1,3-Butadiene; Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Science Advisory Committee on Chemicals (SACC) Peer Review; Notice of SACC Meeting, Availability of Draft Documents and Request for Comment

<NOTICE> ENVIRONMENTAL PROTECTION AGENCY <DEPDOC>[EPA-HQ-OPPT-2024-0425; FRL-12241-02-OCSPP]</DEPDOC> <SUBJECT>1,3-Butadiene; Draft Risk Evaluation Under the Toxic Substances Control Act (TSCA); Science Advisory Committee on Chemicals (SACC) Peer Review; Notice of SACC Meeting, Availability of Draft Documents 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 soliciting public comment on the draft risk evaluation for 1,3-butadiene. The draft risk evaluation was prepared under the Toxic Substances Control Act (TSCA) and will be submitted to the Science Advisory Committee on Chemicals (SACC) for peer review. EPA is also announcing that there will be two virtual public meetings of the SACC: On February 4, 2025, a preparatory meeting for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on February 25 through 28, 2025, the peer review meeting for the SACC to consider the draft documents and public comments. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> <E T="03">Preparatory Public Meeting:</E> <E T="03">Meeting date:</E> February 4, 2025, 1:00 p.m. to approximately 4:00 p.m. (ET). <E T="03">Registration:</E> To request time to present oral comments during the preparatory meeting, you must register by noon (12:00 p.m. ET) on January 31, 2025. For those not making oral comments, registration will remain open through the end of this meeting on February 4, 2025. <E T="03">Comments:</E> Submit written comments on the scope and clarity of the charge questions, by noon (12:00 p.m. ET) on January 28, 2025. (Submit a written version of your oral comments by noon (12:00 p.m. ET) on January 31, 2025.) <E T="03">SACC Peer Review Public Meeting:</E> <E T="03">Meeting dates:</E> February 25 through 28, 2025, 10:00 a.m. to approximately 5:00 p.m. (ET). <E T="03">Registration:</E> To request time to present oral comments during the peer review meeting, you must register by noon, February 18, 2025. For those not making oral comments, registration will remain open through the end of this meeting on February 28, 2025. <E T="03">Comments:</E> Submit written comments on the draft documents, and written version of your oral comments, on or before February 3, 2025. <E T="03">Special Accommodations:</E> To allow sufficient time for EPA to process your request for special accommodations before the meeting, please submit the request at least ten business days in advance of the relevant meeting. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> <E T="03">Comments:</E> Submit written comments, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0425, 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 information on commenting or visiting the docket, along with more information about dockets generally, is available at <E T="03">https://www.epa.gov/.</E> <E T="03">Meeting Registration:</E> Online registration will be available beginning in January 2025. Please refer to the SACC website at <E T="03">https://www.epa.gov/tsca-peer-review.</E> After registering, you will receive the webcast and streaming service meeting links and audio teleconference information. <E T="03">Special accommodation requests:</E> To request an accommodation for a disability, please contact the Designated Federal Official (DFO) listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> . <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> <E T="03">Designated Federal Official (DFO):</E> Alie Muneer, Mission Support Division (7602M), Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency; telephone number: (202) 564- 6369 or call the main office number: (202) 564-8450; email address: <E T="03">muneer.alie@epa.gov.</E> <E T="03">Technical information:</E> Brooke Porter, Existing Chemicals Risk Management Division, Office of Pollution Prevention and Toxics, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency; telephone number: (202) 564-6388; email address: <E T="03">porter.brooke@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. Executive Summary</HD> <HD SOURCE="HD2">A. What action is the Agency taking?</HD> EPA is announcing the availability of and soliciting public comment on the draft risk evaluation for 1,3-butadiene. The draft risk evaluation was prepared under the Toxic Substances Control Act (TSCA) and will be submitted to the Science Advisory Committee on Chemicals (SACC) for peer review. EPA is also announcing that there will be two virtual public meetings of the SACC: On February 4, 2025, a preparatory meeting for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on February 25 through 28, 2025, the peer review meeting for the SACC to consider the draft risk evaluation and public comments. This document provides instructions for accessing the materials, submitting written comments, and registering to provide oral comments and attend the public meetings. <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> EPA established the SACC in 2016 in accordance with TSCA, 15 U.S.C. 2625(o), to provide independent advice and expert consultation with respect to the scientific and technical aspects of issues relating to the implementation of TSCA. The SACC operates in accordance with the Federal Advisory Committee Act (FACA), 5 U.S.C. 10, and supports activities under TSCA, 15 U.S.C. 2601 <E T="03">et seq.,</E> the Pollution Prevention Act (PPA), 42 U.S.C. 13101 <E T="03">et seq.,</E> and other applicable statutes. <HD SOURCE="HD2">C. 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, and disposal of the subject chemical substances, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA (including members of at-risk communities, non-governmental organizations (NGOs), federal, state, and local officials). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested. <HD SOURCE="HD2">D. What should I consider as I submit my comments to EPA?</HD> 1. <E T="03">Submitting CBI.</E> Do not submit CBI or other sensitive information to EPA through <E T="03">https://www.regulations.gov</E> or email. To include information in your comment that you consider to be CBI or otherwise protected, please contact the DFO listed under <E T="02">FOR FURTHER INFORMATION CONTACT</E> to obtain special instructions before submitting that information. 2. <E T="03">Tips for preparing comments.</E> When preparing and submitting your comments, see <E T="03">https://www.epa.gov/dockets/commenting-epa-dockets.</E> See also the instructions in Unit III.C. <HD SOURCE="HD2">E. How can I stay informed about SACC activities?</HD> You may subscribe to the following listserv for alerts regarding this and other SACC-related activities: <E T="03">https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.</E> <HD SOURCE="HD1">II. Background</HD> <HD SOURCE="HD2">A. What is the purpose of the SACC?</HD> The SACC provides independent advice and recommendations to the EPA on the scientific and technical aspects of risk assessments, methodologies, and pollution prevention measures and approaches for chemicals regulated under TSCA. The SACC is composed of experts in toxicology; environmental risk assessment; exposure assessment; and related sciences ( <E T="03">e.g.,</E> synthetic biology, pharmacology, biotechnology, nanotechnology, biochemistry, biostatistics, physiologically based pharmacokinetic (PBPK) modeling, computational toxicology, epidemiology, environmental fate, and environmental engineering and sustainability). When needed, the SACC committee will be assisted by <E T="03">ad hoc</E> reviewers with specific expertise in the topics under consideration. <HD SOURCE="HD2">B. Why is EPA conducting these risk evaluations?</HD> TSCA requires EPA to conduct risk evaluations on prioritized chemical substances and allows chemical manufacturers to request an EPA-conducted risk evaluation of a chemical substance (or category of chemical substances) using the procedures established in 40 CFR 702.37. TSCA also identifies the minimum components EPA must include in all chemical substance risk evaluations. The purpose of conducting risk evaluations is to determine whether a chemical substance presents an unreasonable risk to human health or the environment under the Conditions of Use (COUs). These evaluations include assessing unreasonable risks to relevant potentially exposed or susceptible subpopulations. As part of this process EPA: (1) Integrates hazard and exposure assessments using the best available science that is reasonably available to ensure decisions are based on the weight of the scientific evidence, and (2) Conducts peer review for risk evaluation approaches that have not been previously peer-reviewed. For more information about the TSCA risk evaluation process for existing chemicals, go to <E T="03">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca.</E> <HD SOURCE="HD ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 21k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━