The existence of several medium-oriented statutes explains why EPA has multiple risk-assessment programs. This circumstance often draws criticism as “stovepiping” that leads to delay and inconsistency in both risk assessment and regulation. In the early 1990s, Congress considered but did not pass legislation to incorporate common risk-assessment terminology, concepts, and requirements into comprehensive risk-assessment legislation.3 Instead, recent enactments are notable for precise terms that amplify and clarify legislative objectives in individual statutes by specifying elements that assessments subject to particular statutes must include

  • The 1996 Food Quality Protection Act specifies that “in the case of threshold effects … an additional ten-fold margin of safety for the pesticide chemical residues shall be applied for infants and children” (FFDCA § 408 (b)(2)(C)).

  • 1996 amendments to the Safe Drinking Water Act are similarly explicit about the presentation of risk estimates and uncertainty: “The Administrator shall, in a document made available to the public in support of a regulation promulgated under this section, specify, to the extent practicable

    • Each population addressed by any estimate of public health effects

    • The expected risk or central estimate of risk for the specific populations

    • Each appropriate upper-bound or lower-bound estimate of risk” (SDWA § 300g-1 (b)(3)).

Provisions like those that apply to individual programs (the examples above appear in pesticide and water legislation, respectively) account for some of the variation in risk-assessment practices and results. However, although the new terms apply directly only to the program governed by the statute, other programs have adopted some of the changes.

Despite differences in statutory language, environmental media, and pollutants, several factors common to the major statutes continue to shape EPA’s regulatory structure and function and its perspectives on risk assessment:

  • The emphasis in each statute on protecting human health and the environment provides the basis of EPA’s purported conservative approach to risk assessment. Examples range from generic “adequate margin of safety” language in the Clean Air Act (CAA) amendments of 1971 (§ 109) to the required additional safety factor of 10 for protection for infants and children in the 1996 Food Quality Protection Act (FQPA; FFDCA § 408 (b)(2)(C)). As explained recently, “consistent with its mission, EPA risk assessments tend towards protecting public and environmental health by preferring an approach that does not underestimate risk in the face of uncertainty and variability” (EPA 2004a, p. 11).

  • Except as noted above (footnote 2) and later in this chapter (page 51), the statutory provisions related to EPA’s main standards for protecting human health and the environment treat scientific analysis as a central element in regulatory decision-making and call for collection and evaluation of scientific information related to the pollutant undergoing regulatory review. Statutes often detail the kinds of information, analyses, and formal documentation required in the rule-making record.


A bipartisan coalition of senators sponsored the Thompson-Levin bill (S981), titled “Regulatory Improvement Bill,” which would have codified the Office of Management and Budget (OMB) role in review of agency regulations; some provisions later appeared in the OMB Bulletin (70 Fed. Reg. 2664 [2005]). The Moynihan bill (S123) called for comparative risk assessment.

The National Academies | 500 Fifth St. N.W. | Washington, D.C. 20001
Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement