Summary of a Recent
Judicial Development in
Pesticide Regulation

EPA Order Remanded for Failure to Provide Reliable Data Justifying
a Deviation from Margins of Safety

Eric H. Foy
National AgLaw Center Research Associate

Summary of Decision

In Northwest Coalition for Alternatives to Pesticides v. U.S. Environmental Protection Agency, 544 F.3d 1043, 2008 WL 4276915 (9th Cir. 2008), the United States Court of Appeals for the Ninth Circuit granted in part and denied in part an order of the United States Environmental Protection Agency (EPA). Petitioner environmental groups challenged an EPA order that established tolerance levels for seven pesticides used in the production of food, because the agency did not apply the presumptive tenfold safety factor. The court granted the petitions for review of three of the seven tolerance levels because the EPA failed to adequately explain the basis for its deviation from the presumptive safety factor, but the court denied the petitions for review on all other issues.

Background

Between December 2001 and April 2002, the EPA published regulations establishing tolerance levels for seven pesticides used on many foods, including fruits, vegetables, milk, and eggs. Id. at *5. In 1996, to protect infants and children, Congress enacted the Food Quality Protection Act (FQPA), which directs the EPA to use a tenfold margin of safety to all tolerance levels. Id. at *4. The FQPA provides the EPA some flexibility to use a different margin of safety "only if, on the basis of reliable data, such margin will be safe for infants and children." Id. In 2002, the petitioners filed objections to the tolerance levels at issue because the EPA did not apply the presumptive tenfold margin of safety for any of the seven pesticides. Id. at *6. The petitioners argued that the EPA did not have sufficiently reliable data to deviate from the presumptive margin of safety. Id. On August 10, 2005, the EPA issued a final order rejecting the petitioners' objections. Id. They petitioned for review of the final order. Id. at *7.

Arguments

The petitioners challenged the EPA's final order approving seven pesticide tolerance levels because they alleged that the agency did not have reliable data to deviate from the presumptive tenfold margin of safety. Specifically, the petitioners challenged the completeness of the exposure data and the reliability of the toxicity data that the EPA used to reduce the margins of safety. Id. at *16.

Analysis and Holdings

Because the EPA lacked sufficient drinking water exposure data for the pesticides at issue, it used computer modeling to determine drinking water exposure for the seven pesticides. Id. at *10. The petitioners argued that modeling data, as opposed to studying tangible water samples, did not constitute reliable data within the meaning of the FQPA. Id. Disagreeing with the petitioners, the court held that computer modeling could provide more reliable data than actual water sampling could provide. Id. at *10-11. Therefore, the court concluded that using computer modeling to calculate the safety of drinking water was neither contrary to law or arbitrary and capricious. Id. at *15.

The EPA established tolerance levels for three of the seven pesticides at issue (for acetamiprid, mepiquat, and pymetrozine, collectively "AMP tolerance levels") before the results of certain developmental neurotoxicity studies (collectively "DNT studies") were available. Id. at *16. The petitioners contended that the DNT studies were essential to assessing pesticide effects, and that the EPA acted arbitrarily and capriciously by failing to wait for the studies' results before setting the AMP tolerance levels. Id. The court held that the petitioners' position was inconsistent with the United States Supreme Court's holding in National Association of Home Builders v. Defenders of Wildlife, 127 S. Ct. 2518 (2007). Id. at *17. Under Home Builders, the Court held that as long as an agency follows proper administrative procedures, it can have internally inconsistent positions throughout the decision-making process without rendering a final decision arbitrary and capricious. Id. at *17-18. On such questions of scientific judgment, the court stated that it was required to defer to the EPA. Id. at *18.

Finally, the petitioners challenged the EPA's deviation from the presumptive child safety factor for AMP tolerance levels, because the EPA did not have reliable data showing that the lower margin of safety would not harm infants and children. Id. The court believed this challenged had merit because the EPA's final order was impermissibly vague, making it impossible for the court to determine whether the EPA's deviation from the AMP tolerance levels was supported by reliable data. Id. at *19. Accordingly, the court remanded the AMP tolerance levels to the EPA for further proceedings. Id. at *21.

The case was decided on September 19, 2008.