EPA Proposes Settlement for Claims Relating to Endocrine Disruptor Screening Program
Today, the U.S. Environmental Protection Agency (EPA) released a proposed plan to settle legal claims on the Agency's implementation of the Endocrine Disruptor Screening Program (EDSP). EPA is providing a 30-day public comment period on the proposed plan.
Endocrine systems, also referred to as hormone systems, are found in all mammals, birds, fish, and many other living organisms. The systems regulate many biological processes in the body from conception through adulthood and into old age, including the development of the brain and nervous system, the growth and function of the reproductive system, and metabolism and blood sugar levels.
Endocrine disruptors are chemicals that mimic, block, or disrupt the normal function of hormones. 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. Since that time, EPA has encountered several challenges with administering the EDSP. For example, data generation has been slow, as 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 that the Agency had made limited progress in implementing the EDSP and recommending, among other things, that the Agency develop an EDSP strategic plan.
In 2022, a coalition of plaintiffs filed a complaint against EPA concerning EPA’s implementation of the EDSP.
In October 2023, EPA issued its new EDSP strategic plan to ensure that its assessments of pesticides more closely, quickly, and effectively evaluate the potential for endocrine effects in humans. The proposed plan aims to resolve legal claims raised by plaintiffs through a settlement between EPA and the plaintiffs. As part of the proposal, EPA is committing to several actions to confirm that its Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) assessments address the potential endocrine effects of conventional pesticide active ingredients on human health. These actions are consistent with and implement the EDSP strategic plan. For example, as explained in the near-term strategy document, EPA is requiring data under FIFRA earlier in the registration review process for conventional pesticides that are shown to impact estrogen or androgen pathways. The Agency has also started issuing FIFRA data call-in notices (DCIs) for EDSP data for the other conventional pesticides during the regular registration review process unless it can confirm that it already has enough data to determine the potential for adverse effects to the estrogen, androgen, or thyroid pathways in humans.
As part of the strategic plan, EPA identified a group of conventional pesticide active ingredients with reproductive toxicity studies with sufficient estrogen and androgen data to meet EPA's FFDCA 408(p) obligations and commitments. EPA recently issued an update on the list of chemicals for which sufficient estrogen and androgen, and in some cases thyroid, data are available (see EPA-HQ-OPP-2023-0474-0066). EPA has committed to posting regular updates through its website on the status of any FIFRA DCIs for conventional pesticide active ingredients.
To read the proposed plan for settlement and to submit a comment, see docket EPA-HQ-OGC-2024-0391 on Regulations.gov. The public comment period will close on November 12, 2024, 30 days after the publication date in the Federal Register. EPA and the U.S. Department of Justice, as appropriate, will review public comments as it makes a decision on moving forward with the settlement proposal.
For further information on endocrine disruption and the EDSP, visit EPA’s website.
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