New Mexico Among States Exempting Fluoropolymers from PFAS Bans

Recently, a number of U.S. states have enacted bans on products containing per- and polyfluoroalkyl substances (PFAS) comprehensively defined to include thousands of substances. On April 8, New Mexico enacted a PFAS ban notable for its exemption of fluoropolymers — a subset of PFAS crucial for commercial products including implantable medical devices, non-stick cookware, and waterproof jackets.

New Mexico's exemption reflects evolving U.S. state regulatory approaches to fluoropolymers and a deepening understanding among lawmakers and other stakeholders of these chemicals. Fluoropolymers are distinctive in their size and chemistry compared to other subsets of PFAS, and they are generally considered non-bioaccumulative and non-toxic. Furthermore, they are essential to a wide range of products across critical applications and industries.

As other U.S. states consider broad bans of products containing intentionally added PFAS, some, including California, are weighing fluoropolymer exemptions like the one enacted in New Mexico — a development that underlines further accounting for the low-risk toxicological profiles of fluoropolymers and their fundamental, ubiquitous role in products and processes across industries.

U.S. state PFAS laws exempting fluoropolymers

While the first state laws banning the sale of consumer products containing PFAS — in Maine and Minnesota — included prohibitions on products containing fluoropolymers, other recently passed and proposed bills and amendments explicitly exempt fluoropolymers, including the following:

• HB2516: Illinois proposed a PFAS ban in February that incorporates a fluoropolymer exemption.
• AB 872 and SB 730: California's proposed house and senate bills introduced in February incorporate fluoropolymer exemptions.
• H 6059 and S 645: Rhode Island proposed a house bill amendment and a senate bill in March restricting PFAS in food-contact materials, including cookware, that exempt fluoropolymers authorized as safe by the Food and Drug Administration.
• LD 827: Maine proposed a house bill amendment in March restricting PFAS in food-contact materials, including cookware, that exempts fluoropolymers authorized as safe by FDA.
• HB 212: New Mexico's bill enacted April 8 adopts a phased approach to broadly ban PFAS other than fluoropolymers.

Fluoropolymer applications

Fluoropolymers have been used for decades in a wide assortment of products and manufacturing processes, offering vital advantages in durability, thermal stability, chemical- and radiation-resistance, flame retardancy, and electrical properties. As a result of their strong carbon-fluorine bonds, fluoropolymers have exceptional utility in harsh chemical and radiation environments, extreme temperatures, and in non-stick and water- and oil-repelling applications. Products that rely on fluoropolymers include lithium-ion batteries, electronics, semiconductors, cellphones, laptops, automotive parts, aerospace fuel tubing, solar panels, waterproof jackets, air and water filtration membranes, and automotive brakes and emission control systems, to name a few.

Numerous products that fall under FDA's authority also rely on fluoropolymers. This is in part because these fluoropolymers have been demonstrated through testing and use to be non-toxic and biocompatible, facilitating their use in an array of medical and food processing applications. They are broadly used in implantable medical devices, catheters, non-stick cookware, pharmaceutical packaging, and elsewhere. FDA has approved the use of fluoropolymers in food-contact materials and medical devices since the 1960s and has continued to permit their use, despite revoking approvals for certain other PFAS compounds.

Lack of fluoropolymer substitutes

Fluoropolymers possess unusual and valuable performance characteristics, including chemical and biological inertness and biocompatibility, making substitution for fluoropolymers challenging in many applications. Proposed alternatives lack equivalent characteristics to their fluoropolymer counterparts and often cannot be used as direct substitutes because they cannot achieve necessary product performance targets. As an example, possible alternatives for automotive seals, gaskets, and O-rings — such as non-fluorinated polymers and elastomers, hydrocarbon rubbers, and silicone rubbers —  exhibit lower maximum operating temperatures and may be susceptible to embrittlement, resulting in shorter lifespans.

Likewise, noting that fluoropolymers are currently used "at every stage" of semiconductor fabrication, a 2023 U.S. Department of Defense Report on Critical Per- and Polyfluoroalkyl Substances concluded that no alternatives have been identified for the photolithography process  — in which microchip circuitry patterns are transferred onto bare silicon surfaces  — and that lack of access to these fluoropolymers "could lead to an inability to produce and supply semiconductor manufacturing technology."

Suitable alternatives have not been identified in a wide range of other applications, and even applications where alternatives exist may require additional redesign beyond a materials substitution.

What lies ahead for fluoropolymer exemptions

The recent legislative activity across U.S. states signals a trend towards stringent controls on PFAS, including restrictions on fluoropolymers. However, hurdles to implementation and a more nuanced understanding of the properties of fluoropolymers, including their toxicology and risk profiles, may result in broader adoption of exemptions for these chemicals to facilitate their continued use in critical applications across industries.

Fluoropolymer exemptions like those adopted by New Mexico represent one clear avenue for U.S. state legislators contemplating PFAS bills or amendments to enacted bills. Yet another path forward for fluoropolymers — and the products and manufacturers incorporating these chemicals — is through "currently unavoidable use" (CUU) exemptions. 

Three U.S. states have enacted sweeping PFAS bans — Maine, Minnesota, and New Mexico — that allow for CUU designations for PFAS, including fluoropolymers, in products deemed "essential" for human health and safety. However, these CUU rules may require industry to petition for individual exemptions with little time between when petitions can be submitted and when product bans take effect. 

Industry stakeholders should closely watch related developments in Minnesota, New Mexico, and other states such as New York that are preparing PFAS regulations incorporating CUUs for guidance on submitting applications for exemptions in those states.