Statistics for Risk Assessment of Chemical Carcinogens*

Abstract

Risk assessment is a scientific process of evaluation of potential health risks of chemical exposures to humans from available information. It involves analysis of the relationship between exposure and health related outcomes to derive an allowable exposure level. Because of lack of human exposure data, the major source of information for studying potential health effects of chemicals on humans is generally obtained from animal dose response experiments. Animal data are often evaluated in two aspects via statistical analysis: qualitative testing and quantitative estimation. The qualitative testing is to determine if the chemical causes an adverse health effect, i.e., if there is a statistically significant difference between treated and control animals. Quantitative estimation involves fitting a dose-response model to derive an allowable exposure level for humans. This paper reviews statistical principles and procedures for qualitative and quantitative approaches to human risk assessment. *The views presented in this paper are those of the authors and do not necessarily represent those of the U.S. Food and Drug Administration.