Significant New Use Rules on Certain Chemical Substances (19-5.F)

<RULE> ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Parts 9 and 721</CFR> <DEPDOC>[EPA-HQ-OPPT-2019-0530; FRL-7645-02-OCSPP]</DEPDOC> <RIN>RIN 2070-AB27</RIN> <SUBJECT>Significant New Use Rules on Certain Chemical Substances (19-5.F)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> EPA is issuing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for certain chemical substances that were the subject of premanufacture notices (PMNs). The SNURs require persons to notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use in the SNUR. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until they have submitted a Significant New Use Notice (SNUN), and EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken any risk management actions as are required as a result of that determination. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective on March 7, 2025. For purposes of judicial review, this rule shall be promulgated at 1 p.m. (EST) on January 21, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified under docket identification (ID) number EPA-HQ-OPPT-2019-0530, 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). 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:</E> James Yan, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-2138; email address: <E T="03">yan.james@epa.gov.</E> <E T="03">For technical information:</E> William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address: <E T="03">wysong.william@epa.gov.</E> <E T="03">For general information:</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. 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 the factors in TSCA section 5(a)(2) (see also the discussion in Unit II.). <HD SOURCE="HD2">B. What action is the Agency taking?</HD> EPA is finalizing SNURs under TSCA section 5(a)(2) for chemical substances that were the subject of PMNs P-16-541, P-17-299, P-18-172, P-19-99, P-19-118, and P-19-120. The SNURs require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use in the SNURs to notify EPA at least 90 days before commencing that activity. Previously, in the <E T="04">Federal Register</E> of December 6, 2019 (84 FR 66855) (FRL-10001-48), EPA proposed SNURs for these chemical substances along with nineteen other SNURs. EPA finalized the proposed SNURs for P-17-393, P-19-86, P-19-87, P-19-89, P-19-90, P-19-91, P-19-92, P-19-93, P-19-97, P-19-100, P-19-101, P-19-102, P-19-103, P-19-104, P-19-105, P-19-106, P-19-107, P-19-108, and P-19-110 in a previous <E T="04">Federal Register</E> notice of August 18, 2021 (86 FR 46133) (FRL-8000-02-OCSPP). EPA is not currently finalizing the SNURs for the chemical substances which were the subject of PMNs P-18-387 and P-18-388 and will address these SNURs in a future notice in order to consider new information about exposures. More information on the specific chemical substances subject to this final rule can be found in the <E T="04">Federal Register</E> document proposing the SNURs. The docket includes information considered by the Agency in developing the proposed and final rules, including the public comments received on the proposed rules that are described in Unit II. <HD SOURCE="HD2">C. Does this action apply to me?</HD> <HD SOURCE="HD3">1. General Applicability</HD> This action may apply to you if you manufacture (defined by statute to include import), process, or use the chemical substances addressed in this <E T="04">Federal Register</E> document. 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: • Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110), <E T="03">e.g.,</E> chemical manufacturing and petroleum refineries. <HD SOURCE="HD3">2. Applicability to Importers and Exporters</HD> This action may also affect certain entities through pre-existing import certification and export notification requirements under TSCA. Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the import provisions promulgated at 19 CFR 12.118 through 12.127 (see also 19 CFR 127.28), and the EPA policy in support of import certification at 40 CFR part 707, subpart B. Importers of 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. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance identified in this document are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D. <HD SOURCE="HD2">D. What are the estimated incremental impacts of this action?</HD> EPA has evaluated the potential costs of establishing SNUN reporting requirements for potential manufacturers (including importers) and processors of the chemical substances included in these SNURs. This analysis, which is available in the docket, is briefly summarized here. <HD SOURCE="HD3">1. Estimated Costs for SNUN Submissions</HD> If a SNUN is submitted, costs are an estimated $45,000 per SNUN submission for large business submitters and $14,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $37,000 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission for SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in these SNURs. Additionally, these estimates reflect the costs and fees as they are known at the time of this rulemaking. <HD SOURCE="HD3">2. Estimated Costs for Export Notifications</HD> EPA has also evaluated the potential costs associated with the export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications ( <E T="03">i.e.,</E> the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by these SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per unit basis is approximately $106. <HD SOURCE="HD1">II. Background</HD> Unit II. of the proposed rule provides general information about SNURs, and additional information about EPA's new chemical program is available at <E T="03">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.</E> <HD SOURCE="HD2">A. Significant New Uses Claimed as Confidential Business Information (CBI)</HD> EPA is establishing certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 703. Absent a final determination or other disposition of the confidentiality claim under these regulations, EPA is required to keep this information confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with the situation where a specific significant new use is CBI. Under these procedures a manufacturer or processor may request EPA to identify the confidential significant new use under the rule. The manufacturer or p ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 41k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━