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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 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

Administrative Order Exempting A. radiobacter from EDSP Screening and Testing

EDSP Comprehensive Management Plan (PDF) (29 pp, 429K, About PDF)

EDSP21 Workplan Summary (PDF) (6 pp, 791K, About PDF)

Weight-of-Evidence: Evaluating Results of EDSP Tier 1 Screening to Identify the Need for Tier 2 Testing

Resources for Test Order Recipients

Data Entry Spreadsheet Templates (DESTs)

Standard Evaluation Procedures (SEPs)

Study Profile Templates

Technical Questions/ Answers about the Assays

Policies and Procedures for the EDSP

Second List of Chemicals for Tier 1 Screening

Initial List of Chemicals to Undergo Tier 1 Screening

EDSP Tier 1 Screening Battery Test Guidelines (Harmonized Test Guidelines Series 890)

Join the EDSP Listserv

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. Testing will eventually be expanded to cover all pesticide chemicals, as well as substances that may occur in sources of drinking water to which a substantial population may be exposed. 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.

EPA has developed a second list of chemicals for screening and draft policies and procedures that the Agency will use to require testing of chemicals for Tier 1 screening.

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.

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 at under Docket ID. No. EPA-HQ-OPP-2009-0878-0009.


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