EPA Seeks Public Comments on Petition to Amend Pesticide Labeling Requirements
Signaling renewed interest in a longstanding area of tension between federal and California labeling requirements for pesticide products, the U.S. Environmental Protection Agency (EPA) recently extended the public comment period for a petition that seeks to bar use of state-mandated cancer risk warnings such as those required under California’s Proposition 65 on pesticide labeling.
The petition -- originally submitted to EPA on August 7, 2024 by the Attorneys General of Alabama, Arkansas, Georgia, Indiana, Iowa, Louisiana, Montana, Nebraska, North Dakota, South Carolina, and South Dakota – was first made available to the public on January 21, 2025 with a 30-day comment deadline. EPA will now continue to accept comments from stakeholders and other members of the interested public for an additional 30 days, until March 24, 2025.
Background
Unless otherwise exempted, every pesticide must be registered under the Federal, Insecticide, Fungicide, and Rodenticide Act (FIFRA) based on EPA’s determination that it will perform its intended function without causing unreasonable adverse effects to human health or the environment. To make these determinations, EPA assesses a wide variety of studies that must be submitted by pesticide registrants in accordance with detailed testing guidelines and requirements. Through the registration process, EPA also closely evaluates and approves the language that appears on each pesticide label, and FIFRA prohibits the distribution or sale of pesticides with labeling that bears any statement that is “false or misleading in any particular.” 1
Proposition 65, formally known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a California mandate that requires businesses in the state to provide warnings to consumers about potential chemical exposures. In 2017, California’s Office of Environmental Health and Hazard Assessment (OEHHA) listed the widely used herbicide glyphosate under Proposition 65 as a chemical “known to the state to cause cancer.” OEHHA stated it based this listing on a 2015 classification of glyphosate as “probably carcinogenic to humans” by the World Health Organization’s International Agency for Research on Cancer (IARC).
IARC’s classification was inconsistent with EPA’s conclusion and the findings of many other government agencies and health organizations that have reviewed glyphosate studies over the years and determined there is no evidence that it is carcinogenic. Glyphosate was first registered by EPA under FIFRA in 1974 and has undergone periodic reviews under FIFRA (including EPA’s most recent reassessment in 2020) that have reinforced EPA’s determination that glyphosate is “not likely to be carcinogenic to humans.”
Under these circumstances, the U.S. District Court for the Eastern District of California issued a preliminary injunction in 2018 to prevent California from enforcing the Proposition 65 warning requirement on glyphosate labels, calling it “inherently misleading” to state that a chemical is known to cause cancer based on the finding of one organization when EPA and “all other regulatory and governmental bodies have found the opposite.” 2 In 2019, EPA announced that pesticide products bearing the Proposition 65 warning statement due to the presence of glyphosate would be considered false or misleading, and therefore “misbranded” under FIFRA. Nevertheless, the U.S. Court of Appeals for the Ninth Circuit subsequently found that EPA’s position represented only an “informal policy opinion” that did not preempt enforcement of “failure-to-warn” claims under state law. 3
In 2022, EPA agreed to accept a new proposal from OEHHA to use a revised Proposition 65 statement on glyphosate product labels that expressly acknowledged the positions of both IARC and EPA. However, use of this revised statement was permanently enjoined by the Ninth Circuit in 2023, which held on First Amendment grounds that a cancer warning requirement cannot be applied to glyphosate under circumstances where “IARC stands essentially alone in its determination that glyphosate is probably carcinogenic to humans, while EPA, OEHHA, and regulators from around the world conclude that it is not.” 4
Petitioners Seek Amendment to Clarify That State-Mandated Warnings on Pesticide Labels Constitute “Misbranding” Under FIFRA
In their petition, the Attorneys General ask EPA to amend its regulations at 40 C.F.R. section 156.10(a) to expressly provide that “statements or conclusions on FIFRA-registered products that are different from EPA’s express findings and conclusions made during the product’s registration review regarding the product’s likelihood to cause cancer, birth defects, or reproductive harm” are “false and misleading.” With such a change to EPA’s regulations, the petitioners assert that Proposition 65 warnings and common law failure-to-warn claims will be clearly preempted by FIFRA.
According to the petitioners, this amendment is necessary because the Ninth Circuit’s recent opinion, while enjoining California from enforcing Proposition 65 as applied to glyphosate labeling, leaves the door open for Proposition 65 warnings on pesticide products under other factual circumstances, and it does not address state “failure-to-warn” claims at all. The petitioners also emphasize that their interest extends beyond glyphosate, as confusion around state and federal pesticide labeling requirements also impacts other FIFRA-regulated pesticides.
EPA’s decision to extend the public comment period on a rulemaking petition is not unusual in and of itself. However, EPA’s current attention to this particular petition represents something of an exception in the wake of the administration’s general moratorium on new regulations established by President Trump’s January 20, 2025, executive order and related efforts to cap all new agency regulations this year. Interested parties should consider submitting comments to EPA before the March 24 deadline to provide information that may help shape future pesticide labeling regulations.
Beveridge & Diamond’s Pesticides practice has worked for forty years with state, U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use pesticidal products and devices, including in California. We represent large and small companies with an emphasis on entities that invest in research to discover, develop, and defend new technology. Our Pesticides practice helps clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives.
1 FIFRA §§ 12(a)(1)(E); 2(q)(1)(A).
2 National Assoc. of Wheat Growers v. Rob Bonta, et. al., No. 20-16758 (9th Cir. 2023).
3 Hardeman v. Monsanto, 997 F.3d 941, 957-58 (9th Cir. 2021).
4 The decision can be found here: 20-16758.pdf.