Important recent advances in the practice of health risk assessment: implications for the 1990s.

Health risk assessments have been so widely adopted in the United States that their conclusions are a major factor in many environmental decisions. The procedure by which these assessments are conducted is one which has evolved over the past 10-15 years and a number of short-comings have been widely recognized. Unfortunately, improvements in the process have often occurred more slowly than advancements in technology or scientific knowledge. Recent significant advances for more accurately estimating the risks posed by environmental chemicals are likely to have a dramatic effect on the regulation of many substances. Each of the four portions of risk assessment (hazard identification, dose-response assessment, exposure assessment, and risk characterization) has undergone significant refinement since 1985. This paper reviews some of the specific changes and explains the likely benefits as well as the implications. Emphasis is placed on the improved techniques for (a) identifying those chemicals which may pose a human cancer or developmental hazard, (b) using statistical approaches which account for the distribution of interindividual biological differences, (c) using lognormal statistics when interpreting environmental data, (d) using physiologically based pharmacokinetic models for estimating delivered dose and for scaling up rodent data, (e) using biologically based cancer models to account for the seven or more apparently different mechanisms of chemical carcinogenesis, (f) describing the severity of the public health risks by considering those portions of the population exposed to various concentrations of a contaminant, and (g) reviewing how criteria for acceptable risk have been influenced by the number of exposed persons. The net benefit of these improvements should be a reduction in the uncertainty inherent in current estimates of the health risks posed by low level exposure to carcinogens and developmental toxicants.