Natural Resources Defense Council v. United States Environmental Protection Agency
658 F.3d 200
2d Cir.2011Background
- NRDC petitions EPA to revoke all tolerances and cancel all registrations for dichlorvos under FDCA/FIFRA; EPA relied on a 1997 human dosing study (Gledhill) with 6 treated subjects and 3 controls to set safe margins, including LOAEL-to-NOAEL adjustments and MOEs under FQPA; NRDC challenges reliance on the Gledhill study as unethical, invalid, and not a reliable data basis, and argues EPA failed to apply the presumptive 10X FQPA safety factor for children; EPA’s Interim Reregistration Eligibility Decision (IRED) allowed broader residential and agricultural uses; NRDC submitted objections requesting a public evidentiary hearing on the Gledhill study and the 10X factor; EPA denied NRDC’s objections and requests for a hearing in 2008; NRDC petitions to review, challenging both the Gledhill-based risk assessments and the reduced children’s safety factor.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether EPA’s reliance on the Gledhill study was arbitrary and capricious. | NRDC: Gledhill is unethical/invalid and statistically weak. | EPA: 9 subjects adequate for LOAEL-to-NOAEL conversion; study valid for limited purpose. | Yes; portions relying on Gledhill vacated and remanded. |
| Whether EPA properly reduced or waived the 10X children’s safety factor without reliable data. | NRDC: no reliable data to justify <10X; endocrine data incomplete. | EPA: reliable data support reduction; data outside endocrine program acceptable. | Partially; vacate Gledhill-based reductions; deny broader challenge to non-Gledhill risk assessments. |
| Whether NRDC was entitled to an evidentiary hearing on these issues. | NRDC: hearing needed to resolve data and ethical concerns. | EPA: many issues are legal/policy; hearing not required. | Court leaves remand possibility; not resolved on hearing for the Gledhill issues. |
| Whether EPA properly explained why a 10X safety factor could be reduced or waived before endocrine disruptor testing completed. | NRDC: EPA failed to provide reasoned basis for reduction. | EPA: could rely on reliable data beyond screening program. | Arbitrary and capricious regarding Gledhill risk assessments; remand warranted. |
Key Cases Cited
- Johnson v. Nat. Res. Def. Council, 461 F.3d 164 (2d Cir. 2006) (FQPA/FDCA framework; safety standards and data completeness considerations)
- State Farm Mut. Auto. Ins. Co. v. Argus, 463 U.S. 29 (U.S. 1983) (requirement of a rational connection between facts and decision; not supplying missing rationales)
- Citizens to Preserve Overton Park, Inc. v. Volpe, 401 U.S. 402 (U.S. 1971) (arb- cap review standard for agency action; need reasoned decisionmaking)
- Pub. Citizen, Inc. v. Mineta, 340 F.3d 39 (2d Cir. 2003) (need for reasoned basis in agency actions; consistency with evidence)
- Nat’l Res. Def. Council v. EPA, 571 F.3d 1245 (D.C. Cir. 2009) (administrative procedure; reliance on data and rational basis for agency determinations)