Inhance Technologies Regulatory Update on Fluorinated Packaging

About Inhance Technologies 

Inhance Technologies, a Responsible Care™ company, has served customers with its fluorination technology for over 40 years and is committed to safe operations that are protective of its workers, local communities, the public, and the environment. Fluorinated barrier packaging is critical in protecting the environment and human health by preventing permeation of container contents through evaporative emissions.

What is TSCA Section 6?

TSCA Section 6 was specifically designed by Congress to afford EPA rulemaking authority to evaluate whether utilizing existing chemistries present an unacceptable risk. In so doing, Section 6 requires EPA to balance the risk presented by an existing chemical against the costs and economic impact of prohibiting or restricting future manufacture. This assessment, amongst other things, includes understanding the safety and environmental impacts of the existing use, as well as economic impact of a technology, impact on jobs, and all available alternative technologies 

Any Section 6 action by EPA would have to go through the full notice-and-comment rulemaking process, which typically takes many years to complete and would necessarily sweep in a broader industry group, who would be concerned about the impact of prohibiting or restricting the use of the regulated chemical in commerce  – e.g., health care, electronics, agriculture, outdoor power equipment, etc. During its assessment, EPA will have to consider amongst other things, the economic impact of imposing restrictions on a chemical, effect on jobs, as well as safety and environmental impacts of the existing use of the chemical, and all available alternative technologies. 

What is the status pertaining to Inhance Technologies and TSCA Section 6?

The Environmental Protection Agency (EPA) issued a notice on September 30, 2024, seeking public comments on the manufacture of certain per- and polyfluoroalkyl substances (PFAS), including perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA), during the fluorination of high-density polyethylene (HDPE) and other plastic containers to inform regulators as appropriate under the Toxic Substances Control Act (TSCA). Inhance Technologies submitted comments and information responsive to the topics identified in EPA’s September 30, 2024, notice. Specifically, Inhance Technologies: (1) provided information describing the importance of fluorination to the United States economy; (2) explained why there are not viable alternative technologies to fluorination; and (3) described available measures to minimize the potential for the unintentional generation of PFOA, PFNA, and PFDA as impurities during fluorination. This comment letter also addressed the various legal requirements EPA must meet to promulgate a rule under Section 6(a) of the Toxic Substances Control Act (“TSCA”).

The EPA will take time to process, review, and analyze all the information it received before deciding how to proceed. This process is expected to take several months.  

Summary of Inhance Technologies’ comments to the EPA

Below is the summary of the response from Inhance Technologies to the EPA on certain per- and polyfluoroalkyl substances (PFAS) risk management under the Toxic Substances Control Act (TSCA).

1. Fluorination Does Not Pose an Elevated Risk to Human Health or the Environment.
Containers fluorinated by Inhance Technologies meet all applicable PFAS regulations. To date, EPA has not promulgated any regulations limiting concentrations of PFAS in articles, including fluorinated containers. The European Union (“EU”), however, has set threshold limits on PFAS in articles. Specifically, the European Chemicals Agency (“ECHA”) requires that articles have 25 parts per billion (“ppb”) or less for any singular PFAS compound and 250 ppb for all PFAS species in articles. Inhance Technologies has global operations, including in the EU, and ensures that all its fluorinated containers are compliant with all relevant regulations for PFAS in articles, including Substance of Very High Concern (“SVH”); Registrations, Evaluation, Authorization, and Restrictions of Chemicals (“REACH”); and Restrictions for Hazardous Substances (“RoHS”) regulations.

The amounts of PFOA, PFNA, and PFDA that could be unintentionally formed during fluorination are insignificant. Based on data collected from May 2024 through August 2024, Inhance Technologies estimates that less than one gram cumulatively of PFOA, PFNA, and PFDA are unintentionally formed as impurities in its barrier packaging across 25 million pounds of plastic articles treated annually. In comparison, based on available literature review, Inhance Technologies estimates that the amount of these PFAS in commerce in 2023 from the sales of various products in the United States are as follows:
•    PFOA: Between 5,500 kilograms (5,500,000 grams) and 55,000 kilograms (55,000,000 grams)
•    PFNA: Between 150 kilograms (150,000 grams) and 1,500 kilograms (1,500,000 grams)
•    PFDA: Between 160 kilograms (160,000 grams) and 1,600 kilograms (1,600,000 grams)

Inhance Technologies has developed and implemented an extensive research and development program (R&D) efforts that have led to significant improvements in Inhance Technologies’ fluorination process. Specifically, the company has modified its fluorination parameters and significantly upgraded its process equipment. Since implementing its R&D program, Inhance Technologies has reduced the unintentional formation of PFAS in fluorinated packaging by more than 90 percent. While the amount of PFAS unintentionally generated during fluorination is minuscule and insignificant, Inhance Technologies is continuing its R&D program to refine its processes to further suppress PFAS formation.

2. Fluorinated Containers are Essential to the United States Economy.
Fluorination is a well-known process that has been approved by the Government. Fluorination is recognized as an approved regulatory use for the treatment of fuel tanks and certain food purposes. Indeed, EPA has long acknowledged the robust barrier protection benefits that fluorination provides. As early as 1994, EPA recognized fluorination as a viable technology for fuel tanks to meet evaporative emission standards under the Clean Air Act. In its final rule setting forth evaporative emissions standards for large spark-ignition engines, EPA describes the fluorination process and notes that fluorination could result in a “more than a 95-percent reduction in permeation emissions from new fuel tanks . . . .”. EPA describes and reiterates the benefits of fluorination technology in subsequent rulemakings, including in a 2004 final rule adopting new permeation evaporative emission standards for highway motorcycles, and a 2008 final rule regulating new non-road spark-ignition engines.

Fluorination has multiple critical uses across various sectors. Fluorinated containers play a crucial role in the production, storage, and distribution of many essential products and goods used throughout, and vital to, the United States economy. Given the number of products that require packaging with barrier protection, many industries—including in the agricultural, chemical manufacturing, healthcare, and transportation sectors—rely on fluorinated packaging. Products that require fluorinated containers include vaccines, prescription medications, surgical products, and solvent-based chemicals used for crop production.

Inhance Technologies is the predominant fluorination company in the United States. In 2023, Inhance Technologies commissioned an independent firm—NERA Economic Consulting (“NERA”)—to assess the economic impact the absence of Inhance Technologies’ fluorination technology would have on the economy. Based on its analysis, NERA concluded that the United States economy would face an estimated economic output loss of approximately $39.8 billion. NERA also estimated that a prohibition of fluorination by EPA would result in a loss of approximately 112,100 jobs.

3. Alternatives to Fluorination are Inadequate.
Currently, there are no viable alternative barrier technologies that can match the efficacy, flexibility, and scalability that fluorination provides. Industry itself has made this point undeniably and abundantly clear. In amici brief to the United States Court for the Fifth Circuit of Appeals, a coalition of trade associations representing hundreds of companies across various industries said in no uncertain terms that there are no available alternatives to fluorination.

Third Party research confirms that Inhance Technologies’ fluorination does not pose unreasonable risk

A highly reputable and internationally recognized third party – ToxStrategies LLC – recently published a scientific article in the highly rated international journal Regulatory Toxicology and Pharmacology.  The conclusions of the study are quoted here – “This study indicates that consumers may potentially be exposed to PFCAs that may migrate into liquid products stored in fluorinated HDPE containers. However, importantly, the SLCRs for all use scenarios and products are well below 1.0, demonstrating that such products and uses do not pose an unacceptable non-cancer hazard even with all of the many worst-case assumptions and inputs used in this assessment. Similarly, worst-case modeling indicates that PFCA concentrations potentially released to the environment from fluorinated HDPE container product use do not pose an unacceptable non-cancer hazard to humans, aquatic species, or terrestrial animals.”

Summary

Fluorination plays a significant role in environmental protection and legal compliance. Inhance Technologies’ barrier packaging is used in the processing of 25 million pounds of plastics packaging annually and is integral to multiple sectors of the economy and critical supply-chains. Inhance Technologies’ barrier packaging remains compliant with all relevant regulations globally and is crucial for safeguarding environmental and human health, complying with regulations, ensuring product efficacy, and advancing sustainability.

For any questions, or additional information, please contact Inhance Technologies through your sales representative or send an inquiry through the website.