Guidelines for Developmental Toxicity Risk Assessment

These Guidelines provide a general format for analyzing and organizing the available data for conducting risk assessments. The Agency previously has issued testing guidelines (U.S. EPA, 1982b, 1985a, 1989a, 1991a) that provide protocols designed to determine the potential of a test substance to induce structural and/or other adverse effects during development. These risk assessment Guidelines do not change any prescribed statutory or regulatory standards for the type of data necessary for regulatory action, but rather provide guidance for the interpretation of studies that follow the testing guidelines and, in addition, provide limited information for interpretation of other studies (e.g., epidemiologic data, functional developmental toxicity studies and short-term tests) that are not routinely required, but may be encountered when reviewing data on particular agents.