EPA Settles Case Concerning Human Subjects Protections Rule

On June 18, 2010, the U.S. Environmental Protection Agency (EPA) announced that it has settled a lawsuit over its 2006 final rule regarding protections for subjects in human research. Under the settlement, EPA agrees 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. EPA states that the proposed changes “will formalize many current procedures that EPA has been following as it implemented the 2006 rule and address the three principal areas identified by the petitioners: the scope of the rule, its consistency with the 2004 National Academy of Science (NAS) recommendations, and its consistency with the Nuremberg Code.” As required by the settlement, EPA will publish the proposed amendments in a Federal Register notice before January 16, 2011, and open a public comment period at the same time. EPA will promulgate a final rule by December 16, 2011. EPA’s announcement is available online, and the settlement is available online.

In 2006, EPA stated that its final rule strengthened and expanded the protections for participants in third-party research by:

• Prohibiting new research involving intentional exposure of pregnant women or children, intended for submission to EPA under the pesticide laws;
   
• Extending the ethical protections in the Federal Policy for the Protection of Human Subjects of Research (the “Common Rule”) to other human research involving intentional exposure of non-pregnant adults, intended for submission to EPA under the pesticide laws;
   
• Requiring submission to EPA of protocols and related information to ensure any future studies meet this highest ethical safeguard; and
   
• Establishing an independent Human Studies Review Board to obtain expert peer review of both proposals for new research and completed third-party intentional dosing, research on which EPA may rely on under the pesticide laws.

In addition, the final rule:

• Categorically prohibits any EPA-sponsored research involving intentional exposure of pregnant women or children to any environmental substance; and
   
• Adopts the Department of Health and Human Services regulations to provide additional protections beyond those of the Common Rule to pregnant women and children in EPA observational research where there is only minimal risk and when research does not involve intentional exposure to any substance.

The petitioners sued EPA in 2006, claiming that the final rule violated language in the fiscal year 2006 appropriations bill, in which Congress asked EPA to incorporate the Nuremberg Code on medical experiments and recommendations from NAS into the rule, as well as a restriction on testing on pregnant women and children. The settlement includes language intended to close a “loophole” that petitioners claimed allowed some tests to be conducted on pregnant women and children, would eliminate a provision that allowed an “authorized representative” to consent to the testing on behalf of a subject, and would require human testing to adhere to a set of scientific and ethical standards based on the NAS recommendations.

The changes expected from the settlement are expected to capture formally procedures and interpretations the Office of Pesticide Programs has operated under since the issuance of the rule and which would clarify the EPA position on the alleged “loopholes.” The question remains whether EPA, intentionally or unintentionally, will open other issues to reconsideration as it develops the rulemaking process agreed to in the settlement. It is also unclear if any interested parties might be able to use the rule revisions to propose changes to the rule not outlined in the settlement. A variety of parties have expressed concerns over the current implementation of the rule, either as too stringent or too expansive, so it is not certain that a “narrow fix” will in fact be as straightforward as EPA anticipates at the present time.