Environmental chemicals that may disrupt the hormonal or endocrine systems of humans as well as wildlife and other animals have been a concern since at least the 1960s. Congress passed the Food Quality Protection Act (FQPA) in 1996, requiring that the U.S. Environmental Protection Agency (EPA) screen pesticide chemicals for their potential to produce effects similar to those produced by hormones—including those needed for reproduction and fetal development—in humans. The act also gives EPA the authority to screen certain other chemicals and to include other endocrine effects.Through the Endocrine Disruptor Screening Program(EDSP), active since 2001, the EPA has sponsored the development and validation of a suite of screening assays and more in-depth assays to identify,evaluate, and prioritize chemicals that may cause changes in the estrogen, androgen, and thyroid systems of aquatic invertebrates, amphibians, fish, birds, and mammals.Because the chemical substances of interest tend to be widely used commercial products, the EDSP is subject to a high level of scrutiny from industry as well as the environmental community. In recent years, the EDSP has moved toward greater use of high-throughput and computational toxicological tools to screen and test the potential endocrine bioactivity of chemicals. However, data from well designed in vivo and in vitro studies are also needed to evaluate and refine the models that predict endocrine responses to environmental chemicals.
Battelle has supported the EPA EDSP since its inception, preparing numerous data analyses, data reviews, reports on in vivo and in vitro assay development and validation, and scientific documents for the EDSP under three multi-year contracts. More than 100 assignments and special studies have been conducted successfully under Battelle’s contracts. Battelle has a robust network of contacts from past and current consultation on the EDSP and other environmental and ecotoxicology projects, and we use this network to identify the most qualified in-house expert consultants or subcontractors. In addition to project management, Battelle operated the EDSP data coordination center and a dedicated chemical repository from 2001 to 2013. These activities supported method development and validation, including complex, multi-laboratory comparisons and advanced biostatistical analysis of study data. Battelle also provided expert consultation on the writing and revision of more than 10 Detailed Review Papers and six Integrated Summary Reports, which support research and decision making.
Many of the endocrine screening assays and other tests in use today are based on or supported by research that was led by Battelle, including the fish short-term reproduction assay, avian two-generation test, amphibian metamorphosis assay, vitellogenin evaluation, avian embryo assay, and male and female pubertal rat assay. Battelle continues to provide project management, statistics, scientific literature search, and toxicology expertise on task orders for the EPA.