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:
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
For more information on EPA's proposed amendments and the obligations under the current human subject test rule, please contact Mike Novak at firstname.lastname@example.org, or Anna Kuperstein at email@example.com.