Endocrine Disruptor Screening Program

This site provides information about EPA's approach toward and progress on screening chemicals for endocrine effects. If you are new to the topic of endocrine disruption you might want to read the EDSP Overview and EDSP Primer for more detailed information on the endocrine system and the EDSP.

In the 1990's, some scientists proposed that certain chemicals might be disrupting the endocrine systems of humans and wildlife. A variety of chemicals have been found to disrupt the endocrine systems of animals in laboratory studies, and compelling evidence shows that endocrine systems of certain fish and wildlife have been affected by chemical contaminants, resulting in developmental and reproductive problems. Based on this and other evidence, Congress passed the Food Quality Protection Act and the Safe Drinking Water Act (SDWA) Amendments in 1996 requiring that EPA screen pesticide chemicals for their potential to produce effects similar to those produced by the female hormones (estrogen) in humans and giving EPA the authority to screen certain other chemicals and to include other endocrine effects. Based on recommendations from an Advisory Committee, EPA has expanded the EDSP to include male hormones (androgens) and the thyroid system, and to include effects on fish and wildlife.

Highlights

EPA announced the initial list of chemicals to be screened for their potential effects on the endocrine system (or Tier I testing) on April 15, 2009, and the first test orders were issued on October 29, 2009. Test orders are requests for data. Now that screening is underway, EPA is reviewing test order responses and making available the status or test order responses (PDF) (53 pp, 555K, About PDF) and/or any decisions regarding testing requirements.

EPA will use a two-tiered screening and testing process: Through Tier 1, EPA hopes to identify chemicals that have the potential to interact with the endocrine system. Through Tier 2, EPA will determine the endocrine-related effects caused by each chemical and obtain information about effects at various doses.

Endocrine disruptor screening is currently proceeding on three fronts: 1) developing and validating Tier 2 tests; 2) selecting chemicals for screening and testing; and 3) implementing the policies and procedures the Agency will use to require screening.

In November 2010, EPA developed a second list of chemicals for screening and draft policies and procedures for the Agency's use to require testing of chemicals for Tier 1 screening. On June 14, 2013, EPA issued a revised second list of chemicals and revised policies and procedures for screening SDWA chemicals, including the statutory requirements associated with and format of the test orders, as well as EPA's procedures for fair and equitable sharing of test costs and data confidentiality.

EPA has also developed the EDSP Comprehensive Management Plan (PDF) (29 pp, 429K, About PDF) that provides strategic guidance for agency personnel and outlines the critical activities that are planned for the EDSP over the next five years. The plan describes the technical review processes that will be used in implementing this program and how the agency intends to factor technology advancements into the program. The plan is flexible to allow opportunities to streamline and promote efficient processes. This EDSP Comprehensive Management Plan was developed as an internal EPA document, however, it is being made publically available consistent with the EPA's transparency objectives.

Developed in response to recommendations from the Office of Inspector General, The EDSP Universe of Chemicals and General Validation Principles (17 pp, 197.94K, About PDF) document provides an overview of the general validation principles that will be used to evaluate computational toxicological methods for chemical prioritization. EPA has also presented the List of EDSP Universe of Chemicals (177 pp, 2.54M, About PDF) as a separate document which will be updated as new information becomes available. The List of the EDSP Universe of Chemicals contains approximately 10,000 chemicals as defined under FFDCA and SDWA 1996 amendments, although not all of the chemicals are expected to undergo EDSP Tier 1 screening. The agency plans to prioritize these chemicals for screening by considering physical chemical properties, exposure, and an effect-based approach using advanced computational toxicological methods. These methods and tools will be evaluated using OECD validation principles for their utilization in chemical prioritization and this topic was the focus of a January 29-31, 2013 FIFRA Science Advisory Panel meeting.

EPA issued an order exempting the microbial pesticides Agrobacterium radiobacter (A. radiobacter) strains K84 and K1026 from the screening and testing requirements of the EDSP. EPA considered all the available scientific evidence and determined these specific microbial pesticides are not anticipated to produce any effects on the estrogen, androgen or thyroid hormone systems. The FFDCA authorizes the EPA to exempt biologic substances or other substances from EDSP requirements if they are not anticipated to produce an endocrine effect. See the administrative order exempting A. radiobacter under Docket ID. No. EPA-HQ-OPP-2009-0878-0009.

Highlights

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