EPA Proposes to Strengthen Rule on Human Testing that Involves Pesticides

Date: Feb 15, 2011

On February 2, 2011, the Environmental Protection Agency (EPA) issued proposed revisions to the Rule on Protections for Subjects in Human Research Involving Pesticides (76 Fed. Reg. 5,735, available at http://www.gpo.gov/fdsys/pkg/FR-2011-02-02/pdf/2011-1629.pdf). Comments must be received by EPA on or before April 4, 2011. The proposed amendments implement a settlement agreement arising out of a lawsuit against EPA by public interest groups. (The settlement agreement is available at http://www.epa.gov/oppfead1/guidance/human-studies-settlement.pdf.)

The proposal includes the following notable amendments:

  • The current rule governs human testing with pesticides, if test results are intended for submission to EPA (or held for review by EPA) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) or the Federal Food, Drug, and Cosmetic Act (FFDCA). The proposal broadens the rule to cover test results involving a "pesticide" (as defined in FIFRA) submitted to EPA under any statute administered by the Agency.
  • Currently, the rule allows a person who lacks the capacity to consent for himself to participate in a pesticide study, as long as the person's legally authorized representative provides consent. The proposal prohibits this, instead restricting participation to those who can personally provide "free and fully informed consent."
  • Through the Human Studies Review Board (HSRB), EPA obtains peer review of proposals for new research and completed studies. The proposed amendments would require EPA and the HSRB to consider specific factors in their science and ethics reviews of proposed and completed human research. These factors are based on recommendations of the National Academy of Sciences (NAS) and the Nuremberg Code.

These proposed amendments build on the core provisions of the Rule (codified at 40 C.F.R. Part 26), which were finalized on February 6, 2006 (71 Fed. Reg. 6,138). The original rule

  • Extended 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, when intended for submission to EPA under FIFRA and FFDCA.
  • Required submission to EPA of protocols and related information to ensure any future studies meet the highest ethical safeguards.
  • Established the independent HSRB to obtain expert peer review of proposals for new research and results of completed research.
  • Prohibited new research involving intentional exposure of children or pregnant or nursing women.

For more information on EPA's proposed amendments and the obligations under the current human subject test rule, please contact Mike Novak at novak@khlaw.com, or Anna Kuperstein at kuperstein@khlaw.com.