N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) and its Transformation Product, 6PPD-quinone; Regulatory Investigation Under the Toxic Substances Control Act (TSCA)

ENVIRONMENTAL PROTECTION AGENCY <CFR>40 CFR Part 751</CFR> <DEPDOC>[EPA-HQ-OPPT-2024-0403; FRL-11628-01-OCSPP]</DEPDOC> <RIN>RIN 2070-AL16</RIN> <SUBJECT>N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) and its Transformation Product, 6PPD-quinone; Regulatory Investigation Under the Toxic Substances Control Act (TSCA)</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Advance notice of proposed rulemaking (ANPRM). <SUM> <HD SOURCE="HED">SUMMARY:</HD> In granting a petition filed under the Toxic Substances Control Act (TSCA) by Earthjustice on behalf of the Yurok Tribe, the Port Gamble S'Klallam Tribe, and the Puyallup Tribe of Indians, the Environmental Protection Agency (EPA or Agency) committed to pursuing an action to solicit and collect information from the public on the potential risks associated with N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8, DTXSID 9025114) and its transformation product, 6PPD-quinone (CASRN 2754428-18-5, DTXSID 301034849). With this document, EPA is soliciting that information, along with information about potential alternatives and regulatory options to help inform the Agency's consideration of potential future regulatory actions under TSCA. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> Comments must be received on or before January 21, 2025. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0403, through <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> Wyn Zenni, 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) 565-6294; email address: <E T="03">zenni.wyn@epa.gov.</E> <E T="03">For general information on TSCA:</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> You may be potentially affected by this action if you manufacture (including import), process (including recycling), distribute in commerce, dispose of, or use 6PPD and/or 6PPD-quinone. The following list of North American Industry 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: • 325130 Synthetic Dye and Pigment Manufacturing; • 325199 All Other Basic Organic Chemical Manufacturing ; • 325212 Synthetic Rubber Manufacturing; • 325998 All Other Miscellaneous Chemical Product and Preparation Manufacturing; • 326211 Tire Manufacturing (Except Retreading); • 326291 Rubber Product Manufacturing for Mechanical Use; • 336999 All Other Transportation Equipment Manufacturing; and • 424690 Other Chemical and Allied Products Merchant Wholesalers. If you have any questions regarding the applicability of this action to you, please consult the technical information contact 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> This action is being taken under the Toxic Substances Control Act (TSCA), 15 U.S.C. 2601 <E T="03">et seq.</E> TSCA section 21 allows any person to petition EPA to initiate a rulemaking proceeding for the issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8 or an order under TSCA sections 4, 5(e) or (f). If EPA grants the petition, the Agency must promptly commence an appropriate proceeding. Under TSCA section 6(a), if EPA determines that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance presents an unreasonable risk to human health or the environment, it must “apply one or more of the [TSCA section 6(a)] requirements . . . to the extent necessary so that the chemical substance . . . no longer presents such risk,” which may range from prohibiting or otherwise restricting the manufacturing, processing, or distribution in commerce of the chemical substance (or a particular use), to commercial use requirements or disposal restrictions, to labeling and recordkeeping. <HD SOURCE="HD2">C. What action is the Agency taking?</HD> EPA is seeking public comment on all of the information included in and referenced by this ANPRM. EPA also seeks any additional information relevant to 6PPD, 6PPD-quinone, and potential 6PPD substitutes that could help inform potential future rulemakings. Topics in this ANPRM include but are not limited to: Information on the chemicals' environmental effects on aquatic and terrestrial ecosystems, potential human health effects, environmental fate and transport, exposure pathways, persistence and bioaccumulation, additional uses of 6PPD, and releases from consumer products ( <E T="03">e.g.,</E> sneakers, playgrounds, rubber-modified asphalt, reused tire or other rubber products, etc). EPA is also seeking comment and information related to alternatives to 6PPD, as well as potential chemical transformation products associated with potential alternatives. When submitting information, the Agency is interested in receiving quantitative information, data and/or case examples, including peer-reviewed studies, statistical analyses, and industry, scientific, or technical reports describing datasets or syntheses of environmental or human health impacts of 6PPD, 6PPD-quinone, or potential alternatives for 6PPD. <HD SOURCE="HD2">D. What are the incremental costs and benefits of this action?</HD> This action does not propose or impose any requirements, and instead seeks comments and suggestions that will help inform the Agency's consideration of potential future actions for 6PPD and/or 6PPD-quinone. As such, there are no incremental costs or benefits associated with this ANPRM. Should the Agency pursue a rulemaking in the future, EPA will conduct the appropriate assessments of the potential costs and benefits associated with the proposed action. <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 <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 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/dockets/commenting-epa-dockets.html.</E> <HD SOURCE="HD1">II. Background</HD> <HD SOURCE="HD2">A. What was requested in the TSCA section 21 petition for 6PPD?</HD> On August 1, 2023, Earthjustice, on behalf of the Yurok Tribe, the Port Gamble S'Klallam Tribe, and the Puyallup Tribe of Indians, filed a TSCA section 21 petition requesting that EPA establish regulations prohibiting the manufacturing, processing, use, and distribution of 6PPD (CASRN 793-24-8, DTXSID 9025114) in and for tires under EPA's TSCA section 6(a) authority, 15 U.S.C. 2605(a). The petitioners requested that such regulation take effect as soon as practicable to eliminate the unreasonable risk 6PPD in tires presents to the environment (Ref. 1). In the petition, concerns were raised that the chemical 6PPD, which has been used in tires since the 1960s to prevent tire degradation (Ref. 2), poses unreasonable risk to the environment due to the acute toxicity of its transformation product, 6PPD-quinone (CASRN 2754428-18-5, DTXSID 301034849), to coho salmon <E T="03">(Oncorhynchus kisutch)</E> and other fish species. The petition described that the presence of 6PPD-quinone in stormwater runoff and urban watersheds are at levels that can kill coho salmon <E T="03">(O. kisutch)</E> , steelhead trout <E T="03">(Oncorhynchus mykiss)</E> , and other aquatic organisms. The petition also referenced the presence of 6PPD-quinone in sediments and soils, road and household dust, and the urine of pregnant women, with emerging science pointing to potential risks to human health and to a larger extent, toxicity in mammals (Ref. 1). On November 2, 2023, EPA granted the petition, stating that the petition, along with information reasonably available to EPA, set forth facts establishing that it was appropriate to initiate a TSCA section 6(a) proceeding to address risks to the environment from 6PPD and its transformation product, 6PPD-quinone (Ref. 3 [3]). Specifically, EPA committed to: (a) Issuing an ANPRM for 6PPD and 6PPD-quinone under TSCA section 6(a) by fall 2024; and (b) Finalizing a TSCA section 8(d) rulemaking by the end of 2024 that would require persons who manufacture (including import) 6PPD to submit lists or copies of unpublished health and safety studies to EPA. With this action, the Agency has promptly commenced an appropriate proceeding. The expected infor ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 103k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━