The Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65 (Prop 65), recently finalized a regulation that addresses when acrylamide in cooked or heat processed foods creates an exposure requiring a warning under Prop 65. The new regulation takes effect April 1, 2023. OEHHA’s publication of the final rule concludes a lengthy rulemaking process that involved significant substantive modifications to the text originally proposed by OEHHA. Notwithstanding OEHHA’s issuance of the new regulation, a preliminary injunction barring the filing of any new Prop 65 challenges alleging failure to warn over exposure to acrylamide in foods remains in effect.
Background
OEHHA first proposed to establish a regulation that specifically addresses exposures to acrylamide from cooked and heat processed foods in August 2020. Following an initial round of comments from stakeholders, OEHHA modified the proposal and submitted the text to California’s Office of Administrative Law (OAL) for approval in September 2021. In an unusual move, OAL disapproved OEHHA’s text, citing concerns about vagueness and lack of clarity. In response, OEHAA made substantial substantive modifications to the proposal and republished it in October 2022. Following a 15-day public comment period, OEHHA submitted the text, which it declined to modify in response to the latest round of comments, to OAL, which approved it on December 20, 2022.
Key Provisions of the Final Regulation
As summarized in our October 2022 update,1 the new regulation addresses what constitutes an “exposure” to acrylamide from cooked or heat processed food. As a general matter and for all types of foods, acrylamide formed by cooking or heat processing does not create an “exposure” requiring a warning if a manufacturer has reduced the acrylamide to the “lowest level currently feasible” by employing practices recommended in the Codex Code of Practice for the Reduction of Acrylamide in Foods.2 In addition, the regulation establishes safe harbor levels for a few specific categories of foods (see chart below). Products in these categories that contain acrylamide at or below the specified level need not bear a warning regardless of the production processes employed by the manufacturer. These levels are deemed to be the “lowest level currently feasible”; no further showing by the manufacturer is necessary. Apart from the level for bread, OEHA drew these safe harbor levels from prior court-approved Prop 65 settlements.
Two additional provisions round out the new regulation. The first clarifies that nothing in the regulation precludes a manufacturer from relying on other data, information, or provisions of the regulations (e.g., food intake, cooking exemption, standard safe harbor levels) to demonstrate that a warning is not required under Prop 65 for any particular product. The second clarifies that acrylamide compliance levels in court-ordered settlements and final judgments entered prior to April 1, 2023, to the extent they differ from the safe harbor levels in the new regulation, continue to apply to the parties to those settlements.
We will continue to monitor Prop 65 developments of interest to the food industry.
References
1 See Hogan Lovells Update OEHHA announces new modification of proposed acrylamide regulation for foods - Hogan Lovells Engage (October 12, 2022).
2 Available here.
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