November 28, 2021

Volume XI, Number 332

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California OEHHA Proposes New Safe Harbor Warnings for Acrylamide in Foods

On September 17, 2021, the California Office of Environmental Health Hazard Assessment (“OEHHA”) proposed new, alternative safe harbor warnings for acrylamide exposures in food.  OEHHA’s stated goal is to reduce the potential for litigation concerning the sufficiency of warnings, because the new, optional safe harbor warnings are deemed “clear and reasonable” by the lead agency for purposes of Proposition 65. 

Proposition 65, California Health and Safety Code § 25249.5 et seq. (“Proposition 65”), requires companies to provide “clear and reasonable” warnings before “knowingly and intentionally” exposing California consumers to any chemicals listed as known to the State of California to cause cancer or reproductive toxicity.  There are limited exceptions to the warning requirement, including where it can be shown that exposure levels are below certain “safe harbor” threshold levels determined by the state.  Proposition 65 already provides generally-worded food exposure warning safe harbor language that is deemed to be “clear and reasonable” at Sec. 25607.2. 

OEHHA’s actions come partially in response to concerns raised by the parties in Cal. Chamber of Commerce v. Bonta, No. 2:19-cv-02019-KJM-JDP (E.D. Cal. Mar. 30, 2021) (“CalChamber”).  In the CalChamber case, the plaintiffs argue that the existing safe harbor warnings for exposure to acrylamide in foods – which state that acrylamide is “known” by the state to cause cancer – are overbroad, are false and misleading, and constitute a violation of First Amendment rights.

While the CalChamber case makes its way through the courts, and while OEHHA is still in the process of determining safe harbor levels for acrylamide in certain foods, OEHHA has proposed alternative safe harbor language that it intends to implement later this year, and which effectively softens the discussion of potential cancer risks.  If the proposed regulations are finalized without change, businesses can elect to use the safe harbor warning language for acrylamide exposure in food as follows:

"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."

© 2021 Foley & Lardner LLPNational Law Review, Volume XI, Number 273
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About this Author

Nathan A. Beaver, Foley Lardner, FDA Enforcement Lawyer, Regulatory Attorney,
Partner

Nathan A. Beaver is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval...

202.295.4039
Sarah Slack, environmental compliance counseling lawyer, Foley Lardner law
Partner

Sarah Slack is senior counsel and an environmental lawyer in the Business Law Department at Foley & Lardner LLP. Ms. Slack is a member of the Environmental Regulation Practice and the Life Sciences and Energy Industry Teams.

Ms. Slack divides her time between remediation/redevelopment work, environmental compliance counseling, transactions and environmental litigation. Ms. Slack has extensive experience on the cutting edge of Clean Air Act, Clean Water Act, Superfund, and RCRA enforcement, as well as citizen suit litigation, settlement...

608-258-4239
Erik K. Swanholt, Foley Lardner, litigation attorney
Partner

Erik Swanholt is a partner and litigation attorney with Foley & Lardner LLP. Mr. Swanholt has substantial experience in a broad range of litigation matters, with an emphasis on product liability, pharmaceutical defects, complex commercial and consumer class action litigation, toxic torts, as well as cybersecurity, privacy, and data protection. He has defended individual and class action product liability and toxic tort claims in a variety of industries, including consumer products, fashion, pharmaceuticals, off-road vehicles, industrial safety equipment, asbestos,...

213.972.4614
Nicholas R. Johnson Foley Lardner Law Firm state voluntary cleanup programs lawyer
Associate

Nicholas (Nick) Johnson is an associate with Foley & Lardner LLP and a member of the firm’s Environmental Regulation Practice.

Mr. Johnson has substantial experience in all facets of environmental law and corporate environmental risk management, including both contested proceedings and general regulatory guidance and advice with respect to CERCLA, RCRA, TSCA, the Clean Water Act, the Clean Air Act, state voluntary cleanup programs, and other state and federal environmental laws. Mr. Johnson routinely works with buyers, sellers, investment...

414-297-5340
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