On March 28, 2018, Superior Court Judge Elihu Berle issued a proposed statement of decision that would require coffee roasters and retailers to provide Proposition 65 cancer warnings for coffee sold in California.

What the case is about

Plaintiff Council for Research and Education on Toxics (CERT) asserts that approximately 70 coffee roasters and retailers are required to provide cancer warnings for exposure to acrylamide in coffee. Acrylamide is listed as a carcinogen based on laboratory animal studies, but has not been proven to cause cancer in humans. Acrylamide is not added to coffee, but is formed in a complex chemical reaction when coffee is roasted (as is the case with other foods such as French fries and potato chips, in which acrylamide is formed when they are baked or fried).

Prop 65 liability issues

Once a plaintiff demonstrates an exposure to a listed chemical, Prop 65 puts the burden on defendants to demonstrate that the amount of exposure to a carcinogen such as acrylamide falls below the level at which a warning is required. For carcinogens, that level is defined as the no significant risk level, which is a default level of one excess case of cancer in 100,000 persons exposed. A business may seek to apply an “alternative significant risk level” (ASRL), where justified by “sound considerations of public health.” One such consideration is the so-called “cooking exemption”: “Where chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbiological contamination.”

Phased dispute

The decision followed an initial phase of trial, in which Judge Berle found that the roasters failed to prove that:

  • the level of acrylamide in coffee was below the NSRL;
  • requiring a Proposition 65 warning for exposure to acrylamide in coffee violated the First Amendment by imposing misleading speech because coffee use was not associated with an increased risk of cancer, and was actually associated with a decreased risk of certain cancers; and
  • the Proposition 65 warning requirement was preempted by federal law.

Before the second phase of trial, the court granted summary adjudication to the plaintiff, finding that virtually all of the defendants knowingly and intentionally exposed individuals to acrylamide in coffee without providing a warning, on at least one occasion.

The second phase

The issues remaining to be tried were the ASRL defense, and the issues of civil penalties and injunctive relief, if the defendants did not prevail. In the first part of this phase, the parties submitted expert testimony on the ASRL defense.

The defense argued that the “cooking exception”—where chemicals in food are produced by cooking necessary to render the food palatable or to avoid microbiological contamination—supported a de facto defense, since acrylamide was formed during the roasting process. Roasting is both necessary to render coffee palatable and to destroy microbiological contamination. The defense argued alternatively that substantial epidemiological literature supported the concept that coffee had significant health benefits, justifying a lower risk level, and relied in part on the testimony of former FDA Commissioner David Kessler to support this argument. The defense also introduced testimony about the amount of the exposure based on testing of over 500 samples of coffee performed at Covance Laboratories and analyzed by an expert in exposure assessment. Plaintiff presented no evidence to counter this evidence.

Judge Berle rejected the defense’s assertion that the cooking exception was sufficient to avoid liability without quantifying the amount of the exposure. He also rejected Commissioner Kessler’s testimony about alternative risk levels, and the defense’s exposure assessment evidence, finding that the Covance data was not shown to be reliable because it was a novel technique that the scientific community has not yet generally accepted. He alternatively found that the Covance lab director and the expert were not credible, although he did not explain his reasoning on these findings.

Going forward

The defense will file objections to the proposed statement of decision shortly, although there is no reason to believe that Judge Berle will change his decision. The final phase of the dispute is not yet completed, as there will be a trial for the court to take evidence on the issues of civil penalties and injunctive relief. The potential exposure in this case is astronomical, with millions of units of coffee sold each year, and a maximum penalty of up to $2,500 per violation per day. It is anticipated that plaintiff will move for an injunction requiring the defendants to provide Proposition 65 warnings pending the conclusion of the case and appeal. There is no date yet set for this remedies phase, which could take upwards of two months to complete, based on the number of companies involved in the litigation.