[Author note: this post was written by Wendel Rosen attorney Wendy Manley.]

Just weeks after a court determined that a Proposition 65 (Prop 65) warning is required for acrylamide in coffee, a California appellate court ruled a warning is NOT required for acrylamide in breakfast cereals.  Acrylamide is listed as a carcinogen by the State of California and, consequently, a warning must be provided before exposing California consumers to acrylamide.

Warning exemption pending for acrylamide in coffee 

Not surprisingly, the coffee decision created a high degree of confusion and disbelief among dedicated coffee drinkers who, just months earlier, embraced the good news that coffee may protect against certain cancers.  In June, the International Agency for Research on Cancer (IARC) released a monograph that reviewed more than 1,000 studies of coffee and cancer.  IRAC concluded that coffee is associated with a reduced risk of liver and uterine cancer and there is inadequate evidence that coffee causes cancer.  In other words, the scientific studies show that while acrylamide causes cancer, coffee — which contains acrylamide — does not.

Recognizing that the Prop 65 warning requirement cannot be reconciled with the science, OEHHA (the Office of Environmental Health Hazard Assessment) immediately proposed a new (and still pending) regulation exempting coffee from Prop 65 warning requirements with respect to acrylamide and certain other chemicals.  The proposed rule states: “Exposures to listed chemicals in coffee created by and  inherent in the processes of roasting coffee beans or brewing coffee do not pose a significant risk of cancer.”  In its Initial Statement of Reasons supporting the rule, OEHHA identifies other Prop 65 chemicals formed in the brewing of coffee that would be encompassed by the exemption, including acetaldehyde, furfuryl alcohol, formaldehyde, naphthalene, and several chemicals with polysyllabic, tongue-twisting names.

The coffee research highlights a gap in Prop 65’s science: the mere presence of a chemical known to cause cancer (even at levels above what is believed to be safe), does not necessarily equate to a risk of cancer from exposure to an item that contains that chemical.  Most products, unlike coffee, have not been exhaustively studied for cancer risk, and few manufacturers either have or are willing to expend the resources necessary to undertake a comprehensive risk assessment to determine whether a product containing a Prop 65 chemical in fact presents a risk of cancer or reproductive toxicity under Prop 65.  As a result, many warnings are not supported by science, and some may not be supportable were the research performed.  To add further uncertainty, OEHHA has not established “safe harbor” levels for most of the more than 900 chemicals listed under Prop 65, making it even more difficult for manufacturers to complete a risk assessment.

OEHHA will hold a hearing on the proposed coffee warning exemption on August 16, 2018, and will accept comments through August 30, 2018.  Follow developments on the OEHHA website.

Warning requirement for acrylamide in breakfast cereal preempted

In another recent decision, a court determined that Prop 65 warnings are NOT required for breakfast cereal.  The basis for the decision was the principle of federal preemption: states cannot implement laws that conflict with federal laws.  The court found that Prop 65 poses an obstacle to the accomplishment and execution of a policy under federal law in which the Food and Drug Administration (FDA) promotes whole grain foods in the American diet.  When there is no express preemption provision in federal law, the court examines the entire scheme of a federal statute for implied preemption, and if the court determines that its purpose and operation are frustrated by the state law, then the state law is preempted.  In Post Foods v. Superior Court, the court found Prop 65 is an obstacle to the accomplishment and execution of the FDA policy of promoting whole grain foods in the American diet.

Although most cereals contain acrylamide at a level that would require a Prop 65 warning, whole grains are a significant source of important vitamins, minerals and fiber.  Based on research demonstrating the health benefits of whole grains, the FDA established a policy to promote the consumption of whole grains.

FDA described its policy in two letters to OEHHA and the Attorney General in 2003 and 2006 advising against acrylamide warnings on food.  FDA was concerned that labeling foods with warnings about dangerous levels of acrylamide would confuse and potentially mislead consumers, both because the labeling would be so broad as to be meaningless and because the risk of consumption of acrylamide in food is not yet clear.  FDA also worried the warning would dilute its messaging about healthy eating, mislead consumers into thinking acrylamide is only a hazard in store-bought foods, and ultimately cause consumers to avoid grains (specifically breads and cereals), potentially increasing their risks of disease from less fiber and other beneficial nutrients in their diets.  FDA concluded that Prop 65 warnings on foods would “conflict with FDA’s ongoing efforts to provide consumers with effective scientifically based risk communication to prevent disease and promote health.”  FDA’s advised that Prop 65 warnings for acrylamide should not be placed on foods, including breakfast cereals, unless and until the science supports such a warning.  FDA noted that even if acrylamide warnings became warranted, FDA may require manufacturers (as it does with trans fats) to identify foods containing acrylamide and the amount based on quantities consumed.

The Second District Court of Appeal found FDA’s letters thorough, consistent, and containing persuasive reasoning why Prop 65 acrylamide warnings on whole grain cereals would mislead consumers and lead to health detriments.  Prop 65 warnings, it concluded, conflict with a clear federal program to encourage healthy eating by consumers, and so is preempted.

Under the Post Foods case, breakfast cereals are now exempt from Prop 65 warnings (pending any potential appeal).  The exemption should extend to other grain products such as bread and granola bars, and arguably to other foods encompassed by FDA’s letters, but it is not generally felt that the decision will discourage all Prop 65 food claims based on acrylamide.  The decision may also invigorate other defendants to pursue federal preemption arguments, given appropriate supportive facts.

My favorite Megan Mullally quote, and there are many, is her ode to coffee: “I’ll quit coffee. It won’t be easy drinking my Bailey’s straight, but I’ll get used to it. It’ll still be the best part of waking up.”

Wendel Rosen attorney, Wendy Manley, recently wrote about the new labeling requirements for coffee. As she noted, a California court recently determined that coffee must bear a warning under the state’s Safe Drinking Water and Toxic Enforcement Act (aka “Prop 65”) regarding acrylamide, a carcinogen found in low levels in coffee due to the roasting and/or brewing process. As it turns out, things may not be so dire after all, and coffee lovers may soon raise a mug to celebrate California regulators.

On Friday, June 15, the Office of Environmental Health Hazard Assessment (OEHHA) proposed to add a new section of the California Code of Regulation, stating that no significant risk of cancer is presented by drinking coffee. OEHHA is the lead state agency that implements Prop 65 and has the authority to promulgate and amend regulations pertaining to it. Citing to the International Agency for Research on Cancer (IARC) in its press release, OEHHA justified its proposed regulation, in part, on the IARC’s conclusion that drinking coffee does not present a significant risk of cancer. Thus, while acrylamide is designated as a probable human carcinogen, a cup of joe is not considered to be, according to IARC research.

This conclusion isn’t surprising to the coffee industry. In 2016, the cancer agency of the World Health Organization removed coffee from its “possible carcinogen” list, and there have been numerous published studies touting the potential health benefits of drinking coffee over the years.

OEHHA maintains that its proposed regulation will benefit “the health and welfare of California residents by helping to avoid cancer warnings for chemicals in coffee that do not pose a significant cancer risk.” One can’t help but wonder, though, if this regulatory about face is intended to benefit Prop 65, too. As reported in Law360 (a subscription is required), a bipartisan group of members of the U.S. Senate and the U.S. House of Representatives may be looking to undermine labeling requirements on the federal, state and local levels, and in particular, Prop 65, by requiring that labels clearly identify potential cancer risks of products based on the “best available science.”

The proposed legislation, H.R. 6022 and S. 3019, would require labeling warnings that are supported by science that is based upon objective scientific practices, which includes findings and data that are reliable and peer reviewed when possible. According to Rep. Adam Kinzinger (R-Ill.), the proposed federal legislation is intended to counter state laws that may cause some products to be “incorrectly labeled with warnings about harms that do not exist.”

To be sure, the fight over coffee and the scope of Prop 65 will not end soon. Public comment on the proposed regulation will be open until August 30, 2018, likely fielding comments for and against the regulation. Should OEHHA’s proposed regulatory change pass, it is also likely that it would be challenged in court. And, given the detractors of Prop 65 both in and outside of California, a challenge to OEHHA’s proposal may be the least concern. Congress rarely agrees on much these days, but they definitely seem jittery over the recent efforts to regulate their morning cup. So, we’ll continue to monitor this potential food fight and keep you posted.  For now, just “sip” back and relax.

[This post was written by Wendel Rosen environmental attorney Wendy Manley.]

Coffee drinkers were pleasantly surprised recently to learn their daily beverage may afford a number of health benefits. The beverage contains antioxidants and nutrients, and may protect against Type 2 diabetes, Parkinson’s, Alzheimer’s and liver cancer. Make that a double latte, please.

            NEWS FLASH:

Warning: coffee contains acrylamide, a chemical known by the State of California to cause cancer.

What just happened?

In short, after eight years of litigation, a California court determined that coffee must bear a warning under the state’s Safe Drinking Water and Toxic Enforcement Act, otherwise known as Proposition 65 or “Prop 65.”

Prop 65 was enacted by voters in 1986 with the objective of eliminating toxic chemicals in consumer products by requiring a warning before exposing a person in California to a chemical listed by the State as causing cancer or reproductive toxicity. If your product contains a listed chemical, it may need a Prop 65 Warning.

While there have been some success stories – trichloroethylene out of correction fluid and lead out of wine bottle caps, jewelry, brass faucets, calcium supplements and ceramic ware, for example – Prop 65 has spawned a cottage industry of citizen enforcers, some of which seek to safeguard human health, others of which are motivated by the reward of penalties and attorney fees.

There are more than 900 chemicals on the Prop 65 List that cause cancer or reproductive toxicity or both. In a few cases, the state has set a “safe harbor” level below which no warning is required. Plaintiffs can initiate an enforcement suit based on a lab test showing the presence of a listed chemical, and the burden falls to the defendant to prove the exposure poses “no significant risk,” which is one excess case of cancer in an exposed population of 100,000 assuming a 70 year lifetime of exposure at that level. The risk assessment needed to establish the no significant risk level (NSRL) is complicated, expensive, and vulnerable to attack in a courtroom. Consequently, the vast majority of cases are settled regardless of the merits of the claim.

Acrylamide was added to the Proposition 65 list in 1990, but not discovered in food until 2002. Since that time, more than 650 Prop 65 claims have been brought for failure to warn about acrylamide in a wide range of food products, including french fries, potato chips, sweet potato chips, vegetable chips, hash browns, bread, bagels, English muffins, breakfast cereals, granola bars, animal crackers, ginger snap cookies, molasses, toasted almonds, black olives, and coffee.

A listed chemical is often times present as an ingredient or contaminant. In many cases, such as lead or cadmium in chocolate or seaweed, it is naturally occurring, and exempt from the Prop 65 warning. Acrylamide is unusual in that it is neither added to coffee nor does it occur naturally – it is created during roasting. Cooking at high temperatures, including frying, roasting and baking, transforms sugars and the amino acid asparagine into acrylamide through the Maillard reaction. Consequently, acrylamide is unavoidable in conventional coffee roasting techniques.

Back to the coffee case. In Council for Education and Research on Toxics v. Starbucks, defendants first argued and lost several defenses based on the NSRL, First Amendment and preemption by federal law. In the second phase of the trial, which concluded in January 2018, defendants argued a rarely utilized defense involving an Alternative Significant Risk Level (ASRL) based on considerations of public health. The regulations provide that “where chemicals in food are produced by cooking necessary to render food palatable or to avoid microbiological contamination,” considerations of public health allow for an ASRL.

The Coffee defendants’ risk assessment calculated an ASRL of 19 micrograms per day, which was an order of magnitude higher than the State’s established NSRL of 0.2 micrograms per day.

To their disappointment, the coffee producers failed to persuade the judge that the ASRL should apply. The court found their expert’s quantitative risk assessment deficient, analytical chemistry methods unacceptable, evidence of health benefits unpersuasive, and the minimum quantity of acrylamide necessary to render the coffee palatable unsubstantiated, among other things. In their objections to the proposed Order, the defendants took issue with a number of the court’s findings and regulatory interpretations. Although the plaintiff immediately filed a motion for permanent injunction, it is widely expected that some or all of the defendants, which total 91, will appeal.

Just as Yogi Berra famously said, it ain’t over till it’s over. If the case is appealed, it will likely be quite some time before we know whether a Prop 65 warning is required for acrylamide in coffee. If a warning is ultimately required, specific warning language may be developed for coffee. Meanwhile, high doses of acrylamide administered to rodents suggests acrylamide may cause cancer in humans, but questions still remain whether one can even drink enough coffee to raise the risk or whether the health benefits more than offset the potential risks.

Food producers investigating acrylamide in their products need to think more broadly, since furfural alcohol is also a Prop 65 chemical generated from the Malliard reaction during cooking. And the Prop 65 plaintiff’s bar knows about it.