This is the first in a series of articles published by the Product Liability and Complex Torts group at Nilan Johnson Lewis, P.A., for product manufacturers as they prepare to respond to PFAS regulatory demands and mitigate their risk of PFAS litigation exposure.
Part 1. First Things First: What Are PFAS?
PFAS, known by the moniker “forever chemicals,” are the focus of rapidly evolving regulatory regimes at the U.S. federal and state levels, which in turn are driving novel theories of litigation against manufacturers whose products contain PFAS. This article offers a foundational understanding of what PFAS are, how they are used, and how they are defined by regulators.
What Manufacturers Should Know
Per- and polyfluoroalkyl substances, or “PFAS,” are a large class of synthetic chemical compounds that were first developed in the 1940s. PFAS offer favorable manufacturing properties: oil, water, stain, and soil resistance; chemical and thermal stability, etc. Consequently, PFAS are used to manufacture a wide variety of consumer products, such as food packaging and cookware, textiles and carpets, cosmetics and personal care products, and household cleaning products. They are also used in industries such as aerospace, semiconductor production, automotive, electronics, and construction. Certain PFAS (such as PTFE) are approved by the U.S. Food and Drug Administration for use in medical device and medical equipment, including surgical implants.
The strength and stability of PFAS’ chemical bonds—i.e., what makes them so useful in industrial applications—also makes them persistent in the environment and resistant to biodegradation. PFAS are found in the soil, groundwater, wildlife, and humans. PFAS “bioaccumulate,” meaning they build up in the body and do not go away. For these reasons (and alleged connections between exposure to certain PFAS compounds and adverse health effects), PFAS have become a topic of concern for regulators and other stakeholders. The goal of such regulation, particularly at the federal level, is to further research PFAS, reduce their use, and remediate PFAS in the environment. Accordingly, regulators have codified or introduced broad PFAS definitions that impact product manufacturers.
The U.S. Environmental Protection Agency (EPA) has imposed a major PFAS reporting requirement on product manufacturers, pursuant to the EPA’s authority under the Toxic Substances Control Act (TSCA). By May 2025, companies that manufacture or import PFAS, or any product or component containing PFAS, will need to submit a detailed report to the EPA on their use of PFAS over the past 10 years. The EPA defines PFAS by chemical structure, for purposes of this reporting requirement, in an effort to define PFAS broadly but precisely.[1] To help manufacturers apply this non-intuitive definition to, say, a bill of materials or Material Safety Data Sheet, EPA maintains a non-exhaustive list of specific PFAS.
Many states also are active in regulating PFAS, and likewise have defined PFAS broadly. One definition, followed by many states, is that of the State of Maine, which defines PFAS as “substances that include any member of the class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.” (Maine Rev. Stat. § 1614.) This definition is deceptively simple, because it pulls in an expansive list of thousands (or tens of thousands) of PFAS compounds. Nevertheless, some states are applying definitions of this breadth to ban PFAS in certain product categories (like food packaging, personal care products, and children’s products). Maine, for its part, is requiring all manufacturers that sell products in the state containing “intentionally added” PFAS to submit a report to the state by January 1, 2025, on the PFAS used in such products.
What Manufacturers Should Do
What PFAS are, and where they are found in products, are priority items for manufacturers to understand. When preparing for state or federal reporting requirements, manufacturers should proceed with caution when undertaking an effort to identify PFAS in their products. Certain manufacturers may wish to adopt a uniform definition of PFAS that is consistent with the EPA and other regulations. Once adopted, manufacturers should apply the PFAS definition as uniformly as possible: in product specifications; bills of material and safety data sheets; vendor and supplier contracts and communications; and distributor and retailer certifications.
The next article in our series will offer a “business case” for manufacturers to make a plan—now—to deal with their PFAS regulatory burden and litigation risk.
[1] The EPA issued a chemical structural definition, for reporting purposes under TSCA, that includes all PFAS meeting any of the three following structures:
- R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons;
- R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons; and
- CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons.
