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EPA Proposes Amendments to Rules of Testing Involving Pesticides Done on Human Subjects
(February 2011)

EPA suggested changes to a portion of its guidelines concerning the protection of human subjects taking part in research studies involving pesticides.

EPA has proposed an amendment to a portion of its rules concerning the protection of human subjects taking part in research studies involving pesticides. The changes apply to third parties conducting or supporting research that involves intentional exposure to pesticides of human subjects and persons submitting the results of human research with pesticides to EPA.

In addition, the proposed revisions would extend the rules to include human testing with pesticides submitted to EPA under any regulatory statute it administers. The amendment to the rules would also disallow participation in third-party pesticide studies by subjects who cannot consent for themselves. Lastly, EPA will address specific issues in its scientific and ethical review of proposed and completed human research with pesticides, based on recommendations from the National Academy of Sciences (NAS). 
 
In seeking comments on these proposed amendments, EPA was not implying that the current Federal Policy for the Protection of Human Subjects (the “Common Rule”), which oversees research with human subjects, is inadequate. The proposed modifications make no changes to the Common Rule or EPA’s codification of the Common Rule; instead EPA is proposing these amendments to other portions of its regulation as a result of a settlement agreement.

The settlement agreement clearly indicates that EPA retains full discretion concerning proposed amendments, and which, if any, are finalized. Furthermore, no research has been identified that is outside the scope of EPA’s current rule, but that would be within the scope of these proposed amendments.

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