Packaging barrier maker Inhance Technologies LLC is facing questions about the safety of its fluorination coating process for high density polyethylene containers, including an investigation and lawsuit from the U.S. Environmental Protection Agency.
Two public health groups have also filed a lawsuit against Inhance, reportedly the largest supplier of post-mold container fluorination in the U.S., alleging that the company is ignoring new EPA regulations designed to limit releases of so-called "forever chemicals."
Houston-based Inhance defended itself, saying it believes it is complying with regulations and operating safely and lawfully, and it noted in a statement it made changes to its manufacturing after EPA raised concerns.
At issue is whether the company's specialty process to fluorinate the surface of HDPE bottles to create a barrier layer on packaging generates per- and polyfluoroalkyl substances, or PFAS chemicals, on the containers.
Environmental groups that have sued Inhance say tens of millions of containers have been treated by its process, and they say researchers at EPA, the University of Notre Dame and other organizations have found PFAS on the inner and outer surfaces of the containers and in their contents.
They say the PFAS is likely formed from chemical reactions during fluorination.
Inhance, however, said its processes are safe.
"When we were informed by EPA of some data suggesting the potential for certain PFAS to be present in fluorinated [HDPE] containers, we engaged outside laboratories to conduct intensive testing as Inhance Technologies has never used or added PFAS as raw materials in any of our processes," the company said.
But EPA, in a highly redacted lawsuit filed Dec. 19 in federal court in Pennsylvania, said it gave the company a "notice of violation" in March. It said in the lawsuit that Inhance's manufacturing may pose risks to people exposed to its products.
"Inhance's past and continuing manufacture of [redacted] for a significant new use subject to the [redacted] rule may present an unreasonable risk of injury to the health of individuals exposed to its products, the employees and workers involved in the manufacturing process at Inhance, and the environment," EPA alleged.
The public version of EPA's lawsuit does not specify the Inhance chemical it alleges could present risks, instead redacting that information.
But the agency's lawsuit comes two months after two public interest groups — the Center for Environmental Health and Public Employees for Environmental Responsibility — sent EPA and the company letters saying they planned to sue over alleged regulatory violations surrounding Inhance's fluorination process and PFAS exposure.
On Dec. 27, CEH and PEER filed their lawsuit in federal court in the District of Columbia.
It's a complex case but part of the disagreement is over a regulation EPA enacted in 2020, called a significant new use rule, to limit environmental leakage of some long-chain PFAS chemicals under the Toxic Substances Control Act.
The 2020 regulation requires companies to stop making or using certain PFAS chemicals until they notify EPA and the agency determines they are safe.
The environmental groups contend Inhance did not properly submit approval, and EPA's lawsuit, as well, asks the federal court to restrain the company from manufacturing or processing for an unspecified chemical in violation of federal regulations.
EPA said Inhance is violating the federal TSCA law.
"The defendant has and continues to [redacted] in violation of TSCA and its implementing regulations," the EPA's lawsuit said. "Scientific studies have linked exposure to [redacted] with a range of adverse health impacts on humans and animals and harm to the environment."