EPA orders manufacturer to stop producing PFAS and manufacturer petitions court
The EPA has ordered Inhance Technologies, LLC not to produce per-and-polyfluoroalkyl substances that are created in the production of its high-density polyethylene (HDPE) plastic containers. The EPA orders prohibit the nine significant new use notices the company submitted in December 2022 and are effective February 28, 2024.
PFAS and related regulatory background
- 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 has many discrete sections, including TSCA section 8 which requires the EPA to compile, keep current and publish a list of each chemical substance that is manufactured or processed, including imports, in the U.S for uses under TSCA. Also called the “ TSCA Inventory” or simply “the Inventory,” it plays a central role in the regulation of most industrial chemicals in the United States.
- TSCA section 5 includes a subsection for Significant New Use Rules (SNURs) which require a manufacturer or importer to notify the EPA before a chemical is utilized in a new way. The EPA defines a “significant new use” by reviewing the projected volume of the manufactured substances, the extent that the use may change the type or incidence of exposure to humans or the environment, the extent to which the use will change the magnitude of the exposure, and any “reasonably anticipated” methods for manufacturing and processing the substance. Significant new use rules require industry to notify EPA at least 90 days before commencing the manufacture (including import) or processing of subject chemical substances for a significant new use. The required significant new use notification (SNUN) initiates EPA’s evaluation of the conditions of use associated with the significant new use. Entities may not commence manufacturing (including import) or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.
- Numerous PFAS were registered on the TSCA Inventory but are no longer in use. The EPA wanted to ensure a review of these PFAS before they could be used by manufacturers again and proposed their uses as SNURs. These were known as “dead-chemical” SNURs. This is one of the ways EPA fulfills the “restrict” component of the PFAS Roadmap.
- In June 2023, EPA’s New Chemicals Program incorporated the 1999 Persistent Bioaccumulative, and Toxic (PBT) Policy into the PFAS Framework for the review of PFAS premanufacture notices (PMNs) and SNUNs. The purpose of the PFAS Framework is to provide a clear approach for the New Chemicals Program to review PFAS PMN and SNUN substances in light of significant health and environmental concerns associated with, widespread environmental exposure to, and environmental persistence of PFAS, and to identify any appropriate risk mitigation (including banning manufacture, if warranted) and any appropriate PFAS testing requirements.
PFAS in pesticides
- PFAS are consistently used in pesticides as anti-foaming or dispersing agents for insecticides or inert additives. In addition, fluorine gases are used on high density polyethylene (HDPE) plastic packaging to improve container stability. However, the PFAS may migrate from those containers into the pesticide formulation itself.
- EPA was made aware and confirmed by testing that certain per- and polyfluoroalkyl substances (PFAS) had formed and migrated from fluorinated high-density polyolefin containers into the products they contain. EPA first discovered this in pesticides. On March 16, 2022, the EPA issued a compliance letter to companies that manufacture, import, process, distribute, use, and/or dispose of fluorinated high-density polyolefin (HDPE) containers. EPA issued the letter to: (1) remind industry of this issue to help prevent unintended PFAS formation and contamination and (2) emphasize the requirement under TSCA as it relates to PFAS and fluorinated polyolefins.
- Although these PFAS are the by-product of the manufacturing process for fluorinated polyolefins, they don’t meet the byproduct exemption for the 2020 TSCA SNUR for the type of PFAS produced; long-chain perfluoroalkyl carboxylate or LCPFAC, and therefore a SNUN must be submitted to EPA. EPA explained an alternative fluorination process used so that these PFAS are not produced when manufacturing the containers. The US Food and Drug Administration (FDA) also dealt with this issue concerning food contact articles in August of 2021.
- In December 2022, EPA removed 12 PFAS as inert ingredients for use in pesticide products. Manufacturers would now be required to petition for the use of any of these PFAS; the petitions would require support from data such as studies on carcinogenicity, adverse reproductive effects, developmental toxicity, genotoxicity, and environmental effects for any chemical substance that is persistent or bioaccumulative. These reports would be reviewed by the EPA as part of a new inert ingredient submission request.
- In December 2022, Inhance submitted two consolidated SNUNs for a total of nine substances which are formed as byproducts during the surface coating (via fluorination) of high density polyethylene (HDPE) fuel and non-fuel storage containers and remain in or on the walls of the container and migrate into any liquid subsequently stored in the container. Seven of the nine substances are existing chemicals and are included on the TSCA Inventory; the exceptions are SN-23-0006 [PFuDA] and SN-23-0009 [PFTrDA].
- This table provides the nine long-chain PFAS accompanied by their SNUN numbers and CAS RNs.
|Perfluorooctanoic acid (PFOA)
|Perfluorododecanoic acid (PFDoA)
|Perfluorononanoic acid (PFNA)
|Perfluorodecanoic acid (PFDA)
|Perfluoroundecanoic acid (PFuDA)
|Perfluorotetradecanoic acid (PFteDA)
|Perfluorotridecanoic acid (PFtrDA)
|Perfluorohexadecanoic acid (PDHxDA)
|Perfluoroocttadecanoic acid (PFODA)
- EPA determined that the nine substances are PFAS as defined in the PFAS Framework, containing the structure R-(CF2)-CF(R’)R” where both the CF2 and CF moieties are saturated carbons. More specifically, the EPA identifies the nine substances as perfluorocarboxylic acids containing fluorinated carbon chain lengths of 8-18 carbon atoms.
- EPA explains there are challenges to precisely quantifying risk for PBT PFAS since there is insubstantial toxicity data on most of the thousands of PFAS (except for those most studied). Those PFAS that have been most studied, PFOA, PFOS, PFHxA, PFBS, and GenX, demonstrate very high toxicity. PFOA is one of the nine SNUNs and has strong toxicity information for both human health and environmental organisms. EPA does not have this information for the remaining eight PFAS.
- EPA also explains that exposure to multiple PFAS will most likely lead to additional toxicity which needs to be considered, however quantifying the risk is not possible since a widely accepted method has not been established. EPA concluded that the persistence in the environment, bioaccumulation in humans and organisms, and toxicity are not accounted for in the New Chemicals Program’s traditional quantitative methodologies or in Inhance’s risk assessments.
EPA order to Inhance Technologies
- 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.
- In a response on its website, Inhance asserted, “The EPA decision to ban the fluorination of plastics defies sound science, data-driven risk assessment, and is a significant departure from past and current policies and practices. Inhance Technologies does not use any PFAS in its fluorination processes and any PFAS, if present, are unintended impurities that serve no commercial purpose. The company has provided EPA data demonstrating that less than five grams of these long chain PFAS impurities are present in its packaging applications, annually, which is significantly less than other EPA-authorized uses or releases of the same PFAS in question.”
- Inhance released a second statement declaring they would seek legal remedies in the courts.
Insights on the Fifth Circuit petition
- On December 8, 2023, Inhance petitioned the Fifth Circuit Court of Appeals over the orders from the EPA. In the wake of the December 1, 2023 orders, the government and Inhance apparently came to an agreement on a decision to pursue expedited review of the case at the Circuit and for the court to issue an administrative stay of the order until it determined whether the EPA could actually issue and enforce the orders.
- Courts are able to pick up a case for expedited review if the court finds that the petitioners have demonstrated good cause. In this case, Inhance argues that the orders are unlawful, and that the enforcement of the orders would cause irreparable injury to the company (even if they were temporary).
- Inhance primarily argued that the EPA’s orders were “unlawful thrice over.” Inhance asserts that the EPA’s orders violate TSCA, violate the EPA’s own rules, and are arbitrary and capricious in violation of the Administrative Procedure Act (APA). The company noted that the agency’s efforts to apply a PFAS SNUR to Inhance’s fluorination process should fail because Inhance’s use is not a new one, it produces long-chain PFAS only as impurities, and the company lacked fair notice of the agency’s reinterpretation of the regulation.
- The company asserts that its technology is not a new use for the purposes of TSCA, and cannot regulate as a new use, as it has been ongoing since the mid 1980’s. The brief notes that the agency’s SNUR determined that all uses that predate the publication of the rule are “ongoing” uses, and any commenced after are considered new. Additionally, Inhance argues that the SNUR was never intended to cover intended uses when it was proposed in 2015.
- Inhance also argued that the SNUR does not govern impurities, noting that the long-chain PFAS that are generated during the fluorination process are unintentionally generated, have no commercial use, and are impurities and therefore exempt from the rule. The company pointed to the agency’s own rule, which explained that long-chain PFAS present as unintended residues during the manufacture of fluoropolymers are considered impurities and exempt from the SNUR itself.
- The final major argument asserted that Inhance lacked fair notice of the agency’s “reinterpretation” of the rule, stating that the agency had failed to provide Inhance with fair notice that it was subject to the SNUR. Inhance characterized the EPA’s argument as asserting that the rule applies broadly to all industries that generate PFAS. The firm argued instead that, because the EPA does not specifically identify the fluorination industry as part of the SNUR, it is not applicable to that industry. The company argued that this makes it clear that the agency was not “promulgating an economy-wide rule, but instead only targeting industries listed in the rule.”
- Inhance argues that the orders “imminently threaten” the company’s existence. The company stated that it would have to cease all operations and shutter all facilities while the EPA’s orders are active, meaning bankruptcy for the company. The company noted that this threatens “the very existence” of the business, and that the financial loss caused by the orders would be considered an irreparable harm.
- The EPA has been relentless in issuing regulatory actions and decisions to curtail the manufacture, import, processing, and sale of PFAS. The use of SNURs and PMNs is another method for the EPA to control the entrance into the market and the environment of PFAS. However, the EPA has also been working with industry to manage the risks from toxic chemicals to humans and the environment while dealing realistically with technology, supply chains and markets.
- As of December 12, 2023, the Circuit has granted the petition for review and will impose an injunctive stay until it decides on the merits of the case. The EPA traditionally has faced incisive scrutiny from the Fifth Circuit, indicating that the court could vacate the orders. From there, the EPA could appeal the orders to the Supreme Court, but the Court’s reduced deference to the agency may also hand the agency a loss at the higher court.
- Consequently, the Fifth Circuit’s decision will not only affect Inhance but also EPA actions and review of PFAS SNUNs and PMNs going forward.
To contact the editor of this analysis, please email Kari Oakes.
This analysis was updated on December 13, 2023 to reflect the Fifth’s Circuit’s decision to grant the petition for review.
Key documents and dates
- EPA Orders to Inhance Technologies Related to Long-Chain PFAS Significant New Use Notices· Risk Assessment of the Per- and Polyfluoroalkyl Substances (PFAS) in SN-23-0002-0006 and SN-23-0008-0011 (pdf)
- TSCA Section 5 Order for a Significant New Use of Certain Chemical Substances (PFOA, PFDA, PFNA) (pdf)
- TSCA Section 5 Order for a Significant New Use of Certain Chemical Substances (PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA and PFODA)
- PFAS Strategic Roadmap
- PFAS National Testing Strategy
- Toxic Substances Control Act
- Framework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs)