Modification of Significant New Use Rules of Certain Chemical Substances (23-1.M)

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Parts 721 and 725</CFR> <DEPDOC>[EPA-HQ-OPPT-2022-0863; FRL-12967-01]</DEPDOC> <RIN>RIN 2070-AB27</RIN> <SUBJECT>Modification of Significant New Use Rules of Certain Chemical Substances (23-1.M)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Proposed rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> EPA is proposing to amend the significant new use rules (SNURs) for certain chemical substances identified herein, which were the subject of one or more premanufacture notices (PMNs), a Microbial Commercial Activity Notice (MCAN) for one substance, and in some cases significant new use notices (SNUNs). This action would amend the SNURs to (1) allow certain new uses reported in the SNUNs or PMNs without additional notification requirements, (2) modify the significant new use notification requirements based on the actions and determinations for the SNUN or PMN submissions or based on the examination of new test data or other information, and (3) make technical amendments to several SNURs. EPA is proposing these amendments based on our review of new and existing data for the chemical substances. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before November 28, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2022-0863, online at <E T="03">https://www.regulations.gov.</E> Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is 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> Brianna Godwin, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 565-0076; email address: <E T="03">godwin.brianna@epa.gov.</E> <E T="03">For general information on SNURs:</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 on TSCA:</E> The TSCA Assistance Information Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (800) 471-7127 or (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.). Procedures and criteria for modifying or revoking SNUR requirements appear at 40 CFR 721.185 or 725.984 (for microorganisms). <HD SOURCE="HD2">B. What action is the Agency taking?</HD> EPA is proposing amendments to the SNURs for certain chemical substances in 40 CFR part 721, subpart E and part 725, subpart M (for microorganisms). A SNUR for a chemical substance designates certain activities as a significant new use. Persons who intend to manufacture or process the chemical substance for the significant new use must notify EPA at least 90 days before commencing that activity. The required notification ( <E T="03">i.e.,</E> a SNUN) initiates EPA's evaluation of the intended use. Manufacture and processing for the significant new use 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. <HD SOURCE="HD2">C. Does this action apply to me?</HD> <HD SOURCE="HD3">1. General Applicability</HD> This action applies to you if you manufacture, process, or use the chemical substances contained in this proposed rule. 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 apply to certain entities through pre-existing import certification and export notification requirements under TSCA ( <E T="03">https://www.epa.gov/tsca-import-export-requirements</E> ). Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements in 19 CFR 12.118 through 12.127; see also 19 CFR 127.28. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. Chemical importers 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. Pursuant to 40 CFR 721.20 or 40 CFR 725.920 (for microorganisms), 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)) and must comply with the export notification requirements in 40 CFR part 707, subpart D. <HD SOURCE="HD2">D. What are the incremental economic impacts of this action?</HD> <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="HD2">E. What should I consider as I prepare my comments for EPA?</HD> <HD SOURCE="HD3">1. Submitting CBI</HD> Do not submit CBI to EPA through email or <E T="03">https://www.regulations.gov.</E> If you wish to include CBI in your comment, please follow the applicable instructions at <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets#rules</E> and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703. <HD SOURCE="HD3">2. Tips for Preparing Your Comments</HD> When preparing and submitting your comments, see the commenting tips at <E T="03">https://www.epa.gov//epa-dockets.</E> <HD SOURCE="HD1">II. Background</HD> This unit provides general information about SNURs. For additional information about EPA's new chemical program go to <E T="03">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.</E> <HD SOURCE="HD2">A. Significant New Use Determination Factors</HD> TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including: • The projected volume of manufacturing and processing of a chemical substance. • The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance. • The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance. • The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance. In determining whether and how to modify EPA's identification of significant new uses for the chemical substances that are the subject of these SNURs, EPA considered the four factors specifically identified in TSCA section 5(a)(2) and relevant informat ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 63k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━