On December 1, 2023, the EPA issued orders to Inhance Technologies LLC (Inhance) directing it not to produce per- and polyfluoroalkyl substances (PFAS), chemicals that are created in the production of its fluorinated high-density polyethylene (HDPE) plastic containers.
“This action, taken under the authority of the Toxic Substances Control Act (TSCA), will help protect the public from exposure to dangerous PFAS chemicals in containers used for a variety of household consumer, pesticide, fuel, automotive and other industrial products,” states an EPA news release.
“PFAS should not be in the plastic containers people use every day, period,” said Michal Freedhoff, assistant administrator for the Office of Chemical Safety and Pollution Prevention, in the release. “EPA’s action today is one more way we are furthering the Biden-Harris Administration’s Strategic Roadmap to combat PFAS pollution.”
PFAS are a group of manufactured chemicals that include chemicals known as perfluorooctanesulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and GenX. There are nearly 5,000 different types of PFAS, some of which have been more widely used and studied than others, according to the U.S. Food and Drug Administration (FDA). PFAS are often referred to as “forever chemicals” because of their persistent nature in both the human body and the environment. They also build up in our bodies over time.
“People may be exposed to these PFAS through their drinking water, fish they eat from PFAS-contaminated waters, and through groundwater that has been contaminated by PFAS,” the EPA news release continues. “Centers for Disease Control and other data show that nearly 100% of people tested have at least one of seven of the types of PFAS that Inhance manufactures in their blood already. Even without further exposure, it would take more than a decade for PFOA from a single exposure, one of the types of PFAS manufactured by Inhance, to leave people’s bodies.”
Background
In 2019, the drinking water used by the town of Easton, Massachusetts, tested positive for PFOA, which was traced back to a mosquitocide used by state officials. In September 2020, the EPA was made aware of this PFAS contamination in the mosquitocide. EPA scientists then determined that the PFAS found in the mosquitocide came from the fluorinated HDPE plastic container used to store the product, which was manufactured by Inhance. The EPA determined that when Inhance fluorinates containers, it manufactures many types of PFAS, including PFOA. The EPA announced in March 2021 that these PFAS can migrate into liquid products like pesticides and can continue migrating over time.
“In March 2022, EPA issued a Notice of Violation to Inhance for its failure to notify the Agency before it began manufacturing PFAS,” adds the Agency news release. “Inhance had five years from the proposal of EPA’s long-chain PFAS significant new use rule in 2015 to when it was finalized in 2020 to inform EPA that it was manufacturing long-chain PFAS as part of its process.
“Following this notice, EPA’s Office of Enforcement and Compliance Assurance (OECA) engaged with Inhance to determine if Inhance had ceased manufacture of the regulated PFAS. Upon determining that Inhance was still manufacturing the regulated PFAS and intended to continue to engage in its fluorination process, OECA referred enforcement to the Department of Justice (DOJ) and DOJ filed suit on behalf of EPA against Inhance in December 2022. Only after these actions did Inhance submit significant new use notices (SNUNs) for the nine PFAS it manufactures to EPA for review on Dec. 30, 2022.”
Consequences
Upon review of the SNUNs and consistent with the Framework for Addressing New PFAS and New Uses of PFAS, the EPA determined that three of the PFAS (PFOA, perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA)) are highly toxic and present unreasonable risks that can’t be prevented other than through prohibition of manufacture.
“Therefore, under TSCA section 5(f), EPA is prohibiting the continued manufacture of PFOA, PFNA and PFDA that are produced from the fluorination of HDPE,” the release continues. “The EPA also determined that the remaining six of the nine PFAS chemicals manufactured by Inhance may present an unreasonable risk of injury to health or the environment and, under TSCA section 5(e), is requiring the company to cease manufacture of these chemicals, and to perform additional testing if it intends to restart production. However, Inhance’s current fluorination process for plastics produces all nine of the PFAS chemicals subject to these orders simultaneously, including PFOA, PFNA, and PFDA. Thus, the production of the other six PFAS could not restart so long as the fluorination process continues to produce PFOA, PFNA and PFDA. These orders become effective February 28, 2024.”
Alternatives to this fluorination process exist that will allow for many sectors to continue to provide products with the necessary protective packaging. Inhance has stated it’s working on changes to its process, with a stated goal of eliminating all PFAS production, according to the EPA.
“As always, EPA will review options for ensuring compliance with the orders, consistent with its enforcement policies, either through further litigation or an appropriate settlement,” according to the Agency release. “EPA also notes that TSCA provides waivers for national defense purposes.”