How Many Times Do I Have to Tell You?!: EPA's Ongoing Struggle with Data from Third-Party Pesticide Toxicity Studies Using Human Subjects

Abstract

This article addresses EPA's current and historic policy struggle regarding the position the Agency should take with respect to pesticide toxicity studies done by third parties in their attempts to register pesticides. Chemical companies often conduct these studies, or seek third-parties to do so, and submit the results to EPA in support of applications for pesticide registration. Although EPA had a high level joint Science Advisory Board/FIFRA Science Advisory Panel make recommendations to it on this subject in 1999, last year EPA asked the National Academy of Sciences to conduct additional, almost certainly duplicative review. Specifically, EPA has asked the NAS to review the complex scientific and ethical issues posed by EPA's possible use of third-party studies which intentionally dose human subjects with toxicants to identify or quantify their effects, essentially the same charge the EPA issued to the 1999 panel.

Keywords: pesticides, ethics, human subjects, common rule, EPA, environmental law, environmental protection agency