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Published October 6, 2017 | Updated
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A Framework for Unreasonable Risk in the Toxic Substances Control Act

Page, Talbot

Abstract

"Unreasonable risk" is a key term in the Toxic Substances Control Act. A finding that a chemical "may present an unreasonable risk" must be made before testing can be required, under section 4a of the Act; a finding of "presents or will present an unreasonable risk" must be made before a chemical can be regulated under section 6a. In the act and legislative history, "unreasonable risk" was defined in very general terms as a balancing of the probability of harm, the severity of harm, and benefits of the chemical in question. The Environmental Protection Agency was delegated the responsibility to define a legal concept of unreasonable risk. I wrote this paper while in residence at the Office Pesticides and Toxic Substances (EPA) as part of the effort to define "unreasonable risk" for regulatory purposes. This paper develops a concept of unreasonable risk based on economic efficiency. Three ingredients are brought together in a common framework: baseline or existing information; the characteristics of a test, if testing is to be an option; and the valuation of the costs and benefits of the various control options. The framework is designed to accommodate "typical" characteristics of toxics problems: "zero-infinity" dilemmas and the low statistical power of tests. Because of pervasive uncertainties in both baseline information and in new information, several rules of thumb and policy directions are suggested. A complete definition of unreasonable risk would go beyond minimization of expected costs to incorporate considerations of equity.

Additional Information

Published as Page, Talbot. "A framework for unreasonable risk in the Toxic Substances Control Act (TSCA)." Annals of the New York Academy of Sciences 363.1 (1981): 145-166.

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