A ruling this week from the U.S. District Court for the Eastern District of California held that requiring registrants of glyphosate products to be the subject of a Proposition 65 cancer warning would violate the 1st Amendment rights of such registrants.  National Association of Wheat Growers et al v. Becerra, Attorney General of California [No. 2:17-cv-2401 WBS; opinion available only through Federal PACER System.]  The Court ruled that by compelling them to engage in speech that is controversial and in the opinion of the U.S. Environmental Protection Agency (“EPA”) false would make the products misbranded would violate the registrants’ rights under the 1st amendment.

Proposition 65 requires sellers of products in California that the state has determined contain substances which are carcinogenic or teratogenic to provide warnings of exposure to such substances. Warnings can be in the form a statement on the product label or a notice placed at the point of sale.  California can make such a determination on its own but is also required under the law to accept the determinations of outside expert bodies, including EPA, the U.S. National Institute for Occupational Safety and Health (or NIOSH, a component of the Centers for Disease Control), the U.S. National Toxicology Program (or NTP which is part of the National Institutes of Health), and the International Agency for Research on Cancer (or IARC, which is the research arm of the U.N. World Health Organization (“WHO”).

The dispute in this case involves the assertion by California that glyphosate causes cancer. That determination was based upon a 2015 determination by IARC that glyphosate is a probable carcinogen. As an outside expert body whose determination is binding under Prop 65, California proceeded on July 7, 2017, to add glyphosate to the Prop 65 list and advise registrants of their obligation to comply within one year.  

The IARC determination of carcinogenicity of glyphosate is the only review that reached such an outcome. EPA has adamantly contended that glyphosate is not a carcinogen.  See EPA Review of the Carcinogenic Potential of Glyphosate.  Reviews by other international bodies, such as the European Commission for Health and Consumer Protection Directorate-General, the WHO International Programme on Chemical Safety, as well as other individual nations, such as Canada and Australia, concurred with EPA and not IARC.

A group of twelve national and state trade associations and grower groups, as well as the registrant Monsanto brought suit, and on February 26, 2018, the Court preliminarily enjoined California from enforcing the warning requirement. The issue now before the Court was whether to permanently enjoin the warning requirement for glyphosate, which it did.

The Court presented a history of the litigation over commercial speech, beginning with the U.S. Supreme Court decisions in Central Hudson Gas & Electric Corporation v. Public Service Commission  (1980) and Zauderer v. Office of Disciplinary Counsel of Supreme Court of Ohio  (1988), which addressed respectively a speech limitation imposed by New York State and speech compelled by the State of Ohio. The standard established by Zauderer requires a determination by the reviewing Court that the compelled speech is factual and non-controversial. If not, then the stricter standard of review established by Central Hudson applies.

The Court found that the required notice was not purely factual and was in fact controversial, this triggering the stricter standard of review. The Court found that in the context of the professional disagreements on the carcinogenicity of glyphosate, the required warnings would be false and misleadingly imply that no dispute exists as to the issue of carcinogenicity. The Court also pointed out the irony that while EPA is an expert outside body under Proposition 65 whose position is binding, EPA has determined that placing the required warning on a pesticide would make the product misbranded, since EPA contends the statement is false.

In an effort to salvage a warning requirement, California offered a variety of alternative wordings for the warning. The Court rejected all alternatives, saying they would not adequately advise the public of the underlying scientific conflict and would still subject registrants to potential enforcement litigation brought by private parties.

It remains to be seen whether California will appeal this decision to the 9th Circuit.  If it does so the chances for success seem limited. While this decision may conclude this aspect of the controversies over glyphosate, the various tort suits alleging that glyphosate causes Parkinson’s Disease continue to wend their way through various trials and appeals.   

Meanwhile as of this writing EPA continues to refuse to allow any pesticide registrant whose product is subject to a Proposition 65 notice requirement to place such a notice on a pesticide label. This limitation was originally imposed during the litigation, but EPA gives no indication as to when or how it will address notice requirements for other ingredients  Registrants with such products are left with the unsavory choice of forging the California market or risk State or private enforcement action.