California Adds Perfluorooctanoic Acid (“PFOA”) and Perfluorooctane Sulfonate (“PFOS”) to the Proposition 65 list, Continuing Trend of Increased Regulation of perfluorinated chemicals (“PFCs”) Nationwide
Effective November 10, 2017, the California Office of Environmental Health Hazard Assessment (“OEHHA”) added Perfluorooctanoic Acid (“PFOA”) and Perfluorooctane Sulfonate (“PFOS”) to the list of chemicals known to the state to cause reproductive toxicity under the Safe Drinking Water and Toxic Enforcement Act of 1986, also known as Proposition 65.
Although these chemicals have been the target of federal action under the Toxic Substances Control Act (“TSCA”) since 2002, the release of new drinking water standards by the Environmental Protection Agency (“EPA”) in May 2016 spurred increased litigation and regulation of these chemicals throughout the United States, including their listing under Proposition 65.
No later than November 10, 2018, (12 months from the date of adoption) companies with 10 or more employees will be required to provide a “clear and reasonable” warning before exposing any individual to PFOA or PFOS. Though less commonly used, Proposition 65 also regulates the discharge to or release of carcinogens and reproductive toxicants to water. Now that PFOA and PFOF have been listed, companies have 20 months, until July 10, 2019, to comply with the water discharge requirements.
During this phase-in period, companies should take steps to evaluate if their products are impacted by this new regulation.
Background on PFOA and PFOS
PFOA and PFOS belong to a class of man-made chemicals referred to as per- and polyfluoroalkyl substances (together, “PFASs”). PFOA and PFOS have been the most extensively produced and studied of this family of chemicals.
PFASs are widely used in a variety of consumer products, including carpets, textiles, leather, non-stick cookware, and paper coatings used in food packaging. These chemicals are used to make products more stain-resistant, waterproof and/or nonstick. In addition, they have been used to help fight fires at airfields and other places where petroleum-product-based fires are a risk.
PFOA and PFOS are no longer manufactured in the United States as a result of voluntary phase-out’s which began in the early 2000s. However, although they are no longer manufactured in the United States, these chemicals are still produced throughout the world and continue to be imported into the United States in consumer products such as carpets, leather and apparel, textiles, paper and packaging, coatings, and rubber and plastics.
In addition, these chemicals are extremely persistent in the environment and a ubiquitous contaminant throughout the United States. They have been found worldwide in soil, water, wildlife, and humans. They are present at detectable levels in landfills, wastewater treatment facilities, and stormwater runoff. In addition, PFOA and PFOS have been found in a number of drinking water systems due to localized contamination.
Federal Action on PFOA and PFOS
To date, these chemicals have been primarily regulated under TSCA, after they were discovered in the bloodstreams of Americans in the 1990s. EPA action under TSCA has included a voluntary phase-out program for manufacturers as well as a PFOA stewardship program with the goal of eliminating PFOA as an industrial emission. In 2015, EPA issued a significant new use rule (“SNUR”) under TSCA requiring companies to report any new uses of PFOA or PFOA-related chemicals to EPA at least 90 days before the chemicals’ use or import.
In addition, in January 2016, the U.S. Food and Drug Administration (“FDA”) banned three perfluorinated compounds from use in food packaging because of concern regarding the toxicity of those chemicals. That action was taken in response to a petition filed by, among others, the Center for Environmental Health (“CEH”), a public interest group that is very active in Proposition 65 litigation in California.
In May 2016, EPA released new drinking water health advisory levels for PFOA and PFOS. The new levels, .07 parts per billion (ppb) for both chemicals, are significantly lower than the standards issued by the Agency in 2009. This revised standard brought increased attention to the chemicals from the public, as well as plaintiffs’ attorneys and other parties involved in litigating their cleanup. Also, the revised level set by EPA is significantly lower than levels set in Germany, the U.K, Denmark, the Netherlands and Sweden.
In December 2017, EPA announced a cross-agency effort to address PFAS, including PFOA and PFOS. As part of this effort, EPA continues to collect data regarding these chemicals, and has collected data on six PFAS substances in public drinking water systems.
Proposition 65 Listing
In September 2016, following on the heels of increased federal action, OEHHA published a notice of intent to list PFOA and PFOS as known to cause reproductive toxicity under Proposition 65. This decision was based on EPA’s 2016 Drinking Water Health Advisories for the chemicals, and premised on the statute’s authoritative bodies listing mechanism. This Notice initiated a public comment period that closed on November 16, 2016.
Effective November 10, 2017, OEHHA officially added PFOA and PFOS to the Proposition 65 list of chemicals known to the state to cause reproductive toxicity. The warning provision of the listing takes effect 12 months after adoption; the discharge provision takes effect 20 months after adoption. Small businesses with fewer than 10 employees, governmental agencies, and public water systems are exempt from the warning requirement and discharge prohibition of Prop 65.
As of November 10, 2018, all businesses that sell products into California will be required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to PFOA or PFOS. Although the use of these chemicals has been phased out domestically, there is the possibility for entry into industrial facilities through the water supply. These chemicals could then remain on finished consumer products in detectable levels as contaminants. Testing has shown the presence of these chemicals as impurities in food sources (snack foods, vegetables, meat, dairy), soil, and indoor air and dust, and other consumer products. In addition, these chemicals have not been banned internationally, and are still present in many textile fabrics, especially those designed for outdoor and performance wear, and nonstick pans imported from China. Accordingly, companies doing business internationally should evaluate their supply chains for the presence of these chemicals.
At this time OEHHA has not set a maximum allowable dose level (“MADL”) for either chemical. Accordingly, if the chemical is present at any detectable level in a product, it would be prudent to provide a warning to the consumer prior to purchase.
Proposition 65 also prohibits companies in California from knowingly discharging or releasing a listed chemical into the state’s drinking water or onto land where such chemical passes or will probably pass into any source of drinking water. The term “source of drinking water” is defined in the statute as “either a present source of drinking water or water which is identified or designated in a water quality control plan adopted by a regional board as being suitable for domestic or municipal uses.” Businesses are exempt from this provision if they can show exposures they cause are significantly below levels observed to cause birth defects or other reproductive harm. For purposes of the discharge prohibition, and in light of the incredibly low level set by the 2016 EPA drinking water advisory, significant likely means any detectable amount of either chemical. Once a chemical is listed, a company has 20 months to comply with the discharge prohibition, accordingly, the discharge prohibition for PFOA and PFOS will go into effect July 10, 2019.
Proposition 65 allows the California Attorney General, California proposition 65 lawyers, local district attorneys, and citizens to sue to enforce the statute. Prior to the filing of any suit, a private party must serve a “Notice of Violation” on an alleged violator. Companies should anticipate that private litigants will look to begin enforcing these new warning provisions in November 2018, and the discharge provisions in July 2019.
To date, the discharge to drinking water provisions of Proposition 65 have rarely been enforced by private litigants. However, given the presence and persistence of these chemicals in water, companies should anticipate that that may change. Recently, the drinking water provisions of Proposition 65 have been used by CEH to challenge the disposal of fracking waste in water wells in Northern California. The additional of PFOA and PFOS to the Proposition 65 list of chemicals presents another potential area for enforcement.
Anticipating Further Regulation and Litigation
The listing of these chemicals under Proposition 65 significantly impacts their management in California going forward. First, the listing will raise the profile of these chemicals among the public, private litigants and groups interested in eliminating or reducing exposure to these chemicals. Companies should expect private litigants to begin testing products, especially textiles and imports from China, specifically for PFOA and PFOS.
In addition, as these chemicals continue to increase in profile, further regulation seems likely. EPA continues to prioritize these chemicals as a result of growing public health concerns, and could potentially take steps to further regulate these chemicals under the revised TSCA statute. In addition, the states of Connecticut, Maine, Massachusetts, Michigan, Minnesota, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, and Washington have all taken steps to independently regulate these chemicals.
Companies should also anticipate increased litigation over the presence of these chemicals in the environment. For instance, several personal injury class actions are already underway in states where consumers allege they consumed contaminated drinking water. Companies that previously manufactured these chemicals are also potentially subject to lawsuits from public entities responsible for water supplies. For instance, currently, the Minnesota Attorney General is suing the 3M Company for $5 billion in damages, in a case set for trial in February 2018. In Alabama, a manufacturer and landfill owner are currently defending a case regarding these chemicals brought by a private citizens group under the Resource Conservation and Recovery Act (RCRA).
There may also be future implications for PFAS alternative chemicals, such as GenX. GenX is a PFOA alternative that went into production in 2010, and has recently caused concern due to its presence in drinking water. There are currently no regulatory limits for GenX, however EPA included it in its recent press release regarding Agency action on PFAS. The California proposition 65 lawyers at Bick Law will continue to monitor this evolving issue and provide updates as further regulations are passed.