Human Testing Case Victory

As reported in BNA's Daily Environment,¹ on June 3, a unanimous panel of the US Court of Appeals for the DC Circuit vacated the US Environmental Protection Agency’s (EPA) interim policy of not relying on third-party human tests for regulatory decisions.  CropLife America v. EPA, No. 02-1057 (DC Cir. June 3, 2003).  Seth Goldberg, Cynthia Taub, and Amber Blaha of Steptoe & Johnson LLP represented the American Chemistry Council, which intervened to support the petitioners.  Their brief and argument are reflected in the opinion.

Properly designed and ethically conducted volunteer human testing data are used for many regulatory programs within EPA, as well as by other governmental authorities, such as the Food and Drug Administration.  Human testing studies are scientifically recognized as providing accurate information, and are very useful in making judgments about the potential risks of exposure to chemical products.  EPA’s moratorium on the consideration of human test data would have forced the Agency to ignore relevant data and instead rely on assumptions and default models that may vastly overstate risk.

The CropLife America v. EPA court found that EPA's policy was a regulation that should have been issued persuant to notice and comment: "[b]ecause the new rule effects a dramatic change in the agency's established regulatory regime, EPA was required to follow notice and comment procedures..."  The decision is significant because EPA often tries to avoid rulemaking in issuing binding directives.  This decision, along with Appalachian Power v. EPA, 251 F.3d 1026 (DC Cir. 2001) and others, should encourage EPA and other agencies to follow appropriate procedures before taking any action that constitutes a regulation.
    
For more information, please review our Environmental and Chemical Regulatory Update on this matter.


¹Karen L. Werner, Federal Court Vacates Agency Policy; Human Testing to be Accepted Case-by-Case, Daily Env't. (BNA) No. 107, at A1 (June 4, 2003).