We previously reported on several significant actions by the California Office of Environmental Health Hazard Assessment (OEHHA) listing six types of PFAS as chemicals known to cause cancer or reproductive harm – PFOA, PFOS, PFDA, PFHxS, PFNA, and PFUnDA. At the time, we predicted that these steps would lead to increased enforcement action targeting products with the listed PFAS. So far in the month of October, there has been a nearly 100% increase in the number of Prop 65 PFAS notices, including PFOA enforcement notices and companies seeing for the first time PFOS enforcement notices sent for a variety of product types. Enforcement actions are but one of the compliance issues companies face with PFAS listed under Prop 65, as the regulation also carries with it warning label requirements.
Companies with current or legacy uses of certain PFAS must be cognizant of the strict Prop 65 requirements in order to avoid significant penalties, and must take a close look at chemical composition of their product lines to avoid expensive enforcement action defense.
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 potential exposure to chemicals identified as carcinogens and/or reproductive toxicants. Proposition 65 requires “clear and reasonable” warnings to be placed on products where exposure to a chemical on the Proposition 65 list would exceed a safe harbor level as a result of normal, foreseeable use of the product. .
When Prop 65 began, there were 26 chemicals on the list. The list now has over 950 chemicals, with new chemicals being added regularly. OEEHA is the agency tasked with making determinations as to the chemicals that will be regulated under Prop 65, and the chemicals can be added to the list through four different mechanisms.
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 and costs, most Proposition 65 matters carry great financial risk and are very expensive to litigate.
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 manufacturers, distributes or sells products to anyone in the state of California.
Prop 65 PFAS Actions To Date
On November 10, 2017, OEHHA listed perfluuorooctanoic acid (PFOA) and perfluuorooctanesulfonic acid (PFOS) as substances that have a recognized reproductive harm 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 19, 2021, OEHHA published a notice of intent to list PFOA as a chemical that causes cancer. On December 22, 2021, OEHHA approved the listing of PFOS as a carcinogen under the Prop 65 laws. In addition, effective December 31, 2021, PFNA was listed as a chemical capable of causing male reproductive harm under the Prop 65 laws. Three other PFAS (PFDA, PFHxS, and PFUnDA) are currently under review by OEHHA for possible reproductive toxicity.
Prop 65 PFAS Enforcement Actions
In 2022, there have been nine 60-day Notices filed against companies, with four of the notices filed in the last 30 days. The most recent notices have targeted the following products: umbrellas, shower liners, crib mattress pads, and tablecloths. Similarly, four PFOS 60-day Notices have been filed, all within the last two weeks, for bibs, jackets, and bath pillows.
This increase in Notices sent to companies with respect to PFOA and PFOS show that private enforcers of the Prop 65 laws are increasingly targeting these PFAS for enforcement actions. This is likely due to the fact that, while PFOA and PFOS were phased out of use in the United States years ago, they continue to be manufactured overseas and are used in products or components used in finished goods that are ultimately sold in the United States.
Prop 65 PFAS Decision Impacts On Businesses
Companies that were already testing products, conducting due diligence to determine whether any of its products contain PFOA, PFOS, or PFNA (or any of the other PFAS under consideration for purposes of Prop 65), and ensuring proper warning labels on applicable PFAS-containing products to comply with Prop 65’s strict regulatory requirements must now factor in the PFOA carcinogenic determination. This may require modifications to any necessary warning labels, unless a business is already availing itself of a long-form or short-form safe harbor warning that covers both cancer and reproductive harm, or if any exposure would be below safe harbor levels.
The requirements for the language, size, lettering, etc. of the warning labels considered to be “Safe Harbor” is set forth under regulations adopted by OEHHA, 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 civil penalties 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.
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, accurate and up-to-date “Safe Harbor” warnings 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.