EPA grants petition on PFAS in fluorinated containers

Background: PFAS and TSCA

• Per- and polyfluoroalkyl substances (PFAS) are a group of synthetic chemicals that have been in use since the 1940s. PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.
• Consequently, due to their widespread use and the fact that they break down very slowly in the environment, they have earned the sobriquet “forever chemicals.” As a result of their persistence and longevity, PFAS have been found in the blood of people and animals worldwide. Various studies suggest that high levels of certain PFAS may lead to increased cholesterol levels, changes in liver enzymes, and increased risk of kidney or testicular cancer, among others. For example, the International Agency for Research on Cancer (IARC)recently released a toxicological review for perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), including their corresponding isomers and salts. Monograph 135 reviewed the carcinogenicity of these two substances and classified PFOA as a Group 1 carcinogen, and PFOS as a possible carcinogen.
• The EPA administers the Toxic Substances Control Act (TSCA), which governs the registration, review, reporting, recordkeeping, and regulation of many chemical substances in the United States. TSCA also focuses on regulating chemical substances which may present an unreasonable risk of injury to health or the environment. TSCA Section 6 controls risk evaluations performed by the EPA, and the agency must consider “reasonably available information” as well as operate in a matter that is consistent with the best available science, ultimately making decisions based on the weight of scientific evidence.
• TSCA risk evaluations determine whether a chemical substance presents an unreasonable risk to health or the environment under its conditions of use. The EPA reviews the hazards and exposures to both the general population in addition to relevant potentially exposed or susceptible subpopulations (PESS). The U.S. Code describes a PESS as “a group of individuals within the general population identified by the Administrator who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.”
• After the EPA determines that that a chemical represents an unreasonable risk, the agency must begin rulemaking to manage the unreasonable risks. The EPA can manage risk through a variety of options, including prohibitions, reductions in concentration, personal protective equipment (PPE), and workplace controls to reduce risk to a reasonable level. The agency may also require warnings or instructions for use on the labeling of a chemical or chemical mixture deemed to pose an unreasonable risk.

Background: the Inhance suit and the Fifth Circuit

• On December 1, 2023, EPA issued orders to Inhance Technologies, LLC directing it to not produce PFAS that are created in the production of its fluorinated high-density polyethylene (HDPE) plastic containers. EPA issued the order under TSCA section 5 authority. Inhance uses fluorination processes to impart barrier protection, i.e., enhanced container stability and reduced permeation capabilities, to plastics, such as high-density polyethylene (“HDPE”) packaging and fuel containers.
• On December 8, 2023, Inhance petitioned the Fifth Circuit Court of Appeals over the orders from the EPA. The court stayed the effectiveness of the order until it could rule on the merits of the case.
• On March 21, 2024, the Fifth Circuit vacated the EPA’s orders, finding that the agency “ may not contort” TSCA’s language to deem that the firm’s 40 year old fluorination process was a “significant new use.” The court held that the EPA could certainly regulate the Inhance processes, but it could not do so via the December 2023 orders. Instead, it could utilize TSCA Section 6 traditional rulemaking to regulate the processes, “ a proposition even Inhance concedes.”

Petition to regulate three PFAS in plastic containers during the fluorination process

• Spurred on by the Fifth Circuit’s opinion, the Center for Environmental Health (CEH) and several other environmental organizations petitioned the EPA on April 11, 2024 to establish regulations under TSCA Section 6 for the fluorination of plastic containers. The petition requested that the EPA specifically prohibit the manufacturing of three different PFAS, perfluorooctanoic acid (CAS RN 335-67-1) (PFOA), perfluorononanoic acid (CAS RN 375-95-1) (PFNA), and perfluorodecanoic acid (CAS RN 335-76-2) (PFDA) that are formed during the fluorination of plastic containers.
• On April 18, 2024, the EPA announced receipt of the petition and stated that the agency would grant or deny the petitions by July 10, 2024.

On July 10, 2024, the EPA granted the petition

• In a letter to the parties, the EPA announced that it would “promptly commence an appropriate proceeding” under TSCA Section 6, but that it would not signal what its planned rulemaking the agency would be. The agency cited the petition’s assertion about the human health and environmental effects of the three PFAS, and that exposure to the substance can occur at “all stages of the lifecycles” of the containers.
• The EPA stated that the petition properly set out the necessity for a Section 6 rulemaking to address PFOA, PFNA, and PFDA. The agency cited both the petition’s exhibits, as well as its own risk assessments of PFOA, PFNA, and PFDA finding that there were risks of concern from the manufacture, distribution, use, and disposal of the PFOA, PFNA, and PFDA.
• The EPA is planning on requesting information on fluorinated containers in the U.S., in addition to alternatives to the fluorination processes that generate the target three PFAS, and measures to address the risk posed by the three PFAS in plastic containers.

Impact of the regulations

• The EPA has shown more of a willingness to begin the rulemaking process when prompted by petitions in recent years. The agency also relatively recently granted a petition to begin the rulemaking process for 6PPD (and its transformation product, 6PPD-q). However, due to the scope and timeline of these regulations, the EPA’s announcement that they will grant a petition begins a much longer process that will realistically take years to complete.
• But: The EPA did not state that it would specifically ban the chemicals used in plastic fluorination in the future. Still, the agency is likely to restrict the use of the substances outside of essential uses of the products. However, as stated previously, there are years before this regulation would even be drafted, leaving the agency ample opportunities to tighten or loosen its potential proposals.

To contact the author of this analysis, please email Walker Livingston ( wlivingston@agencyiq.com).
To contact the editor of this analysis, please email Kari Oakes ( koakes@agencyiq.com).

Key Documents and Dates

• Grant of Petition (July 10, 2024)
• Petition (April 11, 2024)
• Inhance Technologies, LLC v. EPA (March 21, 2024)