On January 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed a significant new use rule (SNUR) for those per- and polyfluoroalkyl substances (PFAS) that are currently on the Toxic Substances Control Act (TSCA) Inventory but that have not been actively manufactured (including imported) or processed in the United States since 2006 and are consequently designated as inactive on the TSCA Inventory. 88 Fed. Reg. 4937. Persons subject to the SNUR would be required to notify EPA at least 90 days before commencing any manufacture (including import) or processing of the chemical substance for a significant new use. Once EPA receives a notification, EPA must review and make an affirmative determination on the notification, and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. EPA states that such a review will assess whether the use may present unreasonable risk to health or the environment and ensure that EPA can prevent future unsafe environmental releases of the PFAS subject to this SNUR. Comments on the proposed SNUR are due March 27, 2023.
If a chemical is on the TSCA Inventory, that chemical substance is considered an “existing” chemical substance in U.S. commerce. In some instances, chemicals listed on the TSCA Inventory have not been actively manufactured for many years and are designated as “inactive” on the TSCA Inventory. According to EPA, the chemical substances for which it is proposing a 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 cited at 40 C.F.R. Sections 721.9582 and 721.10536. EPA states that there are 330 inactive PFAS that are not subject to an existing SNUR. The specific chemical identities for 30 of these substances that have been claimed as confidential business information (CBI) have generic names that do not contain “fluor” or “fluorine.”
EPA proposes 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. Section 721.45(d) through (f) “because notification for the commercial activity designation (as active or inactive) on the TSCA Inventory is not required for such substances.” (See 40 C.F.R. Section 710.27(a)).
EPA “welcomes comment on all aspects of this proposed rule.” In providing comments on an ongoing use of inactive PFAS, EPA states that it would be helpful if stakeholders provide sufficient information for EPA to substantiate any assertions of an ongoing use.
EPA notes that the proposed SNUR is part of the comprehensive approach outlined in the Agency’s “PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024” “to proactively prevent PFAS from entering air, land, and water at levels that can adversely impact human health and the environment.” More information on EPA’s PFAS Strategic Roadmap is available in our October 19, 2021, memorandum.
Commentary
This “dead chemical” SNUR proposal has been expected as part of EPA’s broader PFAS Strategic Roadmap. The list of substances in the proposal includes many that are longer-chain PFAS (e.g., C7 and longer perfluoro groups), reflecting the fact that many longer-chain PFAS have already been phased out. There are also several shorter-chain PFAS, even several with C2 perfluoro groups. It is less clear why these are believed to be no longer active.
In this rule, EPA proposes another definition of PFAS — a proposal that will undoubtedly add to confusion about substances to which the SNUR applies. EPA proposes this category approach to preserve the confidential identity of 30 substances that do not specify “fluor” or “fluorine” in the generic name, but also proposes using its authority under TSCA Section 14(d)(7) to disclose that those 30 substances do, in fact, contain fluorine atoms. EPA’s proposed alternative strikes us as the preferred option. It will disclose limited information about the substances (only that they contain fluorine atoms) while providing certainty about which substances are subject to the SNUR. Because these substances are classified under TSCA as inactive in commerce, there should be little, if any, adverse commercial result to companies that might submit a Significant New Use Notice (SNUN) in the future and would not be able to claim as confidential the fact that a fluorine is present.
Detractors might point out that EPA does not propose voiding exemptions for these substances (such as the article exemption). EPA’s rationale is that it is not seeking to prohibit what may be ongoing uses that were exempt from Notice of Activity (NOA) reporting. Rather, EPA is prohibiting manufacturing, importing, and processing, conditions of use for which EPA has a basis to conclude are not ongoing — that basis being the lack of an NOA.
We are disappointed that this proposal repeats an inaccurate talking point that “EPA completed formal reviews on only about 20% of new chemicals.” We assume that this statement refers to the approximately 20 percent of new chemicals that underwent “standard reviews.” This statement ignores all the effort that went into developing and implementing the new chemical categories — a process that was specifically designed to allow EPA to review and, as warranted, regulate more efficiently new chemicals for which EPA had identified health or environmental concerns. The rule also mischaracterizes EPA’s authority to require testing (“[EPA] had no authority to address chemicals about which the Agency lacked sufficient information”). While stakeholders may disagree about whether EPA exercised that authority frequently enough, EPA clearly had the authority and exercised it in many consent orders. EPA now knows more about PFAS than it did when these substances were placed on the Inventory and has a reason to suspect there may be unreasonable risk if they were to be reintroduced without restriction. This fact alone is enough to justify the SNUR proposal.
EPA’s proposal is an appropriate, protective use of its SNUR authority and will help guard against future reintroduction of these substances unless and until a submitter can demonstrate in a SNUN that the substance would not be an unreasonable risk. It will not protect against all possible PFAS risk, but it is an expeditious way for EPA to close the door on the reintroduction of these 330 PFAS. We suggest that stakeholders comment on EPA’s proposal to define a new PFAS category specifically for this SNUR rather than specifying which 30 substances that do not specify fluorine in the generic name, thereby disclosing a minor, likely inconsequential detail for those substances.