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Regulacje i polityka gospodarcza · 21.10.2009

Endocrine Disruptor Screening Program (EDSP); Announcing the Availability of the Tier 1 Screening Battery and Related Test Guidelines

EPA is announcing the availability of the Endocrine Disruptor Screening Program (EDSP) Tier 1 battery of assays and availability of test guidelines (protocols) for conducting the assays included in the battery. The EDSP was established under section 408(p) of the Federal Food, Drug, and Cosmetic Act (FFDCA), which directed EPA "to develop a screening program. . .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 endocrine effect as the Administrator may designate." Coordinated by EPA, several in vitro and in vivo screening assays were developed, standardized, and validated to identify the potential of a chemical substance to interact with the estrogen, androgen or thyroid (E, A, or T) hormonal systems. Test chemicals that were thought to be potentially interactive as well as non-interactive with the E, A, or T hormonal systems were used to evaluate feasibility of the protocols, relevance of endpoints and reliability of results within and among independent contract laboratories. Subsequent independent peer review of individual assays helped to clarify the strengths and limitation

Source: Federal Register — All DocumentsOpen original release →