Benzyl Butyl Phthalate (BBP), Dibutyl Phthalate (DBP), Di(2-ethylhexyl) Phthalate (DEHP), Diisobutyl Phthalate (DIBP), and Dicyclohexyl Phthalate (DCHP); Technical Support Documents; Science Advisory Committee on Chemicals (SACC) Peer Review; Request for Nominations of Ad Hoc Reviewers

<NOTICE> ENVIRONMENTAL PROTECTION AGENCY <DEPDOC>[EPA-HQ-OPPT-2024-0551; FRL-12418-01-OCSPP]</DEPDOC> <SUBJECT>Benzyl Butyl Phthalate (BBP), Dibutyl Phthalate (DBP), Di(2-ethylhexyl) Phthalate (DEHP), Diisobutyl Phthalate (DIBP), and Dicyclohexyl Phthalate (DCHP); Technical Support Documents; Science Advisory Committee on Chemicals (SACC) Peer Review; Request for Nominations of Ad Hoc Reviewers</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 seeking public nominations of scientific and technical experts that EPA can consider for service as <E T="03">ad hoc</E> reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the Agency's technical support documents for benzyl butyl phthalate (BBP), dibutyl phthalate (DBP), di(2-ethylhexyl) phthalate (DEHP), diisobutyl phthalate (DIBP), and dicyclohexyl phthalate (DCHP) and the cross-phthalate technical support documents for human health benchmark dose (BMD) analysis, cancer analysis, and cumulative risk analysis. To facilitate nominations, this document provides information about the SACC, the intended topic for the planned peer review, the expertise sought for this peer review, instructions for submitting nominations to EPA, and the Agency's plan for selecting the <E T="03">ad hoc</E> reviewers for this peer review. EPA is planning to convene a virtual public meeting of the SACC in the spring of 2025 to review the technical support documents. </SUM> <DATES> <HD SOURCE="HED">DATES:</HD> Submit your nominations on or before January 2, 2025. </DATES> <HD SOURCE="HED">ADDRESSES:</HD> Submit your nominations to <E T="03">SACC@epa.gov.</E> <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> The Designated Federal Official (DFO) for the SACC is 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: <E T="03">kamel.alaa@epa.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">I. General Information</HD> <HD SOURCE="HD2">A. What action is the Agency taking?</HD> The Agency is seeking public nominations of scientific and technical experts that EPA can consider for service as <E T="03">ad hoc</E> reviewers assisting the SACC with the peer review of the Agency's technical support documents for the evaluation of the risks from BBP, DBP, DEHP, DIBP and DCHP to inform risk management decisions under TSCA. EPA is planning to hold a virtual public meeting in the spring of 2025 for the SACC to consider and review technical support documents. At that time, EPA will solicit comments from the SACC on the critical inputs and novel approaches for a variety of charge questions related to individual, draft chemical risk evaluations and the draft cumulative risk analysis. To facilitate nominations, this document provides information about the SACC, the intended topic for the planned peer review, the expertise sought for this peer review, instructions for submitting nominations to EPA, and the Agency's plan for selecting the <E T="03">ad hoc</E> reviewers for this peer review. <HD SOURCE="HD2">B. What is the Agency's authority for taking this action?</HD> TSCA section 6(b) requires that EPA conduct risk evaluations on existing chemical substances and identifies the minimum components EPA must include in all chemical substance risk evaluations (15 U.S.C. 2605(b)). The risk evaluation must not consider costs or other non-risk factors (15 U.S.C. 2605(b)(4)(F)(iii)). The specific risk evaluation process is addressed in 40 CFR part 702 and summarized on EPA's website at <E T="03">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/risk-evaluations-existing-chemicals-under-tsca.</E> The SACC was established by EPA 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. This action may, however, be of particular interest to those involved in the manufacture, processing, distribution, and disposal of chemical substances and mixtures, and/or those interested in the assessment of risks involving chemical substances and mixtures regulated under TSCA. Members of at-risk communities, non- governmental organizations (NGOs) (particularly those with an interest in protecting health for at-risk communities), and Federal, State and local officials may also be interested. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities to which this action may apply. <HD SOURCE="HD2">D. 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 comprised 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, environmental engineering and sustainability). The SACC currently consists of 20 members. When needed, the 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 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 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 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 ( <E T="03">i.e.,</E> prioritization, risk evaluation, and risk management), go to <E T="03">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/how-epa-evaluates-safety-existing-chemicals.</E> <HD SOURCE="HD2">C. Why did EPA develop these documents?</HD> EPA designated the following chemicals as High-Priority Substances for risk evaluation under TSCA in December 2019: BBP (Butyl Benzyl Phthalate, CASRN 85-68-7), DBP (Dibutyl Phthalate, CASRN 84-74-2), DEHP (Di(2-ethylhexyl) Phthalate, CASRN 117-81-7), DIBP (Diisobutyl Phthalate, CASRN 84-69-5), and DCHP (Dicyclohexyl Phthalate, CASRN 84-61-7). For these chemicals, EPA published draft and final scope documents in April and August 2020, respectively and, is currently in the risk evaluation process. 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. Because of the significant similarities in exposure and physical chemical properties of these phthalates, EPA is developing these risk evaluations and the cumulative risk assessment in parallel. DIDP and DINP were reviewed previously by the SACC (July 30-August 1, 2024); the draft risk evaluations for BBP, DBP, DEHP, DIBP and DCHP are incorporating many of the SACC recommendations from this previous peer review. EPA is soliciting comments from the SACC on a variety of charge questions related to the data, methods, models, approaches for these draft chemical risk evaluations, including the supporting draft cumulative risk assessment analysis. Many of the methods and analyses used in these evaluations are not novel and have been reviewed in the development of the tools used in various agency work products or in previous TSCA assessments. EPA is focusing peer review on the critical inputs and novel approaches. The draft risk evaluations for BBP, DBP, DEHP, DIBP and DCHP include analyses of physical chemical properties, fate and transport in the environment, exposure to workers, consumers and general population including potentially exposed susceptible subpopulations, releases ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 25k characters. 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