lic health or environmental benefits, the committee concludes that such studies that pose no identifiable risk to study participants or that present a reasonable certainty of no harm, based on a careful review of an adequate body of scientific evidence, can be justified under restricted conditions and with appropriate oversight and review regardless of whether the information obtained from the study results in a less stringent or more stringent regulatory outcome.

The committee determined that the analysis and conclusions presented in this chapter could clarify some issues regarding the use of studies that deliberately expose participants to toxicants for EPA regulatory decision making purposes, but it does not pretend to resolve here all of the nettlesome issues that arise from intentional human dosing studies. These ultimately must be resolved through EPA’s publicly transparent policy deliberations and through the case-by-case decisions of duly constituted review bodies charged with protecting the interests of participants in particular studies.


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