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The US EPA's Endocrine Disruptor Screening Program: In VItro and In Vivo Mammalian Tier 1 Screening Assays
Citation:
Laws, S C., T E. Stoker, J M. Goldman, V S. Wilson, L E. Gray Jr., AND R L. Cooper. The US EPA's Endocrine Disruptor Screening Program: In VItro and In Vivo Mammalian Tier 1 Screening Assays. 2nd, Chapter 11, Hood, RD (ed.), Developmental and Reproductive Toxicology: A Practical Approach. CRC Press - Taylor & Francis Group, LLC, Boca Raton, FL, , 489-524, (2005).
Impact/Purpose:
To discuss EPA's endocrine disruptor screening program
Description:
In response to emerging concerns that environmental chemicals may have adverse effects on human health by altering the function of the endocrine system, the Food Quality Protection Act mandated that the U.S. EPA develop and implement an endocrine disruptor screening program (EDSP). Working toward this goal, the U.S. EPA is currently implementing a proposed EDSP that is designed to detect chemicals that alter the estrogen, androgen, and thyroid systems in human, fish and wildlife. This program, based largely upon recommendations made in 1998 by the Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), will allow for (1) the initial sorting and prioritization of the 80,000 plus chemicals under the purview of the U.S. EPA, (2) the identification of chemicals for further testing using a Tier I Screening Battery (TIS) that includes both in vitro and in vivo mammalian and ecotoxicological assays, and (3) the characterization of adverse effects and establishment of dose response relationships for hazard assessment using a Tier II Testing Battery. Here we discuss the in vitro and in vivo mammalian TIS assays that are currently undergoing a validation process that will document the biological relevance and reliability of each assay. Each assay is discussed with respect to its purpose, technical issues, strengths, limitations, and interpretation of the data. Criteria for evaluating data from all the assays to support a conclusion based upon the weight-of-evidence as to whether or not a test chemical is capable of disrupting the endocrine system are discussed. Finally, avenues are discussed for identifying new assays that will enhance and/or refine the 'first generation' screening and testing batteries.