New Acrylamide Prop 65 lawsuits: preliminary injunction reinstated; proposed regulation disapproved

California Chamber of Commerce v. Council for Education and Research on Toxics (CERT)

On March 17, 2022, the Ninth Circuit reinstated the preliminary injunction, by finding that given the robust disagreement by reputable scientific sources over whether acrylamide in food causes cancer in humans, the district court did not abuse its discretion in concluding that the warning was controversial.¹  Ninth Circuit also noted that the district court similarly did not abuse its discretion in finding the warning was misleading. With the preliminary injunction reinstated, both the state Attorney General and private enforcers are again prohibited from filing or prosecutive new lawsuits to enforce the Proposition 65 warning requirement for cancer as applied to acrylamide in food and beverage products. Importantly, the preliminary injunction does not alter any existing consent decrees, settlements, or other agreements related to Proposition 65 warning requirements.

Background

In October 2019, the California Chamber of Commerce (CalChamber) filed a lawsuit against the California Attorney General (AG) asking the court to rule that Proposition 65 warning requirements for cancer as applied to acrylamide in food products violate the First Amendment, and seeking injunctive relief prohibiting the Attorney General and private bounty hunters from enforcing Proposition 65 warning requirements for cancer with respect to acrylamide in food products.²  In March 2021, the United States District Court for the Eastern District of California granted the CalChamber request for preliminary injunction, halting the filing of new lawsuits until the case could be decided on the merits.³  Following the preliminary injunction, an intervening defendant, the Council for Education and Research on Toxics (CERT) appealed to the Ninth Circuit claiming the injunction was an unconstitutional restraint of its interest in pursuing the lawsuits. In May 2021, the Ninth Circuit panel stayed the District Court’s preliminary injunction while the merits of the appeal were being litigated.⁴

Decision

Yesterday, the Ninth Circuit issued its final decision on the appeal, finding the District Court’s determination that the acrylamide warning requirement was likely unconstitutional was not an abuse of discretion and therefore the preliminary injunction is not an unconstitutional or otherwise impermissible restraint against CERT’s interest in filing lawsuits to enforce Proposition 65.⁵ The decision revives the preliminary injunction prohibiting the filing of new acrylamide lawsuits while the First Amendment case at the District Court continues on the merits. The Ninth Circuit’s decision notes, however, that its decision applies only to the interests of CERT and not other possible private enforcers because CERT only asserted its own rights.⁶ Nevertheless, given the precedent, it is unlikely other private enforcers will seek to challenge the injunction. The preliminary injunction will remain in effect pending the decision on the merits of the case at the district court.

California Office of Administrative Law (OAL) Decision Regarding Regulatory Action to Adopt Title 27, California Code of Regulations, Section 25505

On March 10, 2022, OAL issued a decision disapproving of a regulation proposed in August 2020 by the Office of Environmental Health Hazard Assessment (OEHHA), the lead agency that implements California’s Proposition 65. As proposed, the regulation would have significantly changed the warning requirements for listed chemicals formed by the cooking or heat processing of foods, such as acrylamide.⁷ The proposed regulation was submitted to OAL in September 2021 for review under the California Administrative Procedures Act (APA)⁸  prior to being finalized. OAL disapprovals are rare and the action sends the proposed regulation back to OEHHA with the opportunity to submit a revised regulation by July 8, 2022, 120 days after the decision.

Among other things, the disapproval cites failures to comply with the clarity and necessity standards of the APA. In particular, the disapproval takes issue with the following terms at the heart of the regulation, calling them “vague” and “can reasonably and logically be interpreted to have more than one meaning, and does not have a meaning generally familiar to those ‘directly affected.’:

• “Lowest level currently feasible.” The proposed regulation noted that “some degree of formulation of listed chemicals in many foods is unavoidable” and therefore levels present at the “lowest level currently feasible” should not be considered exposures. OAL found that because the phrase is not defined in the proposed regulation or governing statutes, and OEHHA did not provide sufficient details.
• “Quality control measures.” The Initial Statement of Reasons (ISOR) for the proposed regulation included “examples of specific ways to feasibly reduce acrylamide” as examples of “quality control measures” that manufacturers could use to avoid the duty to warn. OAL noted that OEHHA received numerous written comments indicating the phrase is unclear, which OEHHA failed to address. Further, OAL noted that examples of only acrylamide quality control measures were provided and the regulation is intended to apply to “all” Proposition 65 listed chemicals created as a result of cooking or heat processing.
• “Measured.” OAL found that the term “measured” is unclear because it does not specify which analytical methods are appropriate for measuring the listed chemicals that would be subject to the regulation.
• Proposed Food categories. Among other things, the proposed regulation sought to define several product categories and respective maximum acrylamide levels, based on previous lawsuits. OAL found that some categories such as “cookie products,” “potato products,” and “waffle products” are insufficiently defined and it is not clear which products would fall under the proposed maximum levels.

In addition to the issues noted above, OAL’s decision notes that OEHHA failed to prepare a sufficient economic impact assessment, include in the rulemaking record copies of all public comments submitted, summarize and respond to all public comments containing objections or recommendations.

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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, and Mary Lancaster.