Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides; Notification to the Secretary of Agriculture

요약

This document notifies the public that the Administrator of EPA has forwarded to the Secretary of Agriculture a draft proposed rule as required by section 25(a) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). As described in the Agency's semi-annual Regulatory Agenda, the draft proposed rule would amend the portions of EPA's rules for the protection of human subjects of research that apply to third parties who conduct or support research for pesticides involving intentional exposure of human subjects, and to persons who submit the results of human research for pesticides to EPA. EPA agreed to propose these amendments as a result of a settlement agreement resolving a judicial challenge to the promulgation of these rules in 2006, and is now seeking comments on these draft proposed amendments from the Secretary of Agriculture. The draft proposed amendments would clarify the applicability of the rules to human testing for pesticides submitted to EPA under any statute, would disallow consent by a legally authorized representative of participants in pesticide studies who cannot consent for themselves, and would identify specific considerations to be addressed in EPA s