High-Priority Substance Designations Under the Toxic Substances Control Act (TSCA) and Initiation of Risk Evaluation on High-Priority Substances; Notice of Availability

<NOTICE> ENVIRONMENTAL PROTECTION AGENCY <DEPDOC>[EPA-HQ-OPPT-2023-0601; FRL-11581-07-OCSPP]</DEPDOC> <SUBJECT>High-Priority Substance Designations Under the Toxic Substances Control Act (TSCA) and Initiation of Risk Evaluation on High-Priority Substances; 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 designating five chemicals as High-Priority Substances for risk evaluation. This document provides the identity of five chemical substances for final designation as High-Priority Substances for risk evaluation, EPA's rationale for final designation as High-Priority Substances, and instructions on how to access the chemical-specific information, analysis, and basis EPA used to support final designations for the chemical substances. A designation of a substance as a High-Priority Substance is not a finding of unreasonable risk. Rather, the designation of these chemical substances as high priority constitutes the initiation of evaluation of associated risk. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> The designations of High-Priority Substances for risk evaluation in this notice are effective December 18, 2024. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-2023-0601, is available online at <E T="03">https://www.regulations.gov</E> . In addition, the docket ID numbers for the individual chemical substances designated in Unit IV. are as follows: Acetaldehyde (EPA-HQ-OPPT-2018-0497); Acrylonitrile (EPA-HQ-OPPT-2018-0449); Benzenamine (EPA-HQ-OPPT-2018-0474); Vinyl Chloride (EPA-HQ-OPPT-2018-0448); and 4,4′-Methylene bis (2- chloroaniline) (MBOCA) (EPA-HQ-OPPT-2018-0464). Additional information about dockets generally, along with instructions for visiting the docket in-person, 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, and users, non-governmental organizations in the environmental and public health sectors, state and local government agencies, Tribes, and members of the public. Since other entities may also be interested, EPA 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 finalizing the designation of five chemical substances as High-Priority Substances for risk evaluation pursuant to section 6(b) of TSCA, 15 U.S.C. 2605(b). This document includes a high-level summary of comments received during the two 90-day comment periods during which the public submitted comments on EPA's initiation of prioritization (Ref. 1) and the proposed designations of those five chemicals as High-Priority Substances for risk evaluation (Ref. 2), as well as a high-level summary of Agency responses to those comments received during both 90-day public comment periods. The comments and EPA's responses are discussed in more depth in the response to comments document (Ref. 3). EPA also considered comments received during and following the prioritization public webinar that occurred in February 2024, during which EPA explained the prioritization process and provided an overview of information that may be used to inform the considerations that ultimately support a High- or Low-Priority Substance designation, such as information on conditions of use and health effects resulting from exposure to the chemicals of interest. <HD SOURCE="HD2">C. Why is the Agency taking this action?</HD> TSCA section 6(b) and implementing regulations at 40 CFR part 702, subpart A require EPA to carry out a prioritization process for chemical substances that may be designated as high priority for risk evaluation. EPA generally expects to complete five risk evaluations per year over the next several years, and TSCA section 6(b)(3)(C) requires EPA to designate at least one High-Priority Substance upon completion of each risk evaluation for a High-Priority Substance. Pursuant to TSCA section 6(b)(2)(B), EPA is finalizing the designation of the five chemical substances as High-Priority Substances for risk evaluation identified as candidates for High-Priority Substance designation when EPA initiated the prioritization process on December 18, 2023 (Ref. 1). As required under TSCA section 6(b)(3)(C), EPA is specifying the designation of: MBOCA to replace the final risk evaluation for 1,1-dichloroethane; acetaldehyde to replace the final risk evaluation for 1,3-butadiene; acrylonitrile to replace the final risk evaluation for dicyclohexyl phthalate; benzenamine to replace the final risk evaluation for formaldehyde; and vinyl chloride to replace the final risk evaluation for tris(2-chloroethyl) phosphate. <HD SOURCE="HD2">D. What is the Agency's authority for taking this action?</HD> This document is issued pursuant to TSCA section 6(b)(1) and 6(b)(3)(C). <HD SOURCE="HD2">E. What are the estimated incremental impacts of this action?</HD> This document identifies the five chemical substances for which EPA is initiating the risk evaluation process and the five chemical substances that have already or will have risk evaluations completed which they will replace. This document does not establish any 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="HD1">II. Background</HD> TSCA section 6(b)(1) requires EPA to prioritize chemical substances for risk evaluation. In accordance with TSCA section 6(b) and 40 CFR 702.7, on December 18, 2023 (Ref. 1) EPA initiated the prioritization process for five chemical substances identified as candidates for High-Priority Substance designation. On July 25, 2024, EPA proposed to designate the same five chemical substances as High-Priority Substances for risk evaluation (Ref. 2). That notice included a summary of the approach used by EPA to support the proposed designations, links to the proposed designation document for each of the chemical substances, and instructions on how to access the chemical-specific information, analysis, and basis EPA used to make the proposed designation for each chemical substance. Under TSCA section 6(b)(1)(B) and implementing regulations (40 CFR 702.3), a High-Priority Substance is defined as “a chemical substance that EPA concludes, 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 a potentially exposed or susceptible subpopulation identified as relevant by EPA.” A designation of a substance as a High-Priority Substance is not a finding of unreasonable risk. Rather, when prioritization is complete, for those chemicals designated as High-Priority Substances, the Agency will have evidence on hazards and exposures that supports a finding that the substances may present an unreasonable risk of injury to health or the environment 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 of injury to health or the environment under the conditions of use. As described in the notice proposing to designate the five chemical substances as High-Priority Substances for risk evaluation (Ref. 2), “EPA will generally use reasonably available information to screen the candidate chemical substance[s] against the following criteria and considerations: • The chemical substance's hazard and exposure potential; • The chemical substance's persistence and bioaccumulation; • Potentially exposed or susceptible subpopulations; • Storage of the chemical substance near significant sources of drinking water; • The chemical substance's conditions of use or significant changes in conditions of use; • The chemical substance's production volume or significant changes in production volume; and • Other risk-based criteria that EPA determines to be relevant to the designation of the chemical substance's priority” (40 CFR 702.9(a)). When selecting candidates for prioritization, the Agency also generally intends to consider (1) Agency priorities (with consideration of the priorities of other Federal agencies), (2) Quantity and quality of information (to ensure that information necessary to prioritize the subs ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 27k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━