Inhance faces EPA, environmental group lawsuits

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."

Inhance has not responded in court but defended its actions in a statement. It said it supports EPA science-based decision making to address PFAS concerns.

"Inhance Technologies believes we have been, and continue to be, in full compliance with all relevant regulations and regulatory guidance, and are operating safely, responsibly and lawfully," it said. "We look forward to resolving this matter as expeditiously as possible and remain committed to protecting human health and the environment."

It said that outside labs it hired after EPA raised concerns found that some PFAS may be unintentionally produced from its manufacturing process.

"The results suggested the potential for certain PFAS to be unintentionally produced in very low concentrations in the fluorination process as secondary reaction products — or impurities — that may remain with the HDPE containers," the company said. "In response, Inhance Technologies developed and readily adopted process enhancements in order to reduce PFAS species down to nondetectable levels."

The company said its hired experts to perform exhaustive risk assessments that have confirmed the safety of its fluorination process for both people and the environment.

And it noted a study it said questioned whether even under "worst-case calculations," the levels of PFAS from fluorinated HDPE pesticide containers would be measurable in a drinking water reservoir.

The environmental groups said the Inhance process is used to treat containers for cleaning supplies, art products, food and household products, but Inhance pushed back on the contention that its process treats food packaging.

"Following several stories inaccurately linking Inhance Technologies' operations to food packaging, we can confirm that the HDPE containers fluorinated by Inhance Technologies are not used as packaging for consumer food and less than 1 percent of those HDPE containers are used by the food industry for additives or similar products," the company said.

A Jan. 9 article in the National Law Review said there have been relatively few citizen lawsuits around TSCA regulations, as CEH and PEER are doing, and it questioned whether byproducts or impurities from a manufacturing process would be covered by the "significant new use" regulations at issue.

The article said the case should be watched closely for TSCA implications.

But the environmental groups said the health risks from the PFAS releases are real.

"This is not an academic violation," said Tim Whitehouse, PEER's executive director and a former EPA enforcement attorney. "The leaching of PFAS from packaging and containers threatens our food supply and exposes all of us to harmful toxic chemicals.

"We are acting now because EPA has dragged its feet in ensuring that Inhance comes immediately into compliance with the law and stopping TSCA violations that represent a serious and ongoing threat to human health," Whitehouse said in a statement.

The groups said EPA and Inhance had been in discussions for two years, and it said EPA only sued after CEH and PEER said they would bring legal action under provisions of the law allowing public interest lawsuits.

The environmental groups want the federal court to restrain Inhance from making PFAS, stop distributing fluorinated containers until it complies with EPA regulations and direct it to tell users of the containers of the risks of PFAS exposure.

CEH called the Inhance fluorinated containers "an ongoing danger to workers, consumers and the environment" and said it could be introducing PFAS into recycling feedstocks.

"The fluorination process contributes to the overall prevalence of this already-ubiquitous class of chemicals, and could be introducing PFAS into the recycling stream, as many of these containers bear recycling symbols," Sarah Packer, director of CEH's petrochemicals, plastics & climate program.

In 2020, Inhance's technology received backing as recyclable from the Association of Plastic Recyclers and Plastics Recyclers Europe.

After their lawsuit, the groups pushed EPA to make more information public on what it knows about Inhance's fluorination process. They sent EPA a letter and Freedom of Information Act request January 5.

"EPA should not use the cloak of confidential business information to hide health and safety dangers from the public," said Colleen Teubner, litigation & policy attorney with PEER. "Studies show that PFAS from these fluorinated containers leaches into the container contents, thus exposing millions around the globe to PFAS."