40 CFR 26 - PROTECTION OF HUMAN SUBJECTS

EPA proposes to amend the portions of its rules for the protection of human subjects of research applying to third parties who conduct or support research with pesticides involving intentional exposure of human subjects and to persons who submit the results of human research with pesticides to EPA. The proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. They would also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Finally the proposed amendments would identify specific considerations to be addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn from the recommendations of the National Academy of Sciences (NAS). In seeking comments on these proposed amendments, EPA does not imply that the current Federal Policy for the Protection of Human Subjects (the “Common Rule”), which governs research with human subjects conducted or supported by EPA and many other Federal departments and agencies, is inadequate. Indeed, the amendments proposed here would make no changes to the Common Rule or EPA's codification of the Common Rule. Rather, EPA is proposing these amendments to other portions of its regulation as a result of a settlement agreement, and is now seeking comment on these proposed amendments. The settlement agreement makes clear that EPA retains full discretion concerning what amendments are proposed, and what, if any, amendments are finalized. Furthermore, no research has been identified that is outside the scope of EPA's current rule, but that would be within the scope of these proposed amendments. EPA seeks comments on the need for and value of the proposed changes.