California’s Office of Environmental Health Hazard Assessment (OEHHA) has proposed regulations to limit the rash of Proposition 65 actions alleging failure to provide a warning for exposure to acrylamide in food items as a result of cooking or heat processing. The August 4 proposal would establish that consumption of foods containing acrylamide does not represent an “exposure” for Prop 65 purposes if the concentrations are “reduced to the lowest level currently feasible using appropriate quality control measures.” The measure also would adopt specific acrylamide concentration limits for certain food items that are deemed by OEHHA to be the lowest levels currently feasible. Concentrations of acrylamide at or below these levels would not require a warning.
Acrylamide is not naturally present in food products but is created by the Maillard reaction, which occurs between amino acids and sugars at high temperatures. A wide variety of food products, including, most prominently, baked and fried starches, contain acrylamide at relatively low levels, but nevertheless in amounts that numerous plaintiff actions have asserted require a Prop 65 warning. (At last count, 218 Prop 65 Notices of Violation had been filed by plaintiffs in 2020 alone.) Acrylamide, formed during brewing, also is at the heart of the (absurd) controversy over whether coffee should be served with a side of Prop 65 warning. (For further details on the coffee imbroglio, see my prior blog posts here, here and especially here).
Ubiquitous warnings prevent consumers from distinguishing between products with very high concentrations of a listed chemical from those with considerably lower levels. Over the past several years there has been an increase in enforcement activity related to chemicals such as acrylamide that can be formed in a multitude of foods during heat processing and cooking. In the absence of regulatory action, the proliferation of enforcement actions related to listed chemicals formed in food could result in businesses putting warnings on foods that do not require them, which is contrary to the statutory purpose of enabling consumers to make informed choices.
While acrylamide is formed naturally during the cooking process, because cooking is a human activity, the Prop 65 exemption for “naturally occurring chemicals in food” does not apply. The proposal recognizes that certain amounts of acrylamide in food products are “unavoidable,” but that “in many circumstances the level of the chemical formed can be lowered by optimizing certain practices.” Accordingly, the proposed rule attempts to navigate this space “by incentivizing food manufacturers and producers to reduce listed chemicals formed through cooking or heat processing to the lowest level currently feasible, while continuing to require warnings for such chemicals in food when present at levels above the lowest levels currently feasible.”
At its heart, the proposed rule would provide an exemption from Prop 65 by establishing that a business does not “expose” consumers if a listed chemical in food was created by cooking or other heat processing, and the producer, manufacturer, distributor, or holder of the food has utilized quality control measures that reduce the chemical to the lowest level currently feasible. OEHHA notes that various federal and international authorities have issued guidance on how to reduce acrylamide concentrations in foods, including the US FDA, the WHO, and European agencies. Notably, this provision is not limited to acrylamide, but can be applied to any chemical that may be formed during the cooking or heat processing of food, such as furfuryl alcohol.
As a practical matter, experienced Prop 65 counsel will recognize quickly that the requirement for a business to make this demonstration may not do much to inhibit Prop 65 plaintiffs from initiating lawsuits. Establishing the exemption would require businesses to demonstrate — to a plaintiff and/or a court — that the quality control measures it utilized were consistent with agency guidance or otherwise appropriate and sufficient to achieve the “lowest level currently feasible.” Successfully employing the defense will require maintaining thorough documentation of quality control procedures and vigilance in identifying and implementing “lowest level currently feasible” control measures.
In contrast, the specific maximum concentration levels for acrylamide set forth in the proposal are of much greater practical utility as a defense against a Prop 65 action — though limited in the scope of the products covered. Most of the proposed levels are based on limits agreed to in recent court-approved settlements. As such, they are presumed to be feasible. The proposal would establish maximum acrylamide levels for the following food items:
Almonds, roasted, roasted almond butter, and chocolate-covered almonds
Bread, non-wheat-based products including loaves, rolls, buns, baguettes
Bread, wheat-based products including loaves, rolls, buns, baguettes
Cookies, animal and animal crackers (sweet)
Cookies, thin and crispy
Cookies, sandwich wafers
Crackers, savory, including crispbread
Potato products, French fried potatoes
Potato or sweet potato products, not otherwise specified, such as hash browns and potato puffs
Potato or sweet potato products, sliced chips
Prune juice, 100% (not from concentrate)
Prune juice, made with concentrate
OEHHA may add additional foods to this list (and/or establish concentration limits for other food-related chemicals), and may revise the concentration limits to reflect improvements in the methods for reducing acrylamide in these food items.
The proposal undoubtedly will attract an outpouring of feedback from the business community, food safety advocates, and the Prop 65 plaintiff’s bar, with comments due by October 6. The text of the proposed regulation and supporting documents are available at OEHHA’s website: https://oehha.ca.gov/proposition-65/crnr/notice-proposed-rulemaking-adoption-section-25505-exposures-listed-chemicals.