May Pose Risks
Businesses that make products with PFAS may face unexpected issues.
By Jeffrey M. Karp
Per- and polyfluoroalkyl substances (PFAS) are a class of more than 3,000 man-made chemicals that are receiving heightened public awareness due to concerns about their potential impact on human health and the environment. Many of these chemicals were used over the past 70 years in the manufacturing processes for various consumer, commercial, industrial and military-grade products because of their unique structure and physicochemical properties, such as heat resistance, oil and water repellence and friction reduction. Despite a production phase-out for some of these compounds beginning in the 2000s, the environmental persistence and mobility of PFAS contribute to continued detections in drinking water, groundwater, soil, human blood serum, plants, fish and animals. A 2018 study conducted by the Environmental Working Group estimates that as many as 110 million Americans may be consuming tap water containing PFAS.
Compared to other well-studied contaminants in the environment, the levels of ingestion at which many PFAS may pose human health risks have not yet been clearly defined, as evidenced by current state and federal guidance levels and criteria that differ by orders of magnitude. Furthermore, studies of human exposure to particular perfluoroalkyl acids (PFAAs) generally have not shown consistent associations between blood serum levels and adverse health impacts. However, general associations that have been identified include decreased fertility rates, increased risk of certain cancers, and impaired function of the immune system.
PFAS were widely used for many years by industry sectors as diverse as textiles, metal plating, semiconductors, aviation, packaging, medical devices, cosmetics and personal care products before potential health impacts were publicly disclosed. However, as health concerns about PFAS have intensified, regulators have begun reassessing the exposure, toxicity, and potential risks from some of these chemicals. In 2016, EPA established a Safe Drinking Water Act (“SDWA”) Lifetime Health Advisory (“LHA”) for perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) in drinking water of 70 parts per trillion (ppt). This threshold accounts for the combined concentrations of PFOA and PFOS in drinking water sources, and is designed to offer a margin of protection from adverse health effects resulting from exposure to these PFAS. However, in June 2018, the Department of Health and Human Services’ (“HHS”) Agency for Toxic Substances and Disease Registry (“ATSDR”) released an 852 page draft report in which it found the minimal risk levels (MRL) for PFOA and PFOS in drinking water to be markedly lower, at 11 and 7 ppt respectively.
Measured concentrations of legacy PFAS like PFOA and PFOS appear to be declining in the US, as many businesses phased them out of production and began switching to alternative chemistries. Despite this trend, many PFAS continue to persist in the environment and also may bioaccumulate, which has led to a proliferation of lawsuits targeting the manufacturers of PFAS products. These cases typically involve governmental bodies or private citizens seeking redress from manufacturers for polluting groundwater with PFAS. The most prevalent defendant in these lawsuits is 3M, which used PFAS to make nonstick cookware, fire extinguishers, and stain repellent. In a lawsuit settled earlier this year, the Minnesota attorney general sought $5 billion in damages from 3M for polluting groundwater that served as the drinking water source for five Minnesota cities. The parties settled for $850 million.
Presently, 3M is defending with others a series of lawsuits brought in multiple jurisdictions by individuals, municipalities, and local water authorities involving products made with aqueous fil-forming foams (AFFF). 3M has sought consolidation in one federal district court of the cases concerning AFFF, as well as cases that may not involve AFFF but feature the same underlying PFAS chemical group. Most recently, 3M and 10 other companies, including DuPont and Chemours, were named as defendants in a lawsuit in Ohio federal court seeking class action certification on behalf of every person in America with a detectable level of PFAS in their blood serum.
PFAS litigation has commenced in many other states, including Alabama, Colorado, Massachusetts, New Hampshire, New Jersey, North Carolina, Pennsylvania, and West Virginia. PFAS were used in commerce legally for decades without public knowledge of their potential health risks. However, now that the scientific community is aware of the potential risks of PFAS exposure, large financial outlays may be expected by affected companies to perform testing, treat and remove these chemicals from the environment, and compensate for harm attributed to their exposure.
Companies facing potential PFAS liability must be cognizant of new and rapidly evolving regulatory regimes. While EPA has issued an advisory under the SDWA that recommends lifetime safe levels for PFAS ingestion, it has yet to promulgate enforceable Maximum Contaminant Levels (“MCLs”) for any of these compounds. Thus, individual states have stepped in to fill that void with a wide range of advisories, guidelines, and regulations. For example, Massachusetts and Connecticut have followed EPA guidance, adopting PFAS regulatory thresholds of 70 ppt in drinking water. New Jersey recently promulgated a drinking water MCL of 13 ppt for perfluorononanoic acid (“PFNA”), a PFAS used in the manufacture of high performance plastics. Vermont issued a health advisory for groundwater and drinking water, establishing a health advisory level of 20 ppt for five PFAS: PFOA, PFOS, PFHxS, PFHpA, and PFNA. Moreover, other states have pending or recently enacted labeling requirements for PFAS-containing products, restrictions on the use of PFAS in products such as firefighting foams and food packaging, prohibitions on the discharge of PFAS into drinking water sources, and requirements to remediate PFAS released into the environment.
Although the EPA has not listed PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA” or “Superfund”), EPA is requiring testing for such “emerging contaminants” (which EPA defines as “characterized by a perceived, potential, or real threat to human health or the environment or by a lack of published health standards…or because a new source or a new pathway to humans has been discovered”) in the context of performing Five Year Remedy Reviews to assess the continuing effectiveness of remedial actions. Under CERCLA, EPA is required to review remedial actions involving “hazardous substances, pollutants, or contaminants remaining at the site” no less than each five years after the initial remedial action. Therefore, where PFAS are detected, the Agency may require additional investigations to assess whether further site remediation is needed to protect human health and the environment. For example, in 2017, a Five Year Review at the Hanscom Air Force Base Superfund Site in Massachusetts found elevated levels of PFOA and PFOS in a fire training area. Further sampling is ongoing, and if PFAS levels exceed the advisory level, EPA may seek to require additional site remediation.
In addition to federal and state regulatory activities, two Senate bills ? the PFAS Accountability Act of 2018 (S.3381) and the PFAS Detection Act of 2018 (S.3382) ? have been introduced and referred to the Environment and Public Works Committee. S.3381 seeks to “encourage” Federal agencies to enter into or amend cooperative agreements with states to address PFAS removal and remedial actions. S.3382 would require the United States Geological Survey (“USGS”) to perform a nationwide survey of perfluorinated compounds, beginning with sampling sources of drinking water near locations with known or suspected releases of PFAS.
As awareness of PFAS health concerns grow, so too must the attention level of businesses that have used PFAS in their manufacturing processes. Although more stringent regulatory standards and cleanup requirements are being imposed, the test methods needed to meet these standards and requirements are not well established. For example, in November 2018, EPA released a drinking water testing detection method for four additional PFAS compounds (GenX, ADONA, 11C1-PF3OUdS, and 9CI-PF3ONS). The addition of this testing method brings to 18 the number of PFAS compounds out of the many thousands found in the environment for which a drinking water testing method exists.
Moreover, concern regarding the validity of the PFAS testing methods has been raised due to the potential for sample contamination from testing equipment that may contain trace amounts of PFAS. Precise, replicable testing methods are needed to properly measure samples for detectable levels of PFAS. Further, when testing identifies the presence of PFAS above regulatory limits or standards, cost-efficient technologies must be available that effectively treat and remediate PFAS in a variety of environmental media.
The potential for costly litigation is upon us, evidenced by the growing number of lawsuits across the United States. Thus, it behooves potentially affected businesses to create a response plan to proactively address the impending PFAS storm.
Jeffrey Karp is a partner at the law firm of Sullivan & Worcester LLP and the leader of the firm’s Environment, Energy, and Natural Resources practice group. Assistance in preparing this article was provided by associates Zachary Altman and Ryan Rosenblatt, and law clerk Kevin Fink.