2024-29829. Initiation of Prioritization Under the Toxic Substances Control Act (TSCA); Notice of Availability

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Environmental Protection Agency

1. [EPA-HQ-OPPT-2023-0601; FRL-11581-06-OCSPP]

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

Under the Toxic Substances Control Act (TSCA) and related implementing regulations, EPA is initiating the prioritization process for five chemical substances as candidates for designation as High-Priority Substances for risk evaluation. This action provides the identity of the chemical substances being initiated for prioritization, a general explanation of why the Agency chose these chemical substances, and information on the data sources EPA plans to use to support the designation. EPA is providing a 90-day comment period, during which interested persons may submit relevant information on these chemical substances.

DATES:

Comments must be received on or before March 18, 2025.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number, through https://www.regulations.gov. Follow the online instructions for submitting comments. For comments not related to a specific chemical, including general comments on Unit IV.A., use docket ID number EPA-HQ-OPPT-2023-0601; submit information on the candidates for which EPA is initiating the prioritization process to the applicable chemical-specific docket ID number identified in Unit III.B.; submit information on the potential candidates for which EPA is not currently initiating the prioritization ( print page 102904) process to the docket ID number identified in Unit IV.B. 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 or visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information: Sarah Au, Data Gathering, Management, and Policy Division (7406M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: [phone]; email address: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Executive Summary

A. Does this action apply to me?

This action is directed to the public in general and may be of interest to entities that currently or may manufacture (including import) a chemical substance regulated under TSCA ( e.g., entities identified under North American Industrial Classification System (NAICS) codes 325 and 324110). The action may also be of interest to chemical processors, distributors in commerce, users, non-profit organizations in the environmental and public health sectors, state and local government agencies, Tribes, and members of the public. Because other entities may also be interested, the Agency has not attempted to describe all the specific entities and corresponding NAICS codes for entities that may be interested in or affected by this action.

B. What action is the Agency taking?

EPA is initiating the prioritization process under TSCA, 15 U.S.C. 2601 et seq., for five chemical substances as candidates for designation as High-Priority Substances for risk evaluation. This document includes the identity of the chemical substances entering the prioritization process before designation and a general explanation of why the Agency chose to initiate prioritization on these chemical substances. In addition, EPA is providing a 90-day comment period during which interested persons may submit relevant information on these chemical substances. Relevant information might include, but is not limited to, any information that may inform the prioritization screening review conducted pursuant to 40 CFR 702.9(a).

C. Why is the Agency taking this action?

TSCA section 6(b) requires that EPA initiate the prioritization process for chemical substances that may be designated as high priority or low priority for risk evaluation. Because EPA generally expects to complete five risk evaluations per year over the next several years, EPA is initiating the prioritization process for five chemical substances per TSCA section 6(b)(3)(C), which requires EPA to designate at least one High-Priority Substance upon completion of each risk evaluation for a High-Priority Substance. In the Federal Register on December 18, 2023 (88 FR 87423) (FRL-11581-01-OCSPP)), EPA initiated prioritization for five chemical substances that have undergone consideration as High-Priority Substances pursuant to TSCA section 6(b)(2)(B). By initiating prioritization another five chemical substances pursuant to TSCA section 6(b)(2)(B), EPA intends to maintain a sustainable pipeline of existing chemical risk evaluations under TSCA section 6(b). The request for interested persons to submit relevant information on a chemical substance for which EPA has initiated the prioritization process is required by TSCA section 6(b)(1)(C)(i).

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

This document is issued pursuant to the authority in TSCA section 6(b)(1) and (3)(C).

E. What are the estimated incremental impacts of this action?

This document does not establish requirements on persons or entities outside of the Agency. No incremental impacts are therefore anticipated, and consequently EPA did not estimate potential incremental impacts for this action.

F. What should I consider as I prepare my comments for EPA?

1. Submitting CBI

Do not submit CBI to EPA through https://www.regulations.gov or email. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/​dockets/​commenting-epa-dockets#rules and clearly mark the part or all the information you claim to be CBI. In addition to one complete version of the comment including information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2 and/or 40 CFR part 703, as applicable.

2. Tips for Preparing Your Comments

When preparing and submitting your comments, see the commenting tips at https://www.epa.gov/​dockets/​commenting-epa-dockets.html.

II. Background

TSCA section 6(b)(1) requires EPA to prioritize chemical substances for risk evaluation and to establish a process for prioritizing chemical substances. Under TSCA section 6(b) and as described in 40 CFR 702.7, EPA is initiating the prioritization process for five chemical substances as candidates for High-Priority Substances for risk evaluation.

Under TSCA section 6(b)(1)(B) and its implementing regulations (40 CFR 702.3), a High-Priority Substance is defined as a chemical substance that EPA determines, without consideration of costs or other non-risk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant by EPA.

Initiation of prioritization for chemical substances as High-Priority Substance candidates is not a finding of risk. Rather, when prioritization is complete, for those chemicals designated as High-Priority Substances, EPA will have evidence that this substance may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use. Final designation of a High-Priority Substance initiates the risk evaluation process (40 CFR 702.17), which culminates in a finding of whether the chemical substance presents an unreasonable risk under the conditions of use.

This document is intended to fulfill the TSCA section 6(b)(1)(C)(i) requirement that the Administrator request interested persons to submit relevant information on chemical substances for which the Administrator has initiated the prioritization process. As described in 40 CFR 702.7, this document initiates the prioritization process and provides 90 days during which interested persons may submit relevant information. ( print page 102905)

As described in 40 CFR 702.9(b), in conducting the screening review during the prioritization process, EPA will consider sources of information relevant to the screening review criteria as outlined in the statute (TSCA section 6(b)(1)(A)) and implementing regulations (40 CFR 702.9(a)) and consistent with the scientific standards of TSCA section 26(h), including, as appropriate, sources for hazard and exposure data listed in Appendices A and B of the TSCA Work Plan Chemicals: Methods Document (February 2012).

Consistent with the approach described in 40 CFR 702.7, and the “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization” document (September 27, 2018), available at https://www.epa.gov/​sites/​default/​files/​2018-09/​documents/​preprioritization_​white_​paper_​9272018.pdf, EPA consulted with other federal agencies and intends to continue to collaborate with them to identify information that is useful throughout the prioritization process.

III. High Priority Candidate Chemical Substances for Which EPA Is Initiating Prioritization

A. How did EPA select these candidates for prioritization for potential designation as High-Priority Substances for risk evaluation?

In general, EPA's working approach to select candidates for designation as High-Priority Substances for risk evaluation is outlined in the document, titled “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization,” released to the public on September 27, 2018, available at https://www.epa.gov/​sites/​default/​files/​2018-09/​documents/​preprioritization_​white_​paper_​9272018.pdf. To identify candidates for designation as High-Priority Substances, EPA primarily reviewed the “TSCA Work Plan for Chemical Assessments: 2014 Update (2014 TSCA Work Plan),” available at https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca/​tsca-work-plan-chemical-assessments-2014-update. TSCA requires EPA to preferentially consider chemicals on the 2014 TSCA Work Plan that are persistent and bioaccumulative and those that are known human carcinogens and highly toxic, based on scores and criteria documented in the Work Plan, as these chemicals were selected for inclusion on the Work Plan due to their potential risk to human health and the environment. Aside from this statutory requirement, TSCA gives EPA discretion in how the Agency ultimately selects a chemical substance for prioritization. EPA strives to designate as High-Priority Substances those chemicals with the greatest hazard and exposure potential first, consistent with the policy objectives codified in 40 CFR 702.5(a) in the Federal Register on July 20, 2017 (82 FR 33753) (FRL-9964-24)).

The number of chemical substances remaining on the 2014 TSCA Work Plan with persistence and bioaccumulation scores of 3 has been significantly reduced over time as EPA has expedited rulemaking under TSCA section 6(h) for five persistent, bioaccumulative, and toxic (PBT) chemical substances and as the Agency has conducted risk evaluations and promulgated risk management for rules for other chemical substances from the 2014 TSCA Work Plan. TSCA section 6(b)(2)(B) further requires that at least 50 percent of all ongoing risk evaluations be drawn from the 2014 TSCA Work Plan for Chemical Assessments. Given EPA's statutory deadlines and the timing of prioritization actions needed to offset the completion of risk evaluations for chemical substances designated as High-Priority Substances in 2019, EPA heavily weighed data availability in deciding which chemical substances to include in this action. Chemical substances remaining on the 2014 TSCA Work Plan that have persistence and bioaccumulation scores of 3 have significant data gaps, were submitted as potential manufacturer-requested risk evaluation candidates or are categories for which EPA is in the process of determining specific chemical structures that may be considered for inclusion in those categories.

EPA consulted with other EPA program offices and partner federal agencies to inform the Agency's prioritization efforts. With these considerations, the chemicals for which prioritization is initiated in this action were selected based on a variety of factors and reflect Agency priorities. While data availability was a significant driver of the Agency's selections, EPA also considered the complexity of evaluating broad chemical categories such as metal compounds. For EPA to build a sustainable TSCA prioritization, evaluation, and (when appropriate) risk management pipeline, chemicals ultimately designated as High-Priority Substances for risk evaluation should have a robust data landscape. In future rounds of prioritization, EPA intends to use its data gathering authorities earlier and commits to regular stakeholder engagement to ensure the Agency has the information needed to meet its statutory mandates.

Using data sources such as those described in the document titled, “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization,” EPA considered various types of information and data from existing resources such as EPA's National Center for Computational Toxicology's Chemistry Dashboard (CompTox Chemicals Dashboard), available at https://comptox.epa.gov/​ dashboard. EPA also conducted initial searches of additional sources of public and gray literature ( e.g., PubMed, Web of Science, other U.S. government and international websites).

EPA also considered existing information from public and non-public ( i.e., confidential business information) sources maintained by authoritative sources, such as other EPA program offices, state and federal agencies, and various U.S. and international organizations (including but not limited to EPA's Office of Water, EPA's Office of Air and Radiation, EPA's Office of Research and Development, California Environmental Protection Agency, National Institute for Occupational Safety and Health, Agency for Toxic Substances and Disease Registry, European Chemicals Agency, Health Canada, International Agency for Research on Cancer, and Organisation for Economic Co-operation and Development).

After identifying information from reasonably available sources, the information was screened across several data elements including physical and chemical properties, environmental fate and transport properties, hazard, exposure, and use information to determine the breadth of data availability for a chemical substance. Using experience gained from TSCA implementation activities to date, EPA considered previous and planned Agency activities related to a given chemical substance, including how to better leverage experience gained from previously conducted or ongoing risk evaluations. EPA also considered whether analyses from previous risk assessments could be used to better understand each chemical substance's potential exposure and/or hazard characteristics.

In the absence of measured empirical data on chemicals being evaluated, EPA may use alternative means or new approach methods (NAMs) to obtain relevant data. NAMs can reduce vertebrate testing, consistent with TSCA section 4(h)(1)(A). EPA intends to use this approach to the extent practicable and scientifically justified.

EPA also considered information such as data submitted to EPA in 2020 under ( print page 102906) the Chemical Data Reporting (CDR) rule under TSCA regarding reported uses and products to inform prioritization and risk evaluation. EPA considered the use information for these chemicals and screened them according to the types of industrial uses and types of products for which the chemicals were used as reported in the 2020 CDR. Information reported to the Toxics Release Inventory Program was also considered to identify reported uses and releases of chemical substances.

EPA intends to update and refine its initial review based on data sources identified by the public during the comment period (see EPA's request for data in Unit IV.) and, as permitted by TSCA section 14 and subject to EPA confidentiality regulations at 40 CFR part 2, subpart B and 40 CFR part 703, intends to make this information publicly available for the initiated chemicals when EPA publishes the proposed priority designation.

Between December 18, 2023, and October 31, 2024, EPA received information regarding candidate chemical substances being considered for prioritization actions during two periods. During September and October 2023, EPA hosted a series of pre-prioritization meetings with various stakeholders, Tribes, state and local governments, and other federal agencies to explain the prioritization process and provide an overview of information that may be used to inform the considerations that ultimately support a High- or Low-Priority Substance designation. A list of 15 candidate chemical substances being considered for future prioritization actions, including those undergoing initiation in this prioritization action, was presented to provide an opportunity for partners, stakeholders, and any interested persons to comment on the data and scientific literature available that may be used to help EPA determine which chemical substances may undergo prioritization in the near term. EPA also opened docket ID No. EPA-HQ-OPPT-2023-0606 for 90 days to receive any potentially relevant information on the 10 chemical substances communicated as candidates for prioritization but not selected for initiation on December 18, 2023, which included the chemical substances for which prioritization is being initiated with this action.

As a part of EPA's commitment to greater transparency and to maintain engagement with partners, stakeholders or any interested persons about upcoming prioritization actions, EPA hosted public webinars on September 30 and October 1, 2024, that explained the prioritization process, provided an overview of information that may be used to inform the considerations that ultimately support a High- or Low-Priority Substance designation, and shared an expanded list of 27 candidate chemical substances being considered for prioritization actions. This expanded list included the 10 chemical substances previously communicated in 2023 as being potential candidates for prioritization but not yet selected for initiation. Following the public webinars, EPA opened docket ID No. EPA-HQ-OPPT-2023-0606 for 30 days to receive any potentially relevant information on the 27 chemical substances communicated as being candidates for prioritization. EPA also engaged with Tribes, state and local governments, and other federal agencies and presented the same information that was provided during the public webinars.

EPA considered all comments and information received during the various meetings and webinars, as well as those submitted to docket ID no. EPA-HQ-OPPT-2023-0606 on all candidate chemical substances considered for prioritization actions communicated between September 2023 and October 2024 to identify the five chemical substances being initiated for prioritization. During the first 90-day public comment period accompanying the initiation action that began in December 2023, EPA received comments pertaining to six chemical substances communicated as potential candidates for prioritization during the pre-prioritization presentations in September and October 2023 and September and October 2024: 4- tert - octylphenol, N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD), benzene, ethylbenzene, naphthalene, and styrene.

One commentor (EPA-HQ-OPPT-2018-0448-0027) wrote in general support of the consideration of benzene, ethylbenzene, naphthalene, and styrene for upcoming prioritization actions and the consideration of submitted information on natural disasters and environmental impacts on potential exposure.

Some commenters (EPA-HQ-OPPT-2023-0606-0005; EPA-HQ-OPPT-2023-0606-0006; EPA-HQ-OPPT-2023-0606-0007) included information on 6PPD and/or 6PPD-quinone (a degradation product of 6PPD) for consideration in upcoming prioritization actions and in support of the petition submitted under TSCA section 21 requesting the promulgation of risk management regulations under TSCA section 6(a) to prohibit the manufacturing, processing, use and distribution of 6PPD for and in tires to eliminate unreasonable risk to the environment.

Another commenter (EPA-HQ-OPPT-2023-0606-0005) requested that docket ID. No. EPA-HQ-OPPT-2023-0606 remain open to allow for continuous submission of potentially relevant information regarding the characterization of 6PPD risk. EPA intends to re-open docket ID No. EPA-HQ-OPPT-2023-0606 during specific timeframes during pre-prioritization to allow for submission of information using regulations.gov.

As described in Unit IV.B., EPA is also re-opening docket ID No. EPA-HQ-OPPT-2023-0606 to solicit comments and information on 22 chemical substances that are candidates for future prioritization actions. Regarding the TSCA section 21 petition from Earthjustice on behalf of the Yurok Tribe, the Port Gamble S'Klallam Tribe, and the Puyallup Tribe of Indians, EPA issued an Advance Notice of Proposed Rulemaking in the Federal Register on November 18, 2024 (89 FR 91299) (FRL-11682-01-OCSPP)) for 6PPD and 6PPD-quinone under TSCA section 6(a), and is committed to 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.

One commentor (EPA-HQ-OPPT-2023-0606-0003) stated that the information presented in the 2014 TSCA Work Plan was incorrect for 4-tert-octylphenol and that EPA should not include 4-tert-octylphenol on the fourth Candidate Chemical List under SDWA. Under TSCA, EPA is required to consider chemical substances identified in the 2014 TSCA Work Plan and does not plan to revise the Work Plan as part of this action. Additional information received regarding the potential hazard, potential exposure, and bioaccumulation and persistence of 4-tert-octylphenol may be considered during prioritization.

For more information on the comments and EPA's responses regarding the candidate chemical substances, see Section 1.7 and 7.1 of the “EPA Response to Public Comments Received on the “Initiation of Prioritization Under the Toxic Substances Control Act” and “Proposed High-Priority Substance Designations Under the Toxic Substances Control Act” document published in docket ID no. EPA-HQ-OPPT-2023-0601 and EPA-HQ-OPPT-2023-0606. ( print page 102907)

B. What chemicals are being initiated?

EPA is initiating the prioritization process for the following five chemicals as candidates for designation as High-Priority Substances:

1. 4-Tert-Octylphenol, CASRN 140-66-9, Docket ID No.: EPA-HQ-OPPT-2018-0496

This chemical was listed in the 2014 TSCA Work Plan with a hazard score of 3; an exposure score of 3; and a persistence and bioaccumulation score of 2. Exposure to 4-tert-octyphenol (4-(1,1,3,3-tetramethylbutyl)-phenol may result in a range of human health effects such as kidney inflammation and impaired fertility ( i.e., lowered sperm count). Data related to human carcinogenicity have not been identified. Data regarding the use of this chemical was reported to EPA in the 2020 CDR. EPA also receives information annually on this chemical through the Toxics Release Inventory (TRI). Information is available from assessments conducted by international organizations, and other countries.

2. Benzene, CASRN 71-43-2, Docket ID No.: EPA-HQ-OPPT-2018-0475

This chemical was listed in the 2014 TSCA Work Plan with a hazard score of 3; an exposure score of 3; and a persistence and bioaccumulation score of 1. Data regarding the use of this chemical was reported to EPA in the 2020 CDR. Benzene is a known human carcinogen. Exposure to benzene may also result in a range of health effects such as immune function ( e.g., decreased immune lymphocyte count) and developmental abnormalities ( i.e., fetal malformations). EPA also receives information annually on this chemical through the TRI. Information is available from assessments conducted by other federal agencies, the state of California, international organizations, and other countries.

3. Ethylbenzene, CAS RN 100-41-4, Docket ID No.: EPA-HQ-OPPT-2018-0487

This chemical was listed in the 2014 TSCA Work Plan with a hazard score of 3; an exposure score of 3; and a persistence and bioaccumulation score of 1. Ethylbenzene is a probable human carcinogen. Exposure to ethylbenzene may also result in a range of health effects such as changes to liver and kidney tissue, hearing loss, and developmental abnormalities ( i.e., fetal malformations). Data regarding the use of this chemical was reported to EPA in the 2020 CDR. EPA also receives information annually on this chemical through the TRI. Information is available from assessments conducted by other federal agencies, the state of California, international organizations, and other countries.

4. Naphthalene, CASRN 91-20-3, Docket ID No.: EPA-HQ-OPPT-2018-0454

This chemical was listed in the 2014 TSCA Work Plan with a hazard score of 3; an exposure score of 3; and a persistence and bioaccumulation score of 2. Naphthalene is a probable human carcinogen. Exposure to naphthalene may also result in a range of health effects such as destruction of red blood cells resulting in lower blood oxygen, damage to eyesight, and changes to liver, lung, and nasal tissue. Data regarding the use of this chemical was reported to EPA in the 2020 CDR. EPA also receives information annually on this chemical through the TRI. Information is available from assessments conducted by other federal agencies, the state of California, international organizations, and other countries.

5. Styrene, CASRN 100-42-5, Docket ID No.: EPA-HQ-OPPT-2018-0461

This chemical was listed in the 2014 TSCA Work Plan with a hazard score of 3; an exposure score of 3; and a persistence and bioaccumulation score of 1. Styrene is a probable human carcinogen. Exposure to styrene may also result in a range of health effects such as hearing loss, memory loss, fetal death, and tissue changes in the lungs and nasal passages. Data regarding the use of this chemical was reported to EPA in the 2020 CDR. EPA also receives information annually on this chemical through the TRI. Information is available from assessments conducted by other federal agencies, the state of California, international organizations, and other countries.

IV. Relevant Information

A. What additional information is EPA seeking for the five candidate chemical substances for which EPA is initiating prioritization?

Through this initiation of prioritization for chemical substances, EPA is providing a 90-day comment period as required by the statute (TSCA section 6(b)(1)(C)(i)) and implementing regulations (40 CFR 702.7(d)) and requesting that interested persons voluntarily submit relevant information. Relevant information might include, but is not limited to, information that may inform the screening review conducted pursuant to 40 CFR 702.9(a), consistent with the scientific standard of TSCA section 26(h), about the following criteria and considerations:

• The chemical substance's hazard and exposure potential;
• The chemical substance's persistence and bioaccumulation;
• Potentially exposed or susceptible subpopulations which the submitter believes are relevant to the prioritization;
• Whether there is any storage of the chemical substance near significant sources of drinking water, including the storage facility location and the nearby drinking water source(s);
• The chemical substance's conditions of use or significant changes in conditions of use, including information regarding trade names;
• The chemical substance's production volume or significant changes in production volume; and
• Any other information relevant to the potential risks of the chemical substance that might be relevant to the designation of the chemical substance's priority for risk evaluation.

If the information is publicly available, citations are sufficient (including, but not limited to: Title, author, date of publication, publication source), and the submission does not need to include copies of the information.

B. What information is the Agency seeking for the 22 additional chemical substances that EPA considered, but did not select, for the current round of prioritization?

During the pre-prioritization process, EPA hosted public webinars and met with federal partners, industry, environmental organizations, labor organizations, state and local governments, and Tribes to discuss the prioritization process and presented a list of 27 chemical substances EPA was considering for prioritization. EPA took feedback from these discussions into consideration when selecting the five chemicals for prioritization listed in Unit III.B. Interested persons may submit relevant information on the chemical substances listed in this unit that are not currently undergoing prioritization by using docket ID number EPA-HQ-OPPT-2023-0606.

EPA has not yet determined which specific chemical structures are being considered for the chemical substances designated as a category in the 2014 TSCA Work Plan ( i.e., do not have CASRN listed). Therefore, EPA welcomes comments and information on specific chemical structures that may be relevant for addressing the various prioritization criteria and considerations on the chemical categories listed in this ( print page 102908) unit. Information submitted on the substances within a category should be reported for each individual chemical structure, to the extent possible ( i.e., known or reasonably ascertainable). If the chemical identity of some of the individual chemical structures are not known or reasonably ascertainable by the commenter, the information associated with those chemical substances may be reported as a group of chemical structures ( i.e., isomeric mixture) or as the chemical category:

• 1-Hexadecanol, CASRN 36653-82-4;
• 2-Ethylhexyl 2,3,4,5-tetrabromobenzoate (TBB), CASRN 183658-27-7;
• Bis(2-Ethylhexyl)-3,4,5,6-Tetrabromophthalate (TBPH), CASRN 26040-51-7;
• Bisphenol A, CASRN 80-05-7;
• Creosote, CASRN 8001-58-9;
• Di-n-octyl phthalate (DnOP), CASRN 117-84-0;
• N -Nitroso-diphenylamine, CASRN 86-30-6;
• P,P ′-Oxybis(benzenesulfonylhydrazide), CASRN 80-51-3;
• Tribromomethane, CASRN 75-25-2;
• Triglycidyl isocyanurate, CASRN 2451-62-9;
• M-Xylene, CASRN 108-38-3;
• O-Xylene, CASRN 95-47-6;
• P-Xylene, CASRN 106-42-3;
• Antimony and Antimony Compounds, Category;
• Arsenic and Arsenic Compounds, Category;
• Cobalt and Cobalt Compounds, Category;
• Lead and Lead Compounds, Category;
• Long-chain chlorinated paraffins (C18-20), Category;
• Medium-chain chlorinated paraffins (C14-17), Category;
• Bisphenol S, CASRN 80-09-1;
• Hydrogen Fluoride, CASRN 7664-39-3;
• N -(1,3-Dimethylbutyl)- N′ -phenyl- p -phenylenediamine (6PPD), CASRN 793-24-8.

C. How will confidential business information be protected?

A person seeking to protect from disclosure as “confidential business information” any information that person submits under TSCA must assert and substantiate a claim for protection from disclosure concurrent with submission of the information in accordance with the requirements of TSCA section 14 and 40 CFR 703, with limited exceptions provided in the statute. TSCA section 14(b) limits confidentiality protections for health and safety studies and information from such studies, however, and while EPA considers confidential business information when conducting its review under 40 CFR 702.9(a), the Agency encourages submitters to minimize claims for protection from disclosure wherever possible to maximize transparency in EPA's screening review. More information on asserting and submitting confidential business information claims under TSCA can be found at 40 CFR 703 and https://www.epa.gov/​tsca-cbi.

Authority:15 U.S.C. 2601 et seq.

Dated: December 12, 2024.

Michal Freedhoff,

Assistant Administrator, Office of Chemical Safety and Pollution Prevention.