Section of Environment, Energy, and Resources
EPA’s Rule on Protections for Subjects in Human Testing
Program Information
Wednesday, November 16, 2005
12:00 p.m. - 1:30 p.m. Eastern Time / 11:00 a.m. - 12:30 p.m. Central Time
10:00 a.m. - 11:30 a.m. Mountain Time / 9:00 a.m. - 10:30 a.m. Pacific Time
Program Overview:
The U.S. Environmental Protection Agency’s much anticipated final rule imposing new restrictions on the use of data from human testing was issued on January 26, 2006, and will have significant domestic and international implications for businesses, growers, and other chemical stakeholders, and profoundly impact risk assessment principles regarding the appropriateness of tests conducted using human subjects. The debate over whether human data should be used to assess potential risks from chemical products, and in particular pesticide products, has been ongoing for years. In July 2005, Congress passed an appropriations bill that imposed a moratorium on EPA’s ability to consider and rely upon human testing for pesticides until EPA issued a final rule on the conduct of intentional dosing human toxicity studies for pesticides. This program will provide an overview of the new rule, the scope of the new regulations, a review of how EPA intends to implement and run the Human Studies Review Board, what process will apply, how EPA will juggle its already demanding schedule for completion of pesticide tolerance review by the August 2006 FQPA deadline along with the new demands imposed on EPA under the new rule, as well as other critically important issues raised by the rule.
Educational Objectives:
To provide practitioners with a thorough analysis of EPA’s final rule from the perspective of both the agency and nongovernmental organizations.
Faculty:
Moderator:
Lawrence E. Culleen, Arnold & Porter LLP, Washington, DC
Panelists:
Cindy Baker, Gowan Company, Yuma, AZ
Aaron Colangelo, Natural Resources Defense Council, Washington, DC
Bill Jordan, Office of Pesticide Programs, U.S. Environmental Protection Agency, Washington, DC
Keith Matthews, Office of General Counsel, U.S. Environmental Protection Agency, Washington, DC
