The Office of Environmental Health Hazard Assessment (OEHHA) issued a Notice of Proposed Rulemaking on September 17, 2021 proposing to allow an alternative, nonmandatory safe harbor warning option for exposures to acrylamide from food. The public comment period closed on November 8, 2021. OEHHA made no changes in response to the 10 written comments it received.1 OEHHA’s finalization of the alternative safe harbor warning comes shortly after it proposed new changes to its proposed regulation that would establish safe harbor levels for exposures to acrylamide from food.2
Alternative Safe Harbor Warning
OEHHA states in its Final Statement of Reasons (FSOR) that the alternative warning is “intended to provide additional information to individuals who may be exposed to acrylamide in foods to help them make better-informed decisions about those exposures."3
Under the new rule, the alternative, nonmandatory safe harbor warning must include:
- The words “CALIFORNIA WARNING” in all capital letters and in bold print.
- The words: “Consuming this product can expose you to acrylamide, a probable human carcinogen formed in some foods during cooking or processing at high temperatures. Many factors affect your cancer risk, including the frequency and amount of the chemical consumed. For more information including ways to reduce your exposure, see www.P65Warnings.ca.gov/acrylamide.”4
The following example would comply with the new rule, which goes into effect January 1, 2023:
OEHHA Response to Comments
Comments on the proposed alternative warning touched on a variety of topics, including the scientific evidence and debate surrounding the carcinogenicity of acrylamide, omission of the words “known to the state to cause cancer” from the warning and how that approach compares with other safe harbor warnings and prior precedent, and the alleged vagueness of various terms in the warning (e.g., “some foods”, “many factors”). In response to concerns that the warning violates the First Amendment, OEHHA states in the FSOR:
OEHHA disagrees with the commenter’s statements that the proposed warning would violate the First Amendment. In the context of a preliminary injunction against enforcement, the District Court and Ninth Circuit in CalChamber found that the general consumer product safe harbor “known to the state to cause . . . ” warning would be false and misleading as applied to acrylamide in foods, and therefore requiring such a warning would violate the First Amendment rights of CalChamber’s members.
However, the proposed warning differs materially from the warning that was before the District Court and Ninth Circuit in the CalChamber case. In particular, the Ninth Circuit found the general consumer product safe harbor warning to be misleading as applied to acrylamide in foods because of its use of the phrase “known to the state of California to cause cancer”. The warning proposed in this regulation does not use that phrase. It provides consumers with factually accurate information they can use to decide if they want to be exposed to acrylamide, a probable human carcinogen. This furthers the purposes of the statute.5
As noted earlier, the preliminary injunction barring the filing of new Prop 65 lawsuits involving exposures to acrylamide from food, referenced by OEHHA in its response to commenters’ First Amendment concerns about the alternative safe harbor warning, remains in effect.6 The case underlying that injunction, a First Amendment challenge to acrylamide warnings for foods brought by the California Chamber of Commerce in 2019, continues to work its way toward a final disposition on the merits.
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We will continue to monitor all regulatory actions related to Proposition 65. Please contact us if you have any questions.
Authored by Martin Hahn, Xin Tao, Andrea Bruce, and Molly Mulligan.
2 See Hogan Lovells Update, “OEHHA Announces New Modification of Proposed Acrylamide Regulation for Foods” (October 12, 2022).
5 Id. at 20-21.
6 Hogan Lovells Update, “New Acrylamide Prop 65 Lawsuits: Preliminary Injunction Reinstated; Proposed Regulation Disapproved (March 18, 2022).