The U.S. Environmental Protection Agency (EPA) is today publishing in final form a
document entitled Guidelines for Reproductive Toxicity Risk Assessment (hereafter “Guidelines”).
These Guidelines were developed as part of an interoffice guidelines development program by a Technical Panel of the Risk Assessment Forum. They were proposed initially in 1988 as separate guidelines for the female and male reproductive systems. Subsequently, based upon the public comments and Science Advisory Board (SAB) recommendations, changes made included combining those two guidelines, integrating the hazard identification and dose-response sections, assuming as a default that an agent for which sufficient data were available on only one sex may also affect reproductive function in the other sex, expansion of the section on interpretation of female endpoints, and consideration of the benchmark dose approach for quantitative risk assessment. These Guidelines were made available again for public comment and SAB review in 1994. This notice describes the scientific basis for concern about exposure to agents that cause reproductive toxicity, outlines the general process for assessing potential risk to humans from exposure to environmental agents, and addresses Science Advisory Board and public comments on the 1994 Proposed Guidelines for Reproductive Toxicity Risk Assessment. Subsequent reviews have included the Agency’s Risk Assessment Forum and interagency comment by members of subcommittees of the Committee on the Environment and Natural Resources of the Office of Science and Technology Policy. The EPA appreciates the efforts of all participants in the process and has tried to address their recommendations in these Guidelines