De Minimis Considerations in Health Risk Assessment

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Federal statutes concerned with health and safety are attempts by Congress to establish goals and principles for regulatory agencies to use in setting standards and making other decisions.

However, statutory language often provides inadequate guidance or mandate. In some cases, absolute requirements are stated which cannot be satisfied. In other cases, the language is ambiguous as to agency responsibilities and the responsibilities of industry, leaving final interpretations to the courts. This can be costly.

One critical issue resulting from this situation is how to set “de minimis” limits for the regulation of chronic health risks from exposure to hazardous substances. Absence of statutory guidance for determining “de minimis” threshold levels of risk which do not merit regulatory efforts has been identified as a critical regulatory problem by many, including recently the U.S. Supreme Court.

The consistency, effectiveness, and benefits of regulatory programs will be enhanced if a “rational” approach can be made available to agencies for establishing de minimis risk levels. Setting these levels requires consideration of both individual and population risks as well as risk management principles for allocating scarce resources.

The development of a formal de minimis approach requires resolution of several legal and technical issues. In this paper, we provide conceptual and legal rationales for a de minimis policy to determine plausible risk bounds for chronic health risks. We also develop a conceptual framework for adopting generic de minimis policies. Our findings suggest that there are several opportunities for applying this concept under existing statutory mandates.

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