Historical perspective on risk assessment in the federal government.

This article traces the evolution of risk assessment as an essential analytical tool in the federal government. In many programs and agencies, decisions cannot be made without the benefit of information from risk assessment. Although this analytical tool influences important public health and economic decisions, there is widespread dissatisfaction with the day-to-day practice of risk assessment. The article describes the sources of dissatisfaction that have been voiced by scientists, regulators, interest groups and ordinary citizens. Problems include the use of arbitrary exposure scenarios, the misuse of the 'carcinogen' label, the excessive reliance on animal cancer tests, the lack of formal uncertainty analysis the low priority assigned to noncancer endpoints, the poor communication of risk estimates and the neglect of inequities in the distribution of risk. Despite these limitations, the article argues that more danger rests in efforts to make decisions without any risk assessment. Recent Congressional and Administration interest in risk assessment is encouraging because it offers promise to learn from past mistakes and set in motion steps to enhance the risk assessment process.