On December 27, 2022, the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) filed a lawsuit in the U.S. District Court for the District of Columbia to prevent Inhance Technologies USA from generating per- and polyfluoroalkyl substances (PFAS) when fluorinating plastic containers. According to CEH and PEER’s joint press release, testing conducted by the U.S. Environmental Protection Agency (EPA), Notre Dame researchers, and other organizations “has found PFAS chemicals on the inner and outer surfaces of fluorinated containers and in the contents of the containers. The PFAS in the containers are likely formed as a result of chemical reactions that occur during the fluorination process conducted by Inhance.” According to the press release, Inhance “conducts fluorination operations at several facilities in the U.S. and is the leading supplier of post-mold fluorination services” in the United States. The press release notes that in 2020, EPA issued a significant new use rule (SNUR) under the Toxic Substances Control Act (TSCA) barring firms from producing perfluorooctanoic acid (PFOA) and certain other PFAS until EPA had been notified and determined whether the proposed uses of these PFAS might present an unreasonable risk to health. The press release states that [‌i]n this event, the law required EPA to ban or restrict the PFAS for these uses.” According to the lawsuit, Inhance did not notify EPA in 2020 and has been subsequently manufacturing PFOA and other PFAS in violation of TSCA.

CEH and PEER seek a court order restraining Inhance from continued manufacture of PFAS in violation of the SNUR, “requiring it to stop all distribution of fluorinated containers in commerce until and unless TSCA requirements are met and directing it to inform purchasers and users of these containers of the dangers of exposure to PFOA and other PFAS.”

The press release notes that on December 19, 2022, EPA filed suit against Inhance under TSCA. According to the press release, EPA’s suit “followed nearly two years of discussions between the agency and the company during which Inhance continued to produce PFAS in violation of TSCA without any EPA action to protect the public.” The press release states that EPA filed suit only after CEH and PEER wrote to the agency in late October 2022 “threatening to file suit against the company.” CEH and PEER intend to use their suit to ensure that EPA takes all actions authorized under TSCA “to put a stop to Inhance’s unlawful conduct and prevent unsafe exposure to PFAS by users of fluorinated containers.”

Commentary

This lawsuit raises many interesting issues. TSCA Section 20(b)(1)(B) appears to preclude commencement of a Section 20 action if EPA has commenced and “is diligently prosecuting a proceeding” to issue an order under TSCA Section 16 to require compliance. If the plaintiff has given appropriate notice of its pending action before EPA commences its action, it can, however, intervene in EPA’s action as a matter of right. A factual question relevant here is whether EPA is diligently prosecuting the proceeding. The plaintiff seems to address this issue in paragraph 35 of its complaint:

35. Because of the many redactions in the Complaint and the lengthy two-year delay between EPA’s initiation of discussions with Enhance [sic] and the filing of its suit, plaintiffs are concerned that EPA will not “diligently prosecute” its action in the Eastern District of Pennsylvania, removing a possible bar to plaintiffs’ suit in this Court under TSCA section 20(b)(1)(B) and enabling plaintiffs to seek all relief authorized by law in this action.

In that there have been relatively few TSCA Section 20 citizen actions to compel a person or company to come into TSCA compliance, this case could be one to watch. We question that the plaintiffs have made the case that EPA is not diligently prosecuting the case it filed, especially as only eight calendar days passed between the EPA filing and the plaintiffs’ filings, and that period included the Christmas holiday.

Another interesting issue relates to the likelihood that the manufacturing activities addressed in the complaint preceded proposal of the SNUR such that they would have been considered “ongoing,” thus arguably defeating application of the SNUR restrictions. Whether these activities preceded the proposed SNUR and whether EPA was made aware of this are unclear. Given the circumstances of the byproduct chemicals’ manufacture, it seems reasonable that such production would not be understood to be covered by the SNUR, as discussed further below -- and thus trigger the byproduct manufacturer to comment, noting to EPA the ongoing activity.

Notwithstanding EPA’s apparent position, it is questionable whether byproducts with no intentional use that become impurities in the products being processed and distributed are subject to SNURs. The manufacture of the substances of concern may be considered byproducts exempted by the SNUR. Although the byproduct exemption in Subpart A of Part 721 of the SNUR regulation itself, i.e., 40 C.F.R. Section 721.45(e), appears not to cover the activity, the PMN regulations exempt in 40 C.F.R. Section 720.30(h)(2) “[a]ny byproduct which is not used for commercial purposes.” This particular byproduct exemption appears to cover the byproducts in the facts at play, especially when read in the context of the chapeau to 40 C.F.R. Section 720.30(h) and 40 C.F.R. Section 721.1(c) of the SNUR regulations. which states:

The provisions of part 720 of this chapter apply to this part 721. For purposes of this part 721, wherever the phrase “new chemical substance” appears in part 720 of this chapter, it shall mean the chemical substance subject to this part 721. In the event of a conflict between the provisions of part 720 of this chapter and the provisions of this part 721, the provisions of this part 721 shall govern.

Arguably, there is no conflict between the SNUR regulation and the PMN regulations with regard to the applicability of the exemption at 40 C.F.R. Section 720.30(h)(2) to SNURs. In the absence of a provision making the exemption not applicable in specific SNURs, the exemption would appear applicable (as would other exemptions in 40 C.F.R. Section 720.30(h) that are not specifically replicated in 40 C.F.R. Section 721.45, certain of which we assume EPA even more clearly would not intend to include as covered manufacturing activities for SNUR purposes, e.g., a “chemical substance which results from a chemical reaction that occurs incidental to storage or disposal of another chemical substance, mixture, or article” (40 C.F.R. Section 720.30(h)(4)), which could also become an impurity in a product processed and distributed in commerce.). That the SNUR regulation exemptions duplicate certain PMN exemptions but exclude certain others should not be read to mean those excluded exemptions are not applicable given the language in 40 C.F.R. Section 721.1(c), copied above. Another view is that the manufacture of a substance as a byproduct that becomes an impurity in a product that is processed and distributed in commerce is not subject to the SNUR as the substance is not being manufactured “for any use” within the meaning of the SNUR. It is merely being inadvertently produced. Notwithstanding, we recognize EPA’s authority under TSCA to gather information, assess, and manage any unreasonable risks associated with the activity.

This is an interesting case TSCA mavens should monitor.