SUPPLEMENTARY INFORMATION:

I. Executive Summary

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

TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the factors in TSCA section 5(a)(2) (see also the discussion in Unit II.).

B. What action is the Agency taking?

EPA is proposing SNURs for the chemical substances discussed in Unit III. These SNURs, if finalized as proposed, would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.

C. Does this action apply to me?

1. General Applicability

This action applies to you if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:

• Manufacturers or processors of one or more subject chemical substances (NAICS codes 325 and 324110),e.g., chemical manufacturing and petroleum refineries.

2. Applicability to Importers and Exporters

This action may also apply to certain entities through pre-existing import certification and export notification requirements under TSCA ( https://www.epa.gov/​tsca-import-export-requirements).

Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements in 19 CFR 12.118 through 12.127, 19 CFR 127.28, and 40 CFR part 707, subpart B. Importers of chemical substances in bulk form, as part of a mixture, or as part of an article (if required by rule) must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA, including regulations issued under TSCA sections 5, 6, 7 and Title IV.

Pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after December 3, 2025 are subject to TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.

D. What are the incremental economic impacts of this action?

EPA has evaluated the potential costs of establishing SNUN reporting requirements for potential manufacturers (including importers) and processors of the chemical substances subject to these proposed SNURs. This analysis, which is available in the docket, is briefly summarized here.

1. Estimated Costs for SNUN Submissions

If a SNUN is submitted, costs are an estimated $45,000 per SNUN submission for large business submitters and $14,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $37,000 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 700.45(c)(1)(ii) and (d)). The costs of submission for SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in these SNURs. Additionally, these estimates reflect the costs and fees as they are known at the time of this rulemaking.

2. Estimated Costs for Export Notifications

EPA has also evaluated the potential costs associated with the export notification requirements under TSCA section 12(b) and the implementing regulations at 40 CFR part 707, subpart D. For persons exporting a substance that is the subject of a SNUR, a one-time notice to EPA must be provided for the first export or intended export to a ( printed page 49149) particular country. The total costs of export notification will vary by chemical, depending on the number of required notifications ( i.e., the number of countries to which the chemical is exported). While EPA is unable to make any estimate of the likely number of export notifications for the chemical substances covered by these SNURs, as stated in the accompanying economic analysis, the estimated cost of the export notification requirement on a per unit basis is approximately $106.

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

1. Submitting CBI

Do not submit CBI to EPA through email or https://www.regulations.gov. 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 information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703.

2. Tips for Preparing Your Comments

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

II. Background

This unit provides general information about SNURs. For additional information about EPA's new chemical program go to https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

A. Significant New Use Determination Factors

TSCA section 5(a)(2) states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:

• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors listed in this unit and discussed in Unit III.

These proposed SNURs include PMN substances that are subject to orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). The TSCA orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA orders, consistent with TSCA section 5(f)(4).

B. Rationale and Objectives of the SNURs

1. Rationale

Under TSCA, no person may manufacture a new chemical substance or manufacture or process a chemical substance for a significant new use until EPA makes a determination as described in TSCA section 5(a) and takes any required action. The issuance of a SNUR is not a risk determination itself, only a notification requirement for “significant new uses,” so that the Agency has the opportunity to review the SNUN for the significant new use and make a TSCA section 5(a)(3) risk determination.

During review of the PMNs submitted that are subject to these proposed SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. Based on these findings outlined in Unit III., TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow the TSCA Orders with a SNUR that identifies the absence of those protective measures as significant new uses to ensure that all manufacturers and processors—not just the original submitter—are held to the same standard.

2. Objectives

EPA is proposing these SNURs because the Agency wants:

• To identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).
• To have an opportunity to review and evaluate data submitted in a SNUN before the submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• To be obligated to make a determination under TSCA section 5(a)(3) regarding the use described in the SNUN, under the conditions of use. The Agency will either determine under TSCA section 5(a)(3)(C) that the significant new use is not likely to present an unreasonable risk, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator under the conditions of use, or make a determination under TSCA section 5(a)(3)(A) or (B) and take the required regulatory action associated with the determination, before manufacture or processing for the significant new use of the chemical substance can occur.

Issuance of a proposed SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available at https://www.epa.gov/​tsca-inventory.

C. Significant New Uses Claimed as CBI

EPA is proposing to establish certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR parts 2 and 703. Absent a final determination or other disposition of the confidentiality claim under these regulations, EPA is required to keep this information confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with the situation where a specific significant new use is CBI. Under these procedures, a manufacturer or processor may ask EPA to identify the confidential significant new use subject to the SNUR. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will identify the confidential significant new use to that person. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.11 into a single step. ( printed page 49150)

D. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to SNURs, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Pursuant to 40 CFR 721.1(c), persons subject to SNURs must comply with the same requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections 5(h)(1), 5(h)(2), 5(h)(3), and 5(h)(5) and the regulations at 40 CFR part 720. In addition, provisions relating to user fees appear at 40 CFR part 700.

Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence. If EPA determines that the significant new use of the chemical substance is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

As discussed in Unit I.C.2., persons who export or intend to export a chemical substance identified in a proposed or final SNUR are subject to the export notification provisions of TSCA section 12(b), and persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements. See also https://www.epa.gov/​tsca-import-export-requirements.

E. Applicability of the Proposed SNURs to Uses Occurring Before the Effective Date of the Final Rule

To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review and received determinations under TSCA section 5(a)(3)(C). TSCA Orders have been issued for these chemical substances and the PMN submitters are required by the TSCA Orders to submit a SNUN before undertaking activities that would be designated as significant new uses in these SNURs. Additionally, the identities of many of the chemical substances subject to this proposed rule have been claimed as confidential per 40 CFR 720.85, further reducing the likelihood that another party would manufacture or process the substances for an activity that would be designated as a significant new use. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses identified in Unit III. are ongoing.

When the chemical substances identified in Unit III are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. Persons who begin manufacture or processing of the chemical substances for a significant new use identified on or after the designated cutoff date specified in Unit III.A. would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and EPA would have to take action under TSCA section 5 allowing manufacture or processing to proceed.

F. Important Information About SNUN Submissions

1. SNUN Submissions

SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at https://www.epa.gov/​reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

2. Development and Submission of Information

EPA recognizes that TSCA section 5 does not require development of any particular new information ( e.g., generating test data) before submission of a SNUN. There is an exception: If a person is required to submit information for a chemical substance pursuant to a rule, order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, TSCA order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. To assist with EPA's analysis of the SNUN, submitters are encouraged, but not required, to provide the potentially useful information as identified for the chemical substance in Unit III.C.

EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca/​alternative-test-methods-and-strategies-reduce.

The potentially useful information described in Unit III. may not be the only means of providing information to evaluate the chemical substance associated with the significant new uses. However, submitting a SNUN without any test data may increase the likelihood that EPA will take action under TSCA sections 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information about human exposure and environmental release that may result from the significant new use of the chemical substances.

III. Chemical Substances Subject to These Proposed SNURs

A. What is the designated cutoff date for ongoing uses?

EPA designates November 3, 2025 as the cutoff date for determining whether the new use is ongoing. This designation is explained in more detail in Unit II.E.

B. What information is provided for each chemical substance?

For each chemical substance identified in Unit III.C., EPA provides the following information: ( printed page 49151)

• PMN number (the proposed CFR citation assigned in the regulatory text section of the proposed rule).
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service Registry Number (CASRN) or Accession Number (if assigned for confidential chemical identities).
• Basis for the SNUR (effective date of and basis for the TSCA Order).
• Potentially useful information.

The regulatory text section of the proposed rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits and other uses designated in the proposed rules, may be claimed as CBI.

These proposed SNURs include PMN substances that are subject to orders issued under TSCA section 5(e)(1)(A), as required by the determinations made under TSCA section 5(a)(3)(B). Those TSCA Orders require protective measures to limit exposures or otherwise mitigate the potential unreasonable risk. The proposed SNURs identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the restrictions imposed by the underlying TSCA Orders, consistent with TSCA section 5(f)(4).

Where EPA determined that the PMN substance may present an unreasonable risk of injury to human health via inhalation exposure, the underlying TSCA Order usually requires that potentially exposed employees wear specified respirators unless actual measurements of the workplace air show that air-borne concentrations of the PMN substance are below a New Chemical Exposure Limit (NCEL). The comprehensive NCELs provisions in TSCA Orders include requirements addressing performance criteria for sampling and analytical methods, periodic monitoring, respiratory protection, and recordkeeping. No comparable NCEL provisions currently exist in 40 CFR part 721, subpart B, for SNURs. Therefore, for these cases, the individual SNURs in 40 CFR part 721, subpart E, will state that persons subject to the SNUR who wish to pursue NCELs as an alternative to the 40 CFR 721.63 respirator requirements may request to do so under 40 CFR 721.30. EPA expects that persons whose 40 CFR 721.30 requests to use the NCELs approach for SNURs that are approved by EPA will be required to comply with NCELs provisions that are comparable to those contained in the corresponding TSCA Order.

C. Which chemical substances are subject to these proposed SNURs?

The substances subject to the proposed SNURs in this document are as follows, listed by PMN number and with the proposed CFR citation.

P-18-281 and P-21-77 (40 CFR 721.12147)

Chemical name: Cyclic sulfate (generic) (P-18-281 and P-21-77).

CASRN: Not available.

Effective dates of TSCA Orders: January 4, 2025 (P-18-281 Modified Order for SoulBrain MI, Inc.) and April 26, 2022 (P-18-281 joint submitters and P-21-77).

Basis for action: PMN P-18-281 states that the generic (non-confidential) use will be as an electrolyte additive. Based on test data on the PMN substance and comparison to analogous substances, EPA identified concerns for genetic toxicity, skin sensitization, carcinogenicity, systemic effects, corrosion to the skin, eyes, and respiratory tract, and acute toxicity. Based on comparison to analogous substances, EPA also identified concerns for systemic and carcinogenicity effects for the hydrolysis product. Based on comparison to analogous neutral organic substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 152 ppb. EPA issued Orders for the PMN submitter and joint submitters under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Orders require:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate or combination particulate and gas/vapor respirator with an APF of at least 50 (where there is a potential for inhalation exposure) if the PMN submitter uses only up to the confidential annual production volume (measured on a year-to-year basis) at a use site and receives the PMN substance at 1% or less in formulation; or, if these conditions are not met, an APF of at least 1,000;
• No domestic manufacture of the PMN substance (i.e., import only);
• Processing only at SoulBrain MI, Inc.'s Northville, MI facility;
• No processing of the PMN substance above 5% in formulation;
• No processing or use of the PMN substance other than for the confidential use allowed in the Order;
• No release of more than 8.3 kg/year of the PMN substance in the form of dust stack air releases;
• No disposal of the PMN substance by incineration unless the PMN substance has been fully reacted with water or when using a hazardous waste incinerator with ≥99.999% efficiency;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 152 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

These Orders, effective April 26, 2022, required the PMN submitters to process the PMN substance at SoulBrain MI, Inc.'s facility in Northville, MI, among the other restrictions identified above.

On June 2, 2023, SoulBrain MI, Inc. requested a modification of their Order to allow processing of the PMN substance both at SoulBrain MI, Inc.'s facility in Northville, MI and at their new facility in Kokomo, IN. EPA performed a risk assessment based on the new intended conditions of use and subsequently modified the terms of their Order to mitigate any unreasonable risks to human health and the environment and issued a modified Order, effective January 4, 2025. To protect against these risks, the modified Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Prior to conducting exposure monitoring as described in the modified Order, use of a NIOSH-certified particulate or combination particulate and gas/vapor respirator with an APF of at least 50 (where there is a potential for inhalation exposure) if: (1) the PMN submitter uses only up to the confidential volume specified in the modified Order of the PMN substance at the PMN submitter's Northville, MI site and receives the PMN substance at 1% or less in formulation, or (2) the PMN submitter uses up to the confidential volume specified in the modified Order of the PMN substance at the PMN submitter's Kokomo, IN site and receives the PMN substance at 1% or less in formulation; or, if these conditions are not met, an APF of at least 1,000;
• After conducting exposure monitoring as described in the modified Order, use of a NIOSH-certified respirator with an appropriate APF based on the results of the exposure ( printed page 49152) monitoring described in the modified Order;
• No domestic manufacture of the PMN substance (i.e., import only);
• Processing only at SoulBrain MI, Inc.'s Northville, MI and Kokomo, IN facilities;
• No processing of the PMN substance above 5% in formulation;
• No processing or use of the PMN substance other than for the confidential use allowed in the modified Order;
• No release of more than 8.3 kg/year (measured on a year-to-year basis) of the PMN substance in the form of dust air releases at SoulBrain MI, Inc.'s Northville, MI facility;
• No dust air releases of the PMN substance at SoulBrain MI, Inc.'s Kokomo, IN facility;
• No release of the PMN substance to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

On February 3, 2021, EPA received a second PMN, P-21-77, for the same substance due to the fact that the review of PMN P-18-281 had not been completed and the substance had not been added to the TSCA Inventory. PMN P-21-77 states that the generic (non-confidential) use will be as a battery additive. Based on the test data on the PMN substance and comparison to analogous substances, EPA identified concerns for mutagenicity, skin sensitization, carcinogenicity, specific target organ toxicity and acute oral toxicity. Based on comparison to analogous substances, EPA also identified concerns for systemic and carcinogenicity effects for the hydrolysis product. Based on comparison to analogous neutral organic substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 152 ppb. An Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate or combination particulate and gas/vapor respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
• No domestic manufacture of the PMN substance (i.e., import only);
• No manufacture of the PMN substance other than following the confidential manufacturing restriction described in the Order;
• Processing and use of the PMN substance only using the confidential methods and engineering controls described in the PMN submission;
• No processing or use of the PMN substance other than for the confidential use allowed in the Order;
• No disposal of the PMN substance or waste streams containing the PMN substance other than through the method(s) described in the PMN, or by landfill, deep well injection, incineration (only if the substance has been fully reacted with water or using a hazardous waste incinerator with ≥99.999% efficiency), or release to water as allowed in the Order;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 152 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of the following protective measures:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate or combination particulate and gas/vapor respirator of at least 50 where there is a potential for inhalation exposure if using only up to the confidential annual production volume listed in the Order (measured on a year-to-year basis) at a use site and receiving the PMN substance at 1% or less in formulation; or, if these conditions are not met, an APF of at least 1,000;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No domestic manufacture of the PMN substance (i.e., import only);
• No processing or use of the PMN substance other than for the confidential uses allowed in the Orders;
• No processing of the PMN substance above 5% in formulation;
• No dust air releases of the PMN substance;
• No disposal of the PMN substance or waste streams containing the PMN substance other than through the confidential method(s) described in the PMN P-21-77, or by landfill, deep well injection, incineration (only if the substance has been fully reacted with water or using a hazardous waste incinerator with ≥99.999% efficiency); and
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 152 ppb.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitters to modify the Orders, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of carcinogenicity, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Orders do not require these tests, the Orders' restrictions remain in effect until the Orders are modified or revoked by EPA based on submission of this or other relevant information.

P-20-73 (40 CFR 721.12148)

Chemical name: 2,5-Furandione, reaction products with alkylamine, 1-octanol and polyethylene glycol alkoxy-ether, acetates (salts) (generic).

CASRN: Not available.

Effective date of TSCA Order: September 3, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be for oil and gas production chemistry. Based on a structural alert for aliphatic amines, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract and potential lung toxicity (cationic binding). Based on structural alerts for anhydrides and diamines, EPA has identified concerns for respiratory sensitization. Based on a structural alert for imides, EPA has identified concerns for acute toxicity. Based on a structural alert for cationic surfactants, EPA has identified concerns for lung toxicity (surfactant effects) and irritation to the skin, eyes, and respiratory tract. Based on a structural alert for polyethers and the structure of the feedstock residual, EPA has identified additional concerns for lung toxicity (surfactant effects). Based on a structural alert for acid groups and test data for a feedstock residual, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract. Based on test data for feedstock residuals, EPA has identified concerns for acute toxicity, acute neurotoxicity, clinical signs, skin corrosion, eye corrosion, skin sensitization, respiratory sensitization, and body weight, portal-of-entry, lung, kidney, liver, blood, clinical chemistry, spleen, and bladder effects. Based on comparison to analogous alcohol ethoxylates, EPA has also identified concerns for clinical signs and portal-of- ( printed page 49153) entry, developmental, liver, kidney, brain, heart, and thyroid effects. Based on comparison to analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 160 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 160 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, neurotoxicity, reproductive/developmental toxicity, eye damage, skin corrosion, skin sensitization, pulmonary effects, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-2 (40 CFR 721.12149)

Chemical name: Metal oxide chloride (generic).

CASRN: Not available.

Effective date of TSCA Order: September 17, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be for the manufacturing of electronic devices. Based on the release of hydrolysis products, EPA has identified concerns for corrosion to the skin, eyes, and respiratory tract. Based on test data on a hydrolysis product, EPA has also identified concerns for lung effects, systemic effects, reproductive effects, and lung carcinogenicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
• Manufacture of the PMN substance only below the confidential annual production volume listed in the Order;
• Manufacture and processing of the PMN substance only in a sealed, inert atmosphere environment of a sealed drybox wherever feasible. For activities performed outside of the drybox that may generate dust or any exhaust to air, all streams must be treated with caustic water control technology with a minimum of 90% destruction efficiency.
• Use of the PMN substance only for the confidential use listed in the Order; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, pulmonary effects, skin corrosion, eye damage, carcinogenicity, and reproductive toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-53 (40 CFR 721.12150)

Chemical name: Ethanol, 2-amino-, compds. with polyethylene glycol hydrogen sulfate C10-16-alkyl ether.

CASRN: 157627-92-4.

Effective date of TSCA Order: July 10, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an additive in agricultural formulations. Based on chemical structure, EPA has identified concerns for lung effects (surfactancy). Based on comparison to analogous chemical substances, EPA has also identified concerns for skin, eye, and respiratory tract irritation, acute toxicity, skin sensitization, and portal-of-entry (oral/irritation), systemic, and reproductive effects. Based on information in the SDS, EPA has also identified concerns for skin and eye irritation. Based on submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of the PMN substance only for the confidential use listed in the PMN;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 14 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, eye irritation, pulmonary effects, reproductive toxicity, skin irritation, skin sensitization, aquatic toxicity, and specific target organ toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the ( printed page 49154) Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-114 (40 CFR 721.12151)

Chemical name: Edge oxidized carbon matrix (generic).

CASRN: Not available.

Effective date of TSCA Order: September 10, 2024.

Basis for TSCA additive Order: The PMN states that the generic (non-confidential) use will be as an anode material and a corrosion protection. Based on comparison to analogous chemical substances, EPA has identified concerns for lung effects and systemic effects. EPA was unable to estimate the environmental hazard of the PMN substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of a NIOSH-certified respirator with an APF of at least 10,000 where there is a potential for inhalation exposure or compliance with a NCEL of 0.00733 mg/m³ as an 8-hour time-weighted average to prevent inhalation exposure;
• Manufacture of the PMN substance only below the confidential annual production volume listed in the Order;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water;
• Use of the PMN substance only for the confidential use listed in the Order; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-123 (40 CFR 721.12152)

Chemical name: Propaneamine, 3-(alkyloxy)-, structural variants (generic).

CASRN: Not available.

Effective date of TSCA Order: July 24, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a mineral processing aid. Based on comparison to analogous chemical substances and information provided in the SDS, EPA has identified concerns for acute toxicity, skin, eye, and respiratory tract corrosion, portal-of-entry (oral), systemic effects, and reproductive and developmental effects. Based on comparison to analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of the PMN substance only for the confidential use listed in the Order;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 6 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, skin corrosion, eye corrosion, specific target organ toxicity, reproductive toxicity, developmental toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-124 (40 CFR 721.12153)

Chemical name: Propanenitrile, 3-(alkyloxy)-, structural variance (generic).

CASRN: Not available.

Effective date of TSCA Order: July 24, 2024.

Basis for TSCA Order: The PMN states that the use will be as a site-limited intermediate. Based on comparison to analogous chemical substances, data on residuals, a solvent, and a potential metabolite, and information provided in the SDS, EPA has identified concerns for acute toxicity, skin and eye irritation, skin sensitization, neurotoxicity, genotoxicity, carcinogenicity, and systemic, reproductive, and developmental effects. EPA calculated a drinking water equivalent level (DWEL) of 45 ppb that is protective for these effects. Based on comparison to analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 76 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of the PMN substance only as a site-limited intermediate;
• No manufacture of the PMN substance with the confidential residual feedstock listed in the Order present at greater than 1% by weight;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 45 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has ( printed page 49155) determined that the results of skin irritation, skin sensitization, genotoxicity, carcinogenicity, eye irritation, reproductive toxicity, developmental toxicity, specific target organ toxicity, neurotoxicity, acute toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-126 (40 CFR 721.12154)

Chemical name: Cellulose, polymer with 1,1′-[2-ethyl-2-[(3-mercapto-1-oxopropoxy)methyl]-1,3-propanediyl] bis(3- mercaptopropanoate) and 1,2,3-propanetriol bis(2-methyl-2-propenoate), peroxydisulfuric acid ([(HO)S(O)2]2O2) ammonium salt (1:2)- and sodium (disulfite) (2:1)-initiated.

CASRN: 2696236-02-7.

Effective date of TSCA Order: July 18, 2024.

Basis for TSCA Order: The PMN states that the use will be as a polymer for microcapsules containing fragrance that can be used in different home-care and personal-care applications including fabric conditioners, powders, and scent boosters. Based on the high molecular weight, negligible water solubility, and inert properties of the PMN substance, EPA has identified concerns for lung overload. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in consumer products where the concentration of the PMN substance exceeds the confidential percentage by weight listed in the Order;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-137 (40 CFR 721.12155)

Chemical name: Alkyl dialkylamine (generic).

CASRN: Not available.

Effective date of TSCA Order: August 22, 2024.

Basis for TSCA Order: The PMN states that the use will be as an intermediate for making quaternary ammonium salt. Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, skin corrosion, eye corrosion, respiratory irritation, and portal-of-entry, systemic, and reproductive effects. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 110 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance above the confidential annual production volume listed in the Order;
• No manufacture, processing, or use of the PMN substance at any facility not equipped with pollution controls with a destruction efficiency of 99.98% or greater;
• No use of the PMN substance other than as a chemical intermediate for a quaternary ammonium salt;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• Disposal of the PMN substance, or waste streams containing the PMN substance, only by incineration or deep well injection;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, skin irritation/corrosion, eye irritation/corrosion, reproductive toxicity, pulmonary effects, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-138 (40 CFR 721.12156)

Chemical name: Tetraalkylammonium chloride (generic).

CASRN: Not available.

Effective date of TSCA Order: August 22, 2024.

Basis for TSCA Order: The PMN states that the use will be as an intermediate for making hydroxide salt. Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, skin and eye irritation, systemic, and neurotoxic effects. Based on comparison to analogous chemical substances and dialkyl quaternary cationic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 210 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture, processing, or use of the PMN substance at any facility not equipped with pollution controls with a destruction efficiency of 99.98% or greater;
• No use of the PMN substance other than as an intermediate for making hydroxide salt;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance; ( printed page 49156)
• Disposal of the PMN substance, or waste streams containing the PMN substance, only by incineration or deep well injection;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, neurotoxicity, skin irritation, eye irritation, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-22-185 (40 CFR 721.12157)

Chemical name: 1,3,5-Cycloheptatriene.

CASRN: 544-25-2.

Effective date of TSCA Order: June 21, 2024.

Basis for TSCA Order: The PMN states that the use will be as a chemical intermediate. Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, skin, eye, and respiratory tract irritation, respiratory tract corrosion, skin sensitization, portal-of-entry effects, systemic effects, and solvent narcosis-type effects. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Manufacture, processing, or use of the PMN substance only when using engineering control measures that ensure that loading and unloading of transport containers does not result in inhalation exposures to the PMN substance;
• Use of the PMN substance only as a chemical intermediate;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, eye irritation, skin irritation, skin sensitization, specific target organ toxicity, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-15 (40 CFR 721.12159)

Chemical name: Amines, polyalkylenepoly, (disubstitutedcarboxy) derivs., alkali metal salts (generic).

CASRN: Not available.

Effective date of TSCA Order: August 20, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a water treatment chemical. Based on submitted test data on the PMN substance, EPA has identified concerns for skin irritation, systemic, reproductive, and developmental effects. Based on measured pH data for the PMN substance, EPA has also identified concerns for corrosion to the skin, eyes, and respiratory tract. Based on comparison to analogous chemical substances and hydrolysis products, EPA has also identified concerns for acute toxicity, mortality, neurotoxicity, skin corrosion, eye corrosion, skin sensitization, and portal-of-entry (oral), systemic, ocular, reproductive, and developmental effects. Based on submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 23 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 23 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin corrosion, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-30 (40 CFR 721.12160)

Chemical name: Phenol, polyalkylcarbo bis-, polymer with 2-carbomonocyclichaloheteromonocycle, bis[(alkenylcarbomonocyclic)alkyl] ether (generic).

CASRN: Not available.

Effective date of modified TSCA Order: February 19, 2025.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a polymer of insulating materials. Based on the physical/chemical properties of the PMN ( printed page 49157) substance (as described in the New Chemical Program's PBT category at 64 FR 60194, November 4, 1999 (FRL-6097-7)) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 5,000. Based on potential formation of epoxides and the potential for cross-linking, EPA has identified concerns for skin and respiratory sensitization. Based on comparison with analogous chemical substances, EPA has also identified concerns for acute toxicity (inhalation route), skin, eye, and respiratory tract irritation, pulmonary, neurological, reproductive, and systemic effects, genetic toxicity, and carcinogenicity. EPA issued an Order, effective July 26, 2024, under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• Manufacture and processing of the PMN substance only in liquid form;
• No processing or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• Use of the PMN substance only for the confidential use listed in the Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

On January 13, 2025, EPA received a request from the PMN submitter to modify the language in Written Agreement and Exemptions sections of the Order. EPA approved the request and issued a modified Order, effective February 19, 2025, replacing “unless completely reacted and cured” with “upon being dried to the extent that no release of the New Chemical Substance can be detected.”

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, carcinogenicity, genotoxicity, reproductive toxicity, pulmonary effects, skin sensitization, skin irritation, neurotoxicity, eye irritation, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-46 (40 CFR 721.12161)

Chemical name: Siloxanes and silicones, di-alkyl, hydroxy-terminated, polymers with substituted alkane and substituted silane (generic).

CASRN: Not available.

Effective date of TSCA Order: July 26, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a process aid for the fabrication of molded articles. Based on comparison to analogous chemical substances, the reactivity of the PMN substance and test data for a hydrolysis product, EPA has identified concerns for acute toxicity and corrosion to the skin, eyes, and respiratory tract. Based on the siloxane structure of a hydrolysis product, EPA has also identified concerns for lung toxicity (waterproofing). Based on test data for a hydrolysis product, EPA has also identified concerns for acute toxicity, lung, systemic, and reproductive effects. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 570 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Manufacture, processing, and use of the PMN substance only in liquid solution formulation;
• No processing for use or use of the PMN substance in a consumer product;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, eye corrosion, skin corrosion, pulmonary effects, reproductive toxicity, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-65 (40 CFR 721.12162)

Chemical name: Alkyl acid, 2‐hydroxy‐, methyl substituted alkyl ester (generic).

CASRN: Not available.

Effective date of TSCA Order: September 16, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an industrial process chemical. Based on chemical structure, EPA has identified concerns for lung toxicity (surfactancy). Based on comparison to analogous chemical substances and test data on hydrolysis products and a metabolite, EPA has also identified concerns for skin and respiratory tract irritation, eye corrosion, clinical signs, neurotoxicity, systemic effects, reproductive and developmental effects, and carcinogenicity. Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 220 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure; ( printed page 49158)
• Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 220 ppb;
• Processing for use and use of the PMN substance only for the confidential use listed in the Order; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of carcinogenicity, developmental toxicity, eye irritation/corrosion, neurotoxicity, pulmonary effects, skin irritation, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-69 (40 CFR 721.12163)

Chemical name: Oils, Pisum sativum, polymers with 1,6-diisocyanatohexane, 1,5-diisocyanatopentane, glycerol and maltodextrin.

CASRN: 3063505-38-1.

Effective date of TSCA Order: August 29, 2024.

Basis for TSCA Order: The PMN states that the use will be as an encapsulating shell polymer for fragrance encapsulates for industrial or household consumer products such as detergents and fabric softeners. Based on comparison to analogous chemical substances, EPA has identified concerns for lung effects ( i.e., lung fibrosis). The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No processing of the PMN substance for use in a consumer product that can be spray applied;
• No manufacture, processing, or use of the PMN substance in any manner that generates a vapor, mist, dust, or aerosol containing the PMN substance; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-79 (40 CFR 721.12164)

Chemical name: Rosin, maleated, polymer with benzoic acid, glycerol, propylene glycol and 3a,4,7,7a-tetrahydro-1,3- isobenzofurandione.

CASRN: 2766660-60-8.

Effective date of TSCA Order: September 10, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a non-reactive resin to improve ink performance. Based on comparison to analogous chemical substances and information in the SDS, EPA has identified concerns for eye irritation, skin sensitization, and respiratory sensitization. Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• No processing for use or use of the PMN substance in a consumer product;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of eye irritation, skin sensitization, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-88 (40 CFR 721.12165)

Chemical name: Glycine, reaction products with oxidized maltodextrin.

CASRN: 2837980-16-0.

Effective date of TSCA Order: July 25, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a flotation aid for the extraction and removal of ore and a coagulation aid to assist in the removal of waste products in a wastewater treatment plant. Based on test data for chelators, EPA has identified concerns for systemic and developmental toxicity. Based on OncoLogic results, EPA has also identified concerns for carcinogenicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS. ( printed page 49159)

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of carcinogenicity and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-89 (40 CFR 721.12166)

Chemical name: Maltodextrin, 6-[3-(dimethyl-2-propen-1-ylammonio)propyl] ether, chloride.

CASRN: 2839190-60-0.

Effective date of TSCA Order: July 25, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a mining and mineral processing agent and as an industrial wastewater processing agent. Based on the intended use as a chelator, EPA has identified concerns for developmental and systemic effects. Based on allyl content, EPA has also identified concerns for genotoxicity, carcinogenicity, and skin and respiratory sensitization. Based on comparison to analogous cationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 14 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity, carcinogenicity, genetic toxicity, pulmonary effects, skin sensitization, toxicokinetics, reproductive effects, and specific target organ toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-90 (40 CFR 721.12167)

Chemical name: Dextran, 3-(dimethyl-2-propen-1-ylammonio)propyl ether, chloride.

CASRN: 2878360-71-3.

Effective date of TSCA Order: July 25, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a mining and mineral processing agent and as an industrial wastewater processing agent. Based on intended use as a chelator, EPA has identified concerns for developmental and systemic effects. Based on allyl content, EPA has also identified concerns for genotoxicity, carcinogenicity, and skin and respiratory sensitization. Based on comparison to analogous cationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 2 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity, carcinogenicity, genetic toxicity, pulmonary effects, skin sensitization, toxicokinetics, reproductive effects, and specific target organ toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-91 (40 CFR 721.12168)

Chemical name: Maltodextrin, oxidized, reaction products with ethylenediamine.

CASRN: 2824987-68-8.

Effective date of TSCA Order: August 9, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a flotation aid for the extraction and removal of ore and a coagulation aid to assist in the removal of waste products in a wastewater treatment plant. Based on test data for chelators, EPA has identified concerns for systemic and developmental toxicity. Based on OncoLogic results, EPA has also identified concerns for carcinogenicity for the inhalation route. Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product; ( printed page 49160)
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 2 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of carcinogenicity and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-92 (40 CFR 721.12169)

Chemical name: Maleic modified rosin polyol ester cyclic acid (generic).

CASRN: Not available.

Effective date of TSCA Order: September 12, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an additive in ink formulations. Based on comparison to analogous chemical substances and information in the SDS, EPA has identified concerns for eye irritation, skin sensitization, and respiratory sensitization. Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 540 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure, or at least 1,000 when the PMN substance is spray applied;
• No processing for use or use of the PMN substance in a consumer product; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of eye irritation, skin sensitization, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-123 (40 CFR 721.12170)

Chemical name: Phenol, polyalkylcarbomonocycle bis-, polymer with 2- carbomonocyclichaloheteromonocycle, bis[(alkenylcarbomonocyclic)alkyl] ether (generic).

CASRN: Not available.

Effective date of modified TSCA Order: December 23, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a polymer of insulating materials. Based on potential formation of epoxides and the potential for cross-linking, EPA has identified concerns for skin and respiratory sensitization. Based on comparison to analogous chemical substances, EPA has also identified concerns for acute toxicity (inhalation route), skin, eye, and respiratory tract irritation, pulmonary, neurological, reproductive, and systemic effects, genetic toxicity, and carcinogenicity. EPA issued an Order, effective July 26, 2024, under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• Manufacture and processing of the PMN substance only in liquid form;
• No processing or use of the PMN substance in a consumer product;
• No processing or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

On December 17, 2024, EPA received a request from the PMN submitter to modify the language in Written Agreement and Exemptions sections of the Order. EPA approved the request and issued a modified Order, effective February 19, 2025, replacing “unless completely reacted and cured” with “upon being dried to the extent that no release of the New Chemical Substance can be detected.”

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, eye irritation, skin irritation, skin sensitization, genetic toxicity, pulmonary effects, neurotoxicity, reproductive toxicity, carcinogenicity, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-135 (40 CFR 721.12171)

Chemical name: Alken-1-ol, 1-acetate (generic).

Accession No.: 302591.

Effective date of TSCA Order: May 21, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be for a destructive use. Based on comparison to analogous chemical substances, EPA has identified concerns for skin, eye, and respiratory tract irritation and skin sensitization. Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 16 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information ( printed page 49161) to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• Use of a NIOSH-certified gas/vapor respirator with an APF of at least 10 where there is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, skin corrosion, skin sensitization, eye irritation, eye corrosion, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-152 (40 CFR 721.12172)

Chemical name: 1-Alkanethiol, 3-(trialkoxysilyl)- hydrolysis products with silica, oxidized (generic).

CASRN: Not available.

Effective date of TSCA Order: July 8, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be in a chemical mechanical planarization (CMP) slurry. Based on comparison to analogous respirable, poorly soluble particulates, EPA has also identified concerns for lung effects (lung overload). The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-160 (40 CFR 721.12173)

Chemical name: Alkenoyl chloride, 3-methyl- (generic).

CASRN: Not available.

Effective date of TSCA Order: May 21, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be for a destructive use. Based on comparison to analogous chemical substances, data for hydrolysis products, and OECD QSAR Toolbox and Oncologic results, EPA has identified concerns for corrosion to all tissues, acute toxicity, systemic effects, and skin and respiratory sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, pulmonary effects, skin sensitization, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-164 (40 CFR 721.12174)

Chemical name: Bismuth, 1,1′,1″,1′′′-(1,2-ethanediyldinitrilo)tetrakis[2-propanol] 2-(2-ethoxyethoxy)ethanol neodecanoate polypropylene glycol complexes.

CASRN: 2374117-53-8.

Effective date of TSCA Order: June 21, 2024.

Basis for TSCA Order: The PMN states that the use will be as a gelling catalyst for polyurethanes. Based on test data for dissociation products of the PMN substance, EPA has identified concerns for skin, eye, and respiratory tract irritation and systemic effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• Use of a NIOSH-certified combination particulate and gas/vapor respirator with an APF of at least 10 where there is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of the PMN substance only if the concentration of the PMN substance does not exceed the confidential percentage by weight in the final (end use) formulation listed in the Order; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures. ( printed page 49162)

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation, eye irritation, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-169 (40 CFR 721.12175)

Chemical name: Alkane, bis(chlorosilane) (generic).

CASRN: Not available.

Effective date of TSCA Order: July 31, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an intermediate. Based on test data for a hydrolysis product, EPA has identified concerns for corrosion to the skin, eyes, and respiratory tract. Based on comparison to analogous chemical substances of the hydrolysis product, EPA has also identified concerns for acute toxicity, systemic, reproductive, and developmental effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• Use of the PMN substance only as an intermediate;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, skin corrosion, eye corrosion, specific target organ toxicity, reproductive toxicity, developmental toxicity, and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-174 (40 CFR 721.12176)

Chemical name: Mixed metal oxide (generic).

CASRN: Not available.

Effective date of TSCA Order: July 25, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a component used in battery manufacturing. If respirable particles are inhaled, EPA has identified concerns for respiratory effects, carcinogenicity, and genetic toxicity. Based on comparison to analogous chemical substances and test data on components, EPA has also identified concerns for skin sensitization, respiratory sensitization, and systemic, reproductive, and developmental effects. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Manufacture of the PMN substance only by import into the United States (i.e., no domestic manufacture);
• Processing of the PMN substance only with a composition of the confidential substance listed in the Order less than the confidential percentage listed in the Order;
• Processing of the PMN substance only as described in the Order or using process/engineering controls that achieve exposures no greater than those achieved using the controls described in the Order;
• Use of the PMN substance only for the confidential use listed in the Order;
• Disposal of the PMN substance, or any waste stream containing the PMN substance, if disposed of domestically, must be disposed in accordance with RCRA Subtitle D Landfill requirements or RCRA Subtitle C Hazardous Waste Landfill requirements for wastes from equipment cleaning and deionization of defective cells generated during processing or use, and by RCRA Subtitle C Hazardous Waste Landfill requirements for all other wastes;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water;
• Personal breathing zone (PBZ) exposure monitoring for workers likely to have inhalation exposure to the PMN substance, as described in the Order;
• Prior to conducting exposure monitoring, use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;
• After conducting exposure monitoring, use of a NIOSH-certified respirator with an appropriate APF based on the results of the exposure monitoring as described in the Order;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of biosolubility, specific target organ toxicity, reproductive toxicity, developmental toxicity, genetic toxicity, skin sensitization, pulmonary effects, carcinogenicity, neurotoxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-188 (40 CFR 721.12177)

Chemical name: Alkenoic acid, 3-methyl-, 1,1-dimethyl-2-propen-1-yl ester (generic); Alkenoic acid,3-methyl-, 1,1-dimethyl-2-propen-1-yl ester (generic).

CASRN: Not available.

Effective date of TSCA Order: August 29, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be for a destructive use. Based on comparison to analogous chemical ( printed page 49163) substances, EPA has identified concerns for acute toxicity, respiratory tract irritation, systemic effects, and reproductive and developmental effects. Based on comparison to analogous vinyl/allyl/propargyl esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.6 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substances in a consumer product;
• No manufacture, processing, or use of the PMN substances other than in an enclosed process;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Disposal of the PMN substances, or waste streams containing the PMN substances, only by incineration;
• No release of the PMN substances, or any waste stream containing the PMN substances, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity, acute toxicity, developmental effects, pulmonary effects, reproductive toxicity, and specific target organ toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-23-190 (40 CFR 721.12178)

Chemical name: Fluorophospholane, substituted, alkyl (generic).

CASRN: Not available.

Effective date of TSCA Order: August 1, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an electrolyte additive. Based on submitted test data on the PMN substance, EPA has identified concerns for acute toxicity, skin corrosion, systemic, and reproductive and developmental effects. Based on test data on a hydrolysis product, EPA has also identified concerns for acute toxicity (inhalation), pulmonary effects, skin and eye corrosion, respiratory tract irritation, systemic effects (skeletal fluorosis, dental, blood, liver, kidney), and reproductive and developmental effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in a consumer product;
• Manufacture, processing, or use of the PMN substance only in an enclosed process;
• Disposal of the PMN substance, or any waste stream containing the PMN substance, only by incineration;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of eye irritation/corrosion, pulmonary effects, and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-24-71 (40 CFR 721.12179), P-24-72 (40 CFR 721.12180), P-24-73 (40 CFR 721.12181), and P-24-74 (40 CFR 721.12182)

Chemical names: Sulfonyl carbamate of ethoxylated fatty alcohol (generic) (P-24-71), Sulfonyl carbamate of ethoxylated alkyl alcohol (generic) (P-24-72), and Secondary alcohol ethoxylate of sulfonyl carbamate (generic) (P-24-73 and P-24-74).

CASRN: Not available.

Effective date of TSCA Order: August 20, 2024.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as wetting agents. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194, November 4, 1999 (FRL-6097-7)) and test data on structurally similar substances, the PMN substances are potentially PBT chemicals. EPA estimates that the PMN substances will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 5,000. Based on structure, EPA has identified concerns for lung effects (surfactancy). Based on comparison to analogous chemical substances, EPA has also identified concerns for skin irritation, eye irritation, respiratory irritation, and developmental, reproductive, and systemic effects. Based on test data for residuals and analogues of residuals, EPA has also identified concerns for gastrointestinal effects, systemic effects, skin irritation, and eye irritation. Based on comparison to analogous nonionic polymers and carbamate esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.8 ppb for the P-24-72 substance. Based on comparison to analogous carbamate esters, EPA also predicts toxicity to aquatic organisms may occur at concentrations that exceed 3.4 ppb and 9.5 ppb respectively for the P-24-73 and P-24-74 substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substances in a consumer product;
• No manufacture, processing, or use of the PMN substances in any manner that generates a vapor, mist, dust, or aerosol; ( printed page 49164)
• Use of personal protective equipment where there is a potential for dermal exposure;
• Disposal of the PMN substances, or waste streams containing the PMN substances, only by hazardous waste incineration in compliance with the Resource Conservation and Recovery Act;
• No release of the PMN substances, or any waste stream containing the PMN substances, to water; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of bioaccumulation and biodegradation, aquatic toxicity, eye irritation, pulmonary effects, reproductive/developmental toxicity, skin irritation, and specific target organ toxicity testing may be potentially useful to characterize the fate, health, and environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

P-24-122 (40 CFR 721.12183)

Chemical name: Sulfonium, polyphenyl(substituted phenyl) alkylbenzenesulfonate (generic).

CASRN: Not available.

Effective date of TSCA Order: August 27, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as an intermediate for the electronic industry. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194, November 4, 1999 (FRL-6097-7)) and test data on structurally similar substances, the cation of the PMN substance and the PMN substance photolysis product are potentially PBT chemicals. EPA estimates that the PMN substance cation and photolysis product will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 5,000 for the photolysis product and that the cation has unknown bioaccumulation potential. Based on comparison to analogous sulfonium compounds, EPA has identified concerns for acute toxicity, irritation to the skin and respiratory tract, eye corrosion, and neurological and systemic effects for the sulfonium cation of the PMN substance. Based on the photoreactivity of the PMN substance, EPA has also identified concerns for photosensitization. Based on comparison to analogous chemical substances, EPA has also identified concerns for point-of-contact effects for the anion. Due to insufficient information, EPA was unable to estimate the environmental hazard of the PMN substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance beyond the time limits specified in the Order without submittal to EPA the results of certain testing described in the Testing section of the Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No processing of the PMN substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substance only for the confidential use listed in the Order;
• No domestic manufacture of the PMN substance (i.e., import only);
• Import of the PMN substance only in solution or in sealed containers weighing 5 kilograms or less; and
• No exceedance of an annual importation volume of 6 kg for any use.

The proposed SNUR would designate as a “significant new use” the absence of these protective measures.

Potentially useful information: EPA has determined that certain information about the physical/chemical properties, fate, bioaccumulation, environmental hazard, and human health effects of the PMN substance may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. The submitter has agreed not to exceed the time limits specified in the Order without performing the required Tier I and Tier II testing outlined in the Testing section of the Order.

IV. Statutory and Executive Order Reviews

Additional information about these statutes and Executive orders can be found at https://www.epa.gov/​laws-regulations-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review

This action proposes to establish SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993).

B. Executive Order 14192: Unleashing Prosperity Through Deregulation

Executive Order 14192 (90 FR 9065, February 6, 2025) does not apply because a significant new use rule for a new chemical under TSCA section 5 are exempted from review under Executive Order 12866.

C. Paperwork Reduction Act (PRA)

According to the PRA (44 U.S.C. 3501 et seq.), an agency may not conduct or sponsor, and a person is not required to respond to a collection of information that requires OMB approval under PRA, unless it has been approved by OMB and displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register , are listed in 40 CFR part 9, and included on the related collection instrument or form, if applicable.

The information collection requirements related to SNURs have already been approved by OMB pursuant to PRA under OMB control number 2070-0038 (EPA ICR No. 1188). This action does not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per submission. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.

EPA always welcomes your feedback on the burden estimates. When submitting comments on these proposed SNURs, include comments about the accuracy of the burden estimate, and any suggested methods for improving ( printed page 49165) the collection instruments or instruction or minimizing respondent burden, including through the use of automated collection techniques.

D. Regulatory Flexibility Act (RFA)

I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA (5 U.S.C. 601 et seq.). The requirement to submit a SNUN applies to any person (including small or large entities) who intends to engage in any activity described in the final rule as a “significant new use.” Because these uses are “new,” based on all information currently available to EPA, EPA has concluded that no small or large entities presently engage in such activities.

A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 7 in Federal fiscal year (FY) 2020, 9 in FY2021, 9 in FY2022, 23 in FY2023, and 7 in FY2024, and only a fraction of these submissions were from small businesses.

In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $37,000 to $6,480. This lower fee reduces the total reporting and recordkeeping cost of submitting a SNUN to about $14,500 per SNUN submission for qualifying small firms. Therefore, the potential economic impacts of complying with these proposed SNURs are not expected to be significant or adversely impact a substantial number of small entities. In a SNUR that published in the Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its general determination that SNURs are not expected to have a significant economic impact on a substantial number of small entities, which was provided to the Chief Counsel for Advocacy of the Small Business Administration.

E. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by SNURs, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by these SNURs. In addition, the estimated costs of this action to the private sector do not exceed $183 million or more in any one year (the 1995 dollars are adjusted to 2023 dollars for inflation using the GDP implicit price deflator). The estimated costs for this action are discussed in Unit I.D.

F. Executive Order 13132: Federalism

This action will not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999), because it is not expected to have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the requirements of Executive Order 13132 do not apply to this action.

G. Executive Order 13175: Consultation and Coordination With Indian Tribal Governments

This action will not have Tribal implications as specified in Executive Order 13175 (65 FR 67249, November 9, 2000), because it is not expected to have substantial direct effects on Indian Tribes, significantly or uniquely affect the communities of Indian Tribal governments and does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 do not apply to this action.

H. Executive Order 13045: Protection of Children From Environmental Health Risks and Safety Risks

This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997), because it does not concern an environmental health or safety risk. Since this action does not concern a human health risk, EPA's 2021 Policy on Children's Health also does not apply. Although the establishment of these SNURs do not address an existing children's environmental health concern because the chemical uses involved are not ongoing uses, SNURs require that persons notify EPA at least 90 days before commencing manufacture (defined by statute to include import) or processing of the identified chemical substances for an activity that is designated as a significant new use by the SNUR. This notification allows EPA to assess the intended uses to identify potential risks and take appropriate actions before the activities commence.

I. Executive Order 13211: Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use

This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355, May 22, 2001), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.

J. National Technology Transfer and Advancement Act (NTTAA)

This action does not involve any technical standards subject to NTTAA section 12(d) (15 U.S.C. 272 note).

For the reasons stated in the preamble, EPA proposes to amend 40 CFR chapter I as follows:

1. The authority citation for part 721 continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, and 2625(c).

2. Add §§ 721.12147 through 721.12183 to subpart E to read as follows:

90 FR 49148