On December 6, 2021, California approved the listing of PFOS, one of the more prominent chemicals in the PFAS class, as a carcinogen under the California Proposition 65 (“Prop 65”) laws. Prop 65 and PFOS have a history of prior regulatory steps; however, the carcinogenicity determination will further increase risks to businesses of enforcement actions and potential litigation stemming from the sale of products that contain PFOS. Important to note is that the Prop 65 regulations are not applicable only to companies situated in California; rather, they apply to any company (even internet businesses) that sell products to anyone in the state of California.

What Is Proposition 65?

California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (“Proposition 65” or “Prop 65”) was passed with the intention of providing consumers with information regarding potentially cancer-causing agents in products that would allow consumers to make an informed decision as to whether to purchase the product. Proposition 65 requires “clear and reasonable” warnings to be placed on products that contain a chemical that the State of California determines may be cancer-causing or cause reproductive issues.

The list of chemicals currently on the Prop 65 list now numbers at more than 800, with new chemicals being added regularly. The California Office of Environmental Health Hazard Assessment (OEHHA) is the agency tasked with making determinations as to the chemicals that will be regulated under Prop 65.

Prop 65 penalties can be as high as $2,500 per violation per day. As companies often face the added prospect of paying the other side’s attorney fees, most Proposition 65 matters carry great financial risk and are very expensive to litigate.

Prop 65 and PFOS

On November 10, 2017, OEHHA listed perfluuorooctanoic acid (PFOA) and perfluuorooctanesulfonic acid (PFOS) as substances that have a recognized reproductive toxicity by the state of California. This was a significant step, as PFOA and PFOS, while no longer manufactured in the United States, are still widely used internationally and are incorporated into products that are ultimately sold in California. Products sold in the state of California that contained PFOA and PFOS, regardless of where they were made, were required to incorporate warnings established by OEHHA identifying the reproductive toxicity of the chemical(s) in the consumer good.

On March 26. 2021, OEHHA published a notice of intent to review PFOS for carcinogenic properties. It should be noted that around the same time, OEHHA also issued notices to have PFOA listed as carcinogenic and four additional PFAS (PFDA, PFHxS, PFNA, and PFUnDA) for possible reproductive toxicity.

At a Dec. 6 meeting, California’s Carcinogen Identification Committee (CIC) voted 8-2 with one abstention to list PFOS as “known to the state to cause cancer” under Prop. 65, based on a hazard identification document prepared by OEHHA.

Prop 65 and PFOS Decision Impact On Businesses

Companies that were already testing products, conducting due diligence to determine whether any of its products contain PFOS, and ensuring proper warning labels on PFOS-containing products to comply with Prop 65’s strict regulatory requirements must now factor in the PFOS carcinogenic determination. This will require modifications to any necessary warning labels. The requirements for the language, size, lettering, etc. of the warning labels is highly regulated by OEHHA and the Prop 65 regulations, and failure to comply can lead to civil enforcement suits brought by the state attorney general, local government attorneys or citizen enforcers of the law. Any fines associated with non-compliance can apply per product per day of violation, which can quickly add up to significant costs based on the scope of product distribution. Numerous companies have spent hundreds of thousands of dollars ensuring compliance and dealing with violation notices for products that contained PFAS that are regulated by the Prop 65 laws, including PFOS.

Companies doing business in California must heed the Prop 65 notices on PFAS and act now to determine if any products sold in the state of California contain any of the above-listed PFAS. Supply chain analysis is a critical part of the process. This is the first crucial step in determining further action if any. For companies with products that contain the PFAS that are the subject of the notices, precise warnings will need to adhere in the proper way and location (whether on the product packaging, on a website prior to the consumer purchasing the product, etc.) that may not be as simple as it sounds.