On July 12, 2022, the U.S. Court of Appeals for the Eleventh Circuit (Court) issued an opinion in Carson v. Monsanto that reverses a ruling by the U.S. District Court for the Southern District of Georgia (District Court) that the Plaintiff’s failure to warn claim under Georgia law was preempted by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The Plaintiff alleged that Monsanto’s label for its product Roundup®, which contains the active ingredient glyphosate, did not have adequate warning of the “harmful nature of glyphosate under Georgia law.” The District Court ruled that FIFRA preempts Georgia law and Plaintiff’s failure to warn claim because the U.S. Environmental Protection Agency (EPA) classified glyphosate as not likely to be carcinogenic to humans and approved the Roundup label. Plaintiff appealed.
The Court found that the District Court erred in concluding that the Plaintiff’s failure to warn claim was preempted under FIFRA. In its Opinion, the Court stated that a common-law cause of action, such as the failure to warn claim under Georgia law, would be preempted “if two conditions are met: 1) the state requirement must be for ‘labeling or packaging’ under the language of the statute; and 2) the state requirement is ‘in addition to or different from’ requirements derived from FIFRA.” The Court found that EPA’s registration process “is not sufficiently formal to carry with it the force of law” and instead “at most creates a rebuttable presumption of compliance with FIFRA’s registration process and nothing more.” In addition, with regard to FIFRA’s labeling provisions, the Court found that the Georgia law failure to warn claim is not in addition to or different from FFIRA requirements. Instead, the Court states that the Georgia failure to warn claim “simply enforces the FIFRA cause of action, so it is not expressly preempted.”
The Court also responded to Monsanto’s argument providing several EPA documents indicating that it could not label Roundup as carcinogenic. These included various registration reviews and reregistration eligibility decisions regarding glyphosate products, an EPA paper written about the EPA Scientific Advisory Panel’s independent review of the effects of glyphosate, and “[v]arious papers involving scientific analysis where the EPA concluded that glyphosate did not cause cancer.” Monsanto additionally provided evidence regarding the August 2019 letter from EPA to glyphosate registrants that it would not permit label amendments to include warnings under California’s Proposition 65 that glyphosate is known to the State of California to cause cancer. In that letter, EPA stated that it would consider such language to be “false or misleading,” and thus would not approve of such language on any label and further that registrants were to remove such statements from any approved labels.
The Court found, however, that none of these documents had the “indicia of formality” necessary to meet their standard of review. The Court noted that none of the documents identified were the product of notice and comment rulemaking or formal adjudication, and they did not “‘bespeak the legislative type of activity that would naturally bind’ Monsanto.” The Court thus remanded this case back to the District Court for further proceedings on the failure to warn claim.
This case potentially places glyphosate registrants in the position of defending themselves for not warning about the potential carcinogenicity of glyphosate despite past EPA statements that any such warning would be considered a violation of FIFRA. Registrants should pay attention to the potential implications of this case, and others like it, particularly with regard to label claims that EPA has approved. More information on other glyphosate issues is available on our blog.
Regardless of the outcome of this decision, the long and tortured history of the FIFRA preemption issue was expected to, and certainly will, continue. For many years, the debate over the implications of the FIFRA requirement that the EPA label cannot have conflicting (“different from”) language that would be needed, as the argument goes, to comply with state requirements to provide adequately warnings. To a casual observer, the FIFRA label and EPA review should take care of imposing the necessary conditions to avoid harms since it is axiomatic that “the label is the law,” and, if label directions are followed, EPA expects there would be no “unreasonable adverse effects” caused by the pesticide application. But the case law has evolved over the years not only about the confines of FIFRA but also regarding other “failure to warn” cases involving label instructions and warnings approved by other federal agencies (e.g., the U.S. Food and Drug Administration). The result has been a continued series of cases where the courts, state and federal, have to determine where federal requirements end and freedom for state requirements are allowed.
In this case, the outcome was a disappointment to the registrant community but is unlikely to stop the flow of litigation on both sides of the preemption arguments. And the recent announcement in April 2022 by the Biden Administration EPA to reverse effectively the 2019 letter to California about FIFRA labels and California’s Proposition 65 requirements (Letter from California’s Office of Environmental Health Hazard Assessment on California Proposition 65 |to EPA) might further muddy the water of what a FIFRA label really does imply regarding state warnings, “right-to-know” requirements, and the like.