Preliminary Lists Identifying Manufacturers Subject to Fee Obligations for Five Chemical Substances Undergoing EPA-Initiated Risk Evaluations Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 700</CFR> <DEPDOC>[EPA-HQ-OPPT-2024-0501; FRL-12463-01-OCSPP]</DEPDOC> <SUBJECT>Preliminary Lists Identifying Manufacturers Subject to Fee Obligations for Five Chemical Substances Undergoing EPA-Initiated Risk Evaluations Under the Toxic Substances Control Act (TSCA); Notice of Availability and Request for Comment</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Determination; request for comments. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA or Agency) is announcing the availability of and soliciting comment on the preliminary lists of manufacturers (including importers) of five chemical substances that have been designated as High-Priority Substances for risk evaluation under the Toxic Substances Control Act (TSCA) and for which fees will be charged. As required by TSCA, EPA established fees to defray a portion of the costs associated with administering certain provisions of TSCA. The comment period provides an opportunity for the public to provide comments, self-identify, or correct errors on the preliminary lists. In addition, manufacturers (including importers) are required to self-identify as a manufacturer (or importer) of one or more the five identified High-Priority Substances irrespective of whether they are included on the preliminary lists, and may use this period to do so. Where appropriate, entities may also avoid or reduce fee obligations by making certain certifications consistent with the TSCA Fees Rule. EPA expects to publish final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope documents for risk evaluations of these five High-Priority Substances. Manufacturers (including importers) identified on the final lists will be subject to the applicable fees. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before March 3, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0501, 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 or 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> Kathleen Ferry, 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) 564-2214; email address: <E T="03">ferry.kathleen@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. Does this action apply to me?</HD> This action applies to entities that manufacture (including import) a chemical substance undergoing a risk evaluation under TSCA section 6(b) ( <E T="03">e.g.,</E> entities identified under North American Industrial Classification System (NAICS) codes 325 and 324110). The action may also be of interest to chemical processors, distributors in commerce, and users; non-governmental organizations in the environmental and public health sectors; state and local government agencies; and members of the public. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities and corresponding NAICS codes for entities that may be interested in or affected by this action. If you have questions regarding the applicability of this action, please consult the technical person listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> TSCA section 26(b), 15 U.S.C. 2625(b), provides EPA with authority to establish fees to defray a portion of the costs associated with administering EPA-initiated TSCA section 6 risk evaluations. The implementing fee regulations, which are codified in 40 CFR part 700, subpart C, imposes a fee for any person who manufactures (including imports) a chemical substance that is the subject of an EPA-initiated risk evaluation under TSCA section 6 (Ref. 1). The requirements for those fee payments are codified in 40 CFR 700.45. See also <E T="03">https://www.epa.gov/tsca-fees.</E> <HD SOURCE="HD2">C. What action is the Agency taking?</HD> EPA is publishing preliminary lists identifying manufacturers (including importers) that may be subject to fee obligations under 40 CFR 700.45, associated with each EPA-initiated risk evaluation of the following five High-Priority Substances under TSCA section 6 (Refs. 2): • Acetaldehyde (CASRN 75-07-0); • Acrylonitrile (CASRN 107-13-1); • Benzenamine (CASRN 62-53-3); • Vinyl chloride (CASRN 75-01-4); and • 4,4′-Methylene bis(2-chloroaniline) (CASRN 101-14-4). EPA is also providing an opportunity for public comment during which manufacturers (including importers) are required to self-identify as a manufacturer (including importer) of a High-Priority Substance, irrespective of whether they are listed on the preliminary list, unless they meet one or more of the exemptions listed in 40 CFR 700.45(a)(3)(i) through (iii) ( <E T="03">i.e.,</E> importing articles, producing as a byproduct that is not later used or distributed for commercial purposes, and manufacturing as an impurity). During this comment period, manufacturers and importers may make certain certifications to EPA to avoid or reduce fee obligations. The public will also have the opportunity to correct errors or provide comments on the preliminary lists. EPA is providing a 60-day comment period, which exceeds the minimum 30-day comment period established in 40 CFR 700.45(b)(4), to maximize public participation during the comment period for the preliminary lists. EPA expects to publish final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope document for risk evaluations of these five High-Priority Substances. Manufacturers (including importers) identified on the final lists will be subject to applicable fees under 40 CFR 700.45. <HD SOURCE="HD2">D. Why is the Agency taking this action?</HD> TSCA section 26 authorizes EPA to establish, by rule, a fee structure to defray some of the costs of administering certain provisions of TSCA. Established in 2018 and amended in 2024, pursuant to the TSCA Fee Rule EPA will collect payment from manufacturers (including importers) who manufacture (including import) a chemical substance that is the subject of a risk evaluation under TSCA section 6(b). As intended by Congress, these fees are a sustainable source of funds for EPA to fulfill its legal obligations such as conducting risk evaluations to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, as required under TSCA section 6. Pursuant to TSCA section 6(b) and its implementing regulations, EPA designated the five chemical substances listed in Unit I.C. as High-Priority Substances for risk evaluation (EPA-HQ-OPPT-2018-0464-0002). EPA is now preliminarily identifying the manufacturers (including importers) that may be subject to fee obligations associated with the risk evaluations of the five High-Priority Substances. <HD SOURCE="HD2">E. What should I consider as I prepare my comments for EPA?</HD> <HD SOURCE="HD3">1. Submitting Confidential Business Information (CBI)</HD> Do not submit CBI to EPA through <E T="03">https://www.regulations.gov</E> or email. 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 part or all of the information that you claim to be CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. 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/dockets/comments.html.</E> <HD SOURCE="HD1">II. Background</HD> TSCA section 6(b)(3)(C) requires EPA to designate at least one new High-Priority Substance for risk evaluation upon completion of each risk evaluation for a High-Priority Substance. Because EPA generally expects to complete five risk evaluations per year over the next several years, in December 2024, EPA designated the five chemical substances listed in Unit I.C. as High-Priority Substances for risk evaluation. Under TSCA section 6(b)(1)(B) and its implementing regulations (40 CFR 702.3), a High-Priority Substance is defined as a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 28k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━