Consideration Of Risk Characterization

Once the risk assessment process has been completed to provide a mathematical characterization of the risk and a description of the various uncertainties inherent in the calculation of the risk, risk managers will consider this risk estimate as the starting point from which to develop an appropriate risk mitigation strategy, if it is deemed that the risk should be reduced. It should be emphasized that optimal risk management efforts require scientifically appropriate risk assessments.

An important aspect in the consideration of the risk characterization is the need for experienced judgment. Inherent in the risk assessment process are large gaps in knowledge that require many choices to be made among competing models and assumptions; this introduces considerable uncertainty into the risk estimates that must be appreciated in the risk management process. Optimally, risk managers should be allowed the flexibility to make risk-related decisions using a weight-of-evidence approach that allows for the consideration of all available valid scientific data. It has been suggested, however, that risk assessments are often conducted using a strength-of-evidence approach in which experiments demonstrating positive toxicological effects are given more weight than any number of negative experiments of equal quality (6). This may be particularly true in the case of carcinogen risk assessment, where conservative assumptions may exaggerate risks greatly and, therefore, may distort regulatory practices (7).

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