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Elements Of Risk Characterization

EPA's risk-characterization step has four elements: generation of a quantitative estimate of risk, qualitative description of uncertainty, presentation of the risk estimate, and communication of the results of risk analysis.

Quantitative Estimates of Risk

To determine the likelihood of an adverse effect in an exposed population, quantitative information on exposure—i.e., the dose (determined from the analysis in Chapter 3)—is combined with information on the dose-response relationship (determined from the analysis in Chapter 4). This process is different for carcinogens and for noncarcinogens. For noncarcinogens, the dose estimate is divided by the RfD to obtain a hazard index. If the hazard index is less than 1, the chemical exposure under consideration is regarded as unlikely to lead to adverse health effects. If the hazard index is greater than 1, adverse health effects are more likely and some remedial action is called for. The hazard index is thus not an actual measure of risk; it is a benchmark that can be used to estimate the likelihood of risk.

For carcinogens, excess lifetime risk is calculated by multiplying the dose estimate by a potency factor. The result is a value that represents an upper bound on the probability that lifetime exposure to an agent, under the specified conditions of exposure, will lead to excess cancer risk. This value is usually expressed as a population risk, such as 1 × 10-6, which means that no more than one in 1 million exposed persons is expected to develop cancer. Risk estimates obtained in this way are not scientific estimates of actual cancer risk; they are upper bounds on actual cancer risk that are useful to regulators for setting priorities and for setting exposure limits.

When exposure to more than one agent occurs simultaneously, the cancer risk estimates obtained for each agent can be combined in an additive manner for each route of exposure. Hazard indexes for noncarcinogens may be combined when the agents of concern elicit similar end points of toxicity.

Sometimes, this risk-characterization technique is used to estimate an upper bound on excess lifetime cancer risk to exposed individuals, instead of populations. EPA's Guidelines for Exposure Assessment (EPA, 1992a) (not yet implemented) lists some of the questions that should be answered when considering individual versus population risk. These questions are stated by EPA as follows:

Individual Risk

Are individuals at risk from exposure to the substances under study? Although for substances, such as carcinogens, that are assumed to have no threshold, only a zero dose would result in nonexcess risk for noncarcinogens, this



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