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Risk assessment: the default conservatism controversy

R C Barnard1

  • 1Cleary, Gottlieb, Steen, & Hamilton, Washington, DC 20036.

Regulatory Toxicology and Pharmacology : RTP
|June 1, 1995
PubMed
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This study examines the Environmental Protection Agency's (EPA) use of default assumptions in cancer risk assessments. It discusses the controversy surrounding these conservative, science-based principles and their policy implications.

Area of Science:

  • Environmental Science
  • Risk Assessment
  • Toxicology

Background:

  • The U.S. Environmental Protection Agency (EPA) heavily relies on default assumptions in its cancer risk assessments.
  • These defaults are generic scientific principles chosen for policy reasons, emphasizing a conservative approach to avoid underestimating risk.

Purpose of the Study:

  • To examine the controversy surrounding the use of default assumptions in EPA risk assessments.
  • To review the historical context of default conservatism and its scientific basis.
  • To discuss the National Academy of Sciences' (NAS) 1994 report on this issue.

Main Methods:

  • Literature review of the history of default conservatism in risk assessment.
  • Analysis of the CAPRA (Consensus Approach to Probabilistic Risk Assessment) recommendations.

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  • Examination of the EPA's draft response to CAPRA recommendations.
  • Main Results:

    • The paper explores the long-standing debate on the scientific validity of defaults.
    • It highlights the NAS's view that conservatism as a selection criterion is "beyond science."
    • The study touches upon the EPA's initial response to CAPRA's suggestions for reducing reliance on defaults.

    Conclusions:

    • The use of conservative default assumptions in EPA cancer risk assessments is a contentious issue.
    • There is an ongoing debate regarding the scientific basis and policy appropriateness of these defaults.
    • The paper sets the stage for understanding the EPA's evolving approach to risk assessment in light of expert recommendations.