857 F.3d 1030
9th Cir.2017Background
- NSPW-L30SS (NSPW) is a nanosilver-based antimicrobial materials preservative manufactured by Nano-silva LLC for incorporation into plastics and textiles; not allowed for food-contact or drinking-water uses.
- FIFRA generally requires pesticide registration with the EPA based on sufficient health, safety, and environmental data; conditional registration is allowed for new active ingredients when data gaps exist but only if use is in the public interest and will not cause unreasonable adverse environmental effects.
- EPA conditionally registered NSPW in May 2015 for four years after concluding NSPW (a) contains a new active ingredient, (b) would not cause unreasonable adverse effects during the conditional period, (c) has lower application (mass of silver) and lower mobility (release) than conventional silver pesticides, and (d) that Nano-silva lacked sufficient time to generate required data.
- Petitioners (NRDC, Center for Food Safety, International Center for Technology Assessment) challenged the conditional registration, arguing EPA lacked substantial evidence for its public-interest and insufficient-time findings.
- The Ninth Circuit reviewed whether EPA’s public-interest finding under 7 U.S.C. § 136a(c)(7)(C) was supported by substantial evidence and whether EPA impermissibly relied on unproven assumptions about market substitution and new-product incorporation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether EPA’s public-interest finding was supported by substantial evidence | EPA lacked evidence that NSPW would actually reduce environmental silver loading because EPA assumed users would switch to NSPW and that NSPW would not be added to new products (substitution and no-new-products assumptions) | EPA argued NSPW has lower application and mobility, so it has the potential to reduce environmental silver; market substitution is a logical expectation and EPA need not prove a negative (no new incorporations) | Vacated: EPA’s public-interest finding unsupported because it rested on unsubstantiated substitution and no-new-products assumptions |
| Whether EPA’s comparisons (application rate and mobility) between NSPW and conventional silver were supported | EPA’s use of mass as a metric and its toxicity balancing were inadequate; nanosilver may be more toxic and different metrics (particle number, surface area) matter | EPA presented studies and comparisons (16 conventional silver products), accounted for toxicity uncertainty factors and worst-case leaching, and deferred to agency expertise | Held: EPA’s findings that NSPW has lower application and lower mobility were supported by substantial evidence, but those findings alone did not carry the public-interest showing |
| Whether EPA could rely on post-hoc or historical market characterizations to support substitution | Petitioners said EPA cited no record evidence showing actual or likely substitution | EPA cited a historical Federal Register statement describing pesticide markets as saturated/inelastic | Held: Post-hoc rationalizations insufficient; historical market description from 1983 unsupported for current, narrow silver-preservative market |
| Remedy: scope of vacatur and remand | Petitioners sought vacatur of the conditional registration | EPA argued record justified registration or narrower remedy | Held: Court vacated the conditional registration in whole and remanded; did not reach insufficient-time claim; costs awarded to petitioners |
Key Cases Cited
- Pollinator Stewardship Council v. EPA, 806 F.3d 520 (9th Cir. 2015) (describing FIFRA registration/data requirements and standards for review)
- Nat. Res. Def. Council v. EPA, 735 F.3d 873 (9th Cir. 2013) (review of EPA conditional registration and agency mitigation rules)
- Balt. Gas & Elec. Co. v. NRDC, 462 U.S. 87 (1983) (courts defer to agency predictions at the frontiers of science)
- Motor Vehicle Mfrs. Ass’n v. State Farm, 463 U.S. 29 (1983) (agency action must be upheld on the basis articulated by the agency)
- Vermont Yankee Nuclear Power Co. v. NRDC, 435 U.S. 519 (1978) (agency need not explore every alternative scenario)