Characterizing the Reference Dose/Minimal Risk Level/Allowable Daily Dose in a Quantitative Framework of Uncertainty and Variability. P. S. Price and R. E. Keenan, CHEMRISK/A McLaren Co., Stroudwater Crossing, 1685 Congress St., Portland, ME 0410
Toxicological criteria such as the Reference Dose (U.S. EPA), Minimal Risk Level (U.S. ATSDR), and Allowable Daily Dose (WHO) are all products of a similar complex system of science and policy. This icological studies, interpretation of the results of these studies, and the use of a system of uncertainty factors. The result of the application of he existing set of toxicological criteria. A number of questions have been raised on these criteria including; adequacy for protection of children and other specific subpopulations, the potential for over protection, limited ability to consider relevant data, inconsistency in the level and inconsistency across standard setting agencies. In order to understand these issues it is useful to define the criteria in terms of a framework of uncertainty and This paper will seek to define such a framework in terms of a substance’s dose response in the general population, specific subpopulations, and the uncertainty in the estimate of the response at specific doses. The goal of the criteria is assumed to be a measure of the lower confidence limit of estimates of the dose of a compound causing minimal response in sensitive humans. Using this definition it is possible to state whether the existing values of the criteria are adequate and whether changes in setting the criteria should be made.
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