ABSTRACT
A discussion of some of the leading documents on the use of human data in carcinogen risk assessment is provided. Types of epidemiologic studies and how such studies are evaluated are described. Also described are criteria for evaluation of the weight of human evidence. The variability of data from epidemiologic studies makes guidance with regard to dose-response assessment difficult. Risk assessors are cautioned to describe uncertainties and assumptions in the dose-response assessment. Future directions for human data and risk assessment include molecular epidemiology, examination of the variation in susceptibility to toxic substances, and increased international collaboration on epidemiologic research.
