Methods for Dose and Effect Assessment

Humans are exposed to naturally occurring mutagenic compounds as well as compounds which are only present due to industrial, technological, and medical developments. The source of exposure of a human population to the class of mutagenically active chemicals which are artificially present in the environment may range from an unplanned release following an industrial accident to the planned introduction into the market of a chemical with some beneficial uses. An assessment of the dose and the mutagenic effect associated with human exposure is in both cases imperative. For the former, an estimate of the dose and mutagenic effect is required for a full assessment of the impact of the industrial accident. For the latter, an estimate of the dose and mutagenic effect is required in the risk/benefit evaluation, important for the decision if the planned human exposure is justifiable. Confronted with an actual or potential exposure of a human population to a mutagenically active compound, the assessment of dose and mutagenic effect is important if risk-management efforts are to be intelligently pursued. First, it is apparent that society cannot blindly accept the deleterious effects associated with industrial progress only to employ remedial action when the risks become identified. A more intelligent approach is to incorporate an evaluation of any risks as an integral part of the processes involved in industrial progress. Second, due to the heterogeneous nature of human populations and the current status of testing methods, one would not expect epidemiological studies or laboratory studies of human populations to demonstrate de novo mutagenic effects. Further, such an epidemiological approach contradicts the preferred policy of protecting human populations from harm.