Federal laws require a consideration of adverse health effects, including mutagenicity, in arriving at regulatory decisions on chemical substances. Certain laws require balancing the consequences of these risks with the benefits provided by the use of chemical substances. This requires that risk be quantitatively assessed. Estimates of human genetic risk can be made indirectly based on data from animal experimentation and human somatic cells, but it is not practical to estimate genetic risk directly based on data from human germ cells. The indirect estimates are highly debated because of uncertainties about interspecies and interorgan extrapolations. Uncertainties in extrapolating from effects observed in animals at high experimental doses to effects likely to occur in humans at much lower environmental levels further complicate genetic risk assessment. Comparative studies are needed to define the relationships between somatic cell and germ cell events and between experimental animals and humans. This may involve selecting at least one high risk human population for study. These efforts will require a long-term coordination of efforts among the Federal agencies and among government agencies, industrial concerns, and the academic community.

"Sponsored by the U.S. Environmental Protection Agency in cooperation with the Department of Energy/Brookhaven National Laboratory and the Council for Research Planning in Biological Sciences under interagency agreement no. AD89F2A165." Distributed to depository libraries in microfiche. "August 1984." Includes bibliographical references (pages 40-48). "EPA-600/9-84-016."