More Protection for Participants in Human Studies Involving Pesticides

EPA Administrator Lisa P. Jackson has signed amendments that strengthen existing standards for human research involving pesticides submitted by third parties for consideration in EPA decision-making. These amendments will 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.