Recent California Court Cites “Misleading Message” as Part of Ruling Prohibiting Proposition 65 Warnings for Acrylamide in Food

A recent California court ruling prohibiting Proposition 65 warning labels for acrylamide in food provides a notable change in labeling requirements, and states cancer classifications can be misleading.

As part of California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65 or Prop 65), the state publishes a list of chemicals that are “known to the State of California to cause cancer or reproductive toxicity.” A substance can be added to this list as a carcinogen if an “authoritative body” concludes the substance can cause cancer in humans or laboratory animals. Several organizations* are considered to be authoritative bodies by the State of California, and a substance can require labeling based on the conclusions of any particular body. This approach can lead to questions and controversy about how the process addresses substances when there is no scientific consensus – either between scientific disciplines (i.e., human and animal evidence) or across scientific bodies (e.g., the International Agency for Research on Cancer [IARC] and US Food and Drug Administration [US FDA]). The latest California court ruling illustrates the issues related to the labeling process.

On May 2, 2025, the US District Court for the Eastern District of California issued a ruling in California Chamber of Commerce v. Bonta, Case No. 2:19-cv-02019, prohibiting Proposition 65 warnings for acrylamide in food. The basis of the warning was the conclusion by authoritative bodies, including IARC, that used a hazard-based approach to classify acrylamide as a “probable carcinogen” based on animal studies. This conclusion was used over the conclusion of other authoritative bodies, such as US FDA, that take a risk-based approach and have not concluded that dietary exposure to acrylamide can cause cancer. Of note in this case, the court acknowledged that the authoritative bodies’ findings were not in alignment on the cancer risk of acrylamide in food. Further, the court concluded that the classification of an agent, such as acrylamide, as a probable carcinogen is misleading because it implies a cancer risk from food consumption without scientific consensus. Importantly, the court noted that the term “probable” is itself misleading, as it implies a substance is probably carcinogenic even though this is not always the case.

The court’s ruling could indicate future contests to Proposition 65 labeling requirements, particularly when the specific language used in the classification of an agent could be misleading and scientific consensus is lacking.

*Organizations designated as authoritative bodies by the State of California under Proposition 65: US Environmental Protection Agency, US FDA, National Institute for Occupational Safety and Health (NIOSH), National Toxicology Program (NTP) of the US Department of Health and Human Services, and IARC.

Contact:

Denali Boon, Ph.D., M.P.H.
Senior Epidemiologist

Julie E. Goodman, Ph.D., DABT, FACE, ATS
Principal

Gradient Principals Dr. Lisa Bailey, Dr. Robyn Prueitt, and Mr. Michael Peterson have been accepted as Fellows of the Academy of Toxicological Sciences (ATS).

The Academy of Toxicological Sciences (ATS) is a nonprofit organization that exists to certify toxicologists who are recognized by their peers for their expertise and sound scientific judgment.  The purpose of this recognition and certification is to ensure, through peer review of credentials, the competence and experience of professionals whose work affects public welfare.  Candidates for certification must have demonstrated evidence of knowledge of toxicology and active involvement in toxicological activities.  A Fellow of the Academy must have an exemplary record of professional accomplishment, as well as extensive evidence of recognition by peers of competency and sound scientific judgment in toxicology as reflected by appointment or election to councils, committees, etc.

Congratulations, Lisa, Robyn, and Mike!

In this issue of Trends, we provide several articles on the topic of plastics.

Our first article provides an overview of the past, present, and presumable future of plastics.  The second article discusses the environmental fate of bioplastics and how they compare to conventional plastics.  The third article examines the challenges and benefits of advanced recycling, and our fourth article, guest authored by Megan Brillault, Allyn Stern, and Sara Eddy, attorneys at Beveridge & Diamond, discusses litigation targeting plastics manufacturers.

Gradient contributors to this Trends issue include Matthew Tymchak, M.S.; Ifeoluwa Bamgbose, M.S., DABT; and Drs. Haley Gadol and Jessie Kneeland.

Articles:

• A Few Words on the Past and Future of Plastics
• Bioplastics – What They Are and Understanding Their Environmental Fate
• The Promise of Advanced Recycling
• Guest Editorial: Litigation Targeting Plastics Manufacturers
• What’s New at Gradient

The Federal Register has posted a pre-publication document announcing an updated data submission period for the Toxic Substances Control Act (TSCA) per- and polyfluoroalkyl substances (PFAS) reporting rule for PFAS data reporting.  The newly revised submission period timeline is scheduled to be published on May 13, 2025.   The 2025 announcement marks the second extension of this reporting period.  According to the announcement, the latest extension will allow “more time to prepare the reporting application to collect this data,” as well as time for the agency to separately consider “reopening certain aspects of the rule to public comment.”

See the 2025 Federal Register announcement

See the Gradient website 2024 news item

Latest Deadlines (as of May 13, 2025):

Beginning of Data Submission
April 13, 2026

End of Data Submission
October 13, 2026

End of Data Submission for Small Businesses, Article Importers
April 13, 2027

Gradient Contacts:

Chase H. Butler, M.S.
Senior Environmental Chemist

Ari S. Lewis, M.S.
Principal

Caroline B. Tuit, Ph.D.
Principal

Hilary J. Robinson, M.S., P.E.
Senior Environmental Engineer

Jiaru Zhang, M.P.H., DABT
Principal Scientist

Gradient Principal Scientist Dr. Isaac Mohar  is presenting at the Respiratory Drug Delivery (RDD) Europe 2025 conference, taking place in Lisbon, Portugal, May 6-9, 2025.

• “Safety Overview of Zephex^® 152a as a Low GWP Medical Propellant”  I. Mohar.

Gradient Senior Epidemiologist Dr. Denali Boon is presenting at the 2025 CropLife America & RISE Regulatory Conference, taking place in Arlington, Virginia, April 23-25, 2025.

• “Epidemiological Studies: A Path Forward.”  D. Boon, E. Hollcraft (Corteva Agriscience)

Gradient Principal Dr. Robyn Prueitt is presenting at the 34th Annual Sustainability & Environmental Health & Safety Symposium, taking place in Cincinnati, Ohio, April 22-23, 2025.

• “The Rest of the Story Involving Per- and Polyfluoroalkyl Substances (PFAS).”  R. Prueitt, T. Ling (Plaskolite LLC), J. Eagle (Thompson Hine LLC).

Gradient is presenting at SESHA’s 47^th Annual Symposium, taking place in Tempe, Arizona, April 14-17, 2025.

• “US EPA TSCA Risk Evaluation Process: Chemical Case Studies and how Stakeholders can be Prepared.”  S. Marchitti, L. Bailey, D. Dodge.
• “New Photolithography Chemicals and TSCA: Challenges and Lessons Learned.”  J. Kneeland, C. Butler, L. Beu (Laurie S. Beu Consulting), L. Culleen (Arnold & Porter).

Gradient Receives Medical Device and Combination Product Specialty Session (MDCPSS) Best Poster Award at the 2025 Society of Toxicology Annual Meeting

Gradient poster received the Medical Device and Combination Product Specialty Section Award at the Society of Toxicology 64th Annual Meeting and ToxExpo

The Society of Toxicology (SOT) Medical Device and Combination Product Specialty Section has given an award to a poster authored by Gradient as part of the SOT 2025 Annual Meeting.  The winning poster, “Material-Mediated Pyrogens in Medical Devices: Myth or Reality?” was authored by Gradient scientist Lindsey Borton, M.P.H. and Medtronic toxicologist Kelly Coleman.  The poster was presented at SOT’s 64th Annual Meeting and ToxExpo in Orlando, Florida.

SOT has 29 Specialty Sections that “may propose sessions for the Annual Meeting, exchange information via newsletters, present awards, and participate in other scientific activities.”  In particular, the Medical Device and Combination Product Specialty Section provides “an international forum where government, industry, and academic toxicologists can share state-of-the-art knowledge and develop new approaches for the evaluation of medical devices.”

See a list of Gradient’s SOT posters and presentations here.

Gradient is an environmental and risk sciences consulting firm renowned for scientific excellence.  We utilize scientific principles and a systematic study of the data, along with an independent perspective, to help our clients understand their issues.  Since 1985, we have delivered work products that are responsive and protective, with the highest professional standards.

Dr. Tom A. Lewandowski, Ph.D., DABT, ERT, ATS has been selected to serve on the Alternatives Assessment Codes of Practice Technical Committee.  The Technical Committee is charged with establishing the first consensus-based Codes of Practice for alternatives
assessment based on current principles and best practices. The Committee is comprised of 12 experts from academia, industry, government and NGOs, and is a joint collaboration with The Lowell Center for Sustainable Production at the University of Massachusetts Lowell.