Di-isononyl phthalate (DINP); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability, Webinar and Request for Comment

<NOTICE> ENVIRONMENTAL PROTECTION AGENCY <DEPDOC>[EPA-HQ-OPPT-2018-0436; FRL-8806-02-OCSPP]</DEPDOC> <SUBJECT>Di-isononyl phthalate (DINP); Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Notice of Availability, Webinar and Request for Comment</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Environmental Protection Agency (EPA). <HD SOURCE="HED">ACTION:</HD> Notice. <SUM> <HD SOURCE="HED">SUMMARY:</HD> The Environmental Protection Agency (EPA or Agency) is announcing the availability of and seeking public comment on a draft risk evaluation under the Toxic Substances Control Act (TSCA) for di-isononyl phthalate (DINP) (1,2-Benzene- dicarboxylic acid, 1,2- diisononyl ester) (CASRN 28553-12-0). The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the conditions of use (COU). EPA has used the best available science to prepare this draft risk evaluation and to preliminarily determine that DINP poses unreasonable risk to human health. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Written comments: Comments must be received on or before November 4, 2024. <E T="03">Webinar on:</E> September 26, 2024, 2-3 p.m. EST. <E T="03">Register by:</E> September 8, 2024, 12 p.m. EST, to receive the webcast meeting link and audio teleconference information before the meeting. <E T="03">Request special accommodation by:</E> September 8, 2024, 5 p.m. EST, to allow EPA time to process the request before the meeting. <E T="03">Special accommodations:</E> In addition, To allow EPA time to process your request, please submit your request to EPA by 5 p.m. EST on September 8, 2024, 5 p.m. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> <E T="03">Registration:</E> Register online at <E T="03">https://usepa.zoomgov.com/meeting/register/vJIsc-mprzguHuiI1Lu5jNuwk-Q84wPrRr8.</E> <E T="03">Special accommodation requests:</E> Submit your request to the webinar contact person listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <E T="03">Written comments:</E> Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2018-0436, 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">Webinar information:</E> Sarah Soliman, Project Management and Operations Division (7407M), Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency, 1201 Constitution Ave. NW, Washington, DC 20004; telephone number: (202) 564-8820; email address: <E T="03">soliman.sarah@epa.gov.</E> <E T="03">Chemical specific information:</E> Todd Coleman, Existing Chemical Risk Management Division (7404M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-1208; email address: <E T="03">coleman.todd@epa.gov.</E> <E T="03">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 particular interest to those involved in the manufacture, processing, distribution, use, and disposal of the chemical being evaluated, related industry trade organizations, non-governmental organizations with an interest in human and environmental health, state and local governments, Tribal Nations, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA. As such, the Agency has not attempted to describe all the specific entities that this action might apply to. If you need help determining applicability, consult the technical 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> The Agency is conducting this risk evaluation under TSCA section 6, 15 U.S.C. 2605, which requires that EPA conduct risk evaluations on chemical substances and identifies the minimum components EPA must include in all chemical substance risk evaluations. Each risk evaluation must be conducted consistent with the best available science, be based on the weight of the scientific evidence, and consider reasonably available information. 15 U.S.C. 2625(h), (i), and (k). See also the implementing procedural regulations at 40 CFR part 702. <HD SOURCE="HD2">C. What action is the Agency taking?</HD> EPA is announcing the availability of and seeking public comment on a draft risk evaluation under TSCA for DINP (CASRN 28553-12-0). The purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the COU. This draft risk evaluation is consistent with the best available science, based on the weight of scientific evidence, and considers reasonably available information. EPA has preliminarily determined that DINP poses unreasonable risk to human health. <HD SOURCE="HD2">D. What should I consider as I prepare my comments?</HD> 1. <E T="03">Submitting CBI.</E> 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, as applicable. 2. <E T="03">Tips for preparing your comments.</E> When preparing and submitting your comments, see the commenting tips at <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E> <HD SOURCE="HD1">II. Background</HD> <HD SOURCE="HD2">A. What is DINP?</HD> DINP is a common chemical name for the category of chemical substances that includes the following substances: 1,2-benzenedicarboxylic acid, 1,2-isononyl ester (CASRN 28553-12-0) and 1,2-benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C9-rich (CASRN 68515-48-0). Both CASRNs contain mainly C9 dialkyl phthalate esters. Both DINP, and another phthalate also undergoing TSCA risk evaluation, DIDP (1,2-Benzene- dicarboxylic acid, 1,2- diisodecyl ester, CASRN 26761-40-0 and 68515-49-1), are primarily used as plasticizers in polyvinyl chloride (PVC) in consumer, commercial, and industrial applications. DIDP and DINP are both structurally similar phthalates, and therefore many aspects of physical-chemical (p-chem) properties and exposure (to humans and ecological species) are similar, as described further in the draft physical chemical and fate assessments for both chemical substances. <HD SOURCE="HD2">B. Why is EPA evaluating this chemical under TSCA?</HD> On May 24, 2019, EPA received requests to conduct risk evaluations for both DINP and DIDP from ExxonMobil Chemical Company, Evonik Corporation, and Teknor Apex, through the American Chemistry Council's High Phthalates Panel (ACC HPP). In December 2019, EPA notified ACC HPP that the Agency had granted their manufacturer requested risk evaluations. See [insert cite to the FRN that announced this]. On May 17, 2024, EPA released for public comment and peer review draft technical support documents on DINP's physical chemical properties, fate and transport in the environment, environmental hazard for terrestrial and aquatic species, human health non-cancer hazards, and human health cancer hazards. See 89 FR 43847, May 20, 2024 (FRL-11760-02-OCSPP). The draft documents and public comments are in docket ID number EPA-HQ-OPPT-2024-0073. Given the similar exposure and physical chemical properties of DIDP and DINP, EPA is developing these individual risk evaluations in parallel, and similarly the external peer review of the methods and novel analyses for the draft risk evaluations are occurring concurrently. Due to these similarities, EPA sought external peer review of technical portions of the DINP draft physical chemical properties, the fate and transport in the environment, environmental hazard for terrestrial and aquatic species, human health non-cancer hazards, and human health cancer hazards technical support documents, along with the DIDP draft risk evaluation. Thus, the focus of this public comment period is to solicit feedback regarding DINP-specific exposure analyses and the integration of these analyses with previously peer reviewed data. DINP exhibits extremely low water solubility and will be preferentially sorbed into sediments, soils, and suspended solids in surface water and wastewater. It is expected to be persistent in anaerobic environments. Under indoor settings, DINP is expected to partition to airborne particles and is expected to have extended lifetim ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 14k characters. 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