996 F.3d 673
9th Cir.2021Background
- Chlorpyrifos is a widely used organophosphate pesticide with tolerances allowing residues in food; EPA had previously found tolerances safe in 2006 after FQPA-mandated review.
- In 2007 PANNA and NRDC petitioned EPA to revoke all chlorpyrifos tolerances, citing animal and epidemiological studies (notably the Columbia Study) showing neurodevelopmental harm to fetuses and children at exposure levels below established points of departure.
- Over 2008–2016 EPA and its Scientific Advisory Panel (SAP) repeatedly reviewed the evidence; EPA’s interim assessments expressed growing concern that neurodevelopmental effects may occur below levels tied to AChE inhibition, and EPA proposed revocation in 2015 and issued revised risk analyses in 2016.
- Courts repeatedly compelled EPA to act (multiple mandamus writs); in April 2017 EPA denied the 2007 petition citing need to finish FIFRA registration review and resolve remaining scientific uncertainty; EPA finalized denial of objections in 2019.
- Ninth Circuit panel majority held EPA unlawfully left tolerances in effect without required FFDCA safety findings, found the 2017/2019 denials arbitrary and capricious, vacated those orders and remanded with instructions: within 60 days EPA must either revoke all tolerances or modify tolerances and publish concomitant findings that modified tolerances are safe for the general population and for infants and children, and adjust related FIFRA registrations.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether EPA may leave a tolerance "in effect" without a current FFDCA safety finding after a revocation petition | Petitioners: once EPA accepts a revocation petition that raises genuine safety questions, EPA must determine the tolerance remains "safe" to leave it in effect; here EPA never made that finding | EPA: it may deny a petition without a new safety finding and defer consideration to ongoing FIFRA registration review; petitioners bear burden to present sufficient evidence | Held: EPA must determine tolerances are safe to leave them in effect; EPA unlawfully left tolerances without the required safety determination |
| Allocation of burdens when a petition to revoke is filed | Petitioners: petition need only show reasonable grounds; burden of persuasion that a tolerance is safe remains with EPA when EPA keeps a tolerance in effect | EPA: petitioners must present valid, complete, reliable data sufficient to meet EPA’s regulatory threshold before EPA is required to act | Held: petitioners need only meet a low production threshold (reasonable grounds); burden of persuasion on safety stays with EPA, so denial without safety finding was unlawful |
| Whether EPA’s 2017/2019 denials were arbitrary and capricious under the APA | Petitioners: denials were pretextual delay; EPA’s own 2016 assessments showed tolerances were not reasonably certain to be safe | EPA: scientific uncertainty justifies further study and coordination with FIFRA reregistration; agency cited concerns about data completeness and reliability | Held: EPA’s denials were arbitrary and capricious given the administrative record and EPA’s prior analyses indicating lack of safety; generalized calls for more study insufficient |
| Proper remedy and scope of judicial relief | Petitioners: court should compel revocation (or immediate protective action) and set short deadline | EPA / Dissent: courts should remand for further administrative factfinding; aggressive judicially-imposed deadlines risk predetermining agency action and raise due-process/separation concerns | Held: vacated 2017/2019 orders and remanded with instructions: within 60 days EPA must either revoke all chlorpyrifos tolerances or modify tolerances and simultaneously publish that the modified tolerances satisfy FFDCA safety requirements (including infants and children), and correspondingly adjust FIFRA food-use registrations |
Key Cases Cited
- Motor Vehicle Mfrs. Ass'n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (agency must provide reasoned explanation; arbitrary and capricious standard)
- Baltimore Gas & Electric Co. v. NRDC, 462 U.S. 87 (1983) (courts defer on agency matters at scientific frontiers)
- Vermont Yankee Nuclear Power Corp. v. NRDC, 435 U.S. 519 (1978) (review limited to final agency action; courts cannot impose extra procedural requirements)
- Fla. Power & Light Co. v. Lorion, 470 U.S. 729 (1985) (remand principles; courts ordinarily remand to agency)
- INS v. Orlando Ventura, 537 U.S. 12 (2002) (remand doctrine and scope considerations)
- Nat’l Ass’n of Home Builders v. Defenders of Wildlife, 551 U.S. 644 (2007) (agencies may change position; must adequately explain changes)
- FCC v. Fox Television Stations, Inc., 556 U.S. 502 (2009) (reasoned explanation required when an agency changes course)
- San Luis & Delta–Mendota Water Auth. v. Jewell, 747 F.3d 581 (9th Cir. 2014) (warning about courts imposing tight deadlines on complex scientific administrative work)