ABSTRACT

Quantitative dose-response modeling and risk quantification comprise two important inputs to cancer risk assessment which, in turn, can be a major ingredient in cancer risk management and the regulatory process. The risk quantifications currently used to summarize the dose-response relationships are usually inadequate reflections of several risk dimensions and are generally poorly understood by the public. The new modeling components are biologically meaningful and physically identifiable. Hence, their functional form and dependence on dose, time, and age can frequently be determined through scientific studies before they are incorporated into the estimation of the cancer dose-response relationship from chronic bioassays or epidemiological studies. If the uncertainty in a quantitative risk assessment is described in terms of bounds on risk, then both upper and lower bounds should be reported as well as their method of determination including any assumptions made and their impacts.