On August 4, 2020, the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65 (“Prop 65”), proposed to adopt a new regulation that would significantly change the warning requirements for listed chemicals formed by the cooking or heat processing of foods. 1/ The proposed regulation would provide that intake of such chemicals does not represent an exposure for the purposes of Prop 65 if the concentrations are reduced to the lowest level currently feasible using appropriate quality control measures. The proposal would establish maximum concentration levels for acrylamide in specific foods that are deemed by OEHHA to be the lowest levels currently feasible. Concentrations of the chemical at or below the level identified for the specified products would not require a warning.
It is noteworthy the proposed regulation is published at a time when a new wave of Prop 65 challenges are targeting acrylamide in food. In the past three months alone, private litigants have filed close to one hundred 60-day notices indicating their intent to sue food companies for acrylamide. This translates to about one Prop 65 notice filed every day in California for acrylamide in food. In its Initial Statement of Reasons, OEHHA stated the proposal is intended to (1) reduce exposures to listed chemicals present in food due to the human activities of cooking or heat processing, (2) provide warnings for avoidable exposures to acrylamide, and (3) safeguard the effectiveness of those warnings. 2/
The public can request a hearing on the proposed changes and the request must be received no later than September 21, 2020. Written comments to the proposed regulation are due on October 6, 2020.
Background on Acrylamide Prop 65 Litigations
For brief background, Prop 65 requires the Governor of California to publish, at least annually, a list of chemicals known to the state to cause cancer or reproductive toxicity. 3/ Businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone in California to a listed chemical. Acrylamide has been a listed Prop 65 carcinogen since 1990. 4/ The California Attorney General and plaintiff’s lawyers have filed numerous lawsuits in California seeking to impose Prop 65 warning requirements on food products for acrylamide.
Prop 65 permits private litigants or “bounty hunters” to bring private lawsuits to enforce the warning requirements. 5/ A “bounty hunter” seeking to sue for failure to warn as required by Prop 65 must notify the potential defendant and state prosecutors of the alleged violation and its intent to sue 60 days before a suit may be filed. 6/ These 60-day notices are publicly posted on the State’s Office of the Attorney General’s website. 7/ Over the past ten years, there have been multiple consent decrees for various foods that have set the level of acrylamide that does not require a Prop 65 warning. Food companies who are parties to these settlements and produce products within the negotiated levels do not have to provide the Prop 65 warning. The settlement also will identify the dollar damages the company must pay. Based on the most recent data available (i.e., 2018), the average settlement payment is around USD 42,424. 8/
Acrylamide in certain foods are already “exempt” from warning requirements. For example, on June 7, 2019, OEHHA adopted a regulation clarifying that exposures to Prop 65 substances in coffee do not pose a significant cancer risk. 9/ In essence, the regulation exempts coffee products from Prop 65 carcinogen warning requirements for chemicals such as acrylamide, to the extent that these carcinogens are created by and inherent in the process of roasting coffee beans or brewing coffee.
The Proposed Rulemaking
OEHHA is proposing to amend Title 27 of the California Code of Regulations, by adopting a new Section 25505, to address listed chemicals formed by cooking or heat processing foods. OEHHA noted that some degree of formation of listed chemicals in many foods (such as acrylamide) is unavoidable when the foods are cooked or otherwise processed with heat. As such, OEHHA reasoned, exposures to these chemicals in food are not necessarily the type of “knowing and intentional” exposures that require a warning under Prop 65. The proposed regulation provides that a person otherwise responsible for an exposure to a listed chemical in a food does not “expose” an individual to the extent the chemical was created by cooking or other heat processing, if the quality control measures that reduce the chemical to the lowest level currently feasible are utilized.
Lexology, 5 August 2020