After California voters approved the Safe Drinking Water and Toxic Enforcement Act of 1986 (Prop. 65), the state’s Office of Environmental Health Hazard Assessment (OEHHA) began publishing a list of chemicals “known to cause cancer or birth defects or other reproductive harm.” Under the statute, companies must warn consumers about potential exposure to a listed chemical unless the exposures are low enough to pose “no significant risk” of the harms targeted by the provision. OEHHA’s Prop. 65 actions can often precede similar efforts in other states, making California a primary battleground for regulations and bellwether cases.

Prop. 65’s list of chemicals must be updated annually to add chemicals “known to the state to cause cancer or reproductive toxicity,” supported by “scientifically valid testing.” The addition of a chemical can be a contentious process as the science supporting the addition is debated. For example, bisphenol A (BPA), a chemical found in plastics and epoxy resins, was proposed as an addition to the list in 2013 as a developmental toxicant. The American Chemical Council sued OEHHA, arguing that the document OEHHA cited did not conclude that BPA satisfied Prop. 65 list requirements, but the chemical was listed in April 2013. One week later, a court enjoined OEHHA from enforcing the addition and the agency removed BPA from the list. The injunction remained until January 2015, when a court found that OEHHA did not abuse its discretion by relying on studies only examining BPA’s effects on animal subjects rather than humans. Months later, OEHHA added BPA to the list based on its effects on female reproductive toxicity, although it remains delisted in connection with developmental toxicity.

In addition to governmental enforcement, Prop. 65 creates a cause of action for private individuals or organizations acting “in the public interest.” Advocacy groups regularly file lawsuits challenging companies’ compliance with the statute, often focusing on headline-grabbing chemicals such as lead—with targets ranging from baby food, candy and snack bars to meal replacement shakes and balsamic vinegar—as well as acrylamide, arsenic and 4-methylimidazole (4-MEI). A chemical’s inclusion on the Prop. 65 list can also spur consumer putative class actions, such as the consolidated claims against PepsiCo Inc. for its products’ 4-MEI content.

Some companies have successfully fought Prop. 65 enforcement actions. During a two-month trial in 2006, the makers of Chicken of the Sea, StarKist and Bumble Bee tuna products persuaded a court that their products were exempt from Prop. 65 because the mercury content in the tuna was naturally occurring, the levels were too insignificant to require warnings and federal law preempted Prop. 65 on regulating mercury in fish. The decision was later upheld on appeal.

In August 2016, OEHHA amended the Clear and Reasonable Warnings section of Prop. 65 to adjust the warning text on labels, including adding distinctions between the harms targeted by the law. The amendments are scheduled to take effect on August 30, 2018.

About The Author

For decades, manufacturers, distributors and retailers at every link in the food chain have come to Shook, Hardy & Bacon to partner with a legal team that understands the issues they face in today's evolving food production industry. Shook attorneys work with some of the world's largest food, beverage and agribusiness companies to establish preventative measures, conduct internal audits, develop public relations strategies, and advance tort reform initiatives.