EPA Grants TSCA Section 21 Petition for PFAS Rulemaking

The U.S. Environmental Protection Agency (EPA) announced on July 11, 2024, that it has granted a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) to require EPA to establish regulations under Section 6 of TSCA prohibiting the production, processing, use, distribution in commerce, and disposal of three perfluoroalkyl and polyfluoroalkyl substances (PFAS) formed during the fluorination of plastic containers. EPA “will promptly initiate appropriate proceedings under Section 6 of TSCA.” According to EPA’s announcement, EPA intends to request information, including the number, locations, and uses of fluorinated containers in the United States; alternatives to the fluorination process that produces perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA); and measures to reduce the risks associated with PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. This action reflects a growing trend of streamlining TSCA’s citizen petition provisions, a topic discussed extensively during our “TSCA Reform—Eight Years Later” program on June 26, 2024.

Background

As reported in our December 7, 2023 blog post, EPA announced on December 1, 2023, that it had issued orders to Inhance Technologies, LLC (Inhance), requiring it not to produce PFAS, “chemicals that are generated during the production of its fluorinated (high-density polyethylene (HDPE)) plastic containers.” The EPA states that in December 2022, Inhance filed Significant New Use Notifications (SNUNs) for nine long-chain PFASs, including PFOA, PFNA, and PFDA. According to EPA, “(u)pon review of the SNUNs and in accordance with EPA’s Framework for Addressing New PFASs and New Uses of PFASs, EPA has determined that three of the PFASs (PFOA, PFNA, and PFDA) are highly toxic and pose an unreasonable risk that cannot be prevented except by a production ban.” Therefore, under Section 5(f) of TSCA, the Environmental Protection Agency (EPA) has banned further production of PFOA, PFNA, and PFDA, which are produced by fluorination of HDPE.

EPA notes that it has also determined that “the remaining six of the nine PFAS chemicals produced by Inhance (PFuDA (perfluoroundecanoic acid), PFDoA (perfluorododecanoic acid), PFTrDA (perfluorotridecanoic acid), PFTeDA (perfluorotetradecanoic acid), PFHxDA (perfluorohexadecanoic acid), and PFODA (perfluoro-n-octadecanoic acid))” may pose an unreasonable risk of harm to health or the environment and is required under Section 5(e) of the TSCA to cease production of these chemicals and conduct additional testing if it intends to resume production. According to EPA, Inhance’s current plastic fluorination process simultaneously produces all nine PFAS chemicals covered by these orders, including PFOA, PFNA, and PFDA. As a result, the Environmental Protection Agency states that “production of the remaining six PFAS substances cannot resume as long as the fluorination process continues to produce PFOA, PFNA, and PFDA.”

Inhance challenged the EPA 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 “first alleged” that Inhance’s fluorination process was subject to the 2020 Significant New Use Rule (SNUR) for Long-Chain Perfluoroalkyl Carboxylate Chemicals. The court states that it agrees with Inhance that EPA “exceeded its statutory authority by issuing the orders under Section 5 rather than Section 6 because Inhance’s forty-year-old fluorination process is not a ‘significant new use’ under TSCA.” Inhance argued that its fluorination process could not be considered new because it is a “decades-old” process that “has not recently come into effect,” while EPA argued that a significant new use is “any use ‘previously unknown to EPA.’” Because Inhance did not identify its fluorination process as a “current use” during the SNUR rulemaking process, EPA argued that the fluorination process qualifies as a significant new use.

The court “hasten[ed]to add that our ruling (prohibiting EPA from issuing the December 2023 orders) does not deprive EPA of its authority to regulate Inhance’s fluoridation process.” According to the court, EPA “may properly proceed, in accordance with the procedural safeguards (of the Administrative Procedure Act (APA)) under Section 6 of TSCA, by conducting among others appropriate cost-benefit analysis required for current use—a proposition that even Inhance acknowledges.” The court notes that EPA “simply has no right to circumvent the framework established by Congress by arbitrarily declaring Inhance’s decades-long fluoridation process a ‘significant new use.’” For more on the court’s decision, see our March 25, 2024, memorandum.

As reported in our April 15, 2024 blog post, Public Employees for Environmental Responsibility (PEER) announced on April 11, 2024, that a coalition of public health groups has filed a TSCA Section 21 petition seeking an immediate halt to the production and distribution of “hundreds of millions of plastic containers containing unsafe levels of perfluoroalkyl and polyfluoroalkyl substances (PFAS) that leach from these containers into household products and the environment.” The petitioners ask the EPA to use its authority under TSCA Section 6 to immediately ban the production of PFOA, PFNA, and PFDA during this fluorination process.

EPA’s Review of TSCA Section 21 Petition

In its July 10, 2024, letter granting the TSCA Section 21 petition, EPA states that the petition “together with information reasonably available to EPA, sets forth facts supporting that it is necessary to initiate an appropriate proceeding under TSCA Section 6 to address PFOA, PFNA, and PFDA formed during the fluorination of plastic containers.” According to EPA, petitioners have presented sufficient evidence to demonstrate that PFOA, PFNA, and PFDA formed during the fluorination of plastic containers pose a hazard. EPA notes that this evidence is contained in two exhibits accompanying the petition:

• A risk assessment developed by the Environmental Protection Agency (EPA) in the context of a review of two consolidated SNUN reports submitted by Inhance regarding nine PFAS substances (including PFOA, PFNA, and PFDA) generated during fluorinated surface coating of HDPE containers for storing fuel and other materials; and
• An order issued by the Environmental Protection Agency (EPA) in December 2023 to address risks identified in a risk assessment. (EPA notes that while the order was reversed by the U.S. Court of Appeals for the Fifth Circuit, the court did not specifically address the conclusions contained in the EPA’s risk assessment.)

EPA states that it has the discretion to consider all reasonably available information when evaluating a petition, “and has done just that in this case.” According to EPA, in its November 2023 “Risk Assessment of Per- and Polyfluoroalkyl Substances (PFAS) in SN-23-0002-0006 and SN-23-0008-0011,” it determined that PFOA, PFNA, and PFDA (of the nine PFAS assessed) are persistent, bioaccumulative, and toxic (PBT) chemicals. EPA concluded that “there are potential or expected emissions of PFOA, PFNA, and PFDA to the environment, and these emissions are likely to result in exposure to humans and aquatic organisms, based on the production, processing, distribution, use, and disposal of fluorinated containers containing these substances. As a result, the Environmental Protection Agency has determined that there are risks of concern associated with the production, distribution, use, and disposal of PFOA, PFNA, and PFDA.

Expected Actions Regarding PFOA, PFNA and PFDA Formed During Fluoridation

EPA states that it will “promptly initiate an appropriate investigation under Section 6 of the TSCA related to the formation of PFOA, PFNA, and PFDA from the fluorination of plastic containers.” As part of this investigation, EPA intends to request information, including the number, locations, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates PFOA, PFNA, and PFDA; and measures to address the risks associated with PFOA, PFNA, and PFDA from the fluorination of plastic containers. According to EPA, “

Comment

The utility of Section 21 of the TSCA Act is considerable. The non-governmental organization (NGO) community has optimized its value more than others. Given the failure of the EPA to Improve In this case, EPA’s granting of this petition is not surprising. It reflects EPA’s willingness to initiate section 6 rulemaking, although it is not its first option, which is precisely what the United States Court of Appeals for the Fifth Circuit told EPA it should have done to address any unreasonable risks associated with these PFAS. An open question is whether the court’s vacating of the orders and SNUNs also invalidates the findings that are the basis for the section 6 rulemaking. It remains to be seen whether the data EPA relied on in granting the petition are sufficient for section 6 purposes. It is also worth noting that EPA intends to obtain information on the number, locations, and uses of fluorinated containers in the United States, information that could be useful to entities outside EPA.

It will be interesting to see how EPA addresses these issues in addition to its regular programs.