Frequently Asked Questions on Regulatory Topics

What does this mean for Inhance and what does this mean for me as a customer.

This Section 6 proceeding is EPA's initiative to gather more information on the fluorination industry and alternatives, prior to any decision making. We welcome the opportunity to share information with EPA regarding fluorinated packaging. See Inhance Technologies recent press release. It is business as usual for Inhance Technologies.
Please see EPA's press release – https://www.epa.gov/chemicals-under-tsca/epa-grants-petition-three-pfas-found-fluorinated-plastic-containers. EPA has stated in its press release that "The EPA's grant of this petition is not itself a final agency action and does not signal that EPA will ultimately take any particular final agency action." 


How long will this process of assessment by EPA take?

Your question is best directed to EPA. From what we can tell we expect this process of information gathering from the industry and evaluations to take several months to years. In the past, Section 6 rulemaking process has taken years to complete. Inhance Technologies is continuing business as normal, and we do not expect any disruptions in our service to our customers globally.


What is TSCA Section 6?

TSCA Section 6 was specifically designed by Congress to afford EPA rulemaking authority to evaluate whether existing uses present an unacceptable risk. In so doing, Section 6 requires EPA to balance the risk presented by an existing use against the costs and economic impact of prohibiting or restricting future manufacture. This assessment, amongst other things, includes understanding the economic impact of a technology, impact on jobs, as well as the safety and environmental impacts of the existing use, and all available alternative technologies. A third party economic think tank has estimated that Inhance Technologies' barrier technology offerings have an economic impact of ~$40 billion and ~100,000 jobs.  

Any Section 6 action by EPA would have to go through the full notice-and-comment rulemaking process, which typically takes years to complete. The fluorination industry should be concerned about the impact of prohibiting or restricting the fluorination of containers on other industries – e.g., health care, electronics, etc. During the rulemaking process, Inhance Technologies and other potentially regulated entities would have the opportunity to comment on any proposed rule, and potentially challenge any final rule published by EPA.
  
Inhance Technologies conducted a robust risk assessment of its fluorination technologies, using highly regarded third party experts. Based on this work, a paper was recently published in the esteemed journal – Regulatory Toxicology and Pharmacology, 147 (2024), 105560, titled "Assessment of perfluorocarboxylic acids in fluorinated high-density polyethylene containers and estimation of potential non-cancer risks associated with anticipated use scenarios" Refer to the following link to access the article The goal of this study was to evaluate the presence of PFCAs in post-mold fluorinated HDPE containers for six product types, as well as to assess the potential risk to human and ecological receptors as a result of PFCAs migrating into the products stored in such containers or as a result of release in the environment. The study demonstrated that any PFAS, if present in fluorinated packaging and fuel systems do not pose an unreasonable risk to humans or the environment.


Are fluorinated containers subject to TSCA?

The Fifth Circuit decision means that TSCA does not apply to the fluorination of containers, or fluorinated containers. EPA has also stated in its filing in the Fifth Circuit - to entities interacting with the substance, the substance is an impurity. Impurities are exempt from TSCA. Please consult with your own counsel for further clarification. 


What about State Laws?  

Many states are considering laws to regulate products where PFAS is intentionally added. Inhance Technologies does not intentionally add any PFAS to its processes, and only uses elemental fluorine and inert gas in its fluorination process.


Do my products contain PFAS?

PFAS impurities have been identified in paper products, textiles, and non-fluorinated plastics, to name just a few examples. Inhance Technologies treats containers supplied by our customers and cannot speak to our customers' products, formulations, or ingredients.  

We know that packaging treated by our Enkase™ process has only very low levels of PFAS and in many instances levels below the detection limits of analytical methods. Further, extensive, third-party risk assessments show that there is no unreasonable risk to the environment or to human health. We have made process modifications to reduce the formation of the vast majority of the PFAS species in question.  
Based on CEN 15968, LOD 0.3 ppb.


What is Inhance Technologies doing to eliminate unintended PFAS impurities from its process?

Since learning that certain PFAS impurities may be unintentionally formed in minute quantities during the fluorination process, Inhance Technologies has implemented measures to reduce the formation of unintended PFAS impurities in its Enkase™ barrier packaging technology to below non-detect levels.  

Inhance Technologies is committed to the safety of its products, facilities, employees, customers, and the environment. We continue to take actions to reduce any unintentional PFAS impurities generated from the fluorination process. Our goal is to eliminate impurities from the fluorination process.


Can Inhance Technologies still operate outside of the United States?

Inhance Technologies operations are global, across four continents, and we operate in accordance with the laws of the countries in which it operates, which includes ensuring that its fluorination technologies comply with all relevant regulations.


Do you have capacity? What are your lead times?

We are running business as usual. Lead times are normal and we have sufficient capacity to meet all of our customers' needs. For large orders, please speak with your representative to ensure we can meet your specific needs in a timely manner.