38 F.4th 34
9th Cir.2022Background:
- Glyphosate (Roundup) underwent FIFRA registration review beginning in 2009; EPA issued an Interim Registration Review Decision in January 2020 finalizing human-health and ecological assessments and imposing label-based mitigation for ecological risks.
- EPA’s human-health conclusion rested on a Cancer Paper classifying glyphosate as “not likely to be carcinogenic to humans,” despite internal agency critiques (ORD and SAP) noting methodological flaws and epidemiological signals for non‑Hodgkin’s lymphoma (NHL).
- The ecological assessment identified risks to mammals, birds, and non‑target plants (primarily via spray drift) and accompanied a brief cost‑benefit statement that benefits outweigh ecological risks when used per label.
- Rural Coalition and NRDC petitioned for review: Rural Coalition challenged the carcinogenicity conclusion and alleged EPA failed to comply with ESA consultation procedures; NRDC challenged the ecological assessment, cost‑benefit analysis, and mitigation assumptions.
- The Ninth Circuit vacated the human‑health portion (finding EPA’s Cancer Paper inconsistent with its own analysis and Cancer Guidelines), held EPA violated ESA by not making an effects determination before issuing the Interim Decision (but declined broad vacatur), and granted EPA’s request to remand the ecological portion without vacatur, imposing an October 2022 deadline for completion.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Carcinogenicity: whether EPA permissibly found glyphosate “not likely” to be carcinogenic | EPA’s Cancer Paper ignored or misapplied its Cancer Guidelines, treating inconclusive epidemiology and discounted rodent/tumor evidence as support for “not likely” | EPA defended its weight‑of‑evidence judgment and reliance on trend/pairwise, historical controls, high‑dose findings, and exposure relevance | Court: Vacated human‑health portion—EPA’s reasoning conflicted with its own analysis and Cancer Guidelines; determination not supported by substantial evidence |
| ESA consultation: whether EPA had to complete an effects determination/consultation before issuing the Interim Decision | Rural Coalition: Interim Decision was an affirmative, discretionary agency action triggering ESA §7; failing to do effects determination and consultation violated ESA | EPA/Monsanto: Interim Decision was not an affirmative action that changed authorization; litigation moot because EPA later began consultation | Court: EPA’s Interim Decision is an affirmative, discretionary action; EPA violated ESA by not conducting effects determination before issuing the Interim Decision, but court declined broad vacatur given imminent statutory deadline and mitigation in place |
| Ecological risk, cost‑benefit, and mitigation sufficiency | NRDC: EPA failed to consider major ecological/economic costs (e.g., resistance, soil health, pollinators), gave no reasoned weighting of benefits vs risks, and assumed mitigation would work without evidence | EPA sought voluntary remand without vacatur and did not substantively defend the ecological analysis in this appeal | Court: Granted EPA’s motion for remand without vacatur for the ecological portion, directing EPA to issue a new ecological portion by the Oct. 2022 FIFRA deadline |
| Remedy: vacatur vs. remand without vacatur | Petitioners sought vacatur of Interim Decision (or at least ecological portion) | EPA argued remand without vacatur to preserve interim mitigation and avoid disruption | Court: Vacated only the human‑health portion; denied broader vacatur (except human‑health) and remanded ecological issues without vacatur, imposing the statutory deadline to limit delay |
Key Cases Cited
- Pollinator Stewardship Council v. EPA, 806 F.3d 520 (9th Cir. 2015) (agency cannot treat ambiguous or inconclusive studies as affirmatively proving no risk)
- NRDC v. EPA, 857 F.3d 1030 (9th Cir. 2017) (substantial‑evidence standard for FIFRA review)
- Nat’l Family Farm Coalition v. EPA, 960 F.3d 1120 (9th Cir. 2020) (FIFRA cost‑benefit safety standard and vacatur considerations)
- Karuk Tribe of Cal. v. U.S. Forest Serv., 681 F.3d 1006 (9th Cir. 2012) (definition of agency “action” triggering ESA §7 consultation)
- Western Watersheds Project v. Matejko, 468 F.3d 1099 (9th Cir. 2006) (distinguishing agency inaction from affirmative action under ESA)
- Cal. Sportfishing Prot. Alliance v. FERC, 472 F.3d 593 (9th Cir. 2006) (agency must show affirmative act to trigger consultation)
- Tenn. Valley Auth. v. Hill, 437 U.S. 153 (1978) (ESA’s strong protection for listed species)
- Vt. Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519 (1978) (limits on courts dictating agency procedures and timelines)