The challenge of risk characterization: current practice and future directions.

Risk characterization is perhaps the most important part of risk assessment. As currently practiced, risk characterizations do not convey the degree of uncertainty in a risk estimate to risk managers, Congress, the press, and the public. Here, we use a framework put forth by an ad hoc study group of industry and government scientists and academics to critique the risk characterizations contained in two risks assessments of gasoline vapor. After discussing the strengths and weaknesses of each assessment's risk characterization, we detail an alternative approach that conveys estimates in the form of a probability distribution. The distributional approach can make use of all relevant scientific data and knowledge, including alternative data sets and all plausible mechanistic theories of carcinogenesis. As a result, this approach facilitates better public health decisions than current risk characterization procedures. We discuss methodological issues, as well as strengths and weaknesses of the distributional approach.