California coffee drinkers may no longer see cancer warnings along with their morning caffeine fix. The coffee served to consumers has not changed, but a recent proposed regulation by California’s Office of Environmental Health Hazard Assessment (OEHHA) would exempt coffee from cancer warnings required for many consumer products in the state. OEHHA’s proposal comes shortly after a statement of decision by the Los Angeles Superior Court this spring that found that brewed coffee sold at retail stores contains levels of acrylamide that require a warning.
The case was consolidated from two suits filed in 2010 by a Proposition 65 citizen enforcer called the Council for Education and Research on Toxics (CERT), alleging that more than 90 businesses selling brewed coffee had violated California’s Safe Drinking Water and Toxic Enforcement Act of 1986—better known as Proposition 65—by failing to provide warnings to consumers based on the exposure to acrylamide.*
Under California’s Proposition 65, businesses with more than 10 employees must provide “clear and reasonable” warnings for products, including food, that may expose consumers to unacceptable levels of any of more than 900 chemicals listed as known by the state to cause cancer, birth defects, or other reproductive harm. Acrylamide has been on the Proposition 65 list since 1990 as a carcinogen. The International Agency for Research on Cancer identifies acrylamide as a “probable human carcinogen” and the U.S. EPA characterizes it as “likely to be carcinogenic to humans.”
Acrylamide is not a chemical added to coffee. Rather, it occurs naturally during the roasting process as a result of the Maillard reaction (the same chemical reaction that creates browning when searing a steak, for example). Acrylamide is produced when starchy foods like toast, potatoes, or many snack foods are cooked above certain temperatures.
Years of Litigation
Los Angeles Superior Court Judge Elihu Berle’s recent ruling came after nearly eight years of litigation. The decision issued on May 7, 2018, affirming an earlier preliminary decision, marked the end of Phase II in the litigation, which addressed coffee sellers’ Proposition 65 affirmative defense based on an Alternative Significant Risk Level (ASRL) assessment. The court previously rejected several other affirmative defenses during Phase I of the trial, including those based on the First Amendment, federal preemption, and the statutory No Significant Risk Level (NSRL).
Both the ASRL and NSRL are affirmative defenses under Proposition 65 that can be used to demonstrate that no warning is required. Under the NSRL approach, warning requirements do not apply if a defendant can demonstrate “that the exposure poses no significant risk assuming lifetime exposure at the level in question for substances known to the state to cause cancer.” Essentially, the defendants argued during Phase I that no warning was required for coffee because consumers’ exposure to acrylamide was less than the 0.2 micrograms per day NSRL that OEHHA has set.
To prevail on the NSRL defense, a quantitative risk assessment must be performed to prove that exposure to acrylamide is below 0.2 micrograms per day level. Defendants, however, focused on presenting evidence showing that coffee as a whole does not increase cancer risks. Judge Berle agreed with the plaintiff that defendants’ evidence on the cancer risks of coffee as a whole, a mixture of numerous substances, was insufficient to meet their burden to assert the NSRL defense. Instead, he found that a quantitative risk assessment to determine the risk from just acrylamide exposure from coffee, not the drink as a whole, was required.
Phase II of the trial, on the other hand, focused on the ASRL affirmative defense, which is based on interpretation of the Proposition 65 implementing regulations. Effectively, there is no duty to provide a warning even if an exposure exceeds the established NSRL, “where sound considerations of public health support an alternative level,” such as “where chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbiological contamination.” Defendants argued that coffee fits within these “sound considerations” because cooking—roasting—is required to render brewed coffee palatable for consumers.