/>iOn September 30, 2024, the U.S. Environmental Protection Agency (EPA) requested public comment on the manufacture of certain per- and polyfluoroalkyl substances (PFAS), including perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA), during the fluorination of high-density polyethylene (HDPE) and other plastic containers to inform regulations as appropriate under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 79581. EPA notes that this request for comment follows its grant on July 10, 2024, of a TSCA Section 21 petition requesting that EPA establish regulations under TSCA Section 6 prohibiting the manufacturing, processing, use, distribution in commerce, and disposal of PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. Comments are due November 29, 2024.
Background
As reported in our December 7, 2023, blog item, EPA announced on December 1, 2023, that it issued orders to Inhance Technologies, L.L.C. (Inhance) directing it not to produce PFAS, “chemicals that are created in the production of its fluorinated [HDPE] plastic containers.” EPA states that in December 2022, Inhance submitted significant new use notices (SNUN) for nine long-chain PFAS, including PFOA, PFNA, and PFDA. According to EPA, “[u]pon review of the SNUNs and consistent with EPA’s Framework for Addressing New PFAS and New Uses of PFAS, EPA has determined that three of the PFAS [PFOA, PFNA, and PFDA] are highly toxic and present unreasonable risks that cannot be prevented other than through prohibition of manufacture.” Therefore, under TSCA Section 5(f), EPA prohibited the continued manufacture of PFOA, PFNA, and PFDA that are produced from the fluorination of HDPE.
EPA notes that it also determined that “the remaining six of the nine PFAS chemicals manufactured by Inhance (PFuDA [perfluoroundecanoic acid], PFDoA [perfluorododecanoic acid], PFTrDA [perfluorotridecanoic acid], PFTeDA [perfluorotetradecanoic acid], PFHxDA [perfluorohexadecanoic acid] and PFODA [perfluoro-n-octadecanoic acid])” may present an unreasonable risk of injury to health or the environment and, under TSCA Section 5(e), is requiring Inhance to cease manufacture of these chemicals and to perform additional testing if it intends to restart production. According to EPA, Inhance’s current fluorination process for plastics produces all nine of the PFAS chemicals subject to these orders simultaneously, however, including PFOA, PFNA, and PFDA. Thus, EPA states, “the production of the other six PFAS could not restart so long as the fluorination process continues to produce PFOA, PFNA and PFDA.”
Inhance challenged EPA’s orders, and on March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit vacated them. The court notes that in March 2022, EPA “charged for the first time” that Inhance’s fluorination process was subject to the 2020 significant new use rule (SNUR) regarding long-chain perfluoroalkyl carboxylate chemical substances. The court states that it agrees with Inhance that EPA “exceeded its statutory authority by issuing orders under Section 5 instead of Section 6 because Inhance’s forty-year-old fluorination process is not a ‘significant new use’ under TSCA.” Inhance maintained that its fluorination process cannot be considered new because it is a “decades-old” process that did not “recently come into existence,” while EPA argued that a significant new use is “any use ‘not previously known to the EPA.’” Because Inhance did not identify its fluorination process as an “ongoing use” during the SNUR rulemaking process, EPA argued that the fluorination process qualified as a significant new use.
The court “hasten[s] to add that our ruling [prohibiting EPA’s December 2023 orders] does not render the EPA powerless to regulate Inhance’s fluorination process.” According to the court, EPA “can properly proceed, abiding the [Administrative Procedure Act’s (APA)] procedural guardrails, under TSCA’s Section 6 by conducting inter alia the appropriate cost-benefit analysis required for ongoing uses — a proposition even Inhance concedes.” The court notes that EPA “is just not allowed to skirt the framework set by Congress by arbitrarily deeming Inhance’s decades-old fluorination process a ‘significant new use.’” More information on the court’s decision is available in our March 25, 2024, memorandum.
As reported in our April 15, 2024, blog item, the Public Employees for Environmental Responsibility (PEER) announced on April 11, 2024, that a coalition of public health groups filed a TSCA Section 21 petition seeking to stop immediately the manufacture and distribution of “hundreds of millions of plastic containers with dangerous levels of per- and polyfluoroalkyl substances (PFAS) that leach from these containers into household products and the environment.” Petitioners ask EPA to use its TSCA Section 6 authority to prohibit immediately the production of PFOA, PFNA, and PFDA during this fluorination process. More information on EPA’s approval of the petition is available in our July 16, 2024, memorandum,
Request for Comment
EPA states that it seeks information on the manufacture of PFAS, including PFOA, PFNA, and PFDA, during the fluorination of HDPE and other plastic containers. EPA is particularly interested in:
- The number, location, and uses of fluorinated containers in the United States, including any uses critical to the national economy, national security, or critical infrastructure (which may include uses in medical devices);
- Alternatives to the fluorination process that generates PFAS, including PFOA, PFNA, and PFDA; and
- Measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers.
To the extent possible, EPA asks commenters to cite and provide any public data related to or that support comments provided, and to the extent permissible, describe and provide any supporting data that are not publicly available.
Commentary
Bergeson & Campbell, P.C. (B&C®) eagerly awaits the public comments on EPA’s notice. This is a unique situation because it is unclear whether EPA has the authority under TSCA Section 6 to move straight to rulemaking, given the available fact set. EPA cites to TSCA Section 6(a) as the basis for its authority for this action in the Federal Register notice. EPA does not, however, cite to TSCA Section 5(f), which authorizes EPA to issue a proposed rule under TSCA Section 6(a) after it makes a “presents unreasonable risk” determination and without first performing a risk evaluation in accordance with TSCA Section 6(b)(4)(A).
The Fifth Circuit concluded that the language in TSCA Section 5 “plainly prohibits the EPA’s December 2023 orders aimed at Inhance.” The vacated TSCA Section 5(f) order states that “EPA reserves the right, at any time, to issue a rule under Section 6 of TSCA, 15 U.S.C. § 2605, to regulate any of the SNUN Chemical Substances if EPA determines that any of the SNUN Chemical Substances present an unreasonable risk of injury to health or the environment…” While it is true that EPA can initiate prioritization under TSCA Section 6, it is less clear that EPA can use the TSCA Section 5(f) determinations to proceed directly to TSCA Section 6(a) rulemaking under TSCA Section 5(f)(2). The court’s decision mooted the SNUNs that led to the TSCA Section 5(f) orders. It remains to be seen whether the outcome of the mooted SNUNs provide EPA with the scientific and legal predicate for moving directly to TSCA Section 6(a) rulemaking. We suspect that EPA recognizes that its vacated TSCA Section 5(f) order and determination that the subject PFAS “presents an unreasonable risk of injury to health or the environment” lacks precedential authority. EPA stated that “This Order does not affect EPA’s ability to seek information regarding TSCA-regulated chemicals, including the SNUN Chemical Substances.” We note that the scope of EPA’s request for comment in the Federal Register notice was limited to information gathering, an action that is not bound by the vacated TSCA Section 5(f) order. Gathering this information may help remediate one of the weaknesses of the TSCA Section 5(f) order — that EPA did not conduct its standard risk calculations in which EPA compares the hazard Point(s) of Departure (POD) with a predicted exposure. EPA provided PODs but did not predict exposures.
We anticipate that EPA will not move forward with issuing a direct risk management rule on the PFAS subject to the vacated TSCA Section 5(f) order. EPA’s grant of the TSCA Section 21 petition provides some indications for this. For example, EPA states that its grant of the petition “does not signal that EPA will ultimately take any particular final agency action.” EPA also references its risk assessment on the SNUR substances and its conclusion that “there is risk of concern,” but it does not reference its risk determination (i.e., “presents an unreasonable risk”) from the vacated TSCA Section 5(f) order. Finally, EPA states that it “will promptly commence an appropriate proceeding under TSCA Section 6 associated with the formation of PFOA, PFNA, and PFDA during the fluorination of plastic containers. As part of that proceeding, the EPA intends to request information…[emphasis added].” We agree that the sensible step at this point is to seek additional information on container fluorination, how byproduct PFAS are prevented or reduced, how such containers are used, what alternatives exist, and the advantages and drawbacks of those alternatives.
