In the hot seat: Acrylamide-related changes to California Proposition 65 Regulations for foods that undergo cooking or heat processing

31 May 2022

Injunction for acrylamide-related lawsuits upheld and new proposed warnings labels for acrylamide in food

Background 

Proposition 65 (Prop 65), a regulation unique to California, requires businesses to warn consumers if the products they sell may expose the consumer to a chemical that is on a list of "Chemicals Known To The State of California To Cause Cancer Or Reproductive Toxicity."  Failure to comply with the regulation may result in a Notice of Violation (NOV) being filed against the business. Acrylamide, a chemical that is highly targeted in baked goods, chips, crackers, and french fries, was initially listed for causing cancer in 1990 and has since been added as a chemical known to cause male reproductive and developmental toxicity in 2011. From January 2016 to April 2022, 1,292 NOVs were filed against acrylamide, which is startling compared to the 88 NOVs that were filed from January 1998 to December 2015. Controversy has arisen over NOVs filed for acrylamide in food because it is not intentionally added to these foods, but is instead formed during the baking or cooking process.

In October 2019, a lawsuit was filed against the California Attorney General by the California Chamber of Commerce alleging a violation of the First Amendment.  The alleged violation was related to the inclusion of Prop 65 warning labels for food products that naturally contain acrylamide. Recognizing the potential public concerns from including warning labels for cancer on food products, the Office of Environmental Health Hazard Assessment (OEHHA)—the California agency responsible for maintaining the Prop 65 list—recently proposed amendments to Prop 65 regulations related to Clear and Reasonable Warnings for acrylamide exposures from foods. The proposed amendments include more specific and descriptive warnings for exposure to acrylamide from food to better educate the public, as discussed in greater detail below.

In March 2021, the District Court for the Central District of California issued a preliminary injunction against the filing of new enforcement actions after 29 March 2021. This effectively means that no NOVs or lawsuits could be filed against businesses for acrylamide as long as the injunction is in place. An appeal was filed shortly thereafter by the Council for Education and Research on Toxics (CERT) claiming the injunction was unconstitutional, on the grounds that the Prop 65 cancer warning for acrylamide in food was "purely factual and uncontroversial." Upon review of CERT's appeal, a unanimous opinion was filed by the Ninth Circuit Court of Appeals in March 2022 to rule against CERT and uphold the injunction against new acrylamide NOVs or lawsuits. The main arguments in the court hearing claimed that there is robust disagreement between reputable scientific sources (National Cancer Institute, American Cancer Institute, IARC, NTP, and the U.S. EPA) over whether acrylamide in food causes cancer in humans, and that the warning may ultimately mislead consumers.

What this Means for Products Containing Acrylamide

Currently, enforcement action related to Prop 65 cancer warning requirements against acrylamide in food remains prohibited; however, OEHHA has proposed amended warning labels for acrylamide in food products to avoid confusion and better inform consumers.

As part of the amendments, OEHHA proposed that a warning label would outline that acrylamide is a "probable human carcinogen," and that acrylamide is not intentionally added by manufacturers but is instead a by-product of heat processing at high temperatures. Other phrases on the warning label would indicate that the frequency and amount of consumption of acrylamide affect a person's cancer risk, and a link would be provided to the OEHHA's website which includes guidance on food preparation and further information on acrylamide. It is important to note that the proposed amendments would be voluntary and would not alter other sections of the regulation, including those for exposure to a naturally occurring chemical in food. This means that a business may choose to use other methods of warning (including previous warning language).   

Of note, the California Office of Administrative Law (OAL) disapproved of the proposed amendment on 10 March 2022 due to the vagueness of terms critical to the regulation and their failure to meet the clarity required under the Administrative Procedures Act, as well an insufficient economic impact assessment. As such, OEHHA has been given the opportunity to submit a revised regulation by 08 July 2022 to address the concerns of the OAL.

As events unfold, stay tuned for further updates that may be relevant for your California Proposition 65 compliance efforts. For any questions related to acrylamide exposures in food, or other Prop 65 compliance questions, please contact us at is.amercanmssprop65@intertek.com.

How Can Intertek Support?  

Intertek's Prop 65 compliance services provide valuable support to manufacturers, retailers, and importers worldwide that need to comply with this California right-to-know legislation.

Intertek has board-certified toxicologists and other scientific professionals that understand the complexities of Prop 65 compliance issues and know how to address them. In conjunction with its laboratory testing facilities, Intertek has critical components for your Prop 65 compliance needs.

For more information on Intertek's California Prop 65 Services, visit: https://www.intertek.com/assuris/consumer-goods/safety/prop65/.

Disclaimer: The above is the work product of the authors from Intertek Scientific & Regulatory Consultancy (IHSI), which is not associated with OEHHA or CA EPA. The information in this blog is for informational purposes only. IHSI and its affiliates assume no liability for any inaccurate, incomplete information, or for any actions taken in reliance thereon. The information has been obtained from publicly available sources and does not constitute legal advice. Any parties having legal interest in the topic should seek appropriate legal counsel.

References:

• https://www.fda.gov/food/chemical-contaminants-food/acrylamide-questions-and-answers#:~:text=Acrylamide%20is%20found%20mainly%20in,periods%20or%20at%20higher%20temperatures.
• New Acrylamide Prop 65 lawsuits: preliminary injunction reinstated; proposed regulation disapproved | Hogan Lovells - JDSupra
• Notice of Proposed Rulemaking New Subsection 25607.2(b) Warning Content for Acrylamide Exposure from Food - OEHHA (ca.gov)
• https://www.courthousenews.com/ninth-circuit-upholds-block-on-acrylamide-warning-for-food-products-sold-in-california/
• https://oehha.ca.gov/media/downloads/crnr/isoracrylamide091721.pdf