The U.S. Environmental Protection Agency (EPA) released on June 28, 2012, an Endocrine Disruptor Screening Program (EDSP) "Comprehensive Management Plan." While it's intended for internal use, EPA made the plan available to the public to be consistent with its stated objectives for transparency. The plan and its implications are discussed below.
EPA previously released a work plan, referred to as "EDSP21," that described its goals to develop and validate new tools to screen pesticides for EDSP purposes, including computational toxicology methods and high-throughput screens to assess potential toxicity while minimizing conventional whole animal studies.
Specific activities include evaluating the high-throughput assays to build confidence they are useful for EDSP screening and to understand how they compare to current, validated Tier 1 assays and other scientific information, and cataloguing and evaluating the models to build confidence they can adequately predict biological activity and so can be used to prioritize chemicals for the EDSP.
The Comprehensive Management Plan lists several milestones, and the fiscal years (FY) in which these activities will take place:
Of particular interest, EPA says it will review the assay results from the chemicals that received EDSP Tier 1 orders (List 1 Substances) and submit a subset of chemicals for the functionality of each assay and the battery as a whole to the FIFRA SAP in FY 2013. EPA also intends to issue the final second list of chemicals for Tier 1 screening (List 2 Substances) with additional test orders for these chemicals to be issued incrementally over a three-year period. EPA has been criticized for planning to issue the List 2 Substances before the List 1 Substances' Tier 1 assays have been properly reviewed. It appears EPA is intent to develop and issue in FY 2013 the List 2 Substances even though scientific data reviews, preparation of DERs and weight of evidence decisions for List 1 Substances probably won't be completed until FY 2014.
Why You Should Care
How and when EPA assesses chemicals (whether industrial or pesticide) and determines whether they are endocrine disruptors will significantly impact many chemicals and the products in which these chemicals are included. The plan provides insights into EPA's thinking and, most importantly, the timing for the program's completion. Critical decisions are to be made, so companies must carefully review the plan to understand when chemicals that have been identified as potential endocrine disruptors may be subject to further regulatory action and whether this should prompt product reformulation. For these reasons, the plan is a document worth reviewing, especially for product manufacturers using chemical components associated with endocrine disruptor characteristics.
The plan is available at www.epa.gov/endo/pubs/EDSP-comprehensive-management-plan.pdf.
LYNN BERGESON is Chemical Processing's Regulatory Editor. You can e-mail her at firstname.lastname@example.org.
Lynn is managing director of Bergeson & Campbell, P.C., a Washington, D.C.-based law firm that concentrates on chemical industry issues. The views expressed herein are solely those of the author.