The California Office of Environmental Health Hazard Assessment (OEHHA), which oversees the state’s Proposition 65 program, is on the verge of finalizing an exemption from warning requirements for chemicals, such as acrylamide, “created by and inherent in the processes of roasting coffee beans or brewing coffee.”  The new regulation, which recently was sent to the state’s Office of Administrative Law (OAL) for a final review, would establish a new provision (Section 25704) entitled “Exposures to Listed Chemicals in Coffee Posing No Significant Risk.”

Proposed in June 2018, the exemption embodies OEHHA’s response to widespread backlash against a California court decision in favor of the plaintiff, the Council for Education and Research on Toxics (CERT), holding that dozens of coffee-serving defendants in the state violated Prop 65 by failing to provide warnings about exposure to acrylamide, despite the fact that the bulk of the science shows that drinking coffee does not increase cancer risk.  CERT is seeking millions of dollars in fines against the coffee roasting/retail defendants, though the penalty phase of the litigation has been put on hold pending resolution of the exemption rulemaking.  Finalizing the exemption, however, may not be the end of the case, as a CERT challenge to the legal sufficiency of the exemption also is pending in California court.

The OAL has until February 19 to review the regulation, and its accompanying “final statement of reasons,” including response to comments, and decide whether to accept, reject, or request further information from OEHHA.

For further information on the proposed exemption, please see my prior post from June 2018:



Recent events have raised questions about the viability and utility of California’s infamous Proposition 65.  The past few months have seen courts reject the listing of glyphosate as a “known” carcinogen on First Amendment grounds and rule that federal nutrition policy preempted warnings for acrylamide in cereal, as well as the debacle surrounding whether cancer warnings are required for demonstrably non-carcinogenic coffee.  At root, all of these situations reflect a long-standing concern that Prop 65 often requires warnings that are contrary to sound science, as well as common sense.

The result has been a program that — while it has achieved some notable reformulation successes and, perhaps most significantly, focused needed public and corporate attention on the chemicals found in consumer products and the workplace — ultimately is failing at the goal of providing the public with useful information about chemical risks and actual dangers.  When it seems like Prop 65 warnings are everywhere, the meaning of those warnings lose their impact and undermine any credible sense of the term “risk.”

Enter the Accurate Labels Act (“ALA”), federal legislation sponsored by Sen. Jerry Moran (R-KS) and Reps. Adam Kinzinger (R-IL) and Kurt Schrader (D-OR).  The legislation, which was introduced (as HR 6022 and S 3109) in the Spring, would require that any state-mandated “covered declaration” (e.g., a warning requirement on a product label) be based on sound science and proper risk assessment.  Specifically, the ALA would require that warning requirements and similar mandatory labeling be “risk-based,” supported by the “best available science,” and subject to “appropriate weight of the evidence review.”  Significantly, the legislation would place the burden of proving, by a preponderance of the evidence, these elements on the party (government or private plaintiff) seeking to enforce a warning requirement in court.

Such a shifting of the burden of proof would reverse the signature aspect of Prop 65 that makes the law so frustrating for businesses and promotes the filing of so many frivolous nuisance suits:  that is, when confronted by a plaintiff’s data showing potential low level exposure to a listed substance, Prop 65 requires a defendant to prove in court that the exposure level is “safe” (at great cost and effort) or face stiff penalties.  This is true even if the defendant’s choice not to provide a warning is supported by a gold-plated risk analysis.  Hence, because of the heavy burden of proof on the defendant (with the attendant litigation costs), plaintiffs are incentivized to file a multitude of lawsuits often on dubious grounds and with no evidence of actual risk in the hope of extracting a quick settlement, a solution that many businesses see as far cheaper than “fighting the good fight.”  The ALA, by placing the burden on the plaintiff to show that a warning is required due to an actual risk, would steer Prop 65 lawsuits in a more meaningful direction, and away from the “quick buck” settlements that account for the vast majority of cases that are filed.

In doing so, perhaps most importantly, the ALA could make Prop 65 warnings meaningful and reflective of scientifically-based (and common sense) notions of “risk,” and eliminate much of the misinformation that has come to define the program.

The legislation has strong support from the industry-basked Coalition for Accurate Product Labels, but, like most legislation will face significant hurdles in the path to adoption, particularly in light of expected strong opposition from the California delegation.


** UPDATE 8/29/2018 ** NTP just released a draft report recommending that “frequent and long term night shift work … that causes circadian disruption is known to be a human carcinogen” based on human studies.  Continue Reading This is Not a Dream … Agencies Actually are Reviewing the Cancer Risks of Night Shift Work (UPDATED)