Pollinator Stewardship Council v. U.S. Environmental Protection Agency
806 F.3d 520
9th Cir.2015Background
- Dow Agrosciences applied to register sulfoxaflor, a systemic insecticide highly toxic to honey bees, under FIFRA; EPA evaluated using a new tiered Pollinator Risk Assessment Framework.
- Tier 1 (laboratory) tests produced risk quotients far exceeding EPA’s level of concern for both oral and contact exposure; sulfoxaflor classified as "extremely/very highly toxic" to bees.
- Dow submitted six Tier 2 (semi-field/tunnel) studies, most using application rates well below the proposed maximum (0.133 lb a.i./A); many studies had design flaws and did not follow OECD guidance.
- EPA proposed a conditional registration in January 2013, requiring additional Tier 2/OECD-compliant studies and residue data; shortly thereafter, without receiving those studies, EPA unconditionally registered sulfoxaflor in May 2013 at a reduced rate (0.09 lb a.i./A) with mitigation measures and label language.
- Petitioners (beekeepers/organizations) challenged the unconditional registration as unsupported by substantial evidence; the court found the Tier 2 data insufficient to support unconditional registration and vacated the EPA’s approval, remanding for additional studies.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether EPA's unconditional registration of sulfoxaflor was supported by substantial evidence | EPA lacked sufficient studies (Tier 2/OECD-compliant) to show no unreasonable adverse effects on brood development or colony strength | EPA relied on Tier 1/Tier 2 data, agency expertise, and mitigation measures at reduced rate to support registration | Vacated: registration not supported by substantial evidence given data gaps and flawed Tier 2 studies |
| Whether EPA could rely on inconclusive/ambiguous studies to conclude no unreasonable adverse effects | Ambiguous/inconclusive studies cannot be used to affirmatively show no risk | Agency discretion to weigh studies and use professional judgment to resolve uncertainty | Rejected: agency may not rely on ambiguous studies to support a conclusion they do not actually establish |
| Whether remand should be with or without vacatur | Petitioners: vacatur necessary to prevent environmental harm to bees | EPA/Dow: leaving registration in place pending more study would avoid disruption/benefits loss | Vacated: due to potential environmental harm to precarious bee populations, equity favors vacatur |
| Whether EPA complied with its own procedural/data-requirement framework (Tiered approach, OECD guidance) | EPA ignored its conditional requirement and failed to obtain required OECD/Tier 2 studies before unconditional registration | EPA contends it has discretion in data requirements and relied on available data and mitigation | Held: EPA failed to follow its own framework and could not justify bypassing required studies; action arbitrary given its prior conditional stance |
Key Cases Cited
- Washington Toxics Coalition v. EPA, 413 F.3d 1024 (9th Cir.) (discussing FIFRA cost-benefit/unreasonable risk analysis)
- Thomas v. Union Carbide Agr. Prods. Co., 473 U.S. 568 (Supreme Court) (registration application contents under FIFRA)
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (Supreme Court) (arbitrary and capricious review and agency reasoned explanation)
- Natural Res. Def. Council v. EPA, 735 F.3d 873 (9th Cir.) (substantial-evidence review of EPA pesticide decisions)
- Tucson Herpetological Soc. v. Salazar, 566 F.3d 870 (9th Cir.) (agency cannot rely on ambiguous studies to support conclusions)
- Lands Council v. McNair, 537 F.3d 981 (9th Cir.) (deference to agency expertise but need for explanation)
- Cal. Communities Against Toxics v. EPA, 688 F.3d 989 (9th Cir.) (vacatur/remand balancing of environmental harm and disruption)