Food producers can breathe a sigh of relief, at least temporarily, thanks to efforts by the California Chamber of Commerce resulting in a preliminary injunction barring the State of California and all private plaintiffs from filing any new Proposition 65 lawsuits targeting acrylamide in food and beverage products. On March 31, 2021, Chief United States District Judge for the Eastern District of California, Kimberly J. Mueller, issued a 31-page order following the briefing, expert declarations, and a virtual hearing on December 11, 2020. In her order, Judge Mueller held that the State had not shown that the Proposition 65 cancer warnings it requires for acrylamide are purely factual and uncontroversial. Nor did it show that Proposition 65 imposes no undue burden on those who would provide a more carefully worded warning. Judge Mueller also denied a motion for summary judgment brought by the intervening defendant and Proposition 65 enforcer, the Council for Education and Research on Toxics, or (CERT). The Judge rejected CERT's argument that it has a First Amendment right independent of the State to prosecute private enforcement actions.

The case is: California Chamber of Commerce v Becerra, United States District Court, Eastern District Of California, No. 2:19-cv-02019-KJM-EFB

The Chamber of Commerce filed the suit in October 2019. Its legal claim is simple: the First Amendment prohibits California from forcing businesses to make false statements, so because California does not "know" that eating food with acrylamide causes cancer in people, Proposition 65 is unconstitutional if it mandates that assertion.

In summary, the opinion provides:

Although acrylamide was first detected in food in 2002, it has likely always been a part of many foods since they were first cooked. Acrylamide is most commonly found in coffee and foods made from plants. Acrylamide is not added to food; it forms as a result of a reaction between sugars and the amino acid asparagine, which naturally occurs in many foods. Cooking food at a high temperature appears to cause acrylamide formation, whether performed at home or at a business. Acrylamide can also be produced industrially for use in plastics, grouts, water treatment products, and cosmetics. In that context, it is viewed as a toxic chemical and was added to the Proposition 65 list in 1990, 22 years before it was ever detected in food.

Scientific experiments have shown that when mice and rats ingest substantial amounts of acrylamide, cancerous tumors can develop. As a result of these experiments, many public health authorities have concluded that exposure to acrylamide probably increases the risk of cancer in people. However, animal studies have limitations, including the fact that scientists must frequently use very large doses of chemicals that do not reflect real-world human exposures. Conversely, dozens of epidemiological studies conducted in Europe, the United States, and Asia have investigated whether acrylamide in food causes cancer in humans. In support of its motion, the Chamber submitted expert opinion evidence from an epidemiologist who reviewed the studies and found none that showed that eating food with acrylamide increases the risk of cancer in humans.

Judge Mueller concluded, "there is no consistent or reliable evidence to support a finding that dietary exposure to acrylamide increases the risk of any type of cancer in humans." The court also observed that no other public health body has warned that acrylamide in food causes cancer in people or has even reached that conclusion. Further, no regulatory or public health authority has advised against consuming foods with acrylamide.

Despite the conflicting evidence regarding dietary acrylamide, the unique provisions of Proposition 65 required that the State list the chemical as one "known to the state to cause cancer." Upon looking at the evidence, Judge Mueller concluded that although California has a substantial interest in protecting its citizens from substances that cause cancer, "the safe harbor warning is incorrect, and it implies misleadingly that the science about the risks of food-borne acrylamide is settled."

Proposition 65 does not permit businesses to add information to the required warning at their discretion and thus prevents them from explaining their views on the true dangers of acrylamide in food. That prohibition exacerbates the effect of the warning. It threatens to "drown out" a business's "messaging" addressing the claimed dangers of acrylamide in food.

The State cannot "put the burden on commercial speakers to draft a warning that both protects their right not to speak and complies with Proposition 65."

"If the seas beyond the safe harbor are so perilous that no one risks a voyage, then the State has either compelled speech that is not purely factual or its regulations impose an undue burden."

The State may ultimately show the Chamber is not entitled to a permanent injunction. It may also move to dissolve the preliminary injunction, perhaps to permit the enforcement of alternative warnings. But given the record before the court at this juncture, these are questions for another day.

What does this all mean?

The ruling bars the California Attorney General and anyone else from filing new lawsuits against businesses that do not display Proposition 65 acrylamide warnings. However, the ruling does not prohibit the service of new Notices of Violation, nor does it stay any pending litigation. The order provides no immediate relief to businesses that have already settled an acrylamide claim, stating explicitly that it "does not alter any existing consent decrees, settlements, or other agreements related to Proposition 65 warning requirements. For example, this order does not permit businesses that have already agreed to display a certain warning to take those warnings down, and businesses that have agreed to reformulate their products to reduce acrylamide content are not permitted by this order to breach those agreements."

What comes next?

The State can immediately appeal the ruling (perhaps a two-year process), or it can litigate the merits of a permanent injunction to be followed by an appeal (three years or more). See 28 U.S.C. section 1292(a)(1). That was the strategy deployed in National Association of Wheat Growers et al. v. Zeise et al., Eastern District of California No. 2:17-cv-02401-WBS-EFB, where plaintiffs won a permanent injunction barring enforcement of the Proposition 65 warning as to glyphosate. That case is now up on appeal.

While a final decision in the Cal Chamber acrylamide matter is likely many years away, there will be no new lawsuits for the time being. However, given the ongoing uncertainty, producers should continue to evaluate and manage their acrylamide risk.

For more information about Proposition 65 compliance and Notices of Violations, please contact Merton Howard. Learn more about Hanson Bridgett's Product Liability & Torts Practice.