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02-08-13 EPA Strengthens Protections for Participants in Third Party Human Studies Involving Pesticides…

Posted by Brian Allmer on February 8, 2013

epa_seal_mediumcolorWASHINGTON – Furthering the U.S. Environmental Protection Agency’s (EPA) commitment to rigorous science conducted with the highest ethical standards, EPA Administrator Lisa P. Jackson has signed amendments strengthening existing standards for human research involving pesticides submitted by third parties for consideration in EPA 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 third 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 agreement with the Natural Resources Defense Council and other groups who challenged the 2006 rule.

“With this action, EPA 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 EPA 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 standards for research to be considered in EPA 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 EPA and many other Federal departments and agencies.

The amendments are essentially identical to the proposed 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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