Chemicals

California Court Rules Against Prop 65 Warning Labels for Glyphosate

Summary judgment was granted to the Plaintiffs in National Association of Wheat Growers et. al. v. Becerra on June 22, 2020, by the U.S. District Court for the Eastern District of California. A permanent injunction was entered against enforcing the requirement of including a Proposition 65 (Prop 65) warning label on pesticides containing glyphosate. Prop 65 challenges are rarely successful, so this is a big win for the pesticide industry, as it has nationwide impact for any company selling products containing glyphosate in California.

Pesticide application, glyphosateProp 65 warnings are required to be provided by businesses that expose Californians to “certain chemicals known to cause cancer, birth defects or other reproductive harm.” It is administered by the California Office of Environmental Health Hazard Assessment (OEHHA), and violations are enforced by the California Attorney General’s Office. The list is updated each year and now contains approximately 900 chemicals.

“The same District Court had previously entered a preliminary injunction against the Prop 65 warning in 2018, and the required warning has consequently never been in effect,” according to a story published on JDSupra.com.

The EPA has also barred Prop 65 warning labels on registered glyphosate products, declaring them to be “misleading” and further stating this would be to misbrand such products under “Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 2(q)(1)(A).”

The OEHHA added glyphosate to its Prop 65 list based on the recommendation of the International Agency for Research on Cancer (IARC), which determined that glyphosate is “probably carcinogenic” in humans.

The IARC’s determination regarding glyphosate is not consistent with other authoritative bodies’ determinations on the chemical. The EPA, the European Commission, and the World Health Organization all determined that “glyphosate is not likely to be carcinogenic in humans.”

Plaintiff Monsanto and several farming associations sued the state of California on November 14, 2017, “alleging that the listing of glyphosate under Prop 65 as a carcinogen, and the resulting warning requirements, violated Plaintiffs’ First Amendment rights by forcing them to make ‘false, misleading, and highly controversial statements.’”

In making its determination regarding the regulation of commercial speech, the court looked at a couple of U.S. Supreme Court cases to determine whether the precedent utilized in its decision should be determined upon Zauderer v. Office of Disciplinary Counsel or under the intermediate standard set by Central Hudson Gas & Electric v. Public Service Commission. In Zauderer, the standard is applicable to mandatory disclosure of “purely factual and uncontroversial information.” Due to the inconsistencies in determinations regarding the carcinogenic impacts of glyphosate, the court determined that the Prop 65 warning for glyphosate was not factual or uncontroversial. So, the court applied a higher level of scrutiny, as found in the Central Hudson case.

That standard allows a governmental agency to restrict commercial speech when doing so “advances an important governmental interest and the restriction may not be more extensive than necessary to serve that governmental interest.”

In this case, the court found the Prop 65 warning misleading because the warning says the product is carcinogenic when many other organizations reviewing the chemical in the product found it to be safe, and only one organization (the IARC) concluded it was “probably carcinogenic.”

“Requiring a misleading statement does not directly advance the interest of the state in informing consumers regarding potential cancer hazards,” according to an article published in the FDA Law Blog on July 8, 2020, by Riëtte van Laack and Karin F.R. Moore. “Thus, the warning could not be justified as a valid restriction on commercial speech and, therefore, is contrary to the First Amendment of the Constitution.”

In defending the suit, the sate argued that it had set a “safe harbor” level for glyphosate that would mean relatively few products would actually require the Prop 65 label. The court found that being below “safe harbor” levels does not protect companies from enforcement actions, as it does not “prevent parties other than California from bringing separate enforcement actions to enforce the listing,” according to JDSupra.

The Prop 65 statute allows any person to file suit for enforcement. “To bring suit, a private party need only credibly allege that that a product has some amount of the chemical at issue, not that the amount of the chemical is harmful or that it exceeds the safe harbor level; defendants in Proposition 65 enforcement actions have the burden of showing that the level of the chemical in their product falls below the safe harbor level,” according to the FDA Law Blog.

There is currently ongoing litigation with a similar set of circumstances, including the First Amendment challenge regarding acrylamide. This case could experience a comparable decision now that precedent has been set in the glyphosate case.