EPA Finalizes Settlement and Announces New Tracking Website for Endocrine Disruptor Screening Program Data Call-In Notices
Released on January 7, 2025
EPA is announcing the December 12, 2024, final settlement relating to the implementation of the Endocrine Disruptor Screening Program (EDSP). The final settlement terms include EPA’s commitment to several action items to assess the potential effects of conventional pesticide active ingredients on human health. As part of the settlement agreement and to increase transparency related to the EDSP effort, EPA is also announcing a new tracking website to provide updates on Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Data Call-In (DCI) Notices issued to registrants of a group of high priority conventional pesticides. These pesticides, referred to as Group 1, demonstrated potential impact to the estrogen or androgen pathways and may need additional data to inform endocrine-related assessments. EPA’s tracking website includes updates on the release and response to these DCIs including DCI notice number, the issuance date, the acknowledgement of receipt date, the company name and number, the 90-day response date, and the required date of data submission.
Following the 1996 amendment of the Federal Food, Drug, and Cosmetic Act (FFDCA), EPA established the EDSP to evaluate how pesticides and other chemicals may affect estrogen, androgen, and thyroid systems. Endocrine disruptors are chemicals that mimic, block, or disrupt the normal function of these hormones. Since establishing the EDSP, EPA has encountered several challenges with implementing the program. For example, the agency has historically lacked scientific methods to rapidly and cost-effectively test thousands of chemicals for endocrine-disrupting effects. Further, EPA's decisions rarely explained whether or how they complied with FFDCA by protecting humans from potential endocrine effects. EPA staff also received minimal support and direction from leadership in the last Administration to implement the EDSP, and were challenged by repeated Presidential budget proposals to eliminate the program budget. Because of these and other issues, the Office of Inspector General issued a report in 2021 concluding the agency had made limited progress in implementing EDSP and recommending the agency develop an EDSP strategic plan.
In October 2023, EPA issued a Federal Register Notice with EDSP Near-term Strategies and supporting documents that describe how EPA is prioritizing its endocrine disruptor screening, focusing initially on conventional pesticide active ingredients. The supporting documents are available on www.regulations.gov in docket number EPA-HQ-OPP-2023-0474. As explained in these materials, conventional pesticides in registration review that may need additional estrogen or androgen data were placed into one of three priority groups. EPA is requiring data earlier in the registration review process and expediting DCIs for Group 1 chemicals.
FIFRA DCIs were issued to registrants of 24 EDSP Group 1 chemicals between September 30 and November 25, 2024. Registrants may supply the data requested by EPA, request a waiver, or cite existing data to address the FIFRA DCI requirements.
The settlement documents can be found on www.regulations.gov in docket number EPA-HQ-OGC-2024-0391. For further information on endocrine disruption and the EDSP, please visit EPA’s website.