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Realistic risk assessment

G Stöhrer1

  • 1Risk Policy Center, Larchmont, New York 10538, USA.

Regulatory Toxicology and Pharmacology : RTP
|October 1, 1995
PubMed
Summary

Establishing reliable cancer risk standards is crucial for regulatory trust. This study proposes using the lowest effective dose (LOEL) as a foundation for realistic risk assessment and practical safety standards.

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Area of Science:

  • Environmental Science
  • Toxicology
  • Regulatory Science

Background:

  • The scientific basis of regulation is undermined by cancer risk controversies.
  • Current "potential cancer risk" assessments hinder practical standards for drinking water and pesticides.
  • Disputes over defining positive results complicate risk assessment.

Purpose of the Study:

  • To propose a scientifically sound basis for regulatory safety standards.
  • To introduce "realistic risk assessment" using the lowest effective dose (LOEL).
  • To resolve controversies surrounding assumed cancer risks in regulatory programs.

Main Methods:

  • Identifying the lowest effective dose (LOEL) of well-studied carcinogens as a reproducible quantity.
  • Proposing "realistic risk assessment" utilizing the LOEL.
  • Applying traditional regulatory safety margins to the LOEL to establish safety standards.

Main Results:

  • The lowest effective dose (LOEL) is a firm and reproducible quantity for safety standards.
  • Realistic risk assessment, based on LOEL, can eliminate controversy over assumed risks.
  • Superfund clean-up targets (1 in 1 million risk) equate to a 10,000-fold margin over real risk.
  • A 5-fold safety margin for arsenic has proven safe, indicating feasibility of realistic risk approaches.

Conclusions:

  • The LOEL provides an undisputed basis for establishing practical and trustworthy safety standards.
  • Realistic risk assessment offers a transitional solution to regulatory chaos caused by cancer risk controversies.
  • Reevaluation of regulatory priorities is needed, informed by the effectiveness of realistic risk approaches and established safety margins.

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