In the span of one week at the end of March 2021, the state of California issued three separate Prop 65 notices on PFAS that will add significant regulatory, compliance and litigation burdens on a wide array of business types. Important to note is that Prop 65 regulations that take effect 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. Given how prevalent PFAS are in thousands of products, if the actions proposed in the three notices take effect, the result may be a deluge of compliance and enforcement actions that could cost some companies hundreds of thousands of dollars.

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.

What Are PFAS and Why Are They a Concern?

Per- and poly-fluoroalkyl substances (“PFAS”) are a class of over 7,000 manmade compounds. Chemists at 3M and Dupont developed the initial PFAS chemicals by accident in the 1930s when researching carbon-based chemical reactions. During one such experiment, an unusual coating remained in the testing chamber, which upon further testing was completely resistant to any methods designed to break apart the atoms within the chemical. The material also had the incredible ability to repel oil and water. Dupont later called this substance PFOA(perfluorooctanoic acid), the first PFAS ever invented. After World War II, Dupont commercialized PFOA into the revolutionary product that the company branded “Teflon.”

Only a short while later, 3M invented its own PFAS chemical – perfluorooctane sulfonate(PFOS), which they also commercialized and branded “Scotchgard.” Within a short period of time, various PFAS chemicals were used in hundreds of products – today, it numbers in the thousands.

The same physical characteristics that make PFAS useful in a plethora of commercial applications, though, also make them highly persistent and mobile in the environment and the human body – hence the nickname, “forever chemicals.” While the science is still developing regarding the extent of possible effects on human health, initial research has shown that PFOA and PFOS are capable of causing certain types of cancer, liver and kidney issues, immunological problems, and reproductive and developmental harm.

California’s Prop 65 PFAS Steps Thus Far

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.

While there was a one year grace period, until November 17, 2018, for companies to assess product lines, manufacturing processes overseas, and ensure compliance with the warning requirements triggered by Prop 65, in the two years that have passed since then, numerous companies have spend hundreds of thousands of dollars ensuring compliance and dealing with waves of violation notices for products that contained trace amounts of PFOA or PFOS.

Prop 65 Notices On PFAS – March 2021

On March 19, 2021, OEHHA published a notice of intent to list PFOA as a chemical that causes cancer. OEHHA opened the public comment period until May 3, 2021 for comment on whether PFOA meets the criteria to be listed under Prop 65 as a cancer-causing chemical.

Second, on March 26. 2021, OEHHA published a similar notice of intent to review PFOS for carcinogenic properties. The public comment period for this notice will remain open until May 10, 2021.

Finally, on March 26, 2021, OEHHA published a notice announcing its intent to conduct a review of four additional PFAS (PFDA, PFHxS, PFNA, and PFUnDA) for possible reproductive toxicity. The notice is a trigger for the potential listing of all four chemicals under Prop 65. The public comment period for this notice will remain open until May 10, 2021.

Although PFOS, PFDA, PFHxS, PFNA, and PFUnDA are undergoing review concurrently, OEHHA published separate notices on March 26 since the chemicals will be reviewed by two different expert committees of OEHHA’s Science Advisory Board – the Carcinogen Identification Committee (CIC), which will review the PFOS notice, and the Developmental and Reproductive Toxicant Identification Committee (DARTIC), which will review the PFDA, PFHxS, PFNA, and PFUnDA notice.

What’s Next?

It will take time for the above-mentioned Prop 65 notices on PFAS to have final determinations and to be listed under Prop 65 as either cancer-causing agents or reproductive toxins, but the intent of OEHHA and the state of California is clear. They wish to aggressively regulate PFAS, and they intend to do so well beyond just PFOA and PFOS, which are the subject of legislative or regulatory action in several states. There is little doubt that the listings under Prop 65 will take place. While the process could be completed in 2021, it is likely that OEHAA will announce final decisions in early 2022.

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 be adhered 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. Failure to comply with any of the complex requirements under Prop 65 for any of the likely listed PFAS can lead to hundreds of thousands of dollars in costs.