An official website of the United States government.

This is not the current EPA website. To navigate to the current EPA website, please go to This website is historical material reflecting the EPA website as it existed on January 19, 2021. This website is no longer updated and links to external websites and some internal pages may not work. More information »

Risk Assessment

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.
You may need a PDF reader to view some of the files on this page. See EPA’s About PDF page to learn more.