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Pesticide News Story: EPA Settles Lawsuit over Its 2006 Human Subjects Protections Rule

For Release: June 18, 2010

EPA has settled a lawsuit over its 2006 regulation that established protections for subjects of human research. Under the settlement, EPA agrees to propose amendments to the rule consistent with language negotiated with groups who challenged that rule. The proposed changes will formalize many current procedures that EPA has been following as it implemented the 2006 rule and address the three principal areas identified by the petitioners: the scope of the rule, its consistency with the 2004 National Academy of Science recommendations, and its consistency with the Nuremberg Code.

As required by the Human Subjects Protections Rule settlement (7 pp, 68k, about PDF) , EPA will publish the proposed amendments in a Federal Register notice before January 16, 2011, and open a public comment period at the same time. The amendments will be finalized by December 16, 2011.

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