Perfluoroalkyl and polyfluoroalkyl substances (PFAs) continue to garner national attention as emerging chemicals of concern. On November 10, 2017, two prominent forms of PFAs—perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS)—were listed by the State of California as known to cause reproductive toxicity. Pursuant to the California Safe Drinking Water and Toxic Enforcement Act of 1986, commonly known as Proposition 65, companies must now comply with the “clear and reasonable warning” requirement for all products that expose people to significant levels of PFOA or PFOS.
Under Proposition 65, the State of California is required to list chemicals that are known to cause cancer and/or reproductive harm. Perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) were formally added to the list of chemicals known to the state to cause reproductive toxicity on November 10, 2017, using the authoritative body listing mechanism. The California Office of Environmental Health Hazard Assessment (OEHHA) relied on the US Environmental Protection Agency (EPA) as the authoritative body and on publications by the EPA regarding the health effects of PFOA and PFOS. PFOA and PFOS are two of the more prevalent and widely known perfluoroalkyl and polyfluoroalkyl substances (PFAs), which are a group of synthetic, non–naturally occurring chemicals predominantly used in consumer and commercial products for their fire-resistant and oil, grease, and water repellency characteristics. These chemicals were typically incorporated into a variety of products, including foams, nonstick cookware, papers, paints, and carpet products. There is mounting concern over exposure to these chemicals, particularly given certain characteristics that have become the focus of scientific inquiry, including their slow degradation and ability to bio-accumulate.
While the EPA set a health advisory level in 2016 for PFOA and PFOS at a combined 70 parts per trillion for drinking water, this health advisory is nonenforceable. Additionally, since the issuance of that health advisory, the Agency for Toxic Substances and Disease Registry (ATSDR) released a draft toxicological report suggesting that current advisory guidelines for exposure to such contaminants may be too high. In light of the federal government’s perceived inaction and the growing public concern regarding these chemicals, many states have stepped into the fray—all leading to a growing patchwork of regulation and enforcement throughout the United States.
Proposition 65 has two primary substantive provisions: (1) a warning requirement, and (2) a discharge prohibition. The warning requirement provides that businesses with 10 or more employees must provide “clear and reasonable warnings” before knowingly or intentionally exposing individuals in California to any of the chemicals that are listed as known to cause cancer or reproductive harm. The warning requirement applies to all companies within the distribution chain, including all manufacturers, distributers, and retailers (both brick-and-mortar retailers and online retailers). The discharge prohibition provides that companies doing business within California may not knowingly discharge any listed chemicals into water or onto or into land where such chemicals pass or probably will pass into any source of drinking water. The law provides for a 12-month grace period after a chemical is listed for the warning requirement, and a 20-month grace period after listing before discharge prohibition becomes effective. In the case of PFOA and PFOS, the warning requirement became effective on November 10, 2018, and the discharge prohibition will become effective on July 10, 2019.
Although these warning requirements have now gone into effect, California has yet to set a specific maximum allowable dose level for PFOA and PFOS that is deemed to provide a level below which no Proposition 65 warning would be required. In addition, it remains unclear whether products that contained PFOA and PFOS prior to November 10, 2017, are subject to the warning requirement. Regardless, it remains the responsibility of people and companies doing business in California to determine whether a warning is necessary.
In light of these continued regulatory uncertainties, companies doing business in California should closely analyze all supply chains to determine the existence of PFOA or PFOS in any products or emissions. While PFOA and PFOS are no longer manufactured in the United States, these compounds are still produced internationally and may be imported into the United States in goods containing trace amounts of these substances, whether intentional constituents or as impurities.
If you have any questions or would like more information on the issues discussed in this LawFlash, please contact the authors or any of the following Morgan Lewis lawyers:
Glen R. Stuart
Collie James, IV
Ella Foley Gannon