Plaintiff used Roundup on his lawn for over thirty years. When he was diagnosed with malignant fibrous histiocytoma, a form of cancer, he stopped. Plaintiff filed suit against Monsanto alleging that Roundup contained a dangerous carcinogen, glyphosate, and that Monsanto was aware of Roundup’s harmful effects but failed to warn customers of the dangers. He alleged four causes of action under Georgia law: strict liability for a design defect (Count I); strict liability for failure to warn (Count II); negligence (Count III); and breach of implied warranties (Count IV).

Monsanto moved for judgment on the pleadings on the ground that FIFRA’s preemption provision, 7 U.S.C. §136v(b), expressly preempted Carson’s suit. In the alternative, Monsanto claimed that the Agency’s previous approval of Roundup’s labeling and continued adherence to the reasoning for that decision impliedly preempted Carson’s suit. Monsanto argued that because the Agency declined to require a cancer warning when it registered and continued to approve Roundup for sale, requiring a label with such a warning would be “in addition to or different from” FIFRA’s requirements. The district court granted Monsanto’s motion in part. Specifically, the court ruled that FIFRA expressly preempted Carson’s failure-to-warn and breach-of-implied-warranty claims. So the district court dismissed Counts II and IV of the complaint. The court also dismissed Counts I (design defect) and III (negligence) as preempted to the extent that those claims related to Roundup’s labeling or packaging. Because it ruled on express-preemption grounds, the district court did not address Monsanto’s alternative claim that Counts II and IV were impliedly preempted. But it did address and reject implied preemption with respect to Counts I and III. The ditrict court reasoned that, because FIFRA gives states the authority to regulate pesticides, it would not be impossible for Monsanto to comply with both state-law and FIFRA requirements for manufacturing and design.

The parties subsequently settled. In accordance with a “high-low” settlement agreement, Carson moved to amend his complaint to dismiss Counts I and III but preserved his right to appeal Count II, the failure-to-warn claim. The district court granted that motion, and Carson timely appealed.

On appeal, a panel of the U.S. Eleventh Circuit determined that FIFRA did not preempt Carson’s failure-to-warn claim. The Court concluded that Georgia’s common-law standard for product-safety warnings imposes less of a duty than FIFRA’s prohibition against marketing misbranded pesticides, and that the Agency’s approval of Roundup’s labels without a cancer warning did not preempt the Georgia cause of action because only federal action with the force of law has the capacity to preempt state law. The Court analyzed whether the Agency’s registration process carried the force of law, and determined that it did not.

The entire Eleventh Circuit, sitting en banc, then vacated the panel opinion and granted rehearing on the role of a “force-of-law” analysis in the context of express preemption. Sitting en banc, the Court held that a force-of-law inquiry is usually irrelevant where Congress has enacted an express preemption provision.  Rather, an express-preemption analysis applies the text of the preemption provision in line with ordinary principles of statutory interpretation. The En Banc Court remanded to the original panel the question of whether Carson’s failure-to-warn claim was preempted, either expressly or impliedly. The En Banc Court also left for the panel’s consideration Carson’s argument that section 136v(b)’s reference to “requirements” compels a force-of-law inquiry as a matter of statutory interpretation.

On remand, the original panel again rejected preemption.

Initially, as a matter of express preemption, the Court noted that FIFRA does not preempt state-law duties, including common-law claims, that “parallel” or “are fully consistent with” federal requirements. So while FIFRA may preempt additional state “requirements,” it does not preempt additional state “remedies” for violations of federal law. Rather, FIFRA authorizes a relatively decentralized scheme that preserves a broad role for state regulation. Under FIFRA, a pesticide is misbranded if, for example, its label does not contain a warning or caution statement which may be necessary and if complied with is adequate to protect health and the environment. 7 U.S.C. §136(q)(1)(G). FIFRA’s prohibition on misbranding effectively imposes a strict-liability standard, as it contains no element of knowledge or intent. By comparison, under Georgia common law, a pesticide manufacturer breaches its duty to warn if it fails to provide an adequate warning of the product’s potential risks.  But this is not a limitless standard — the manufacturer is liable only if it knows or reasonably should know of the danger arising from the use of its product. And that duty extends to only nonobvious foreseeable dangers from normal use. Hence, if anything, Georgia common law about failure-to-warn claims imposes less of a duty on pesticide manufacturers than FIFRA. “Because Carson’s state failure-to-warn claim is fully consistent with or even narrower than federal requirements, FIFRA does not expressly preempt that claim.”

The Court then rejected the argument that the registration process preempts failure-to-warn claims: “As the en banc Court clarified, we do not undertake a force-of-law analysis before interpreting an express-preemption provision. As a congressionally enacted statute, FIFRA of course carries the force of law, and its plain text preempts state labeling requirements that are ‘in addition to or different from’ federal requirements. But the en banc Court left for us to consider whether section 136v(b)’s reference to ‘requirements’ compels a force-of-law inquiry as a matter of statutory interpretation. To establish whether a particular Agency action amounts to a ‘requirement’ under FIFRA, we must determine whether that Agency action carries the force of law. If it is not a rule of law that must be obeyed, then as the Supreme Court has directed, it is not a ‘requirement’. So though we need not perform a threshold force-of-law analysis before defining the scope of FIFRA’s preemption, we must do that analysis to determine whether an Agency action qualifies as a ‘requirement’.”

Having said that: “On the record before us, we have little trouble concluding that the Agency’s individual approvals are not ‘requirements’ under FIFRA. FIFRA sets forth broadly phrased misbranding standards. Agency regulations, promulgated after notice and comment, give content to those standards. And Congress has given the Agency the authority to determine whether a particular pesticide’s label complies with those broad standards. But we cannot conflate FIFRA’s broad prohibition on misbranding — indisputably a ‘requirement’ — or even generally applicable agency regulations, with an individualized finding that a particular pesticide is not misbranded. This is especially true because Agency approvals provide only prima facie evidence, not conclusive proof, that a pesticide is not misbranded. Indeed, FIFRA specifies that ‘in no event shall registration be construed as a defense for the commission of any offense under’ its provisions. 7 U.S.C. §136a(f)(2). By approving a pesticide’s registration, the Agency signals that the pesticide complies with FIFRA’s requirements, but it does not impose any new requirements beyond FIFRA’s. And significantly, the Agency can later retract its approval. Since the Agency’s determination is neither conclusive nor irrevocable, it would make little sense to deem it a ‘requirement’ on equal footing with FIFRA’s prohibition on misbranding.”

The Court then also rejected Monsanto’s implied preemption argument: “Monsanto relies on the Agency actions we’ve already noted — chiefly, the Agency’s 1993 determination that glyphosate met FIFRA’s requirements for re-registration and its 2019 letter saying that California’s cancer warning for glyphosate would be a ‘false and misleading statement’ in violation of FIFRA. These actions don’t meet the ‘demanding’ standard for impossibility preemption. First, the Agency’s registration, interim registration review, and re-registration of glyphosate without a cancer warning do not show that a cancer warning would be impossible. Put differently, the Agency’s repeated approvals of a label without a cancer warning do not mean the Agency necessarily would have rejected a label with a cancer warning. Nor does the Agency’s concurrent classification of glyphosate as not likely to be carcinogenic to humans alter this conclusion. Based on the record before us, Monsanto did not request — and the Agency did not consider, much less reject — a cancer warning at all. So Monsanto cannot meet its burden to show that the Agency informed Monsanto that it would not approve changing the label to include that warning, and impossibility preemption does not apply. Our conclusion is the same for the Agency’s 2019 letter. Of course, the Agency issued the 2019 letter after Carson was diagnosed with cancer and filed this lawsuit, so it does not necessarily reflect the Agency’s position during the time Carson used Roundup. But even if it did, the 2019 letter was directed at California’s specific Proposition 65 warning and did not conclude that any and all warnings related to glyphosate’s potential cancerous effects would render a pesticide ‘misbranded’. That is not enough for impossibility preemption….

“What’s more, in 2022, the Agency publicly stated that it could approve warning language that the International Agency for Research on Cancer classified glyphosate as probably carcinogenic to humans, and products with that warning would not be considered misbranded. To be sure, the Agency expressed this position years after Carson filed his lawsuit. But it still undercuts Monsanto’s claim of impossibility. If, in the Agency’s own words, it could approve a warning similar to the one Carson seeks, and products with a warning like that would not be ‘misbranded’ under FIFRA, Monsanto could comply with both state and federal labeling requirements. And no irreconcilable conflict exists. As a result, FIFRA does not impliedly preempt the warning that Georgia law would require.”


Carson v. Monsanto Company, No.21-10994, 2024 WL 412081 (11th Cir. Feb. 5, 2024).