EPA developed the Endocrine Disruptor Screening Program (EDSP) in response to a Congressional mandate in the Federal Food, Drug, and Cosmetic Act (FFDCA) "to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other effects as [EPA] may designate" (21 U.S.C. 346a(p)). When carrying out the program, the statute requires EPA to "provide for the testing of all pesticide chemicals." The statute also provides EPA with discretionary authority to "provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticide chemical if the Administrator determines that a substantial population may be exposed to such a substance." In addition, section 1457 of the Safe Drinking Water Act provides EPA with discretionary authority to provide for testing, under the FFDCA 408(p) screening program, "of any other substances that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance."
As required by FFDCA, EDSP was created to screen pesticides, chemicals, and environmental contaminants for their potential affect on estrogen, androgen and thyroid hormone systems. Of the 50 known vertebrate hormones, the estrogen, androgen, and thyroid hormones play major roles in ensuring the reproductive, developmental, and growth capabilities of humans and wildlife. Because these hormones are so important, development of methods and procedures to assess harmful effects of chemicals on these systems is necessary.
EPA has involved the public, stakeholders, and has coordinated with international organizations in implementing EDSP. After the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC) completed its work and disbanded in 1998, EPA organized a Standardization and Validation Task Force (SVTF) consisting of representation from a broad range of sectors, including federal agencies, agrichemical companies, commodity chemical companies, and environmental and public health organizations to coordinate and conduct the scientific and technical work necessary to validate the screens and tests recommended by the EDSTAC. SVTF was replaced by the Endocrine Disruptor Methods Validation Subcommittee (EDMVS), a subcommittee of an Advisory Council (NACEPT) established under the Federal Advisory Committee Act. As a charter member and co-chair of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), EPA (and the EDMVS) is following the interagency validation framework in the development and refinement of assays to reduce animal use, refine procedures involving animals to make them less stressful, and replace animals where scientifically appropriate. When complete, EPA will use these validated methods or assays to identify and characterize the endocrine activity of pesticides, commercial chemicals, and environmental contaminants, specifically in relation to estrogen, androgen, and thyroid hormones. In addition, EPA is working with the Organization for Economic Cooperation and Development's Endocrine Testing and Assessment Task Force to validate and harmonize endocrine screening tests of international interest.
Visit the links below for more information on EDSP:
- Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC)
- August 1998: Federal Register Notice - EDSP [PDF, 4pp., 34KB, About PDF]
- December 1998: Federal Register Notice - Proposed Statement of Policy [PDF, 28pp., 228KB, About PDF]
- Priority Setting
- Tier 1 Screening
- Tier 2 Testing
- Hazard Assessment
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