Assay Validation

EPA’s Endocrine Disruptor Screening Program (EDSP) uses validated methods for screening and testing chemicals to identify potential endocrine disruptors, determine adverse effects and dose response, and assess and manage risk. These methods, or assays, allow EPA to identify and characterize the endocrine activity (specifically, estrogen, androgen and thyroid) of pesticides, commercial chemicals, and environmental contaminants. 

EPA developed the following document to provide guidance to staff and managers regarding EDSP’s universe of chemicals and general validation principles for consideration of computational toxicology tools for chemical prioritization. 

• U.S. EPA Endocrine Disruptor Screening Program Universe of Chemicals and General Validation Principles (pdf) (197.94 KB) 

The concepts of test validation are also outlined in OECD GD34 and are considered during test guideline validation.

The Federal Insecticide, Fungicide and Rodenticide Act Science Advisory Panel (FIFRA SAP) also evaluates relevant scientific issues, protocols, data and interpretations of the data for the assays during the validation process.