March 28, 2023

Volume XIII, Number 87


March 27, 2023

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EPA Proposes to Bar Manufacturing and Processing of 300 PFAS Assumed to be Out of Commerce

The U.S. Environmental Protection Agency (EPA) recently proposed a Toxic Substances Control Act (TSCA) Significant New Use Rule (SNUR) to block companies from manufacturing, importing, or processing over 300 per- and polyfluoroalkyl substances (PFAS) listed on the TSCA Inventory but assumed not to be moving within U.S. commerce because the substances are designated on the Inventory as “inactive.” Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule, 88 Fed. Reg. 4937 (proposed Jan. 26, 2023). Before manufacturing, importing, or processing any of these substances, a company would first be required to prepare and submit a Significant New Use Notice (SNUN) and then await EPA’s review and risk determination. At that time, EPA may elect to impose any of a wide range of risk management measures, if the Agency allows the substance to return to commerce at all. EPA is accepting comments on the proposal until March 27, 2023 (60 days).

Scope of Proposed Rule

EPA defines the category of PFAS that would be covered by the rule as those that are (1) listed on the TSCA Inventory, (2) designated as “Inactive” as of the rule proposal date, (3) not already subject to another individual or categorical PFAS SNUR (e.g., 40 C.F.R. §§ 721.9582 (Certain perfluoroalkyl sulfonates) and 721.10536 (Long-chain perfluoroalkyl carboxylate chemical substances)), and (4) containing one or more of the following 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; or

  • CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons. 

This proposed definition excludes “lightly fluorinated” substances (containing only unconnected CF2 or CF3 moieties), those having only a single fluorinated carbon, and unsaturated fluorinated moieties. These forms are expected by EPA to be less persistent in the environment. EPA has identified the 330 chemicals that it believes meet these criteria. All are listed in the docket (HQ-OPPT-2022-0867), except for 30 for which both the specific identity and “fluor” in a generic name have been claimed as CBI.


Even if a PFAS meets the definitional criteria noted above, a company’s specific use may still be exempt from the proposed SNUR if it meets any of the standard SNUR exemptions. These include exemptions for substances manufactured for R&D, as impurities, or as a byproduct that is burned as fuel or disposed of as waste, or solely for export. And unlike EPA’s other categorical PFAS SNUR (40 C.F.R. § 721.10536 (Long-chain perfluoroalkyl carboxylate chemical substances)), the exemption for substances imported or processed as part of an article also would apply. These SNUR exemptions are narrower than the exemptions from PMN notice requirements (40 C.F.R. § 720.30) and the Active-Inactive rule reporting exemptions (40 C.F.R. § 710.27).

Why it Matters

A primary concern with any SNUR issued for existing chemicals already in commerce is that the rule would effectively bar or restrict an ongoing use of a substance. In principle, ongoing uses cannot be regulated by a SNUR; SNURs may reach only uses that have never been practiced or that have been fully discontinued in the U.S. However, if EPA is not aware of ongoing use, it may act to restrict it with a SNUR. Therefore, it is critical for users to identify and alert EPA during the rulemaking of any ongoing uses of a chemical proposed for SNUR regulation. This rule would include any manufacturing, processing, or use of a covered PFAS chemical for a non-exempt purpose. 

A PFAS chemical on the Inventory may be erroneously listed as “Inactive.” Many individual substances were inadvertently overlooked during the Active-Inactive TSCA Inventory reset process in 2017-2018. A (proposed) SNUR substance’s “Inactive” status also may be mischaracterized if it were manufactured or processed during the reset “lookback period” only in a manner that was exempt from Active-Inactive rule reporting. For example, Inventory-listed chemicals manufactured only as non-isolated intermediates or as impurities were exempt from the Active-Inactive rule and would not have been reported as “Active.” If these were subject to the proposed SNUR, continued manufacture as an impurity would be unaffected because impurities are exempt from the SNUR. However, non-isolated intermediates are not exempt from SNURs. It will be important to alert EPA to any ongoing non-isolated intermediate use so that it may be excluded from EPA’s efforts to prohibit all non-exempt uses of the substances. 

PFAS in Articles

Comments also should address any use of the targeted substances in articles. Although the proposed SNUR would exempt substances imported or processed as part of an article, the proposal explains that the Agency considered negating the article exemption but opted to defer such action to a later date when EPA has knowledge of whether such uses are ongoing. To foreclose EPA’s elimination of the article exemption, companies should indicate to EPA where this use is ongoing.

Proper Characterization and Treatment of Byproducts

A similar issue is presented for some “byproducts.” The Active-Inactive rule exempted from reporting two types of byproducts: (1) “any byproducts not used for commercial purposes,” as defined by 40 C.F.R. § 720.3(h)(2), and (2) byproducts as defined in § 720.30(g), which are used commercially only by being burned as fuel, disposed of as a waste, or used as a source for extracting other chemical substances. In contrast, only one of these “byproduct” types is exempt from SNUR restrictions. “[B]yproducts not used for commercial purposes,” as defined by 40 C.F.R. § 720.3(h)(2), are not expressly exempt, and EPA recently asserted in a September 8, 2022 compliance advisory that such § 720.3(h)(2) byproducts are not treated as impurities and are not exempt from SNURs generally. The broader significance of the “byproducts” exemption issue was discussed in an October 2022 Keller and Heckman TSCA 30/30 presentation and is relevant for all SNUR chemicals. 

In the case of this proposed SNUR, the immediate concern is that certain industries may inadvertently generate or import in formulations containing constituents EPA views as non-exempt “byproducts,” indistinguishable from impurities and in violation of the SNUR when final. This may be a particular concern for industries (such as drinking water systems) using highly reactive ozone or chlorine chemistries, or for fluorine chemistries that may generate PFAS byproducts or impurities. Given the difference between the Active-Inactive and SNUR general provisions exemptions, EPA is seeking comment about whether all byproduct forms should be exempt from the proposed SNUR.

© 2023 Keller and Heckman LLPNational Law Review, Volume XIII, Number 31

About this Author

 Thomas C. Berger, Keller Heckman, Environmental Protection lawyer, Product Liability Management Attorney

Tom Berger joined Keller and Heckman in 1993. Mr. Berger is a partner in Keller and Heckman's Washington DC office and heads Keller and Heckman's Indianapolis satellite office.

Mr. Berger has extensive experience in representing foreign and domestic companies, large and small, in a broad range of areas, including counseling, advocacy, and rulemaking in environmental law, occupational safety and health law, contracts, EPA enforcement proceedings, and chemical and product liability management. Mr. Berger assists clients in bringing new products to...

Gregory A. Clark, Keller Heckman, EPA Contractor Lawyer, Environmental matters Attorney

Gregory Clark joined Keller and Heckman in 2010. He practices in the area of environmental law.

While in law school, Mr. Clark served as an articles editor for the Virginia Journal of Law and Technology. Prior to law school, Mr. Clark worked as an EPA contractor, primarily for the Water Security Division in the Office of Groundwater and Drinking Water. In this arena, Mr. Clark worked on validation of molecular biology and microbiology methods and on emergency preparedness. He led development of what is now EPA's Water Laboratory Alliance...

Herbert Estreicher Ph.D., Keller Heckman, International Regulation Lawyer, Environmental law Attorney

Herbert Estreicher, Ph.D. joined Keller and Heckman in 2003. He has a broad practice in international environmental regulatory law.

Dr. Estreicher has an interdisciplinary approach combining law and science. He represents leading manufacturers of chemicals, pesticides, insect repellents, food additives, and consumer products before Federal and State regulatory agencies.

Dr. Estreicher provides advice on product liability risk control and assists clients with crisis management for embattled products, including...

votaw, KH, portrait

James Votaw has an extensive practice focusing on environmental and health and safety regulation.Within that arena, he concentrates on the regulation of conventional and nanoscale chemicals, pesticides, consumer and industrial products, and industrial processes and wastes.

For his clients, Mr. Votaw obtains pre-market product approvals and exemptions, including the first U.S. approval of a nanoscale pesticide. He negotiates testing orders, defends enforcement actions, advises on restrictions and disclosures associated with the chemical content...

David B. Fischer Counsel Keller and Heckman

David Fischer advises clients on environmental, policy, and health and safety matters, with a concentration on the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). In addition, he has extensive experience with numerous other statutes including the Clean Air Act (CAA), Clean Water Act (CWA), Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), Safe Drinking Water Act (SDWA), and the Emergency Planning and Community Right-to-Know Act (EPCRA), Food Quality Protection Act (FQPA).