Tag Archive for: Plastic Fluorination

EPA Grants Petition to Address PFAS Created by Plastic Fluorination

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On July 10, 2024, EPA granted a citizen petition from environmental groups encouraging EPA to take Toxic Substances Control Act (TSCA) section 6 action for three PFAS substances produced during the fluorination of plastic containers.

The petition alleges that the three PFAS—PFOA, PFNA, and PFDA—pose a variety of serious human health hazards, even at extremely low exposures.  The petition cites EPA’s December 2023 response to significant new use notices filed by Inhance Technologies (“Inhance”), a fluorination company, for substances including PFOA, PFNA, and PFDA.  As discussed in a previous blog post, EPA found that Inhance’s production of the three PFAS presents an unreasonable risk and ordered Inhance to stop producing the chemicals under TSCA section 5, which allows EPA to regulate new substances and significant new uses.

Inhance challenged EPA’s order.  In March, the Fifth Circuit ruled that EPA could not regulate Inhance under TSCA section 5 because Inhance’s fluorination process had been in place for decades; a blog post on the decision can be found here.  However, the court noted that EPA is free to regulate Inhance’s fluorination process under section 6, which allows EPA to restrict existing substances.  Unlike section 5, section 6 requires EPA to conduct a cost-benefit analysis that considers a substance’s benefits and what the economic consequences of regulation would be.

In its letter granting the petition, EPA said that the agency will initiate “an appropriate proceeding under TSCA Section 6 associated with the formation” of the three PFAS during plastic container fluorination.  As part of the proceeding, “EPA intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates PFOA, PFNA, and PFDA; and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers.”

Fifth Circuit TSCA Ruling: Established Process Not a “New Use”

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A decades-old manufacturing process cannot constitute a significant new use under TSCA, the US Court of Appeals for the Fifth Circuit ruled on March 21, 2024, in the case Inhance Techs. v. EPA.

Inhance Technologies LLC (“Inhance”) has strengthened plastic containers using the same fluorination process since 1983.  Unbeknownst to Inhance and EPA until March 2022, the fluorination process resulted in the creation of multiple PFAS chemicals that were included in a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate substances, which took effect in September 2020.

When EPA detected PFAS in a container manufactured by Inhance, it issued the Texas-based company a notice of violation of the SNUR because Inhance had not filed significant new use notices (SNUNs) for the PFAS created during the fluorination process.  EPA instructed Inhance to stop or change the fluorination process so that it no longer created PFAS.  Inhance filed two SNUNs in December 2022 but continued fluorinating plastic containers using the same process.  Following review of the SNUNs, in December 2023, EPA issued two orders under TSCA sections 5(e) and 5(f) prohibiting Inhance from manufacturing or processing PFAS through their fluorination process.  In response, Inhance successfully petitioned the Fifth Circuit for expedited review and a stay pending appeal, stating that the company would be forced to shut down if the orders were put into effect.

Inhance argued that EPA’s orders were unlawful for three reasons.  First, Inhance argued that its fluorination technology could not be understood as a “new” use under TSCA because it had been ongoing for over thirty years before EPA finalized the SNUR.  Second, Inhance argued that the PFAS created during the fluorination process constituted impurities, which are exempted from the scope of the SNUR.  Finally, Inhance argued that EPA’s interpretation of the SNUR as applying to all industries is a “reinterpretation” for which Inhance had not received fair notice.

In the end, the court did not address Inhance’s second and third points, finding the first argument sufficient to vacate EPA’s orders.  Though the statute does not define “new,” the court found Inhance’s interpretation, “not previously existing,” more compelling than EPA’s interpretation, “not previously known to the EPA,” for multiple reasons.  But ultimately, the court just did not think EPA’s interpretation was sensible, stating that it “lacks intuitive force.”  Inhance could not have been expected to submit its fluorination process as an ongoing use during the rulemaking process for the SNUR because it did not know that it created PFAS at that time, the court said.

Writing on behalf of the three-judge panel, Judge Cory T. Wilson concluded by stating that EPA is not powerless to regulate Inhance’s fluorination process.  TSCA section 6 allows for regulation of all chemical substances, unlike section 5, which only applies to new substances and significant new uses.  However, unlike section 5 rulemaking, section 6 requires EPA to conduct a cost-benefit analysis, which takes into account the substance’s benefits and economic considerations.  The court stressed that this requirement indicates that Congress wanted EPA to give more thoughtful consideration to the impact of its regulations on preexisting manufacturing processes.

Judge Wilson was joined by Chief Judge Priscilla Richman and Judge James E. Graves Jr., who concurred in the judgment only.

PEER and CEH Request Court Injunction Against EPA

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On February 15, 2024, the Public Employees for Environmental Responsibility (PEER) and the Center for Environmental Health (CEH) filed a lawsuit against EPA in the U.S. District Court for the District of Columbia stating that EPA failed to comply with a Freedom of Information Act (FOIA) request. The two nonprofit environmental groups said in their claim that they had filed a FOIA request on January 5, 2023, for numerous documents regarding Per-and Polyfluoroalkyl Substances (PFAS), specifically long-chain perfluoroalkyl carboxylate (LCPFAC) substances, created during the fluorination of plastic containers by Inhance Technologies LLC. PEER and CEH claim EPA failed to comply with the FOIA request and are now requesting an injunction for the courts to order EPA to disclose all the documents.

In their complaint, the two groups asserted that a document-by-document review by EPA is inefficient and unnecessary and requested that EPA instead adopt a class determination to expedite disclosure. PEER and CEH acknowledge they have received four interim releases but have yet to receive the full release and “unredacted documents have been produced in accordance with the disclosure requirements of section 14 of TSCA”.

The complaint details the timeline of EPA’s response to the FOIA request.  PEER and CEH note that EPA used an “Unusual Circumstances” exception to the standard time allowed for responding to a FOIA with a new estimated competition date of August 3, 2023. A Continuing Unusual Circumstance letter from EPA pushed the response date back further to December 1, 2023. This is an issue of contention for PEER and CEH, as they state that the FOIA statute allows for 20 working days to comply with FOIA requests and only an additional 10 working days for unusual circumstances. 5 U.S.C. § 552(a)(6). Therefore, according to PEER and CEH, the original competition date should have been February 2, 2023, and then adjusted to February 16, 2023 after including 10 working days for unusual circumstances.

EPA Orders Plastic Fluorination Company to Stop Producing PFAS

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Inhance Technologies LLC (“Inhance”) must stop producing PFAS substances created during its fluorination of high-density polyethylene plastic containers, according to two orders issued by EPA on December 1, 2023.

EPA first became aware of PFAS contamination in fluorinated plastic containers in late 2020.  In March 2022, EPA issued a Notice of Violation to Inhance for creating these PFAS in alleged violation of a significant new use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) substances.  The Texas-based company submitted significant new use notices for nine such substances in December 2022 but has continued fluorinating containers nonetheless.

Three of these significant new use notices are addressed in the first order, which was issued under section 5(f) of the Toxic Substances Control Act (TSCA).  EPA determined that these substances—PFOA, PFNA, and PFDA—present an unreasonable risk due to their persistence, bioaccumulation, and toxicity that can only be prevented by prohibiting their manufacture.

The second order, issued under TSCA section 5(e), addresses the six remaining PFAS: PFuDA, PFDoA, PFTrDA, PFTeDA, PFHxDA and PFODA.  EPA determined that these substances may present an unreasonable risk, and the order prohibits their manufacture until certain testing be submitted to and evaluated by the Agency.

In response to the orders, which take effect February 28, 2024, Inhance stated that “the company will pursue all legal options to protect its customers, suppliers, and employees and to ensure the continued operations of this environmentally critical technology.”

The orders are likely to impact ongoing litigation between EPA and Inhance.  In December 2022, EPA sued Inhance for allegedly violating the LCPFAC SNUR.  Inhance has maintained that its fluorination process is legal, arguing that any PFAS present after fluorination are unintended impurities exempt from the SNUR.  More information on that case can be found in a previous Verdant Law blog post.

Fluorination, or the treatment of plastic with fluorine gas, makes containers less permeable.  According to an EPA press release, Inhance fluorinates up to 200 million containers per year.

Environmental Groups Call on FDA to Revoke Approval of Fluorinated Plastic for Food Contact

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A coalition of environmental and health groups led by the Environmental Defense Fund have petitioned the Food and Drug Administration (FDA) to revoke approval of fluorinated polyethylene as an indirect food additive.  According to the petition, manufacture of fluorinated polyethylene produces PFAS, including harmful perfluoroalkyl carboxylic acids if water or oxygen is present.

FDA approved fluorinated polyethylene as an indirect food additive—a substance that comes into contact with food, but is not intended to be added directly to food—in 1983.  Since then, according to the petition, the dangers of even minimal exposures to PFAS have become clear, and studies have demonstrated that fluorinated polyethylene results in PFAS migration into food.

The petitioners argue that the substance can no longer be considered “safe” as defined at 21 CFR 170.3(i), which requires “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.”  The Agency must consider the following factors when determining whether this safety standard is met:

  • The probable consumption of the substance and any substance formed in or on food because of its use.
  • The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in the diet.
  • Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food ingredients, are generally recognized as appropriate.

The petitioners also claim that revoking approval for fluorinated polyethylene is the logical consequence of a previous FDA statement on the substance.  In a 2021 public letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles, the Agency stated that its regulations “[do] not authorize fluorination of polyethylene containers in the presence of water, oxygen, or gases other than nitrogen.”  The petition, however, alleges that all nitrogen gas contains water and oxygen as impurities.  “If FDA is serious about its claim that no oxygen or water may be present in the nitrogen gas, then the agency has effectively determined that the 1983 approval should be revoked,” the petitioners state.

The petition comes after a July 2022 FDA request for information on food contact uses of fluorinated polyethylene due to PFAS concerns.

TSCA Enforcement Action Taken Over Failure to Comply with PFAS SNUR

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In December 2022, two separate lawsuits were filed against Inhance Technologies USA regarding its alleged production of certain PFAS substances in violation of the Toxic Substances Control Act (“TSCA”). These lawsuits are important as they raise novel questions of TSCA interpretation and enforcement.

The first lawsuit was filed by the U.S. Department of Justice, Environment and Natural Resources Division on behalf of the U.S. Environmental Protection Agency (“EPA”).  The second case is a citizen suit filed by the non-profit organizations Center for Environmental Health (“CEH”) and Public Employees for Environmental Responsibility (“PEER”). U.S. v. Inhance Technologies LLC, U.S. Eastern District of Pennsylvania, Case No. 2:22-cv-05055; Center for Environmental Health v. Inhance Technologies USA, U.S. District Court for the District of Columbia, Case No. 1:22-cv-03819. It is rare that EPA pursues TSCA enforcement actions in federal court. Similarly, the citizen suit provision of TSCA is exercised infrequently.

Defendant Inhance Technologies USA (“Inhance”) is a Texas-based corporation that treats plastic containers, including high-density polyethylene (HDPE), using a fluorination process. Inhance is the principal supplier of post-mold fluorination services in the United States.

According to the Complaints, Inhance has been in violation of the Long-Chain Perfluoroalkyl Carboxylate (“LCPFAC”)  Significant New Use Rule (“SNUR”) that requires manufacturers to file a Significant New Use Notice (“SNUN”) for any manufacturing (including importing) or processing of an LCPFAC for which there were no ongoing uses as of January 21, 2015. See 40 CFR 721.10536. This includes substances that are typically exempt byproducts under TSCA and LCPFACs that are imported as part of articles. Inhance allegedly violated two SNUR requirements.  The complaints assert that Inhance failed to submit a SNUN for LCPFAC substances formed during the fluorination of plastic containers at least 90 days prior to the manufacture of these substances. The second violation charged is the company’s manufacture of these substances before completion of the requisite 90-day SNUN review period.

Inhance received warning of its violation of the LCPFAC Rule by the Plaintiffs of each lawsuit months prior to litigation. The lawsuits follow a March 2022 letter EPA sent to the HDPE industry. EPA issued the letter, first “to remind industry of this issue to help prevent unintended PFAS formation and contamination,” and second, to “emphasize the requirement under TSCA as it related to PFAS and fluorinated polyolefins.” In its letter, EPA reminded the industry of the SNUR, highlighting that while LCPFAC chemical substances are byproducts of the fluorination process from the chemical and commercial standpoint, these substances are not eligible for the byproducts exemption in 40 CFR § 721.45(e). The Agency letter further encouraged the industry to pursue alternative fluorination processes which are less likely to foster unintentional PFAS creation. EPA’s lawsuit is its first enforcement matter against the HDPE industry following the Agency’s warnings.

In March 2022, EPA issued a Notice of Violation (NOV), requesting that Inhance provide the Agency with additional information on changes the company may have made to the HDPE fluorination process that would eliminate PFAS production. The NOV stated that if no changes to the manufacturing process had been made, Inhance would need to immediately cease manufacturing PFAS and submit a SNUN to the Agency for review. Agency review of the information submitted by the company confirmed that the company was producing substances that are subject to the LCPFAC Rule.

In September 2022, Inhance notified EPA that it intended to submit a SNUN for its fluorination processes, but that it was unwilling to cease its fluorination processes before or during the EPA SNUN review period. Inhance has consistently maintained that it believes its operations are in full regulatory compliance.

EPA’s lawsuit was filed on December 19, 2022, with the non-profit lawsuit following about a week behind. The Complaints allege a variety of TSCA violations, namely the following:

  • Section 5(a)(1) of TSCA, which states no person may manufacture or process a chemical substance for a significant new use unless (1) that person submits a Significant New Use Notice (“New Use Notice”) to the EPA; (2) the EPA reviews that notice; and (3) the EPA makes a determination on that use under Section 5(a)(3) of TSCA, 15 U.S.C. § 2604(a)(3). 15 U.S.C. § 2604(a)(1).
  • Title 40 C.F.R. § 721.25 prescribes similar requirements for any person seeking to engage in a significant new use of a chemical substance.
  • Section 15 of TSCA, which states that it is a prohibited act to fail or refuse to comply with any requirement of TSCA or any rule promulgated under TSCA. 15 U.S.C. § 2614.
  • Under 40 C.F.R. § 721.35, it is a violation of Section 15 of TSCA to fail to comply with any provision of Title 40, Part 721 of the regulations implementing TSCA.

Plaintiffs in both cases are seeking declaratory and injunctive relief under Section 15(a) of TSCA (15 U.S.C. § 2616(a)) and the Declaratory Judgment Act (28 U.S.C. § 2201) for Inhance to cease production of all products using the PFAS forming fluorination process. To resume production, Inhance must demonstrate to EPA that it has altered its production process to eliminate PFAS production.

Case Update

In April 2023, the U.S. District Court of the District of Columbia dismissed the lawsuit brought by CEH and PEER. Shortly after CEH and PEER filed their lawsuit, Inhance filed a motion to dismiss the case arguing that the lawsuit was inappropriate under TSCA’s diligent prosecution bar. DOJ filed an amicus brief supporting Inhance’s motion to dismiss. For the CEH and PEER lawsuit to proceed, the organizations would have needed to demonstrate that DOJ was not diligently prosecuting the case. The court granted Inhance’s motion stating that “[n]othing in the eight days between when DOJ filed its lawsuit and when the Plaintiffs filed theirs suggests that [DOJ] was not diligently prosecuting the case.”

On June 13, the court presiding over the DOJ lawsuit scheduled oral arguments for August 23, 2023.

EPA Evaluation of PFAS Leaching in Fluorinated Containers

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On September 8, 2022, EPA announced findings of the Agency’s evaluation of PFAS leaching in fluorinated containers.  Specifically, the evaluation assessed the extent to which PFAS that are present in the packaging leach into the contents of the containers.  The study tested the leaching potential of PFAS over a 20-week test period into water, methanol and similar solutions that were packaged in different brands of HDPE fluorinated containers.  EPA undertook this evaluation after learning of PFAS contamination in some mosquitocide products, and after conducting a study of other pesticides stored in fluorinated high-density polyethylene containers.   In both cases the Agency found varying levels of PFAS in the contents of the containers.

The announcement reported that EPA has determined that any liquid products packaged in HDPE containers that have been treated with fluorination technology could be contaminated with PFAS, including water-based products.  The Agency also reported that the amount of PFAS that leach into the products could increase over time.   EPA noted that the Agency does not know if all fluorinated containers will leach PFAS because the Agency’s analysis did not test all the different fluorination technologies.

The announcement included a reminder that pesticide registrants must notify the Agency if they discover PFAS in any of their products.  Under FIFRA §6(a)(2) and 40 CFR §159.179, “additional factual information on unreasonable adverse effects, including metabolites, degradates and impurities (such as PFAS)” must be reported to EPA within 30 days after the registrant “first possesses or knows of the information.”  Note that the Agency considers any level of PFAS to be potentially toxicologically significant and therefore reportable.

The announcement also noted that in many cases, the manufacture of PFAS from the fluorination of polyolefins is subject to the Agency’s significant new use rule  for long-chain perfluoroalkyl carboxylates (LCPFACs) under the Toxic Substances Control Act (TSCA).  Companies must notify EPA at least 90 days before starting manufacturing or processing of these chemical substances for this significant new use.  TSCA requires significant new use notification in these situations to allow EPA review any associated risks and impose any needed protections.