Law enacted in 1996 (codified at 21 U.S.C. 346a(p)) directs the U.S. Environmental Protection Agency to "develop a screening program, using appropriate validated test systems and other scientifically relevant information, to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen." EPA's implementation of this directive has proved challenging for a number of reasons, including the difficulty of defining "adverse" endocrine effects in humans (mere perturbations of the endocrine system being routine and normal biochemical events), and devising and validating appropriate toxicological test systems that are sufficiently sensitive and specific to achieve the statutory goal.

EPA's Endocrine Disruptor Screening Program (EDSP) consists of a two-tiered testing strategy supplemented, as required by law, with "other relevant scientific information." Tier 1 will screen for potential adverse effects and Tier 2 will characterize human dose-response for (adverse) endocrine effects. However, EPA does not yet have a scientific weight-of-evidence framework for evaluating Tier 1 data and "other scientifically relevant information," both of which the Agency must use to determine whether a substance subjected to Tier 1 testing must proceed to Tier 2.

This workshop has two objectives. First, the morning session will evaluate the Tier 1 test battery to ascertain (a) whether Tier 1 data can satisfy statutory criteria; and (b) if so, how outputs from Tier 1 and "other relevant scientific information" can be used to develop a (minimally) ordinal or (desirably) cardinal ranking of human endocrine effects that is scientific, transparent, reproducible, and objective.

Second, the afternoon session will focus on selecting and designing "appropriate validated test systems" for estimating dose-response. This is a novel assignment because no established methods now exist for discriminating between adverse and nonadverse endocrine effects and objectively estimating human dose-response. For this reason, the EDSP Tier 2 provides a novel opportunity for innovative scientific work in toxicology, modeling and biostatistics. Registrants will have ample opportunity to participate. The workshop will produce a report suitable for submission to a peer reviewed journal.

Lunch is included.

To register, please go to the SRA website. Space is limited. For hotel reservations, click here.

Workshop Agenda