Science Advisory Committee on Chemicals (SACC) Peer Review; High-Priority Phthalates; Draft Risk Evaluations and Technical Support Documents; Notice of SACC Meeting; Availability of Draft Documents and Request for Comment, 24400-24403 [2025-10460]

Download as PDF 24400 Federal Register / Vol. 90, No. 110 / Tuesday, June 10, 2025 / Notices provision and include information on where and how to submit requests to EPA. Burden statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 14.8 hours per response. Burden is defined in 5 CFR 1320.3(b). The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized here: Respondents/affected entities: Entities potentially affected are those that Respondents affected by this activity are mainly government employees (federal, state, local, tribal), as well as medical professionals, such as doctors and nurses. The North American Industrial Classification System (NAICS) codes for health care and social assistance is 62. Respondent’s obligation to respond: Voluntary. Forms: None. Frequency of response: On occasion. Total estimated number of potential respondents: 6. Total estimated average number of responses for each respondent: 1. Total estimated annual burden hours: 89 hours. Total estimated annual respondent costs: $6,585.49, which includes $0 for capital investment or maintenance and operational costs. ddrumheller on DSK120RN23PROD with NOTICES1 III. Are there changes in the estimates from the last approval? There is no change in the estimated total annual burden compared with that identified in the ICR currently approved by OMB, but there is an increase in the estimated burden costs and a decrease in the estimated number of total respondents. The increase in the respondent burden and agency costs were caused by an increase in the hourly wages and a change in the methodology to calculate loaded wages (wages plus fringe benefits and overhead). This is an adjustment. IV. What is the next step in the process for this ICR? EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. EPA will issue another Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval VerDate Sep<11>2014 17:53 Jun 09, 2025 Jkt 265001 process, please contact the person listed under FOR FURTHER INFORMATION CONTACT. Authority: 44 U.S.C. 3501 et seq. Dated: June 4, 2025. Nancy B. Beck, Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2025–10461 Filed 6–9–25; 8:45 am] BILLING CODE 6560–50–P ENVIRONMENTAL PROTECTION AGENCY [EPA–HQ–OPPT–2024–0551; FRL–12418– 02–OCSPP] Science Advisory Committee on Chemicals (SACC) Peer Review; HighPriority Phthalates; Draft Risk Evaluations and Technical Support Documents; Notice of SACC Meeting; Availability of Draft Documents and Request for Comment Environmental Protection Agency (EPA). ACTION: Notice. AGENCY: The Environmental Protection Agency (EPA or Agency) is announcing that there will be two virtual public meetings of the Science Advisory Committee on Chemicals (SACC). On July 21, 2025, a preparatory meeting for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on August 4 through 8, 2025, a peer review meeting for the SACC to consider the dibutyl phthalate (DBP), the dicyclohexyl phthalate (DCHP), and the di(2ethylhexyl) phthalate (DEHP) draft risk evaluations, as well as the technical support documents for butyl benzyl phthalate (also known as benzyl butyl phthalate, BBP) and diisobutyl phthalate (DIBP), and public comments. The charge questions will address scientific and technical issues identified for peer review in all five phthalate risk evaluations scheduled to be finalized in 2025. EPA is also announcing the availability of and soliciting public comment on the draft documents and charge questions that will be provided to the SACC for this peer review. The draft risk evaluations and technical support documents were prepared under the Toxic Substances Control Act (TSCA) and will be submitted to the SACC for peer review. DATES: SUMMARY: Preparatory Public Meeting Meeting date: July 21, 2025, 1 p.m. to approximately 4 p.m. (EDT). PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 Registration: To request time to present oral comments during the preparatory meeting, you must register by noon (12 p.m. EDT) on July 14, 2025, and submit a written version of your oral comments by noon (12 p.m. EDT) on July 18, 2025. For those not making oral comments, registration will remain open through the end of this meeting on July 21, 2025. SACC Peer Review Public Meeting Meeting dates: August 4 through 8, 2025, 10 a.m. to approximately 5 p.m. (EDT). Registration: To request time to present oral comments during the peer review meeting, you must register by noon (12 p.m. EDT) July 28, 2025, and submit a written version of your oral comments by noon (12 p.m. EDT) on August 1, 2025. For those not making oral comments, registration will remain open through the end of this meeting on August 8, 2025. Comments Submit written comments on the draft risk evaluation and technical support documents for consideration by the SACC for peer review, on or before July 25, 2025. To be considered by the SACC during the peer review meeting, the comments must be submitted to the peer review docket by July 21, 2025. Special Accommodations 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. ADDRESSES: Comments: Submit written comments, identified by docket identification (ID) number EPA–HQ–OPPT–2024–0551, through https://www.regulations.gov. 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 https://www.epa.gov/ dockets. Meeting registration: Online registration will be available in July 2025. Please refer to the SACC website at https://www.epa.gov/tsca-peerreview. After registering, you will receive the webcast and streaming service meeting links and audio teleconference information. Special accommodation requests: To request an accommodation for a E:\FR\FM\10JNN1.SGM 10JNN1 Federal Register / Vol. 90, No. 110 / Tuesday, June 10, 2025 / Notices disability, please contact the Designated Federal Official (DFO) listed under FOR FURTHER INFORMATION CONTACT. FOR FURTHER INFORMATION CONTACT: Designated Federal Official (DFO): Dr. Alaa Kamel, Mission Support Division (7602M), Office of Program Support, Office of Chemical Safety and Pollution Prevention, Environmental Protection Agency; telephone number: (202) 564– 5336 or call the SACC main office at (202) 564–8450; email address: kamel.alaa@epa.gov. SUPPLEMENTARY INFORMATION: ddrumheller on DSK120RN23PROD with NOTICES1 I. Executive Summary A. What action is the Agency taking? EPA is announcing that there will be two virtual public meetings of the Science Advisory Committee on Chemicals (SACC). On July 21, 2025, a preparatory meeting for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on August 4 through 8, 2025, a peer review meeting for the SACC to consider the draft risk evaluations and technical support documents and public comments. The charge questions associated with these draft risk evaluations will address scientific and technical issues identified for peer review of all five phthalate risk evaluations scheduled to be finalized in 2025. The charge questions will be available in EPA docket ID No. EPA– HQ–OPPT–2024–0551 on or before June 16, 2025. EPA is also announcing the availability of and soliciting public comment on the draft documents that will be provided to the SACC for this peer review, including the draft charge questions that will be provided to the peer reviewers; the draft risk evaluations to inform risk management decisions under TSCA for DBP, DCHP, and DEHP; the non-cancer human health and environmental hazard draft technical support documents for BBP and DIBP; and three cross-phthalate technical support documents, specifically the: • Draft Meta-Analysis and Benchmark Dose Modeling of Fetal Testicular Testosterone Technical Support Document; • Draft Cancer Human Health Hazard Assessment Technical Support Document; and • Revised Draft Technical Support Document for the Cumulative Risk Analysis (CRA). EPA recently announced the availability of the draft risk evaluations for DBP and DEHP, and two crossphthalate technical support documents (the Draft Cancer Human Health Hazard VerDate Sep<11>2014 17:53 Jun 09, 2025 Jkt 265001 Assessment Technical Support Document and the Revised Draft Technical Support Document for the Cumulative Risk Analysis (CRA)) for public comment (see https:// www.epa.gov/chemicals-under-tsca/ epa-releases-draft-tsca-risk-evaluationsphthalates-dbp-and-dehp-public (FRL– 12808–01–OCSPP)). In January 2025, EPA released the draft risk evaluations for DCHP, along with the draft technical support documents for BBP and DIBP; and the cross-phthalate Draft MetaAnalysis and Benchmark Dose Modeling of Fetal Testicular Testosterone Technical Support Document. The draft risk evaluations were prepared under the Toxic Substances Control Act (TSCA) and will be submitted to the SACC for peer review. This document provides instructions for accessing the materials, submitting written comments, and registering to provide oral comments and virtually attend the public meetings. B. What is the Agency’s authority for taking this action? 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 et seq., the Pollution Prevention Act (PPA), 42 U.S.C. 13101 et seq., and other applicable statutes. C. Does this action apply to me? 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 (including members of at-risk communities, non-governmental organizations (NGOs), and federal, state, and local officials) in the assessment of risks involving chemical substances and mixtures regulated under TSCA. D. What should I consider as I submit my comments to EPA? 1. Submitting CBI. Do not submit CBI or other sensitive information to EPA through https://www.regulations.gov or email. To include information in your comment that you consider to be CBI or otherwise protected, please contact the DFO listed under FOR FURTHER INFORMATION CONTACT to obtain special instructions before submitting that information. PO 00000 Frm 00020 Fmt 4703 Sfmt 4703 24401 2. Tips for preparing comments. When preparing and submitting your comments, see https://www.epa.gov/ dockets/commenting-epa-dockets. See also the instructions in Unit III.C. E. How can I stay informed about SACC activities? You may subscribe to the following listserv for alerts regarding this and other SACC-related activities: https:// public.govdelivery.com/accounts/ USAEPAOPPT/subscriber/new?topic_ id=USAEPAOPPT_101. II. Background A. What is the purpose of the SACC? 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.g., chemistry, 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 ad hoc reviewers with specific expertise in the topics under consideration. B. Why is EPA conducting these risk evaluations? TSCA requires EPA to conduct risk evaluations on high-priority chemical substances and 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 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 assure 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 three stages of EPA’s process for ensuring the safety of existing chemicals (i.e., prioritization, risk evaluation, and risk management), go to https://www.epa.gov/assessing- E:\FR\FM\10JNN1.SGM 10JNN1 24402 Federal Register / Vol. 90, No. 110 / Tuesday, June 10, 2025 / Notices ddrumheller on DSK120RN23PROD with NOTICES1 and-managing-chemicals-under-tsca/ how-epa-evaluates-safety-existingchemicals. C. Why did EPA develop these documents? EPA designated the following chemicals as High-Priority Substances for risk evaluation under TSCA (84 FR 71924, December 30, 2019 (FRL–10003– 15)): butyl benzyl phthalate (also known as benzyl butyl phthalate, CASRN 85– 68–7), dibutyl phthalate (CASRN 84– 74–2), dicyclohexyl phthalate (CASRN 84–61–7), di(2-ethylhexyl) phthalate (CASRN 117–81–7), and diisobutyl phthalate (CASRN 84–69–5). For these chemicals, EPA published draft and final scope documents (85 FR 22733, April 23, 2020 (FRL–10008–05) and 85 FR 55281, September 4, 2020 (FRL– 10013–90)). The scope documents outlined the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Agency expected to consider in its risk evaluations. Although there are some differences in conditions of use and exposures, these chemical substances are primarily used as plasticizers in polyvinyl chloride (PVC) products and in adhesives, sealants, paints, coatings, rubbers, and other applications. Given the significant similarities in exposure and physical chemical properties of these phthalates, EPA is developing these risk evaluations, and the cross-phthalate draft technical support documents in parallel. Diisodecyl phthalate (DIDP) and diisononyl phthalate (DINP) were reviewed previously by the SACC (89 FR 43847, May 20, 2024 (FRL–11760– 02–OCSPP)); the draft risk evaluations for BBP, DBP, DCHP, DEHP, and DIBP are incorporating many of the SACC recommendations from this previous peer review. Draft risk evaluations for BBP and DIBP will be released prior to the SACC peer review meeting and announced subsequently in the Federal Register. In this SACC peer review of the draft risk evaluations for DBP, DCHP, and DEHP, EPA is soliciting comments from the SACC on the draft risk evaluations, including analyses of physical chemical properties, fate and transport in the environment, exposure to workers, consumers and general population including potentially exposed susceptible subpopulations, releases to the environment, environmental hazard and risk characterization for terrestrial and aquatic species, and human health hazard and risk characterization for workers, consumers, and the general population. Along with the full draft VerDate Sep<11>2014 17:53 Jun 09, 2025 Jkt 265001 risk evaluations for DBP, DCHP, and DEHP, EPA is also soliciting feedback on its BBP and DIBP non-cancer human health hazard, and environmental hazard, draft technical support documents and the three cross-phthalate technical support documents (specifically, the Draft Meta-Analysis and Benchmark Dose Modeling of Fetal Testicular Testosterone Technical Support Document, the Draft Cancer Human Health Hazard Assessment Technical Support Document, and the Revised Draft Technical Support Document for the Cumulative Risk Analysis). The Revised Draft Technical Support Document for the Cumulative Risk Analysis was developed based on the Draft Proposed Approach for Cumulative Risk Assessment under TSCA including recommendations from the May 2023 SACC review (see docket ID No. EPA–HQ–OPPT–2022–0918). D. What is the topic of the planned SACC peer review? EPA anticipates that the SACC peer review will focus on the complete draft risk evaluations for DBP, DCHP, and DEHP; the non-cancer human health and environmental hazard draft technical support documents for BBP and DIBP; and the three cross-phthalate technical support documents (specifically, the Draft Meta-Analysis and Benchmark Dose Modeling of Fetal Testicular Testosterone Technical Support Document, the Draft Cancer Human Health Hazard Assessment Technical Support Document, and the Revised Draft Technical Support Document for the Cumulative Risk Analysis). EPA anticipates requesting SACC peer review of the questions pertaining to critical inputs and novel approaches contained in these documents to constitute full peer review of all high priority substance phthalate risk evaluations. III. Public Meeting of the SACC A. What is the purpose of the virtual public meeting(s)? The purpose of the preparatory public meeting is for the SACC to consider and ask questions regarding the scope and clarity of the draft charge questions, and the public peer review meeting is for the SACC to consider, and peer review the draft risk evaluations and technical support documents. These public meetings are part of the SACC’s peer review of the Agency’s methods and novel analyses for the draft risk evaluations. The agenda for these meetings will be posted in the docket and will also be available through the SACC website. PO 00000 Frm 00021 Fmt 4703 Sfmt 4703 Recommendations from this SACC review and public comments will be considered in the development of the TSCA risk evaluations and may inform other EPA efforts related to the assessment and regulation of the chemical substances. The Agency will be seeking SACC review of its data analyses and methodologies relevant to human health hazard and exposure analyses that have not been previously peer-reviewed. B. How can I participate in the virtual public meeting(s)? To participate in these virtual public meetings, you must register online to receive the webcast and streaming service meeting links and audio teleconference information for each meeting. Online registration will be available approximately one month prior to the meeting and will remain open through the end of the meeting. To make oral comments during one of these meetings, follow the instructions in this document. C. How can I access the documents? The draft risk evaluations, related supporting materials and draft charge questions are available in docket ID No. EPA–HQ–OPPT–2024–0551. EPA will include additional meeting background materials as they become available, (e.g., SACC members and the meeting agenda) in the docket and through the Peer Review of High-Priority Phthalates website at https://www.epa.gov/tscapeer-review/peer-review-evaluating-riskhigh-priority-phthalates. D. How can I provide comments? To ensure proper receipt of comments, it is imperative that you identify docket ID No. EPA–HQ–OPPT– 2024–0551 in the subject line on the first page of your comments and follow the instructions in this document. 1. Written comments. Submit written comments by the deadlines set in the DATES section of this document and as described in the ADDRESSES section of this document. 2. Oral comments. To request time to present oral comments during one of the virtual public meetings, you must register online by the deadlines set in the DATES section of this document. Oral comments during the virtual public meetings are limited to five minutes unless arrangements have been made, within the constraints of the meeting agenda, prior to July 24, 2025. In addition, each speaker should submit a written copy of their oral comments and any supporting materials (e.g., presentation slides) to the DFO prior to the meetings for distribution to the E:\FR\FM\10JNN1.SGM 10JNN1 Federal Register / Vol. 90, No. 110 / Tuesday, June 10, 2025 / Notices SACC by the deadlines set in the DATES section of this document. IV. Next Steps After the SACC public meeting, the SACC will prepare the meeting minutes and a final report document summarizing its recommendations to the EPA, which will also be available in the docket and through the SACC website. EPA will consider the SACC recommendations and public comments to complete the risk evaluations and unreasonable risk determinations under TSCA for these chemical substances. Under TSCA, EPA must then initiate risk management actions to address the unreasonable risk it identified. Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10. Dated: June 5, 2025. Nancy B. Beck, Principal Deputy Assistant Administrator, Office of Chemical Safety and Pollution Prevention. [FR Doc. 2025–10460 Filed 6–9–25; 8:45 am] BILLING CODE 6560–50–P FEDERAL COMMUNICATIONS COMMISSION [OMB 3060–1306; FR ID 297448] Information Collection Being Submitted for Review and Approval to Office of Management and Budget Federal Communications Commission. ACTION: Notice and request for comments. AGENCY: As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might ‘‘further reduce the information collection burden for small business concerns with fewer than 25 employees.’’ DATES: Written comments and recommendations for the proposed information collection should be submitted on or before July 10, 2025. ADDRESSES: Comments should be sent to www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search ddrumheller on DSK120RN23PROD with NOTICES1 SUMMARY: VerDate Sep<11>2014 17:53 Jun 09, 2025 Jkt 265001 function. Your comment must be submitted into www.reginfo.gov per the above instructions for it to be considered. In addition to submitting in www.reginfo.gov also send a copy of your comment on the proposed information collection to Cathy Williams, FCC, via email to PRA@ fcc.gov and to Cathy.Williams@fcc.gov. Include in the comments the OMB control number as shown in the SUPPLEMENTARY INFORMATION below. FOR FURTHER INFORMATION CONTACT: For additional information or copies of the information collection, contact Cathy Williams at (202) 418–2918. To view a copy of this information collection request (ICR) submitted to OMB: (1) go to the web page https://www.reginfo.gov/ public/do/PRAMain, (2) look for the section of the web page called ‘‘Currently Under Review,’’ (3) click on the downward-pointing arrow in the ‘‘Select Agency’’ box below the ‘‘Currently Under Review’’ heading, (4) select ‘‘Federal Communications Commission’’ from the list of agencies presented in the ‘‘Select Agency’’ box, (5) click the ‘‘Submit’’ button to the right of the ‘‘Select Agency’’ box, (6) when the list of FCC ICRs currently under review appears, look for the Title of this ICR and then click on the ICR Reference Number. A copy of the FCC submission to OMB will be displayed. SUPPLEMENTARY INFORMATION: The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number. As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501–3520), the FCC invited the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission’s burden estimates; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology. Pursuant to the PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 24403 Small Business Paperwork Relief Act of 2002, Public Law 107–198, see 44 U.S.C. 3506(c)(4), the FCC seeks specific comment on how it might ‘‘further reduce the information collection burden for small business concerns with fewer than 25 employees.’’ OMB Control Number: 3060–1306. Title: Do Not Originate Requirements Voice Service Providers Report and Order. Form Number: N/A. Type of Review: Revision of a currently approved collection. Respondents: Business or other forprofit entities, and state, local, or tribal government. Number of Respondents: 6,493 respondents; 77,916 responses. Estimated Time per Response: 2 hours. Frequency of Response: On occasion reporting requirement. Obligation to Respond: Required to obtain or retain benefits. Statutory authority for these collections are contained in sections 4(i), 4(j), 201, 202, 217, 227, 227b, 251(e), 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 154(i), 154(j), 201, 202, 217, 227, 227b, 251(e), 303(r), and 403. Total Annual Burden: 155,832 hours. Total Annual Cost: No cost. Needs and Uses: This notice and request for comments seeks to revise an existing information collection as it pertains to the Advanced Methods to Target and Eliminate Unlawful Robocalls Sixth Report and Order and Call Authentication Trust Anchor Fifth Report and Order (‘‘Gateway Provider Report and Order’’), FCC 22–37. These revisions stem from the Advanced Methods to Target and Eliminate Unlawful Robocalls Eighth Report and Order (‘‘Call Blocking Eighth Report and Order’’), FCC 25–15. Unwanted and illegal robocalls have long been the Commission’s top source of consumer complaints and one of the Commission’s top consumer protection priorities. Foreign-originated robocalls represent a significant portion of illegal robocalls, and gateway providers serve as a critical choke-point for reducing the number of illegal robocalls received by American consumers. In the Gateway Provider Report and Order, the Commission took steps to prevent these foreign-originated illegal robocalls from reaching consumers and to help track these calls back to the source. Call Blocking Eighth Report and Order, FCC 25–15, paras. 9–14, 47 CFR 64.1200(o). A voice service provider must block any calls purporting to originate from a number on a reasonable do-not-originate E:\FR\FM\10JNN1.SGM 10JNN1

Agencies

[Federal Register Volume 90, Number 110 (Tuesday, June 10, 2025)]
[Notices]
[Pages 24400-24403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2025-10460]


-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2024-0551; FRL-12418-02-OCSPP]


Science Advisory Committee on Chemicals (SACC) Peer Review; High-
Priority Phthalates; Draft Risk Evaluations and Technical Support 
Documents; Notice of SACC Meeting; Availability of Draft Documents and 
Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA or Agency) is 
announcing that there will be two virtual public meetings of the 
Science Advisory Committee on Chemicals (SACC). On July 21, 2025, a 
preparatory meeting for the SACC to consider the scope and clarity of 
the draft charge questions for the peer review; and on August 4 through 
8, 2025, a peer review meeting for the SACC to consider the dibutyl 
phthalate (DBP), the dicyclohexyl phthalate (DCHP), and the di(2-
ethylhexyl) phthalate (DEHP) draft risk evaluations, as well as the 
technical support documents for butyl benzyl phthalate (also known as 
benzyl butyl phthalate, BBP) and diisobutyl phthalate (DIBP), and 
public comments. The charge questions will address scientific and 
technical issues identified for peer review in all five phthalate risk 
evaluations scheduled to be finalized in 2025. EPA is also announcing 
the availability of and soliciting public comment on the draft 
documents and charge questions that will be provided to the SACC for 
this peer review. The draft risk evaluations and technical support 
documents were prepared under the Toxic Substances Control Act (TSCA) 
and will be submitted to the SACC for peer review.

DATES: 

Preparatory Public Meeting

    Meeting date: July 21, 2025, 1 p.m. to approximately 4 p.m. (EDT).
    Registration: To request time to present oral comments during the 
preparatory meeting, you must register by noon (12 p.m. EDT) on July 
14, 2025, and submit a written version of your oral comments by noon 
(12 p.m. EDT) on July 18, 2025. For those not making oral comments, 
registration will remain open through the end of this meeting on July 
21, 2025.

SACC Peer Review Public Meeting

    Meeting dates: August 4 through 8, 2025, 10 a.m. to approximately 5 
p.m. (EDT).
    Registration: To request time to present oral comments during the 
peer review meeting, you must register by noon (12 p.m. EDT) July 28, 
2025, and submit a written version of your oral comments by noon (12 
p.m. EDT) on August 1, 2025. For those not making oral comments, 
registration will remain open through the end of this meeting on August 
8, 2025.

Comments

    Submit written comments on the draft risk evaluation and technical 
support documents for consideration by the SACC for peer review, on or 
before July 25, 2025. To be considered by the SACC during the peer 
review meeting, the comments must be submitted to the peer review 
docket by July 21, 2025.

Special Accommodations

    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.

ADDRESSES: 
    Comments: Submit written comments, identified by docket 
identification (ID) number EPA-HQ-OPPT-2024-0551, through https://www.regulations.gov. 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 https://www.epa.gov/dockets.
    Meeting registration: Online registration will be available in July 
2025. Please refer to the SACC website at https://www.epa.gov/tsca-peer-review. After registering, you will receive the webcast and 
streaming service meeting links and audio teleconference information.
    Special accommodation requests: To request an accommodation for a

[[Page 24401]]

disability, please contact the Designated Federal Official (DFO) listed 
under FOR FURTHER INFORMATION CONTACT.

FOR FURTHER INFORMATION CONTACT: 
    Designated Federal Official (DFO): Dr. Alaa Kamel, Mission Support 
Division (7602M), Office of Program Support, Office of Chemical Safety 
and Pollution Prevention, Environmental Protection Agency; telephone 
number: (202) 564-5336 or call the SACC main office at (202) 564-8450; 
email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. What action is the Agency taking?

    EPA is announcing that there will be two virtual public meetings of 
the Science Advisory Committee on Chemicals (SACC). On July 21, 2025, a 
preparatory meeting for the SACC to consider the scope and clarity of 
the draft charge questions for the peer review; and on August 4 through 
8, 2025, a peer review meeting for the SACC to consider the draft risk 
evaluations and technical support documents and public comments. The 
charge questions associated with these draft risk evaluations will 
address scientific and technical issues identified for peer review of 
all five phthalate risk evaluations scheduled to be finalized in 2025. 
The charge questions will be available in EPA docket ID No. EPA-HQ-
OPPT-2024-0551 on or before June 16, 2025.
    EPA is also announcing the availability of and soliciting public 
comment on the draft documents that will be provided to the SACC for 
this peer review, including the draft charge questions that will be 
provided to the peer reviewers; the draft risk evaluations to inform 
risk management decisions under TSCA for DBP, DCHP, and DEHP; the non-
cancer human health and environmental hazard draft technical support 
documents for BBP and DIBP; and three cross-phthalate technical support 
documents, specifically the:
     Draft Meta-Analysis and Benchmark Dose Modeling of Fetal 
Testicular Testosterone Technical Support Document;
     Draft Cancer Human Health Hazard Assessment Technical 
Support Document; and
     Revised Draft Technical Support Document for the 
Cumulative Risk Analysis (CRA).
    EPA recently announced the availability of the draft risk 
evaluations for DBP and DEHP, and two cross-phthalate technical support 
documents (the Draft Cancer Human Health Hazard Assessment Technical 
Support Document and the Revised Draft Technical Support Document for 
the Cumulative Risk Analysis (CRA)) for public comment (see https://www.epa.gov/chemicals-under-tsca/epa-releases-draft-tsca-risk-evaluations-phthalates-dbp-and-dehp-public (FRL-12808-01-OCSPP)). In 
January 2025, EPA released the draft risk evaluations for DCHP, along 
with the draft technical support documents for BBP and DIBP; and the 
cross-phthalate Draft Meta-Analysis and Benchmark Dose Modeling of 
Fetal Testicular Testosterone Technical Support Document. The draft 
risk evaluations were prepared under the Toxic Substances Control Act 
(TSCA) and will be submitted to the SACC for peer review.
    This document provides instructions for accessing the materials, 
submitting written comments, and registering to provide oral comments 
and virtually attend the public meetings.

B. What is the Agency's authority for taking this action?

    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 et seq., the Pollution Prevention 
Act (PPA), 42 U.S.C. 13101 et seq., and other applicable statutes.

C. Does this action apply to me?

    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 (including members of at-risk communities, non-
governmental organizations (NGOs), and federal, state, and local 
officials) in the assessment of risks involving chemical substances and 
mixtures regulated under TSCA.

D. What should I consider as I submit my comments to EPA?

    1. Submitting CBI. Do not submit CBI or other sensitive information 
to EPA through https://www.regulations.gov or email. To include 
information in your comment that you consider to be CBI or otherwise 
protected, please contact the DFO listed under FOR FURTHER INFORMATION 
CONTACT to obtain special instructions before submitting that 
information.
    2. Tips for preparing comments. When preparing and submitting your 
comments, see https://www.epa.gov/dockets/commenting-epa-dockets. See 
also the instructions in Unit III.C.

E. How can I stay informed about SACC activities?

    You may subscribe to the following listserv for alerts regarding 
this and other SACC-related activities: https://public.govdelivery.com/accounts/USAEPAOPPT/subscriber/new?topic_id=USAEPAOPPT_101.

II. Background

A. What is the purpose of the SACC?

    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.g., chemistry, 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 ad hoc reviewers with specific expertise in the topics 
under consideration.

B. Why is EPA conducting these risk evaluations?

    TSCA requires EPA to conduct risk evaluations on high-priority 
chemical substances and 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 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 assure 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 three stages of EPA's process for ensuring the 
safety of existing chemicals (i.e., prioritization, risk evaluation, 
and risk management), go to https://www.epa.gov/assessing-

[[Page 24402]]

and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-
chemicals.

C. Why did EPA develop these documents?

    EPA designated the following chemicals as High-Priority Substances 
for risk evaluation under TSCA (84 FR 71924, December 30, 2019 (FRL-
10003-15)): butyl benzyl phthalate (also known as benzyl butyl 
phthalate, CASRN 85-68-7), dibutyl phthalate (CASRN 84-74-2), 
dicyclohexyl phthalate (CASRN 84-61-7), di(2-ethylhexyl) phthalate 
(CASRN 117-81-7), and diisobutyl phthalate (CASRN 84-69-5). For these 
chemicals, EPA published draft and final scope documents (85 FR 22733, 
April 23, 2020 (FRL-10008-05) and 85 FR 55281, September 4, 2020 (FRL-
10013-90)). The scope documents outlined the hazards, exposures, 
conditions of use, and the potentially exposed or susceptible 
subpopulations the Agency expected to consider in its risk evaluations. 
Although there are some differences in conditions of use and exposures, 
these chemical substances are primarily used as plasticizers in 
polyvinyl chloride (PVC) products and in adhesives, sealants, paints, 
coatings, rubbers, and other applications.
    Given the significant similarities in exposure and physical 
chemical properties of these phthalates, EPA is developing these risk 
evaluations, and the cross-phthalate draft technical support documents 
in parallel. Di-isodecyl phthalate (DIDP) and di-isononyl phthalate 
(DINP) were reviewed previously by the SACC (89 FR 43847, May 20, 2024 
(FRL-11760-02-OCSPP)); the draft risk evaluations for BBP, DBP, DCHP, 
DEHP, and DIBP are incorporating many of the SACC recommendations from 
this previous peer review. Draft risk evaluations for BBP and DIBP will 
be released prior to the SACC peer review meeting and announced 
subsequently in the Federal Register.
    In this SACC peer review of the draft risk evaluations for DBP, 
DCHP, and DEHP, EPA is soliciting comments from the SACC on the draft 
risk evaluations, including analyses of physical chemical properties, 
fate and transport in the environment, exposure to workers, consumers 
and general population including potentially exposed susceptible 
subpopulations, releases to the environment, environmental hazard and 
risk characterization for terrestrial and aquatic species, and human 
health hazard and risk characterization for workers, consumers, and the 
general population. Along with the full draft risk evaluations for DBP, 
DCHP, and DEHP, EPA is also soliciting feedback on its BBP and DIBP 
non-cancer human health hazard, and environmental hazard, draft 
technical support documents and the three cross-phthalate technical 
support documents (specifically, the Draft Meta-Analysis and Benchmark 
Dose Modeling of Fetal Testicular Testosterone Technical Support 
Document, the Draft Cancer Human Health Hazard Assessment Technical 
Support Document, and the Revised Draft Technical Support Document for 
the Cumulative Risk Analysis). The Revised Draft Technical Support 
Document for the Cumulative Risk Analysis was developed based on the 
Draft Proposed Approach for Cumulative Risk Assessment under TSCA 
including recommendations from the May 2023 SACC review (see docket ID 
No. EPA-HQ-OPPT-2022-0918).

D. What is the topic of the planned SACC peer review?

    EPA anticipates that the SACC peer review will focus on the 
complete draft risk evaluations for DBP, DCHP, and DEHP; the non-cancer 
human health and environmental hazard draft technical support documents 
for BBP and DIBP; and the three cross-phthalate technical support 
documents (specifically, the Draft Meta-Analysis and Benchmark Dose 
Modeling of Fetal Testicular Testosterone Technical Support Document, 
the Draft Cancer Human Health Hazard Assessment Technical Support 
Document, and the Revised Draft Technical Support Document for the 
Cumulative Risk Analysis). EPA anticipates requesting SACC peer review 
of the questions pertaining to critical inputs and novel approaches 
contained in these documents to constitute full peer review of all high 
priority substance phthalate risk evaluations.

III. Public Meeting of the SACC

A. What is the purpose of the virtual public meeting(s)?

    The purpose of the preparatory public meeting is for the SACC to 
consider and ask questions regarding the scope and clarity of the draft 
charge questions, and the public peer review meeting is for the SACC to 
consider, and peer review the draft risk evaluations and technical 
support documents. These public meetings are part of the SACC's peer 
review of the Agency's methods and novel analyses for the draft risk 
evaluations. The agenda for these meetings will be posted in the docket 
and will also be available through the SACC website.
    Recommendations from this SACC review and public comments will be 
considered in the development of the TSCA risk evaluations and may 
inform other EPA efforts related to the assessment and regulation of 
the chemical substances. The Agency will be seeking SACC review of its 
data analyses and methodologies relevant to human health hazard and 
exposure analyses that have not been previously peer-reviewed.

B. How can I participate in the virtual public meeting(s)?

    To participate in these virtual public meetings, you must register 
online to receive the webcast and streaming service meeting links and 
audio teleconference information for each meeting. Online registration 
will be available approximately one month prior to the meeting and will 
remain open through the end of the meeting. To make oral comments 
during one of these meetings, follow the instructions in this document.

C. How can I access the documents?

    The draft risk evaluations, related supporting materials and draft 
charge questions are available in docket ID No. EPA-HQ-OPPT-2024-0551. 
EPA will include additional meeting background materials as they become 
available, (e.g., SACC members and the meeting agenda) in the docket 
and through the Peer Review of High-Priority Phthalates website at 
https://www.epa.gov/tsca-peer-review/peer-review-evaluating-risk-high-priority-phthalates.

D. How can I provide comments?

    To ensure proper receipt of comments, it is imperative that you 
identify docket ID No. EPA-HQ-OPPT-2024-0551 in the subject line on the 
first page of your comments and follow the instructions in this 
document.
    1. Written comments. Submit written comments by the deadlines set 
in the DATES section of this document and as described in the ADDRESSES 
section of this document.
    2. Oral comments. To request time to present oral comments during 
one of the virtual public meetings, you must register online by the 
deadlines set in the DATES section of this document. Oral comments 
during the virtual public meetings are limited to five minutes unless 
arrangements have been made, within the constraints of the meeting 
agenda, prior to July 24, 2025. In addition, each speaker should submit 
a written copy of their oral comments and any supporting materials 
(e.g., presentation slides) to the DFO prior to the meetings for 
distribution to the

[[Page 24403]]

SACC by the deadlines set in the DATES section of this document.

IV. Next Steps

    After the SACC public meeting, the SACC will prepare the meeting 
minutes and a final report document summarizing its recommendations to 
the EPA, which will also be available in the docket and through the 
SACC website. EPA will consider the SACC recommendations and public 
comments to complete the risk evaluations and unreasonable risk 
determinations under TSCA for these chemical substances. Under TSCA, 
EPA must then initiate risk management actions to address the 
unreasonable risk it identified.
    Authority: 15 U.S.C. 2625(o); 5 U.S.C. 10.

    Dated: June 5, 2025.
Nancy B. Beck,
Principal Deputy Assistant Administrator, Office of Chemical Safety and 
Pollution Prevention.
[FR Doc. 2025-10460 Filed 6-9-25; 8:45 am]
BILLING CODE 6560-50-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.