/>iOn July 27, 2020, the U.S. Environmental Protection Agency (EPA) promulgated a final significant use rule (SNUR) for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances. 85 Fed. Reg. 45109. EPA first proposed a SNUR for LCPFAC and perfluoroalkyl sulfonate chemical substances on January 21, 2015. 80 Fed. Reg. 2885. On March 3, 2020, EPA issued a proposed supplemental SNUR for LCPFAC chemical substances that would make inapplicable the exemption for persons who import a subset of LCPFAC chemical substances as part of surface coatings on articles. 85 Fed. Reg. 12479. The final SNUR requires persons to notify EPA at least 90 days before commencing the manufacture (including import) or processing of these chemical substances for the significant new uses described in the notice. The required significant new use notification initiates EPA’s evaluation of the conditions of use associated with the significant new use. Manufacturing (including import) or processing for the significant new use are prohibited from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination. EPA notes that as with any SNUR, the final rule excludes ongoing uses as ongoing uses cannot be subject to a SNUR. The final rule is effective on September 25, 2020.
EPA states that the March 2020 proposed supplemental SNUR was intended “to be responsive to the article consideration provision” at Section 5(a)(5) of the Toxic Substances Control Act (TSCA), which was added by the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). Section 5(a)(5) states that articles can be subject to notification requirements as a significant new use provided that EPA makes an affirmative finding in a rule that the reasonable potential for exposure to a chemical from an article or category of articles justifies notification. More information on the proposed supplemental SNUR is available in our February 28, 2020, memorandum, “Proposed Supplemental SNUR Would Remove Exemption for LCPFAC Chemical Substances Used as Surface Coatings on Articles.”
The final SNUR will require persons to notify EPA at least 90 days before commencing:
- The manufacturing (including importing) or processing of a subset of LCPFAC chemical substances for any use that was not ongoing after December 31, 2015;
- The manufacturing (including importing) or processing of all other LCPFAC chemical substances for which there were no ongoing uses as of January 21, 2015 (the date of the original proposed SNUR);
- The import of a subset of LCPFAC chemicals as part of a surface coating on articles; and
- The import of perfluoroalkyl sulfonate chemical substances as part of carpets.
The final SNUR will preclude the commencement of such manufacturing and processing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.
According to the July 27, 2020, Federal Register notice, in an April 24, 1990, Federal Register notice, EPA “decided that the intent of TSCA section 5(a)(1)(B) is best served by designating a use as a significant new use as of the date of publication of the proposed rule rather than as of the effective date of the final rule.” Uses arising after publication of the proposed rule are distinguished from uses that exist at publication of the proposed rule. EPA states that the former would be new uses and the latter would be ongoing uses, except that uses that are ongoing as of the publication of the proposed rule would not be considered ongoing uses if they have ceased by the date of issuance of a final rule. EPA published the original proposed SNUR on January 21, 2015, and the proposed SNUR contains two significant new use dates. The first significant new use date is the date that the 2015 proposed rule was published and applies to: the manufacturing or processing of all LCPFAC chemical substances, other than those listed in the July 27, 2020, Federal Register notice; the import of articles containing a subset of LCPFAC chemical substances as part of a surface coating; and the import of perfluoroalkyl sulfonate chemical substances as part of carpets. The second significant new use date is December 31, 2015, for the manufacturing or processing of a subset of LCPFAC chemical substances, those listed in the July 27, 2020, Federal Register notice for any use. EPA states that the chemical substances listed correspond to the chemical substances that the principal manufacturers and processors of LCPFAC chemical substances participating in the 2010/2015 PFOA Stewardship Program agreed to phase out by the end of 2015.
In the March 3, 2020, supplemental proposed SNUR, EPA requested comment on whether it could adopt a de minimis threshold for determining “reasonable potential for exposure” and if so, how that de minimis threshold could be established. Additionally, EPA requested comment on whether it should include a safe harbor provision for importers of articles that can demonstrate their use was ongoing prior to the effective date of this rule. EPA states that it “appreciates the comments received,” but that the final SNUR does not include a de minimis threshold for determining “reasonable potential for exposure” or a safe harbor provision. EPA “will, however, continue to engage with interested stakeholders on these two issues.”
The final SNUR modifies the requirements for a subset of LCPFAC chemical substances in the existing SNUR at 40 C.F.R. Section 721.10536 by:
- Designating manufacturing (including importing) or processing of LCPFAC chemical substances listed in the list of LCPFAC chemical substances in the July 27, 2020, Federal Register notice for any use that was no longer ongoing after December 31, 2015, as a significant new use; and
- Designating manufacturing (including importing) or processing of perfluorooctanoic acid (PFOA) or its salts, which are considered LCPFAC chemical substances, and all other LCPFAC chemical substances for any use not ongoing as of January 21, 2015, the date on which the proposed SNUR was published, as a significant new use.
Based on comments on the SNUR, EPA recognized that certain of the LCPFAC chemical substances covered by the action have ongoing uses that cannot be designated as significant new uses. The chemical substances and associated uses that are not considered significant new uses are listed in the final rule at 40 C.F.R. Section 721.10536(b)(5). EPA states that it “will continue to work with industry to phase out LCPFAC, PFOA and its salts, and perfluoroalkyl sulfonate chemical substances and will review the need to promulgate future rules as necessary.”
For the final SNUR, EPA is also making the exemption at 40 C.F.R. Section 721.45(f) inapplicable for persons who import any of the listed LCPFAC chemicals and PFOA or its salts as part of a surface coating on articles based on EPA’s view that there is reasonable potential for exposure if these chemical substances are incorporated as surface coatings in articles and then imported. EPA notes that as it proposed in 2015, the article exemption still applies to LCPFAC chemical substances not listed or that are not PFOA or its salts, with the exception of the import of carpets, for which the import exemption is already inapplicable. The other provision of 40 C.F.R. Section 721.45(f), respecting processing a chemical substance as part of an article, remains applicable.
EPA notes that the term LCPFAC refers to the category of long-chain perfluorinated carboxylate chemical substances with perfluorinated carbon chain lengths equal to or greater than seven carbons and less than or equal to 20 carbons. The category of LCPFAC chemical substances also includes the salts and precursors of these perfluorinated carboxylates. EPA states that in addition to the subset of LCPFAC chemical substances identified, PFOA and its salts are considered LCPFAC chemical substances and are subject to the final rule.
EPA states that it is also amending the existing SNUR at 40 C.F.R. Section 721.9582 for perfluoroalkyl sulfonate chemical substances to make the exemption at 40 C.F.R. Section 721.45(f) inapplicable for persons who import perfluoroalkyl sulfonate chemical substances as part of carpets, which is issued in final as proposed. The perfluoroalkyl sulfonate chemical substances for which EPA is modifying an existing SNUR are currently listed in 40 C.F.R. Section 721.9582(a)(1). EPA notes that in the final SNUR, which is consistent with the proposal and 40 C.F.R. Section 721.9582, the term perfluoroalkyl sulfonates refers to a category of perfluorinated sulfonate chemical substances of any chain length. EPA states that in the 2015 proposed SNUR, as was past practice, perfluoroalkyl sulfonate chemical substances were referred to as “PFAS” chemical substances. According to the final rule, “EPA, however, recognizes that the acronym PFAS is now used for ‘perfluoroalkyl and polyfluoroalkyl substances.’” Moving forward, EPA states that it will use PFAS as an acronym for perfluoroalkyl and polyfluoroalkyl substances.
Commentary
The issuance of the final SNUR on perfluoroalkyl sulfonate and LCPFAC chemical substances has been a long time in the making. Part of the delay can be attributed to the need to meet the new Section 5(a)(5) requirements for including imported articles in SNURs. We note that under Section 7352 of the National Defense Authorization Act for Fiscal Year 2020, EPA was required to “take final action” on the January 21, 2015, proposed rule by June 22, 2020, and that the final rule was signed and EPA posted a prepublication version of it on the June 22, 2020, deadline.
As discussed above, uses that were ongoing at the time of the 2015 proposed rule were not included in the scope of the SNUR. According to EPA, however, import of fluoropolymer dispersions and emulsions made with PFOA and such fluoropolymers as part of articles has now ceased and may become the subject of a future regulation. While EPA does not plan at this time to use Section 6(a) to regulate PFAS, additional future regulation is likely, thus continuing EPA’s almost two-decade effort to identify and manage the risks associated with this broad category of substances.
