Overview
On January 26, 2023, the US Environmental Protection Agency (EPA) issued a proposed significant new use rule (SNUR), under the Toxic Substances Control Act (TSCA), for those per- and poly-fluoroalkyl substances (PFAS) that are currently on the TSCA Chemical Substance Inventory but which have not been actively manufactured (including imported) or processed in the US since June 21, 2006 and are consequently designated as inactive on the TSCA Inventory.1 EPA is seeking public comment on the proposal.
For purposes of the proposed SNUR, the definition of PFAS includes chemicals that contain at least one of three structures:
- R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons.
- R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons.
- CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.2
The chemical substances that would be subject to the SNUR are those PFAS that are both currently designated as inactive on the TSCA Inventory and not subject to an existing SNUR, including the existing SNURs at 40 C.F.R. § 721.9582, regarding certain perfluoroalkyl sulfonates, and 40 C.F.R. § 721.10536, regarding long-chain perfluoroalkyl carboxylate chemical substances.3EPA states that there are 330 inactive PFAS that are not subject to an existing SNUR.4The specific chemical identities for 30 of these substances have been claimed as confidential business information and have generic names that do not contain “fluor” or “fluorine.”5 In the public docket for the proposed rule, EPA provided a list of the 300 inactive PFAS that do not mask “fluor” or “fluorine” in the generic name.6
The proposed significant new uses are manufacture (including import) or processing for any use.7The SNUR would require persons that intend to manufacture (including import) or process any of these chemicals for a significant new use to notify EPA at least 90 days before commencing such manufacture (including import) or processing.8Before the manufacture or processing for the significant new use could commence, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury to health or the environment, or take such regulatory action as is associated with an alternative determination.9 Upon the effective date of the final rule, persons who begin commercial manufacturing (including importing) or processing of the chemical substances for a significant new use identified as of January 26, 2023 would be required to cease any such activity, and in order to resume their activities, such persons would need to comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacturing (including importing) or processing have been satisfied.10
EPA is proposing to exempt from the notice requirement “PFAS present as impurities, certain byproducts, and the importing or processing of inactive PFAS-containing articles defined at 40 C.F.R. §§ 721.45(d) through (f).”11
The agency is requesting public comment on the proposed SNUR, and specifically on EPA’s “description of the significant new uses for the chemicals identified, including specific documentation of ongoing uses, if any.”12 The proposed SNUR identifies various additional topics on which EPA is seeking comment. Comments are due by March 27, 2023.
In a press release, Assistant Administrator for the Office of Chemical Safety and Pollution Prevention, Michal Freedhoff, stated that this proposal “is part of EPA’s comprehensive strategy to stop PFAS from entering our air, land and water and harming our health and the planet…The rule would put needed protections in place where none currently exist to ensure that EPA can slam the door shut on all unsafe uses of these 300 PFAS.”13
Endnotes
1 See Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule, 88 Fed. Reg. 4937, 4938 (Jan. 26, 2023), https://www.federalregister.gov/documents/2023/01/26/2023-01156/per--and-poly-fluoroalkyl-chemical-substances-designated-as-inactive-on-the-tsca-inventory.
2 Id. at 4939-40.
3Id. at 4938.
4Id.
5Id.
6 See EPA, List of Select Chemicals Subject to the Proposed Significant New Use Rule Per- and Poly-fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory (created Nov. 2022), https://www.regulations.gov/document/EPA-HQ-OPPT-2022-0867-0003.
788 Fed. Reg. at 4938.
8 Id.
9Id.
10Id. at 4942.
11Id. at 4939.
12 Id. at 4938.
13News Release, EPA, EPA Takes Key Step to Stop Unsafe PFAS from Reentering Commerce (Jan. 27, 2023), https://www.epa.gov/newsreleases/epa-takes-key-step-stop-unsafe-pfas-reentering-commerce.
