E.P.A. Strengthens Protections for Participants in 3rd Party Human Studies Involving Pesticides

WASHINGTON - Furthering the E.P.A.'s (EPA) commitment to rigorous science conducted with the highest ethical standards, E.P.A. Administrator Lisa P. Jackson has signed amendments strengthening existing requirements for human research involving pesticides submitted by 3rd parties for consideration in E.P.A. decision-making. These amendments apply to studies involving the controlled exposure of participants to pesticides.

The amendments strengthen EPA's 2006 rule, Protections for Subjects in Human Research, and provide guidance to 3rd parties including pesticide companies and other research sponsors who may want to submit research involving pesticides and the controlled exposure to human subjects to the agency. The new amendments also implement the recommendations from a 2004 report from the National Academy of Sciences (NAS) and satisfy EPA's commitments under a 2010 settlement arrangement with the Natural Resources Defense Council and other groups who challenged the 2006 rule.

"With this action, E.P.A. is underscoring the critical importance and fundamental compatibility of sound science and high ethical standards," said James Jones, acting assistant administrator for EPA's Office of Chemical Safety and Pollution Prevention. "These amendments will ensure that E.P.A. decisions will only consider human research that has been conducted according to the highest ethical standards."

The amendments broaden the scope and applicability of the rule, further strengthening the requirements for research to be considered in E.P.A. decisions; clarifying the approach used in the EPA's science and ethics reviews of human research involving pesticides; and formally disallowing participation in testing by subjects who cannot consent for themselves.

The amendments do not make any changes to the current Federal Policy for the Protection of Human Subjects (the "Common Rule"), which governs research with human subjects conducted or supported by the E.P.A. and many other Federal departments and agencies.

The amendments are essentially identical to the suggested amendments that were announced in a February 2, 2011, Federal Register Notice http://www.gpo.gov/fdsys/pkg/FR-2011-02-02/html/2011-1629.htm. For more information, visit: http://www.epa.gov/oppfead1/guidance/human-test.htm

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