Statement on Supreme Court filing

“Congress enacted FIFRA to establish a uniform, nationwide framework governing pesticide registration and labeling, and companies should not face liability under state law for complying with federally approved and scientifically-based labeling determinations. Allowing such claims to proceed invites a patchwork of state standards that conflict with the uniformity objective Congress prescribed in law and creates uncertainties that impede the development of new agricultural innovations. The security and affordability of the nation’s food supply depend on farmers’ and manufacturers’ ability to rely on the science-based judgments of federal regulators. Clarification from the Court is essential to restore uniformity, certainty, and the rule of law.”

Key Excerpts from the Brief

Key Argument

“For decades, EPA has exercised its authority under FIFRA in determining that Monsanto’s Roundup product line and its main active ingredient, glyphosate, do not cause cancer in humans. Consistent with that finding, EPA has repeatedly approved Roundup’s label without a cancer warning. Once EPA approves a label, FIFRA prohibits Monsanto from making any substantive change to the label unless it first obtains EPA’s permission.” (Question Presented)

FIFRA Preempts State-Based Failure-to-Warn Legal Theories

“While that jury [in Durnell] rejected every other one of the plaintiff’s state-law claims, it faulted Monsanto for failing to provide precisely the kind of cancer warning on Roundup’s label that EPA considered and rejected. That state-law claim is preempted by FIFRA both expressly and impliedly. To ensure ‘[u]niformity’ in pesticide labeling, FIFRA expressly preempts any state-law labeling requirement that is ‘in addition to or different from those required under’ the statute.” (Introduction)

“Indeed, under FIFRA, Monsanto could not provide the warnings Missouri law requires without rendering Roundup misbranded under federal law. Accordingly, even in the absence of FIFRA’s express preemption clause, respondent’s label-based failure-to-warn claim would be preempted because simultaneous compliance with federal and state law would be impossible.” (Page 2)

“Once EPA approves a label, the ‘label is the law!’… Manufacturers cannot distribute pesticides with labels that differ from the label approved by EPA.” (Page 8-9)

“Here, EPA has approved Roundup labels without a cancer warning. And because ‘the label is the law,’  Monsanto is not free to change its labels without first seeking and obtaining EPA approval. It is thus impossible for the manufacturer of an EPA-registered pesticide to do independently what state law
requires.” (Page 21-22)

Public Interest in Clear Labeling Complying with FIFRA

“…Pesticides play a critical role in empowering American farmers and protecting the food supply. EPA can strike a balance between those important objectives by ensuring that labels warn against health risks, but neither over-warn nor confuse consumers. But once EPA makes that judgment, the label is the law. It cannot be second-guessed by lay juries applying the law of 50 states without violating Congress’ directive, threatening today’s food supply and impeding tomorrow’s innovation.” (Page 2)

“Allowing lay juries applying the law of 50 states to second-guess EPA’s judgments destroys that balance and undermines Congress’ goals. Congress protected against such results by preempting claims like Durnell’s. This Court should honor Congress’ sound judgment and reverse.” (Page 22)

EPA’s Consistent Findings on Glyphosate Safety

“Having reviewed all relevant available scientific data, and having reconsidered its own views in light of IARC’s findings, EPA concluded that ‘[t]he strongest support’ was for classifying glyphosate as ‘not likely to be carcinogenic to humans.’…EPA thus rejected IARC’s conclusions...EPA’s conclusion was unequivocal.” (Page 15)

Contrary Appellate Decisions Cannot Be Reconciled with Text or Precedent

“The Missouri Court of Appeals came to a contrary conclusion only by assessing FIFRA’s ‘requirements’ at a sky-high level of generality and giving short shrift to Congress’ decision to demand uniformity in this vital area… assessing FIFRA’s requirements at such a high level of generality renders FIFRA’s ‘Uniformity’ provision largely meaningless. Under the court of appeals’ approach, virtually all failure-to-warn claims are ‘consistent’ with FIFRA’s misbranding provision, because virtually all failure-to-warn claims require (as FIFRA’s misbranding provision does) the manufacturer to ‘adequately warn users of the potential dangers of using its product.’” (Page 36)

Legal and Regulatory Clarity Are Key to Agricultural Innovation

“The costs in the case of Roundup are real. The retail version of the glyphosate-based product has been removed from shelves because as long as state-law liability looms, selling is not commercially viable. The commercial and agricultural versions remain available for the time being, but the economics of continuing to market the product remain in substantial doubt, despite the EPA’s repeated examination and rejection of claimed cancer risks.” (Page 52-53)

“The threat is not just to existing products, but to the incentives to develop the next generation of even better pesticides. Given the nature of pesticides, there is no such thing as a no-risk pesticide. And if the ultimate result of exhaustive research-and-development efforts is equally exhaustive state-court litigation under the varying laws of 50 states, then the whole game is not worth the candle.” (Page 53)