On April 11, 2024, EPA received a petition under Section 21 of the Toxic Substances Control Act (TSCA) which requested that EPA establish regulations pursuant to Section 6 of TSCA prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of three PFAS (PFOA – perfluorooctanoic acid, PFNA – perfluorononanoic acid, and PFDA – perfluorodecanoic acid) formed during the fluorination of plastic containers. EPA evaluated the evidence submitted by the petitioners during its 90-day review period, and on July 11, 2024, deemed it necessary to initiate proceedings under TSCA Section 6 to address PFAS production during fluorination of plastics. The outcome of these proceedings has the potential for prohibition or restriction of PFAS at all lifecycle stages of fluorinated plastic containers and can impact many entities in a wide range of industries such as construction, food, medicine, electronics, clothing, fabric, and packaging.

TSCA Section 6 grants EPA the authority to issue regulations on any chemical substance evaluated by the EPA as presenting an unreasonable risk to human health or the environment. Under this law, regulations requiring one or more of the following actions can be issued by EPA to the extent necessary so that the chemical substance no longer presents an unreasonable risk:

The petition cites that the promulgation of a rule under TSCA Section 6 to prohibit the manufacturing, processing, use, distribution in commerce, and disposal of PFOA, PFNA, and PFDA formed during the fluorination of plastic containers is warranted due to the hazardous nature of the three PFAS. Even at low concentrations, PFOA, PFNA, and PFDA cause adverse human health effects, including cancer, developmental harm, reproductive harm, immune system toxicity, liver toxicity, thyroid toxicity, and kidney toxicity. PFOA, PFNA, and PFDA also cause harm to the environment, with research confirming that exposure to these PFAS has adverse effects on aquatic organisms and ecosystems. With these citations, the petition states that the three PFAS formed during fluorination of plastic containers present an unreasonable risk to both human health and the environment.

To demonstrate the need for prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of PFOA, PFNA, and PFDA, the petition references EPA studies which demonstrate that PFAS formed during fluorination process leach from fluorinated plastic containers into the products stored in them. Due to the potential for exposure occurring at all stages of the lifecycles of fluorinated containers, the petition asserts that not just the use of such containers, but all upstream and downstream processes must be prohibited. The petition further cites the ability of PFOA, PFNA, and PFDA to bioaccumulate in the human body and to persist in the environment, and EPA’s conclusion in “TSCA Section 5 Order for a Significant New Use of Certain Chemical Substances” that the agency cannot control potential exposures through means other than prohibition on the manufacture of these substances.

Owing to the reasoning presented in the petition, namely the demonstration of facts that could support an EPA determination of unreasonable risk to human health and the environment, EPA decided to grant the petition and commence proceedings.

As part of the proceeding to be commenced under TSCA Section 6, EPA intends to request the following information: the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates PFOA, PFNA, and PFDA; and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. This action, paired with existing studies and research, will build on efforts underway among governments (e.g., federal, Tribal, and state), non-governmental organizations, academia, and industry, to ensure that any risks associated with PFOA, PFNA, and PFDA are appropriately evaluated and managed. Once adequate information has been collected, rulemaking will be commenced to appropriately manage the risk. Depending on the findings, EPA has adequate authority to ban the manufacture of these substances in this manner, comparable to historical bans on lead paint, asbestos, and PCBs.

On October 14, 2020, EPA received a petition under Section 21 of TSCA requesting requirement of health and environmental effects testing on 54 chemical substances, identified as PFAS in the petition, released into the environment by The Chemours Company at its chemical production facility in Fayetteville, North Carolina. The petition also sought issuance of a rule under Section 4 of TSCA compelling Chemours to fund and conduct testing under the direction of a panel of independent scientists. While the previous Administration denied the petition in January 2021, the petitioners requested EPA to reconsider its denial in March 2021. EPA agreed to a reconsideration in light of the change in administration and policy priorities concerning PFAS, and after reconsideration, granted the petition. Through the tests taking place in Fayetteville, North Carolina, EPA has been exercising its TSCA authorities to compel development of information on PFAS using the National PFAS Testing Strategy. These test results have had further implications by contributing to the knowledge and reasoning behind the ensuing regulatory actions taken by EPA in regard to PFAS.

In March 2022, EPA provided information to manufacturers (including importers), processors, distributors, users, and those that dispose of fluorinated high-density polyethylene containers and similar plastics about the potential for PFAS to form and migrate from these materials. This letter served to raise awareness to prevent unintended contamination and to outline the requirements under TSCA PFAS Significant New Use Rules. Furthermore, in December of 2023, EPA issued orders to Inhance Technologies LLC prohibiting it from producing 6 other PFAS in the production of its fluorinated high-density polyethylene plastic containers. That TSCA Order was intended to protect humans and the environment from exposure to PFAS in household, pesticide, fuel, automotive, and other industrial products.

Trinity anticipates that future petitions under TSCA Section 21 and EPA rulings will only increase potential process changes, litigation, and potential cleanup costs related to PFAS, especially in industries with direct interaction with plastics such as chemical distribution, pesticides, construction, food, medicine, electronics, clothing, fabric, and packaging. Trinity has a dedicated group of practitioners focused on due diligence and regulatory review that is closely following the potential implications of the proceedings under TSCA Section 6.

If you would like to discuss potential PFAS issues, liability at your facilities, or how to get ahead of future enforcement actions, please contact your local Trinity office, Wes Younger, or John Goetze.