By Joshua Bloom
In response to the recent spate of actions by private plaintiffs alleging that food manufacturers and retailers are violating the law by failing to provide Proposition 65 warnings with regard to exposures to acrylamide in food products, the California Office of Environmental Health Hazard Assessment (OEHHA) has proposed a regulation that seeks to stem the tide of those actions.
Although current regulations provide relief with respect to naturally occurring chemicals that are not the result of human activity, that “naturally occurring” provision does not apply to chemicals in food products formed by cooking or heating. As a result, manufacturers or others were left to demonstrate the availability of alternative risk levels to avoid placing warnings on those food products. OEHHA’s proposal seeks to remedy that gap by establishing regulations to set standards for when warnings are required for exposures to chemicals in foods caused by cooking or heating.
Under Proposition 65, products that cause an individual to be exposed to chemicals known to the State of California to cause cancer or reproductive toxicity must be accompanied by a requisite warning. Warnings for chemicals listed for their carcinogenic character are required where exposures exceed a no significant risk level (NSRL), and for those listed on the basis of reproductive toxicity, where exposure exceeds a maximum allowable dose level (MADL). The regulations provide guidance on how to determine both the NSRL and MADL, and for some chemicals, OEHHA has published specific NSRLs and MADLs, establishing “safe harbor” levels, exposures below which do not require a warning label.
Proposition 65, similar to citizen suit provisions in other environmental and consumer laws, allows private plaintiffs to sue on behalf of the people of California for violations of Proposition 65.
Current Proposition 65 regulations exclude concentrations of chemicals in “exposure” calculations to the extent they are “naturally occurring,” e.g., the chemical is naturally present in soils and not the result of human activity. The level of the chemical will not be deemed naturally occurring unless that amount of chemical could not be avoided by good agricultural or manufacturing processes, or otherwise has not been reduced to the “lowest level currently feasible.”
However, the presence of other chemicals listed under Proposition 65, most notoriously acrylamide in food products does occur as a result of human activity but nonetheless cannot be avoided, even with state of the industry quality control measures, when certain foods are heated or cooked. For example, acrylamide is formed when potatoes are cooked to produce potato chips, even when quality control is implemented and acrylamide levels are reduced to the lowest levels currently available. The cooking process is a human activity, meaning that chemicals formed in that way cannot benefit from the existing “naturally occurring” regulation.
Although there have been a number of lawsuits alleging failure to warn of exposures to acrylamide in food products, brought by both the California Attorney General and private plaintiffs over the past decade, recent cases alleging that exposures to acrylamide in coffee products required a Proposition 65 warning have brought the issue into focus. In response to those coffee cases, OEHHA issued a regulation that provides that chemicals caused by and inherent in the process of roasting of coffee beans and brewing coffee are deemed to pose no significant risk of cancer. Now, with this proposed regulation, OEHHA goes a step further and seeks to establish similar relief for other food products containing chemicals created by heating or cooking and sets specific safe harbor levels for acrylamide in designated food product categories.
Under the proposed regulation, a person does not “expose” an individual to the extent the chemical (1) was created by cooking or other heat processing, and (2) the producer, manufacturer, distributor, or holder of the food has utilized quality control measures that reduce the level of the chemical to the lowest level currently feasible. However, the proposed regulation would not limit the availability of demonstrating alternative risk levels, nor would it affect any existing court-ordered settlement or judgment that establishes concentration thresholds for chemicals in foods that result from heating or cooking.
With regard to acrylamide specifically, the regulation proposes maximum average and per unit concentrations, below which are deemed to not expose an individual to a significant cancer risk, and therefore a warning would not be required. Other than levels established for bread, all of the other maximum concentration levels are borrowed from recent court-approved settlements, which, for purposes of the regulation, OEHHA presumes represent the lowest levels currently feasible. Average concentrations are to be measured by averaging concentrations in multiple items or individual packaging units of the respective food product in the form that product is sold in California, whereas the single maximum unit concentration is to be measured in a single food item or individual packaging unit in the form the product is sold in California.
The foods and food groups for which maximum concentration levels are proposed to be established are:
· Roasted almonds, roasted almond butter, and chocolate-covered almonds
· Wheat and non-wheat-based bread products including loaves, rolls, buns, baguettes
· Cookies (including animal crackers, thin and crispy cookies, and sandwich wafers)
· Savory crackers, including crispbread
· Potato or sweet potato products, such as French-fried potatoes, hash browns, sliced chips, potato puffs
· Prune juice
OEHHA is accepting comments on the proposed regulation through October 6, 2020. It can be expected that this proposal will garner significant interest, and it is likely that any final regulation will be subject to litigation.
 Some 271 notices of intent to sue under Proposition 65 pertaining to acrylamide have been filed with the California Attorney General over the last twelve months.  Furfuryl alcohol (FFA) is another Proposition 65 chemical generated by heating or cooking but has received less attention than acrylamide. Over the last twelve months, only two notices of intent to sue have been filed pertaining to FFA.
Joshua Bloom, Partner
Environmental General Counsel