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October 13, 2010

EPA Sends Draft Revisions to Human Research Rule to Secretary of Agriculture

Bergeson & Campbell, P.C.

Today the U.S. Environmental Protection Agency (EPA) published a notice in the Federal Register announcing that it has forwarded to the Secretary of Agriculture, a draft proposed rule that would revise EPA’s 2006 rule on protections for subjects in human research involving pesticides. 75 Fed. Reg. 62738 (found online). EPA announced on June 18, 2010, that it settled a lawsuit over its 2006 final rule. Under the settlement, EPA agreed to propose amendments to the rule consistent with language negotiated by the groups who challenged it — Natural Resources Defense Council, Pesticide Action Network North America, Pineros y Campesinos Unidos Del Noroeste, Physicians for Social Responsibility, Farm Labor Organizing Committee, AFL-CIO, and Migrant Clinicians Network. According to the Federal Register notice, 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 science and ethics reviews of proposed and completed human research for pesticides, based on the recommendations of the National Academy of Sciences and on the Nuremberg Code.”

The notice states that, under Section 25(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA must provide the Secretary of Agriculture with a copy of a proposed regulation at least 60 days before signing it for publication in the Federal Register, and that the draft proposed rule is not available to the public until after it has been signed by EPA. If the Secretary comments in writing within 30 days after receiving it, the EPA Administrator shall include the comments of the Secretary, and the Administrator’s response to those comments, in the proposed rule when it is published in the Federal Register. If the Secretary does not comment in writing within 30 days, the EPA Administrator may sign the proposed regulation for publication in the Federal Register anytime after the 30-day period. EPA submitted the draft rule to the Office of Management and Budget for review on September 29, 2010.

At this stage, this would appear to be mostly a pro forma step to both comply with the FIFRA 60-day notice to the U.S. Department of Agriculture (USDA) requirement, and to allow the EPA to meet its commitment to issue the rule by January 16, 2011. Whether USDA or other federal agencies will seek to significantly affect the draft rule before issuance of the Notice of Proposed Rulemaking (NPRM) is uncertain. The proposed rule is expected to closely track the text that was included in the court settlement (found online). Whether comments submitted on the proposed rule might lead to any significant revisions, which are responsive to critics other than the non-governmental organization (NGO) community, will be of interest to those parties who have had difficulty in complying with the current rule and interpretations.