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 FDA, that 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.