I. Hertzpicciotto, EPIDEMIOLOGY AND QUANTITATIVE RISK ASSESSMENT - A BRIDGE FROM SCIENCETO POLICY, American journal of public health, 85(4), 1995, pp. 484-491
Quantitative risk assessment provides formalized scientific input to r
egulatory agencies that set occupational and environmental standards f
or potentially toxic exposures. Current practice relies heavily on sta
tistical extrapolation from high-dose animal studies. Human data obvia
te the need for interspecies extrapolation and reduce the range of hig
h-to-low dose extrapolation. This paper proposes a framework for class
ifying individual epidemiologic studies as to their adequacy for use i
n 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) quanti
ta- tive exposure assessment for individuals; (5) evidence of a dose-r
esponse 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 ev
aluating the plausibility of animal-derived risk estimates; or (3) use
ful only for hazard identification, not for dose-response assessment.
Methods for using studies in the first two categories are briefly desc
ribed. The emphasis is not on establishing rigid rules, but rather on
ensuring a consistent, reliable process that makes optimum use of avai
lable data.