A recent increase in the number of notices related to per- and poly-fluoroalkyl (PFAS) substances under California’s Proposition 65 raises the potential for significant impacts to manufacturers, sellers, and producers of consumer products. In September through November 2022, 13 notices were submitted to the California Attorney General’s office related to perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA). This compares to 24 notices total in the previous three years, dating back to 2019. In addition, the most recent PFAS notices represent a shift towards other consumer products not previously targeted under Prop 65. The majority of previous relevant notices focused on cosmetic products. Meanwhile, the most recent notices have identified a range of products including pillows, mattress pads, shower liners, tablecloths, bibs, umbrellas, duffle bags, and jackets.

What is Prop 65?

The Safe Drinking Water and Toxic Enforcement Act of 1986, better known as Proposition 65 (Prop 65), requires businesses operating in California to provide warnings about exposures to chemicals or substances that may cause cancer and/or reproductive and developmental toxicity. The California Office of Environmental Health Hazard Assessment (OEHHA) administers the Prop 65 program and has listed over 900 chemicals to date for consideration (https://oehha.ca.gov/proposition-65/proposition-65-list). Prop 65 states that a warning is required for these chemicals unless it can be shown that a significant exposure does not occur under reasonable use. To determine what entails a significant exposure, OEHHA has established safe harbor levels for cancer (No Significant Risk Level or NSRL) or developmental and reproductive harm (Maximum Allowable Dose Level or MADL). A business is exempt from Prop 65 warning requirements if demonstrated that exposure to a chemical occurs at or below safe harbor levels. Penalties for failure to comply with Prop 65 can be substantial, with fines for violations up to $2,500 per day.

Why the increased focus on PFAS?

PFAS generally refers to a group of synthetic chemicals containing at least one carbon-fluorine bond with widespread industrial and commercial use. PFAS compounds are typically utilized for their non-stick, waterproof, and soil, stain, or oil-resistant properties. Common uses include food packaging and wrappers, textiles, paints, cleaners, and fire-fighting foams. The carbon-fluorine bond creates a highly stable molecule that demonstrates high environmental persistence, earning these compounds the moniker “forever chemicals”. Some scientific groups have associated PFAS with adverse health effects including cancer and reproductive toxicity, although observed effects in humans are largely unknown or inconclusive. The most well-studied PFAS compounds with regards to potential human health effects are PFOA and PFOS.

Over the past decade, the US Environmental Protection Agency (EPA) has issued increasingly stringent guidelines for PFAS levels in drinking water. California also recently passed two bills in September 2022 to ban the sale of cosmetics and personal care products, clothing, and textiles containing PFAS starting in 2025. It is noticeable that these actions coincide with the recent Prop 65 notices targeting PFAS.

Warning requirements for PFOS and PFOA were first established in 2017 when these chemicals were listed as developmental toxicants under Prop 65. More recently, PFOS and PFOA were listed as cancer-causing agents in December 2021 and February 2022, respectively. More PFAS are expected to be added to Prop 65 list in the coming years.

With rapidly evolving regulatory standards, it is critical for businesses to keep up to date and take necessary steps to comply with relevant guidelines. CTEH scientists have extensive professional experience evaluating potential health hazards and conducting human health risk assessments for numerous commercial and consumer products, including applications to prepare for and respond to Prop 65 issues. For more information on CTEH’s capabilities, please contact Dr. Derek Drechsel.