its approach to determining additional thyroid data needs following the FIFRA SAP review (anticipated in 2025) of potential revisions to its thyroid framework.

EPA's longstanding goal is for its registration review final decisions to include decisions under FFDCA section 408(p) for potential human estrogen, androgen, and thyroid effects. To continue fulfilling this goal, EPA has created a framework for conventional pesticides awaiting human endocrine decisions that prioritizes obtaining new data based on whether EPA already has data for the pesticide and, if so, whether the data indicate a potential for endocrine disruption. Depending on the answers to these questions, EPA has assigned each conventional active ingredient in registration review into one of three groups. For example, Group 1, which consists of 30 cases, is the highest priority for potential data collection.

Where possible, EPA's goal is to incorporate any data requirements for additional estrogen, androgen, and thyroid data into the start of registration review cases, as EPA does for other potential human health effects. Where the current registration review case is farther along in registration review, EPA will address any additional endocrine data needs by issuing a DCI, as appropriate, in later stages of registration review for a chemical.

The number of registration review cases presented in this section is an approximation and subject to change. Readers should not focus on the number of cases for exactness and instead use them to gain a general understanding of the number of cases currently in registration review that are priorities for further human endocrine screening and decisions. In the future, EPA plans to revise the registration review website to include updates of the number of cases presented in this section.

EPA has developed the framework that EPA will be using to determine which conventional pesticides in registration review require additional estrogen and androgen data for human health effects and how the Agency will prioritize obtaining additional data through DCIs (as discussed in strategy two, EPA will continue its current approach for thyroid). The framework represents EPA's initial approach to organize and prioritize the large number of registration review pesticides for any additional estrogen and androgen data and regulatory decisions, and may evolve as EPA gains experience implementing it. See Figure 1. in Ref. 2 for a diagram of the framework used for prioritizing the 403 conventional pesticide cases currently in registration review for which an FFDCA section 406(p)(6) determination is needed.

EPA has 459 conventional pesticide cases currently in registration review that have neither a registration review final decision nor an FFDCA section 408(p)(6) decision. These cases cover pesticides registered before October 2007 (with a current registration review deadline of October 2026) and some pesticides registered after this date. There are seven cases for which EPA has exempted the pesticide active ingredient from testing under FFDCA section 408(p)(4), and 49 cases from List 1 that EPA is addressing separate from this framework (see List 1 decision memo (Ref. 3)). That leaves 403 cases currently in registration review for further consideration of whether and when to require additional endocrine data. A pesticide registration review case is comprised of one or multiple pesticide active ingredients depending on the case. Many conventional pesticide cases have only one active ingredient.

Table 2 includes estimates of the number of conventional pesticide cases currently in registration review for which an FFDCA section 406(p)(6) determination is needed. EPA is addressing List 1 pesticides separately in the List 1 decision memo (Ref. 3).

As previously stated and further explained in the science support paper, either an updated two-generation reproductive or EOGRT study will generally provide sufficient data on potential estrogen and androgen effects in humans. The Agency has data from at least one of these studies for 86 of the 403 cases (82 cases with the updated reproductive study and 4 cases with the EOGRT study) (Ref. 2).

, and EPA expects to make FFDCA section 408(p)(6) decisions for these human endocrine effects as part of registration review for these pesticides without seeking further estrogen or androgen data.

For the remaining 317 cases without either study, EPA then determined whether it has data on the estrogen receptor and androgen receptor from the ToxCast Pathway Models. The ToxCast program, which generates high throughput data for chemicals of interest to EPA, has produced endocrine screening data for over 1,800 chemicals to inform the estrogen receptor and androgen receptor ToxCast Pathway Models. For 191 of the 317 cases, EPA has ToxCast Pathway Model scores for the estrogen receptor, androgen receptor, or both. The ToxCast Pathway Model scores for 30 of these 191 cases show bioactivity that may provide evidence for a potential effect on estrogen, androgen, or both, indicating the need for additional data to evaluate the potential to interact with the estrogen, androgen, or both pathways (the remaining 161 of the 317 cases without positive ToxCast data are discussed later in this section). EPA is seeking through this notice any Tier 1 data, OSRI, or explanation of how existing data address the ToxCast Pathway Model scores, in order to determine whether there is actually a potential for an estrogen-androgen effect for these 30 cases. During the public comment period, EPA will initiate the process for issuing DCIs for these cases by spring 2024. Because the cases show the potential for endocrine activity, EPA considers them the highest priority for obtaining additional data and will refer to them as “Group 1” cases.

For the remaining 126 of 317 cases, ToxCast Pathway Model scores were not available for the estrogen receptor or androgen receptor. These chemicals are also high priorities for obtaining data, but not as high as Group 1 cases because data currently exist that demonstrate potential activity in the ToxCast models for the Group 1 cases. EPA considers these 126 cases “Group 2” for assessment and potential data collection. While the Agency prioritizes Group 1 cases, it will refine the Group 2 cases as follows. First, EPA will determine whether any of the active ingredients for those cases are exempt from further testing under FFDCA section 408(p)(4) because the Agency has determined that an active ingredient “is anticipated not to produce any effect in humans similar to an effect produced by a naturally occurring estrogen.” If so, EPA will exempt the active ingredient and explain its decision. Second, for the remaining cases, EPA will search for any existing estrogen or androgen data and evaluate its potential as OSRI. EPA will then determine whether further testing is needed for each of the remaining cases to make an FFDCA section 408(p) determination.

Among the 191 cases with ToxCast data, there are 161 cases that show no activity for either estrogen or androgen receptors. EPA has assigned these pesticides a lower priority for obtaining additional data, given current data suggest no potential for estrogen or androgen activity, and is referring to these 161 cases as “Group 3.” In the docket is a document titled, “List of Conventional Registration Review Chemicals for Which an FFDCA Section 408(p)(6) Determination is Needed,” that lists the pesticide cases that fall within each group, accounting for all 403 registration review cases discussed in this strategy (Ref. 2).

For the 30 Group 1 cases, EPA will seek additional data to better understand the positive findings in the ToxCast data for estrogen, androgen, or both. Specifically, for each pesticide, EPA is seeking through this notice any Tier 1 data, OSRI, or explanation of how existing data address the existing ToxCast Pathway Model scores. During this public comment period, EPA will begin the process for issuing DCIs for these 30 cases with the goal to begin issuing them in spring 2024. The DCIs will cover all the Tier 1 data relevant to mammals, except the assays for which the ToxCast Pathway Model scores may serve as alternatives ( i.e., estrogen receptor binding in vitro assay, estrogen receptor transcriptional activation in vitro assay, in vivo uterotrophic assay, and androgen receptor binding in vitro assay). Thus, as part of a DCI, EPA will require data from the following five Tier 1 assays to complete screening for estrogen and androgen effects in humans: Steroidogenesis, aromatase, Hershberger, female rat pubertal, and male rat pubertal (see Table 3). In lieu of all five Tier 1 assays, EPA expects to allow a registrant, in response to a DCI, to submit an updated two-generation reproductive or EOGRT study, or equivalent data, which will generally provide conclusive data for potential estrogen and androgen effects in humans. The DCIs will be based on the Pesticide Data Call-Ins Information Collection Request (EPA No. 2288.04).

As EPA receives data for the Group 1 cases through public comments and any DCIs, it will determine the most efficient way to review the data and integrate them into the registration review process so that the Agency can issue its FIFRA and FFDCA section 408(p) findings for potential human estrogen, androgen, and thyroid effects. EPA must consider multiple factors when developing this timeline, including efficiencies in batching similar chemicals, the timing of when the Agency will receive and review data for other EDSP priority pesticides, the length of time needed to generate the data, the deadlines to complete other aspects of registration review for a pesticide, and the timeframe for amending pesticide labels to reflect any needed updated mitigation measures. EPA expects to release a more detailed timeline in 2024.

EPA is not initiating the process for issuing DCIs for Group 2 cases at this time because the Agency's resources are currently limited to obtaining and reviewing additional data for the Group 1 cases. The more immediate focus on Group 1 cases will also allow EPA to apply any lessons learned in collecting and reviewing data for Group 1 to Group 2 cases. Although EPA does not yet have a precise timeframe for issuing FIFRA DCIs for these cases, it expects to begin drafting them in 2025.

In the meantime, the Agency will make some progress on Group 2 cases in two ways. One is to consider any endocrine data or OSRI that registrants of these pesticides submit to EPA. As with Group 1 cases, EPA is particularly interested in any existing Tier 1 or Tier 2 data that the Agency is unaware of, endocrine data submitted to support distribution and use of the pesticide in other countries, or data from well-conducted studies addressing the pesticide active ingredient's endocrine effects. Although EPA cannot yet commit to reviewing these data within a specific timeframe, the Agency believes it may be useful to, at a minimum, gain a better understanding of the breadth and depth of available data for these pesticides before issuing DCIs. Thus, as with the Group 1 cases, EPA encourages registrants of Group 2 pesticides to identify and submit any relevant endocrine data that have not been submitted to EPA or any explanations for why further testing should not be required.

Second, given the large number of pesticides in the Group 2 list, EPA will identify the pesticides within this group that are higher priorities for endocrine testing. EPA will use comments, data, and explanations submitted, as well as the tools for prioritization described in its January 2023 EDSP NAMs white paper (Ref. 4), to determine which Group 2 pesticides will receive DCIs first. EPA will also use these same data and tools to determine whether to exempt any pesticides on the list from further testing under FFDCA section 408(p)(4) using its current approach to exemptions. In 2024, EPA will provide more information on its timeline for Group 2 chemicals.

As explained earlier, a main goal of rebuilding the EDSP is to incorporate the FFDCA section 408(p) obligations and commitments into the FIFRA process, including the registration review of existing pesticides. EPA will thus begin phasing into registration review those obligations and commitments for the 161 Group 3 cases. By phasing Group 3 cases into the existing registration review schedule, EPA may also need to shift where a case currently stands in registration review.

Most Group 3 cases (approximately 154 out of 161 cases) have active ingredients that were registered before October 2007 and have a current registration review deadline of October 2026. Typically, EPA issues DCIs before the draft risk assessment (DRA) phase of registration review. The pre-2007 cases, however, are generally past the DRA phase, often by several years. EPA will thus likely address its endocrine data needs as part of its continuous work plan (CWP) for these cases. Like a preliminary work plan (PWP), a CWP will provide an overview of the registration review case status, list registrations, and provide other pertinent data or information. As a continuation of an existing registration review case, the CWP will explain any new developments that EPA knows about a case, including any newly identified data or other information needed for a final registration review decision. Thus, EPA currently plans to prioritize the Group 3 cases and use the CWP to notify the public of when additional endocrine data are needed for each case and then issue a DCI to obtain the necessary data before completing a final decision for registration review. Consistent with existing EPA policy, a final decision will include an FFDCA section 406(p)(6) decision for human estrogen, androgen, and thyroid.

For the approximately seven other Group 3 cases with active ingredients registered after October 2007, EPA will determine whether to address its endocrine data needs through a CWP or a PWP. EPA will use the latter approach when it can integrate endocrine data needs into the registration review process from the outset, such as for cases without a PWP yet. Thus, for these cases, EPA will likely address the endocrine data needs before it does so for many Group 2 case, because the Group 3 case happens to be at an early enough stage of registration review where EPA can incorporate those data needs into the normal review process.

The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under FOR FURTHER INFORMATION CONTACT .

The strategies outlined in this document describe information collection activities that do not create any new paperwork burdens that require additional approval by OMB under the PRA, 44 U.S.C. 3501 et seq. The information collection activities associated with pesticide registration are already approved by OMB under OMB Control No. 2070-0226, entitled “Consolidated Pesticide Registration Submission Portal” (EPA ICR No. 2624.01). Information collection activities associated with data call-in activities, including the generation of data for registration review, are approved under OMB Control No. 2070-0174, entitled “Pesticides Data Call-In Program Information Collection Request” (EPA ICR No. 2288.06).

Authority: 7 U.S.C. 136 et seq. and 21 U.S.C. 346a.