12 December 2018, by George Gigounas, Greg Sperla, Adam Baas, Elizabeth Callahan*
California's listing under Proposition 65 of two chemicals receiving increasing attention as environmental contaminants, PFOA and PFOS, became effective on November 10, 2018. See our prior discussions of these chemicals here and here.
This is what businesses should know about the chemicals and their potential compliance obligations.
Background on PFOA and PFOS
PFOA (Perfluorooctanoic acid) and PFOS (Perfluorooctane sulfonate) have been widely incorporated in many consumer products and industrial processes. Most often used for their heat-, fire-, stain- and water-resistant properties, these chemicals have been found in nonstick cookware, carpets, upholstery, clothing and footwear, food packaging, medical devices, cosmetics and personal care items. PFOA and PFOS were also used in firefighting foams, cleaners, paint and sealants, and printer and copy machine parts, as well as in film processing, oil drilling, mining, and metal planting and finishing.
PFOA and PFOS are manmade substances that can persist and accumulate in the human body. Alleged health risks include increased rates of certain cancers and diseases, reduced fertility and negative birth effects.
Proposition 65 listing
In November 2017, the California Office of Environmental Health Hazard Assessment (OEHHA) listed PFOA and PFOS as chemicals known to cause reproductive toxicity under Proposition 65, based on the EPA Lifetime Health Advisory, which established levels for PFOA and PFOS ingested via drinking water sources. Notably, OEHHA's listing of the chemicals under Proposition 65 covers not only ingestion through drinking water sources, but any other form of exposure, including dermal contact. Additionally, the agency has not promulgated a safe harbor exposure level, known for reproductive toxicants as the Maximum Allowable Dose Level or MADL.
As of November 10, 2018, companies doing business in California are required to provide a clear and reasonable warning under Proposition 65 before exposing anyone to the chemicals. Until a safe harbor level is established, Prop 65 permits a private enforcer to issue a Notice of Violation and file lawsuits against companies for any level of exposure, regardless of how minimal, and places the costly burden of proving an exposure created no significant risk on businesses. Thus, products containing any level of the chemicals could now require a Proposition 65 warning or face the threat of litigation.
As of July 2019, California businesses will also be prohibited from releasing PFOA or PFOS into sources of drinking water.
Supply chain and additional litigation risk
Eight major manufacturing companies joined the EPA's PFOA Stewardship Program in 2006, with the goal of phasing out PFOA and PFOS use and emissions. Some manufacturers outside the United States, however, have continued to use PFOA and PFOS in their products. The more significant risk may therefore be from imported products that still contain the chemicals.
Litigation has been pursued around the country regarding PFOA and PFOS contamination of drinking water sources, which, although brought under other statutes, contributes an important element to the overall calculus of Prop 65 and other compliance and litigation risk associated with these chemicals.
Consider risk mitigation now
Given Prop 65's active and litigious enforcers, companies doing business in California that suspect their products may cause an exposure to PFOA/PFOS should consider their compliance options now, including an assessment of whether Prop 65 warnings are warranted or whether other protective measures may be taken.
Those companies that decide to warn are also advised to carefully review the new regulations that went into effect August 30, 2018. Warning language needed for presumptive compliance with the statute has been significantly altered for most industries, among other critical changes to how and when warnings are provided.
For more information about Prop 65 warnings, see our prior articles here. For more information about the implications of these developments on your business, contact any of the authors.
*Elizabeth Callahan is a law clerk in DLA Piper's San Francisco office.Back to news landing page