On December 15, 2022, the United States Court of Appeals for the Eighth Circuit heard argument in Red River Valley Sugarbeet Growers Association et al. v. Regan, Nos. 22-1422 & 22-1530. This may be the most important pesticide case in a generation, and it could set precedent not only in that subject area, but for EPA and other agencies as they make policy choices generally in light of their scientific findings and the statutes that govern their work.

Petitioners, including agricultural groups and one chemical company, challenge EPA’s 2021 revocation of all food residue “tolerances” for the pesticide chlorpyrifos, and the Agency’s 2022 denial of objections to the revocation. Chlorpyrifos is historically one of the nation’s most widely used pesticides, including on many major commodity and non-commodity crops. Petitioners urge that this pesticide is crucial to maintaining an adequate supply of key crops.

EPA does not deny that some uses of chlorpyrifos on food are safe. Instead, its position has been, variously, either that it had no discretion to narrow the tolerances rather than revoke them outright, or that it reasonably exercised its discretion not to do so because the parties that hold chlorpyrifos registrations hadn’t moved quickly enough to cancel or amend those registrations. Petitioners, for their part, charge that EPA had and has everything it needs, both in the scientific-administrative record and in its statutory authority, to narrow the tolerances rather than revoke them all.

Making sense of the dispute requires examining the general statutory context and the regulatory and litigation history of this matter.

The statutory context

This case features the interaction between two statutes governing EPA’s regulation of pesticides:

(1)    the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. § 136 et seq.;

(2)    the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. § 301 et seq., as amended by the 1996 Food Quality Protection Act (FQPA, collectively the food statute), specifically at FFDCA § 408, 21 U.S.C. § 346a.

Under FIFRA, pesticides need EPA registration. EPA must find that the pesticide, under the terms of use permitted on its label, will not pose “unreasonable adverse effects on the environment.” This standard lets EPA balance the economic, social, and environmental costs and benefits of the pesticide’s use. Registrants can voluntarily cancel a registration in summary fashion, but involuntary cancellation initiated by EPA entails lengthy administrative process to protect the registrant’s property rights.

By contrast, under the food statute, EPA can’t balance benefits and harms. Instead, it must determine the safe “tolerance” for pesticide crop residue. If there’s no tolerance in place, you can’t use a pesticide in a manner that leaves residue even if that use is registered under FIFRA.

Specifically, the food statute defines a “safe” tolerance as one which provides:

a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.

21 U.S.C. § 346a(b)(2)(A)(ii) (emphases added).

The FQPA directs EPA to coordinate tolerance revocations, “to the extent practicable,” with “any related necessary action under” FIFRA. And FIFRA incorporates the FQPA risk standard where the pesticide registration is for uses that leave food residues. So, under FIFRA, EPA can only register a pesticide for use on food crops if it meets the “reasonable certainty [of] no harm” standard—while being able to balance costs and benefits outside the food-residue context.

The regulatory and litigation history

In 2006, EPA reviewed and reaffirmed chlorpyrifos registrations for agricultural uses. The next year, an NGO petition demanded EPA revoke all food-residue tolerances for chlorpyrifos. While EPA’s review had historically focused on the substance’s inhibition of the enzyme acetylcholinesterase (which is necessary to regulate nerve function), the petition asserted that chlorpyrifos can also cause neurodevelopmental harm.

After a decade and multiple trips to the Ninth Circuit on mandamus, EPA proposed near the end of the Obama administration to revoke all chlorpyrifos food-residue tolerances, based in part on the child-harm theory despite intense controversy over the provenance and reliability of the underlying studies and methodology. In 2017 (denying the petitions) and again in 2019 (rejecting objections to the denial), however, EPA declined to finalize that proposal, despite increasingly blunt opinions from the Ninth Circuit insisting that it either do so or make an affirmative “reasonable certainty [of] no harm” finding. EPA’s message was that the science was uncertain and controversial, and that Agency should instead focus its efforts towards the 15-year registration review cycle required by FIFRA. The Ninth Circuit’s message was blunt: We think you’re stalling, and we think your time is up.

In 2020, EPA issued new scientific studies. It determined that it could not “make a causal linkage” between chlorpyrifos and the neurodevelopmental effects claimed by the NGO petition. But it also determined that drinking water exposure meant it could not say that all currently allowed uses of the pesticide were safe. However, it also determined that it could say a core set of 11 key uses on crops in certain areas would result in safe levels or exposure. This new phase in EPA’s thinking culminated in a December 2020 document styled a Proposed Interim Decision (PID), in which EPA said that it “has determined” that these 11 uses would not pose concern, even applying the food statute’s “10x” safety factor (generally requiring an order-of-magnitude thumb on the scales where infant and child exposure is at issue).

A new party took the White House, and with it control of the Agency. And the Ninth Circuit, on April 29, 2021, issued yet another opinion (League of United Latin American Citizens v. Regan, 996 F. 3d 673 (9th Cir. 2021)), referred to in the Eighth Circuit matter as “LULAC II,” in which it ordered EPA within 60 days of the mandate to either revoke all chlorpyrifos tolerances, or modify the tolerances and simultaneously make the required safety finding. The Ninth Circuit also ordered EPA to “correspondingly modify or cancel related FIFRA registrations for food use in a timely fashion.”

EPA engaged in negotiations with companies holding chlorpyrifos registrations, including one of the Eighth Circuit petitioners, to explore a voluntary cancellation of some registered uses in light of the 2020 determinations that some uses were safe even under the heightened food-residue standard. The petitioners and EPA in that briefing now essentially accuse each other of not negotiating constructively. As the Ninth Circuit deadline approached, EPA appears to have shifted to prepare a complete revocation of all food-residue tolerances, which it in fact issued in August 2021.

In that revocation order, as in the February 2022 denial of objections (a required step under the food-residue statute), EPA did not abandon its conclusions in the PID that a subset of uses would be safe. Instead, it insisted, as it would later do in its Eighth Circuit briefing, that its mandate to consider “all anticipated” exposures in considering whether tolerances allow a “reasonable certainty [of] no harm” finding means that it must assume all currently FIFRA-registered uses will continue in effect, unless it has a request for voluntary cancellation in hand.

By contrast, objectors (and now petitioners) argue that the term “anticipated” in the phrase “all anticipated” exposures, coupled with the congressional mandate to coordinate food-residue and FIFRA actions and the Ninth Circuit’s order to revoke or modify tolerances on a tight timeline while ordering FIFRA action only on a “timely” basis, means that EPA can and should have first modified tolerances to match the PID’s identification of a safe subset of currently registered uses, and then to proceed to revoke or modify FIFRA registrations to match that subset.

Oral argument

The Eighth Circuit case was heard by Chief Judge Smith and Judges Gruender and Stras. Judge Stras in particular seemed skeptical of EPA’s position (and of the Ninth Circuit’s LULAC II order), repeatedly asking if the Ninth Circuit had simply given EPA too little time, and whether the panel should vacate the tolerance revocation and give EPA more time to coordinate its food-statute actions with its FIFRA actions, or whether alternatively it should remand without vacatur for EPA to reconsider.

Judge Smith asked whether EPA had considered the consequences of total revocation rather than modification, to which the Agency’s DOJ attorney replied that it wasn’t allowed to under the food-statute standard. (This tended to confirm petitioners’ argument that EPA is trying to separate two statutes that Congress explicitly told it to coordinate.) He also asked about the United States Department of Agriculture’s (USDA) views. USDA consistently has disagreed with EPA’s total-revocation approach, including in September 2022 letters from USDA staff to EPA’s pesticide office and from Secretary Vilsack to members of Congress. DOJ first suggested that USDA lacked expertise, before quickly pivoting to stress that the decision to revoke tolerances lies with EPA, not USDA.

Judge Gruender asked petitioners at one point whether, if the panel affirmed EPA’s revocation order, the registrants couldn’t then voluntarily amend their registrations to conform with the subset of uses identified as safe. Petitioners’ counsel responded that this would be expensive and burdensome, with “pest pressure” continually mounting and threatening crops—and that EPA in the interim is proposing to cancel all remaining food-use registrations. The subtext of this response is clear: if you don’t stop EPA now and direct it to coordinate a food-statute tolerance safety finding on the narrowed subset of uses with FIFRA registration actions to reflect that subset, there will be no later chance to fix things.

EPA throughout stressed that the PID was “proposed,” and that it still has not responded to comments from NGOs that even the subset of uses identified as safe may in fact pose risks. But petitioners’ counsel forcefully observed that the PID did not propose to find that that subject was safe, it did so, and that EPA even today has not abandoned that scientific finding. EPA had no rebuttal to this, nor did it ever crisply articulate why, if in fact it had discretion to “anticipate” a narrowing of FIFRA-registered uses when performing its food-statute task, it didn’t do so.

Indeed, at argument, EPA seemed to argue simultaneously that the food statute didn’t allow it to take that step, and that it had discretion not to do so because it wasn’t satisfied with the commitments it had received from the registrants to undergo voluntary cancellation of the other registered uses, and it simply didn’t have enough time under the Ninth Circuit’s order to complete involuntary cancellation. (EPA did not articulate a solid response to Petitioners’ observation that the Ninth Circuit’s order appeared to contemplate food-statute action first, FIFRA action second.) In this light, the assertion in the Petitioners’ brief that the revocation action masked an “unexplained policy choice” took added weight.

Looking forward

The tenor of oral argument suggests the panel is more likely than not to remand to EPA, and vacatur seems at least on the table. Still, the outcome may depend in part on whether and how directly the Eighth Circuit addresses the role of the short deadline imposed by the Ninth Circuit, since both EPA’s positions and the panel’s questioning identified LULAC II’s 60-day deadline as the root of the outcome now before the Eighth. Petitioners pick their venue under the statute, and much pesticide caselaw is made in the Ninth Circuit; decisions in the coastal circuit can have a huge real-world effect on the agricultural heartland.


The implications for the pesticide and agricultural sectors, both for the continued viability of crop uses of chlorpyrifos specifically and for how EPA will (or won’t) coordinate its FIFRA and food-statute actions in the future generally, are weighty. The outcome may also have more general ripple effects in administrative law. EPA’s position reduces largely to the assertion that an agency’s scientific findings connected to a notice-and-comment regulatory process are rendered tentative or uncertain due to that connection. This fact pattern is bound to recur in our system of government, where relatively permanent staffs of civil-servant scientists work under successive presidential administrations that have starkly different policy views. Anyone interested in agricultural policy, science policy, environmental regulation, or administrative law more generally should pay close attention to how the Eighth Circuit resolves this matter.

Note from the Editor: The Federalist Society takes no positions on particular legal and public policy matters. Any expressions of opinion are those of the author. We welcome responses to the views presented here. To join the debate, please email us at [email protected].