Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Parts 9 and 721</CFR> <DEPDOC>[EPA-HQ-OPPT-2022-0867; FRL 9655-02-OCSPP]</DEPDOC> <RIN>RIN 2070-AL10</RIN> <SUBJECT>Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> Under the Toxic Substances Control Act (TSCA), EPA is finalizing a significant new use rule (SNUR) for 329 per- and poly-fluoroalkyl substances (PFAS) that are designated as inactive on the TSCA Chemical Substance Inventory. PFAS are a group of chemicals that have been used in industry and consumer products since the 1940s because of their useful properties, such as water and stain resistance. Many PFAS break down very slowly and can build up in people, animals, and the environment over time. Exposure at certain levels to specific PFAS can adversely impact human health and other living things. Persons subject to the final SNUR are 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. Such a review will assess whether the new use may present unreasonable risk to health or the environment and ensure that EPA takes appropriate action as required to protect health or the environment. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This final rule is effective March 11, 2024. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (EST) on January 25, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2022-0867, is available online at <E T="03">https://www.regulations.gov</E> or in person at the Office of Pollution Prevention and Toxics Docket (OPPT Docket) in the Environmental Protection Agency Docket Center (EPA/DC) in Washington, DC. Please review the visitor instructions and additional information about the docket available at <E T="03">https://www.epa.gov/dockets.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">For technical information contact:</E> Bethany Masten, Existing Chemicals Risk Management Division (7404M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-8803; email address: <E T="03">TSCA_PFAS@epa.gov.</E> <E T="03">For general information contact:</E> The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: <E T="03">TSCA-Hotline@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. Does this action apply to me?</HD> You may be potentially affected by this action if you manufacture (including import), process, or distribute in commerce chemical substances and mixtures. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include: • NAICS 221210—Natural Gas Distribution; • NAICS 236220—Commercial and Institutional Building Construction; • NAICS 324—Petroleum and Coal Product Manufacturing; • NAICS 324—Petroleum and Coal Product Manufacturing; • NAICS 32419—Petroleum Lubricating Oil and Grease Manufacturing; • NAICS 325—Chemical Manufacturing; • NAICS 325120—Industrial Gas Manufacturing; • NAICS 325180—Other Basic Inorganic Chemical Manufacturing; • NAICS 325199—All Other Basic Organic Chemical Manufacturing; • NAICS 325211—Plastics Material and Resin Manufacturing; • NAICS 325212—Synthetic Rubber Manufacturing; • NAICS 325220—Artificial and Synthetic Fibers and Filaments Manufacturing; • NAICS 325320—Pesticide and Other Agricultural Chemical Manufacturing; • NAICS 325411—Medicinal and Botanical Manufacturing; • NAICS 325412—Pharmaceutical Preparation Manufacturing; • NAICS 325612—Polish and Other Sanitation Good Manufacturing; • NAICS 325613—Surface Active Agent Manufacturing; • NAICS 325998—All Other Miscellaneous Chemical Product and Preparation Manufacturing; • NAICS 326113—Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing; • NAICS 327910—Abrasive Product Manufacturing; • NAICS 333999—All Other Miscellaneous General Purpose Machinery Manufacturing; • NAICS 334511—Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing; • NAICS 336111—Automobile Manufacturing; • NAICS 423120—Motor Vehicle Supplies and New Parts Merchant Wholesalers; • NAICS 423420—Office Equipment Merchant Wholesalers; • NAICS 423510—Metal Service Centers and Other Metal Merchant Wholesalers; • NAICS 423740—Refrigeration Equipment and Supplies Merchant Wholesalers; • NAICS 423990—Other Miscellaneous Durable Goods Merchant Wholesalers; • NAICS 424690—Other Chemical and Allied Products Merchant Wholesalers; • NAICS 424720—Petroleum and Petroleum Products Merchant Wholesalers (except Bulk Stations and Terminals); • NAICS 424950—Paint, Varnish, and Supplies Merchant Wholesalers; • NAICS 441110—New Car Dealers; • NAICS 447190—Other Gasoline Stations; • NAICS 551112—Offices of Other Holding Companies; and • NAICS 562—Waste Management and Remediation Services. This action may also affect certain entities through pre-existing import, including import certification, and export notification rules under TSCA. Chemical importers are subject to the import provision of TSCA section 13 (15 U.S.C. 2612), which requires that the Secretary of the Treasury “refuse entry into the customs territory of the United States” of any substance, mixture, or article containing a chemical substance or mixture that fails to comply with any rule issued under TSCA or that “is offered for entry in violation” of TSCA or certain rules or orders issued under TSCA, including rules issued under TSCA section 5. Persons who import any chemical substance in bulk form, as part of a mixture, or as part of an article (if required by rule) are also subject to TSCA section 13 import certification requirements and the corresponding regulations promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR 127.28). Chemical importers of the chemical substances in bulk form, as part of a mixture, or as part of an article (if required by rule) must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including regulations issued under TSCA sections 5, 6, 7 and Title IV. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this final rule are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D. <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including those listed in TSCA section 5(a)(2). Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import) or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA further provides that such manufacturing (including import) or processing may not commence 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 (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A. TSCA section 26(c) (15 U.S.C. 2625(c)) authorizes EPA to take action under other sections of TSCA with respect to categories of chemical substances. <HD SOURCE="HD2">C. What action is the Agency taking?</HD> This final SNUR will require persons to notify EPA at least 90 days before commencing any manufacture (including import) or processing of those 329 PFAS described in Unit II. that are designated as inactive on the TSCA Chemical Substance Inventory (TSCA Inventory) and that are not subject to an existing SNUR, including the existing SNURs cited at 40 CFR 721.9582 and 721.10536, for any use. EPA is providing a list of the 299 inactive PFAS that do not mask “fluor” or “fluorine” in the generic name in the public docket for this rule (Ref. 1). This category of PFAS chemical substances (“inactive PFAS”) is described further in Unit II. EPA is exempting from the notice requirement PFAS present as impurities, any byproducts which are not used for commercial purposes, and the importing or processing of inactive PFAS-containing articles because notification for the commercial activity designation (as active or inactive) on the TSCA Inventory is not required for such substances (see 40 CFR 710.27(a)). Similarly, EPA is exempting from the notice requirement PFAS manufactured or processed: in small quantities solely for r ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 70k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━