Initiation of Prioritization Under the Toxic Substances Control Act (TSCA); Notice of Availability

<NOTICE> ENVIRONMENTAL PROTECTION AGENCY <DEPDOC>[EPA-HQ-OPPT-2023-0601; FRL-11581-06-OCSPP]</DEPDOC> <SUBJECT>Initiation of Prioritization Under the Toxic Substances Control Act (TSCA); Notice of Availability</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> Under the Toxic Substances Control Act (TSCA) and related implementing regulations, EPA is initiating the prioritization process for five chemical substances as candidates for designation as High-Priority Substances for risk evaluation. This action provides the identity of the chemical substances being initiated for prioritization, a general explanation of why the Agency chose these chemical substances, and information on the data sources EPA plans to use to support the designation. EPA is providing a 90-day comment period, during which interested persons may submit relevant information on these chemical substances. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before March 18, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number, through <E T="03">https://www.regulations.gov.</E> Follow the online instructions for submitting comments. For comments not related to a specific chemical, including general comments on Unit IV.A., use docket ID number EPA-HQ-OPPT-2023-0601; submit information on the candidates for which EPA is initiating the prioritization process to the applicable chemical-specific docket ID number identified in Unit III.B.; submit information on the potential candidates for which EPA is not currently initiating the prioritization process to the docket ID number identified in Unit IV.B. 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> Sarah Au, Data Gathering, Management, and Policy Division (7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-0398; email address: <E T="03">au.sarah@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 is directed to the public in general and may be of interest to entities that currently or may manufacture (including import) a chemical substance regulated under TSCA ( <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, users, non-profit organizations in the environmental and public health sectors, state and local government agencies, Tribes, and members of the public. Because 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. <HD SOURCE="HD2">B. What action is the Agency taking?</HD> EPA is initiating the prioritization process under TSCA, 15 U.S.C. 2601 <E T="03">et seq.,</E> for five chemical substances as candidates for designation as High-Priority Substances for risk evaluation. This document includes the identity of the chemical substances entering the prioritization process before designation and a general explanation of why the Agency chose to initiate prioritization on these chemical substances. In addition, EPA is providing a 90-day comment period during which interested persons may submit relevant information on these chemical substances. Relevant information might include, but is not limited to, any information that may inform the prioritization screening review conducted pursuant to 40 CFR 702.9(a). <HD SOURCE="HD2">C. Why is the Agency taking this action?</HD> TSCA section 6(b) requires that EPA initiate the prioritization process for chemical substances that may be designated as high priority or low priority for risk evaluation. Because EPA generally expects to complete five risk evaluations per year over the next several years, EPA is initiating the prioritization process for five chemical substances per TSCA section 6(b)(3)(C), which requires EPA to designate at least one High-Priority Substance upon completion of each risk evaluation for a High-Priority Substance. In the <E T="04">Federal Register</E> on December 18, 2023 (88 FR 87423) (FRL-11581-01-OCSPP)), EPA initiated prioritization for five chemical substances that have undergone consideration as High-Priority Substances pursuant to TSCA section 6(b)(2)(B). By initiating prioritization another five chemical substances pursuant to TSCA section 6(b)(2)(B), EPA intends to maintain a sustainable pipeline of existing chemical risk evaluations under TSCA section 6(b). The request for interested persons to submit relevant information on a chemical substance for which EPA has initiated the prioritization process is required by TSCA section 6(b)(1)(C)(i). <HD SOURCE="HD2">D. What is the Agency's authority for taking this action?</HD> This document is issued pursuant to the authority in TSCA section 6(b)(1) and (3)(C). <HD SOURCE="HD2">E. What are the estimated incremental impacts of this action?</HD> This document does not establish requirements on persons or entities outside of the Agency. No incremental impacts are therefore anticipated, and consequently EPA did not estimate potential incremental impacts for this action. <HD SOURCE="HD2">F. 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 <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 the information you claim to be CBI. In addition to one complete version of the comment including 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 part 2 and/or 40 CFR part 703, as applicable. <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/commenting-epa-dockets.html.</E> <HD SOURCE="HD1">II. Background</HD> TSCA section 6(b)(1) requires EPA to prioritize chemical substances for risk evaluation and to establish a process for prioritizing chemical substances. Under TSCA section 6(b) and as described in 40 CFR 702.7, EPA is initiating the prioritization process for five chemical substances as candidates for 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 relevant by EPA. Initiation of prioritization for chemical substances as High-Priority Substance candidates is not a finding of risk. Rather, when prioritization is complete, for those chemicals designated as High-Priority Substances, EPA will have evidence that this substance 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. Final designation of a High-Priority Substance initiates the risk evaluation process (40 CFR 702.17), which culminates in a finding of whether the chemical substance presents an unreasonable risk under the conditions of use. This document is intended to fulfill the TSCA section 6(b)(1)(C)(i) requirement that the Administrator request interested persons to submit relevant information on chemical substances for which the Administrator has initiated the prioritization process. As described in 40 CFR 702.7, this document initiates the prioritization process and provides 90 days during which interested persons may submit relevant information. As described in 40 CFR 702.9(b), in conducting the screening review during the prioritization process, EPA will consider sources of information relevant to the screening review criteria as outlined in the statute (TSCA section 6(b)(1)(A)) and implementing regulations (40 CFR 702.9(a)) and consistent with the scientific standards of TSCA section 26(h), including, as appropriate, sources for hazard and exposure data listed in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012). Consistent with the approach described in 40 CFR 702.7, and the “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization” document (September 27, 2018), available at <E T="03">https://www.epa.gov/sites/default/f ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 34k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━