Legal Lookout: Proposed Rule on Human Studies
On Sept. 12, 2005, EPA issued its human studies proposed rule, and led a stakeholder briefing on the proposal on Sept. 7. The proposed rule focuses on third-party intentional dosing studies involving pesticides, although EPA seeks comment on alternative approaches with a broader scope. The rule, as proposed, would prohibit new third-party intentional dosing studies for pesticides involving pregnant women or children as subjects, as well as all first- and second-party intentional dosing studies of any substance involving pregnant women or children as subjects. More information on the proposed rule and stakeholder briefing is below. This Legal Lookout column describes this important proposed rule and outlines its implications.