Epidemiology and quantitative risk assessment: a bridge from science to policy

Am J Public Health. 1995 Apr;85(4):484-91. doi: 10.2105/ajph.85.4.484.


Quantitative risk assessment provides formalized scientific input to regulatory agencies that set occupational and environmental standards for potentially toxic exposures. Current practice relies heavily on statistical extrapolation from high-dose animal studies. Human data obviate the need for interspecies extrapolation and reduce the range of high-to-low dose extrapolation. This paper proposes a framework for classifying individual epidemiologic studies as to their adequacy for use in dose-response extrapolation. The framework considers five criteria: (1) a stable positive association with an adverse health outcome; (2) high overall study quality; (3) no substantial confounding; (4) quantitative exposure assessment for individuals; (5) evidence of a dose-response relationship. With these criteria, studies can be categorized as (1) suitable to serve as a basis for extrapolation; (2) inadequate to be the basis for direct extrapolation but appropriate to use for evaluating the plausibility of animal-derived risk estimates; or (3) useful only for hazard identification, not for dose-response assessment. Methods for using studies in the first two categories are briefly described. The emphasis is not on establishing rigid rules, but rather on ensuring a consistent, reliable process that makes optimum use of available data.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Animals
  • Carcinogens / toxicity*
  • Data Interpretation, Statistical
  • Dose-Response Relationship, Drug
  • Epidemiology*
  • Female
  • Humans
  • Male
  • Policy Making
  • Risk Assessment*


  • Carcinogens