Chapter One
Principles of Cancer Risk
Assessment: The Risk
Assessment Paradigm
Vincent James Cogliano
International Agency for Research on Cancer
1.1 THE RISK ASSESSMENT PARADIGM
The United States National Research Council has outlined a series of steps that
many agencies follow in analysing risk (National Research Council, 1983, 1994).
Although this chapter is focused on cancer risk assessment, the risk assessment
paradigm can apply equally to other adverse effects.
Hazard identification asks whether exposure to an agent can cause an increase
in the incidence of an adverse effect. This involves consideration of the
epidemiologic evidence in humans, the evidence in experimental animals, and
other relevant data, including studies of toxicokinetics and mechanisms.
Dose-response assessment characterises the relationship between the dose of
an agent and the incidence of an adverse health effect. The fundamental
activity of dose-response assessment is modelling, which can range from
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