Written on: June 1, 2024 by Nicholas Georges
Over the last few years, the conversation around Perfluoroalkyl & Polyfluoroalkyl Substances (PFAS) has focused on the manufacturing process and intentionally added ingredients in a product. However, product packaging could also be a source of PFAS and must be reviewed.
Some products utilize fluorinated packaging to protect and maintain the contents throughout their lifespan. Manufacturers will use fluorinated packaging when the average plastic container is not sufficient to hold the product and other packaging materials are either not compatible or have drawbacks. Through various processes, fluorinated packaging undergoes treatment to form a barrier that ensures there isn’t an unintended reaction or permeation that could degrade the integrity of the packaging.
In 2020, the U.S. Environmental Protection Agency (EPA) learned of potential PFAS contamination in an insecticide. After studying the product, the EPA determined1 that the PFAS was likely formed during the fluorination process of high-density polyethylene (HDPE) containers by Inhance Technologies, which bled into the pesticide formulation.
Following this, the EPA contacted a variety of pesticide stakeholders that may have used fluorinated packaging. Under the Federal Insecticide, Fungicide & Rodenticide Act (FIFRA) Section 6(a)(2), companies are required to report certain information about their products, such as unreasonable adverse effects, including metabolites, degradates and impurities, including PFAS. The EPA studied the potential leaching of PFAS over time in various test solutions and found that even water-based products could leak certain PFAS into the formulation from the container.
Under the Toxic Substances Control Act (TSCA), the EPA also requires manufacturers to notify it at least 90 days before commencing the manufacture (including import) or processing of long-chain perfluoroalkyl carboxylate (LCPFAC) substances. Inhance Technologies, who had been producing fluorinated packaging for 40 years, did not view their process as new, even though the EPA was learning new information about its processes and what could happen to products in the marketplace.
This led the EPA to issue2,3 content orders on Dec. 1, 2023, to Inhance Technologies to stop producing certain PFAS incidentally and unintentionally by Feb. 28, 2024, under Section 5 of TSCA. The orders required Inhance to stop the manufacture, sale and distribution in commerce of any fluorinated packaging within the scope of the order, which would have profound impacts on industries that rely on fluorinated packaging. At the time of issuing the consent orders, the EPA could measure PFAS in plastic packaging down to 20 parts per trillion (ppt) (although, recently, the EPA published4 a newer methodology that can measure as low as 2ppt). Inhance petitioned a review by the 5th District Circuit Court of Appeals to stop the consent orders and quickly had its motion to stay granted while the Court considered the appeal.
Due to the significant impact these consent orders could have on Household & Commercial Products Association (HCPA) members that rely on fluorinated packaging for some of their products, HPCA joined and contributed to an amicus brief5 filed by the American Chemistry Council, CropLife America, Outdoor Power Equipment Institute and U.S. Chamber of Commerce in support of Inhance Technologies’ petition. The brief’s key arguments stated that the EPA’s orders are premised on EPA’s incorrect conclusion that Inhance engaged in a “significantly new use” of a substance and highlighted the scale of market disruptions. For example, any replacement packaging would need to undergo compatibility and stability testing along with market considerations.
On March 21, 2024, the 5th District Circuit Court determined6 that the EPA exceeded its authority. The Court’s opinion made it clear that the EPA cannot contort the plain language of TSCA’s Section 5 to deem a 40-year-old manufacturing process a “significant new use” that is subject to the accelerated regulatory process provided by that part of the statute.
This decision does not impede the EPA’s ability to regulate Inhance’s (or other companies’) fluorination processes. In fact, the EPA can utilize the authority7 under Section 6 of TSCA, which nongovernmental organizations (NGOs) have already petitioned8 the EPA to do, as well as other authorities, such as those under FIFRA.
It is critical that companies continue to evaluate their packaging, both to ensure stability throughout the life of the product and adjust to the ever-changing regulatory environment. While the Court’s decision provides companies more time to examine their fluorination processes, it is likely that activity in this space will continue.
For more information about the fluorination process or PFAS specifically, please contact me at ngeorges@thehcpa.org. SPRAY
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7 Unlike Section 5 under TSCA, which requires a company to submit a significant new use notice at least 90 days before manufacturing or import, Section 6 gives EPA the authority to conduct risk evaluations of existing chemicals and their manufacture, processing, or distribution in commerce.
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