## Facts

- EPA issued final rules (2001–2002) establishing or maintaining food-residue tolerances under the FDCA for seven pesticides used largely on fruits and vegetables.
- The FDCA, as amended by the FQPA, requires EPA to find a tolerance “safe,” meaning a reasonable certainty of no harm from aggregate exposure, and to apply an additional 10× safety margin for infants and children unless reliable data justify a different factor.
- EPA did not apply the default 10× factor uniformly; for some pesticides it applied a 3× factor, and for others no additional factor (1×) beyond traditional uncertainty factors.
- For three pesticides, EPA required registrants to conduct developmental neurotoxicity (DNT) studies but finalized the tolerance actions before those studies were completed.
- Environmental organizations petitioned for review, arguing EPA’s tolerance decisions were arbitrary and capricious because they relied on incomplete data and did not adequately justify reducing or eliminating the statutory 10× children’s safety factor.

## Issues

1. Whether EPA acted arbitrarily and capriciously by reducing or eliminating the FQPA default 10× children’s safety factor while acknowledging data gaps, including missing DNT studies.
2. Whether EPA adequately supported, with “reliable data,” its determination that the tolerances were “safe” for infants and children despite using reduced or no additional FQPA safety factor.

## Decision

- The Ninth Circuit granted the petitions in part, denied them in part, and remanded to EPA.
- The court held that, for pesticides where EPA required but had not yet received DNT studies, EPA’s explanation for reducing or eliminating the 10× factor was inadequate and therefore arbitrary and capricious.
- The court upheld EPA’s decisions for other pesticides where the administrative record and reasoning sufficiently supported the selected safety factor.
- The court remanded for EPA to reconsider and/or more fully explain its safety-factor choices and how the tolerances satisfied the FDCA/FQPA safety standard in light of identified uncertainties.

## Legal Principles

- Under the APA, an agency must examine relevant data and articulate a reasoned explanation that connects the facts found to the decision made; technical complexity does not excuse conclusory reasoning.
- The FQPA establishes a presumption favoring an additional 10× margin of safety for infants and children; EPA may depart only if it determines, based on reliable data, that a different factor is safe.
- When EPA identifies material data gaps (including by requiring additional studies), it must explain why the remaining record is nonetheless “reliable” enough to support reducing or eliminating the default 10× children’s safety factor.
- A court may uphold some agency actions and remand others within a consolidated challenge when the adequacy of the record and explanation differs across related determinations.

## Conclusion

The Ninth Circuit required EPA to provide a record-based, coherent justification for reducing the FQPA default 10× children’s safety factor, and it remanded tolerance decisions where EPA proceeded despite acknowledged developmental neurotoxicity data gaps without adequately explaining how the tolerances remained “safe.”


Nw. Coal. for Alts. to Pesticides v. EPA, 544 F.3d 1043 (9th Cir. 2008)