Problems facing the decision-maker in the risk assessment process.
This paper presents an overview of the U.S. Environmental Protection Agency's risk assessment process, describes problems that the Agency faces in conducting risk assessment, in general, and identifies some specific problems that the Agency confronts when conducting risk assessments on suspected developmental toxicants. As noted by the NAS (National Research Council: "Risk Assessment in the Federal Government: Managing the Process." Washington, DC: National Academy Press, 1983, pp 17-83), improving the quality and comprehensiveness of knowledge is the most effective way to improve risk assessment, but some limitations are inherent and may remain unresolvable. Therefore, inferences will always be required. The Agency's challenge is to ensure that these inferences are as soundly based as possible.
D004305:Dose-Response Relationship, Drug; D004353:Drug Evaluation, Preclinical; D005314:Embryonic and Fetal Development / Q000187:drug effects*; D006801:Humans; D012306:Risk; D012308:Risk Management