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 which 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.
In Phase I, the court rejected an argument by CERT that, to qualify for an ASRL, defendants must take measures to reduce acrylamide levels to the lowest possible level. The court also found, however, that defendants had failed to meet their burden to qualify for an ASRL defense because their quantitative risk assessment focused on coffee as a mixture rather than just the acrylamide in it. In Phase II, Judge Berle again rejected defendants’ proposed ASRL defense because the revised quantitative risk assessment was based on acrylamide generally and was not specific to acrylamide in coffee.
The court likewise rejected defendants’ arguments in favor of setting an ASRL 10 times greater than the NSRL for acrylamide, despite expert testimony from a former Commissioner of the U.S. FDA, that the FDA had regulated certain carcinogens in food at a more lenient risk level (10-4 instead of the typical 10-6 standard), and a former OEHHA proposal to regulate acrylamide in bread and cereal at that same 10-4 risk level. The court rejected both rationales as “inadequate grounds for an alternative risk level.” Moreover, the court found that some of the product testing the defendants relied on was scientifically unreliable and inadmissible.
A number of the coffee companies in the case responded to Judge Berle’s proposed ruling issued on March 28, 2018, by arguing that they did prove that acrylamide in coffee is not present at dangerous levels and they need not comply with the warning requirement. Judge Berle nonetheless finalized his decision. CERT filed a motion seeking permanent injunction in light of the court’s ruling. A hearing is scheduled in the case for the end of July to address CERT’s motion for permanent injunction and the companies’ motion to stay.
On June 15, 2018, OEHHA issued its proposed regulation to provide that coffee does not pose a significant cancer risk based on the naturally occurring carcinogens in it, and thus Proposition 65 does not require cancer warnings for coffee. OEHHA relied on a report issued in June 2018 by the World Health Organization’s International Agency for Research on Cancer, which reviewed over 1,000 studies to determine that “inadequate evidence” linking coffee consumption to cancer exists, and that coffee drinkers experience strong antioxidant effects that are related to a reduction in cancer risk. Under the proposal, most brewed coffee would be exempt from Proposition 65 warning requirements, but only for those chemicals that occur naturally in the roasting and brewing process (i.e. not for exposures related to listed chemicals that are intentionally added to the coffee or enter the coffee in some other fashion).
Coffee is not the first food product to be the focus of a Proposition 65 suit over acrylamide exposure. Previous suits alleged failures to warn of acrylamide exposures in some potato products. A suit against Kentucky Fried Chicken for failure to warn of acrylamide in its fried and baked potato products was settled in 2007, as was a similar suit against potato chip manufacturers the following year.
Although OEHHA’s proposed regulation may obviate the impact of Judge Berle’s decision for coffee sellers, his decision could hold meaning for businesses outside the coffee industry. In particular, it demonstrates the incongruous nature of Proposition 65 decisions and the resulting difficulty for businesses to avoid burdensome litigation. For instance, the weed-killing product Roundup need not bear a Proposition 65 warning pursuant to a recent ruling by a federal judge, but as a result of this decision, coffee must.
Moreover, that this case has been litigated for the past eight years evidences the cost and difficulty involved for businesses to deal with Proposition 65 claims and to successfully defend against them. That difficulty is compounded since the burden of persuasion falls to the defendant to prove a defense—even as in this case, where the defendants believed they had a preponderance of evidence to support that coffee on balance has more health benefits than harms. In light of these defense considerations, compliance up front is the best approach for businesses.
The recent decision in the coffee case is a salient example of a common criticism of Proposition 65 that it leads to warning fatigue. As consumers are faced with more and more warnings, the warnings become less and less effective, even when the threat may be significant. Some have argued that warnings do not change consumer behavior at all, meaning that coffee drinkers are unlikely to stop ordering their regular beverage even if it comes with a cancer warning.
OEHHA is accepting public comments on its proposed regulation under August 30, 2018, and a public hearing is scheduled for August 16, 2018.
Weiss is a partner with Hunton Andrews Kurth LLP in Los Angeles. Reach him at mweiss@huntonAK.com. Oldenburg is a senior attorney with the same firm. Reach her at soldenburg@huntonAK.com. And Hamilton is an associate with the firm in Washington, D.C. Reach her at ahamilton@HuntonAK.com.
*Council for Education and Research on Toxics v. Starbucks Corp. et al., No. BC435759, and Council for Education and Research on Toxics v. Brad Barry Company Ltd. et al., No. BC461182, both in the Superior Court of the State of California for the County of Los Angeles.