Companies using fluorinated containers for product transport and storage will want to be aware of U.S. Environmental Protection Agency’s (EPA) recently issued compliance letter to the High-Density Polyethylene (HDPE) container industry. While directed at the HDPE industry, the letter highlights the importance of companies ensuring that their products do not chemically interact with the materials in which they are stored, distributed, and packaged. Over the past year, EPA has determined that certain fluorinated containers can result in per- and polyfluoroalkyl substances (PFAS) formation and leaching into the contained product. The Agency expresses an extremely broad view in the letter – specifically that this unintentional PFAS formation may constitute chemical manufacturing under the Toxic Substances Control Act (TSCA) and expose companies to TSCA notification and chemical review requirements. EPA’s position is likely to be questioned in the coming months given its novelty. In the interim, companies considering an investigation into the chemical interplay between their products and packaging should involve counsel to determine the appropriate approach for the company’s specific circumstances.

Following evidence that fluorinated containers can unintentionally form and leach PFAS into the contained product, on March 16, 2022 EPA issued an open letter advising that such circumstances could trigger liability under TSCA. EPA’s letter alerts the HDPE industry, including manufacturers, processors, distributors, and those that dispose of fluorinated HDPE containers, that PFAS in HDPE containers formed as a byproduct of the fluorination process may be subject to TSCA requirements.

Plastics are fluorinated to create a “high-performance barrier” that protects the plastic from environmental weathering and shelf degradation. As Baker Botts reported last year, the PFAS container leaching issue came to EPA’s attention in 2020 when a citizens group notified EPA that it purchased and tested a pesticide product and found PFAS. EPA’s own subsequent testing confirmed the presence of eight PFAS compounds, and after studying both the product and the fluorinated HDPE containers used to store it, EPA determined that PFAS contamination stemmed from the fluorinated containers.

EPA states that its position that PFAS formation through the fluorination process may be subject to TSCA regulations and enforcement is in line with the Agency’s PFAS Strategic Roadmap, which is focused on preventing PFAS from entering the environment and holding parties accountable for PFAS releases through increased enforcement actions. EPA’s approach also aligns with the activities of several states and the Food and Drug Administration (FDA), which have taken steps to address PFAS in containers – particularly in food packaging. FDA issued a similar letter last year to manufacturers, distributors, and food manufacturers that use fluorinated polyethylene food containers, reminding them that only certain containers are authorized for food use.

Again, as EPA’s letter makes clear, the Agency takes a broad view of “manufacturing” under TSCA. A position that encompasses the unintentional formation of PFAS and potentially extends to end-users of PFAS-contaminated products, is one of first impression. The full range of ramifications of this position is yet to be explored – for example, whether key TSCA exemptions, such as the polymer exemption or articles exemption, apply to certain factual patterns. Companies, particularly end-users, may have opportunities to challenge any future enforcement actions by the Agency taken under the legal theories outlined in the letter. Until that time, however, companies considering assessment of the chemical interplay between a product and its packaging should involve counsel to select a sound approach for the company’s specific circumstances.

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