EPA Proposes Settlement to Enhance Endocrine Disruptor Screening Program

On October 11, 2024, the U.S. Environmental Protection Agency (EPA) proposed a settlement addressing legal claims regarding the implementation of its Endocrine Disruptor Screening Program (EDSP). This initiative aims to strengthen the Agency’s efforts to evaluate chemicals for potential endocrine-disrupting effects, ensuring compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA).

Understanding Endocrine Disruption and EDSP

What are Endocrine Disruptors?
Endocrine disruptors are chemicals that interfere with hormone systems, affecting biological processes such as:

Brain and nervous system development.
Reproductive system growth and function.
Metabolism and blood sugar regulation.

The Purpose of the EDSP
Established in response to the 1996 FFDCA amendment, the EDSP evaluates the impact of pesticides and chemicals on endocrine systems, focusing on estrogen, androgen, and thyroid pathways.

Challenges in Implementing the EDSP

Over the years, EPA faced obstacles in efficiently administering the EDSP:

Slow Data Generation: Lack of cost-effective methods to test thousands of chemicals for endocrine effects.
Limited Leadership Support: Minimal administrative backing and budget constraints under previous leadership.
Regulatory Gaps: Inadequate explanations of how the EDSP aligns with FFDCA requirements.

A 2021 report from the Office of Inspector General identified these issues and recommended the development of a comprehensive EDSP strategic plan.

EPA’s New Strategic Plan and Proposed Settlement

Key Developments in the Strategic Plan
In October 2023, the EPA released a new EDSP strategic plan to improve the evaluation of endocrine effects in pesticides. Highlights include:

Accelerating data collection under FIFRA during registration reviews.
Prioritizing pesticides with sufficient data for endocrine disruption analysis.

Details of the Proposed Settlement
The proposed settlement outlines actions to address legal claims and enhance EDSP implementation, including:

Issuing FIFRA data call-in notices (DCIs) for conventional pesticides lacking sufficient data.
Regular updates on the status of FIFRA DCIs via EPA’s website.

Public Comment Period
The public has until November 12, 2024, to provide feedback on the proposed settlement. Comments can be submitted through docket EPA-HQ-OGC-2024-0391 on Regulations.gov.

Source: EPA

How REACH24H Supports Industry Compliance

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