US EPA

The U.S. Environmental Protection Agency (EPA) is today issuing final amended guidelines for assessing the risks for developmental toxicity from exposure to environmental agents. As background information for this guidance, this notice describes the scientific basis for concern about exposure to agents that cause developmental toxicity, outlines the general process for assessing potential risk to humans because of environmental contaminants, summarizes the history of these guidelines, and addresses public and Science Advisory Board comments on the 1989 Proposed Amendments to the Guidelines for the Health Assessment of Suspect Developmental Toxicants [54 FR 9386-9403]. These guidelines, which have been renamed Guidelines for Developmental Toxicity Risk Assessment (hereafter Guidelines), outline principles and methods for evaluating data from animal and human studies, exposure data, and other information to characterize risk to human development, growth, survival, and function because of exposure prior to conception, prenatally, or to infants and children. These Guidelines amend and replace EPA's 1986 Guidelines for the Health Assessment of Suspect Developmental Toxicants [51 FR 34028-34040] by adding new guidance on the relationship between maternal and developmental toxicity, characterization of the health-related database for developmental toxicity risk assessment, use of the reference dose or reference concentration for developmental toxicity (RfDDT or RfCDT), and use of the benchmark dose approach. In addition, the Guidelines were reorganized to combine hazard identification and dose-response evaluation since these are usually done together in assessing risk for human health effects other than cancer.

U.S. EPA. Guidelines for Developmental Toxicity Risk Assessment. U.S. Environmental Protection Agency, Risk Assessment Forum, Washington, DC, EPA/600/FR-91/001, 1991.