Significant New Use Rules on Certain Chemical Substances (25-1.5e)

sure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

For technical information: Joseph Said, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 566-0848; email address: said.joseph@epa.gov.

For general information on SNURs: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address: wysong.william@epa.gov.

For general information on TSCA: The TSCA Assistance Information Service Hotline, Goodwill Vision Enterprises, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (800) 471-7127 or (202) 554-1404; email address: TSCA-Hotline@epa.gov.

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

, 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

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

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

ements 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

t 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

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

, 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:

• PMN number (the proposed CFR citation assigned in the regulatory text section of the proposed rule)

n 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 for SNURs in 40 CFR part 721, subpart B. 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-20-138 (40 CFR 721.12112)

Chemical name: Alkane diglycidyl ether, polymer with alkyl-cycloalkane diamines (generic).

CASRN or Accession No.: Not available.

Effective date of TSCA Order: October 11, 2024.

Basis for TSCA Order: The PMN states that the use will be as a curing agent for a 2-part epoxy adhesive formulation used to make composite structures for industries such as marine, automotive, and wind energy

gan 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-22-68 (40 CFR 721.12114)

Chemical name: 2-Propanamine, 1,1′-[(1-methylethylidene)bis(oxy)]bis-.

CASRN: 2267262-12-2.

Effective date of TSCA Order: October 22, 2024.

Basis for TSCA Order: The PMN states that the use will be as an epoxy component used in a reaction with other components to produce an epoxy article. Based on submitted test data on the PMN substance, EPA has identified concerns for skin, eye, and respiratory tract corrosion. Based on comparison to analogous chemical substances, EPA has also identified concerns for skin sensitization, acute toxicity, systemic effects, and reproductive and developmental effects. Based on the weight of the scientific evidence, EPA has also identified concerns for respiratory sensitization. Based on

comparison to analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 260 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 analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 550 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 at a concentration of 3% or greater by weight in formulation in a consumer product;

• No use of the PMN substances for commercial or industrial use at greater than the confidential percentage by weight in formulation listed in the Order;

• No use of the PMN substances in spray applications unless contained in an enclosed process, except for the confidential use listed in the Order;

• 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 or compliance with a NCEL of 0.0078 mg/m 3 as an 8-hour time-weighted average to prevent inhalation exposure;

• No release of the PMN substances, or any waste stream containing the PMN substances, resulting in surface water concentrations that exceed 550 ppb of the PMN substances in aggregate; 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

e 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 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-22-116 (40 CFR 721.12121)

Chemical name: Carbopolycycle octa-alkene, alkenylaryloxy- (generic).

Accession No.: 303094.

Effective date of TSCA Order: November 25, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a monomer. 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 PMN substance is a potentially 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 1,000. Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, skin, eye, and respiratory tract irritation, skin sensitization, pulmonary, neurological, reproductive, and systemic effects, genetic toxicity, and carcinogenicity. Based on OECD QSAR Toolbox Alert, EPA has also identified concerns for respiratory sensitization. Based on comparison to analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb

e 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, genetic toxicity, carcinogenicity, 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-22-168 (40 CFR 721.12123)

Chemical name: Amides, alkyl, N-[3-(dimethylamino)propyl] (generic).

CASRN or Accession No.: Not available.

Effective date of TSCA Order: November 27, 2024.

Basis for TSCA Order: The PMN states that the use will be as a chemical intermediate for surfactant end-products. Based on comparison to analogous chemical substances and submitted test data on the PMN substance, EPA has identified concerns for acute toxicity, skin corrosion, point-of-contact effects, and systemic effects. Based on comparison to analogous chemical substances, EPA has also identified concerns for eye corrosion. Based on comparison to analogous aliphatic amines, 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

arison to analogous aliphatic amines, 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 manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure to the PMN substance;

• No manufacture, processing, or use of the PMN substance other than in liquid form;

• 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, 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 eye irritation/corrosion, 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

;

• No manufacture, processing, or use of the PMN substance in any manner that generates a vapor, mist, dust, or aerosol containing the PMN substance;

• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 32 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 eye irritation, neurotoxicity, pulmonary effects, reproductive/developmental toxicity, skin 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-23-16 (40 CFR 721.12125)

Chemical name: 2-Propanol, 1,3-bis[(3-methyl-2-buten-1-yl)oxy]-.

CASRN: 2337348-25-9.

Effective date of TSCA Order: October 16, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an additive for paints, UV inks, coatings, etc. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic effects. Based on submitted test data on the PMN substance, EPA has also identified concerns for respiratory, skin, and eye irritation, and skin sensitization

6, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an additive for paints, UV inks, coatings, etc. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic effects. Based on submitted test data on the PMN substance, EPA has also identified concerns for respiratory, skin, and eye irritation, and skin sensitization. Based submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 230 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:

• Processing for use or use of the PMN substance in a consumer product only if the concentration of the PMN substance is less than 1% by weight in the consumer product;

• Processing for use or use of the PMN substance in an industrial or commercial product only if the concentration of the PMN substance is less than or equal to 2% by weight in the industrial or commercial product;

• Use of a NIOSH-certified 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, resulting in surface water concentrations that exceed 230 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

oes 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-23-87 (40 CFR 721.12127)

Chemical name: Oxirane, 2-methyl-, polymer with 2-[[3-(triethoxysilyl)propoxy]methyl]oxirane, monoether with .alpha.-butyl-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)].

CASRN: 1973415-03-0.

Effective date of TSCA Order: October 31, 2024.

Basis for TSCA Order: The PMN states that the use will be as an adhesive and sealant for various applications. Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, systemic effects, and irritation to the skin, eyes, and respiratory tract. Based on the reactivity of the PMN substance, EPA has also identified concerns for irritation to skin, eyes, and respiratory tract. Based on comparison to analogous alkoxysilanes, EPA has also identified concerns for lung 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 unless the concentration of the PMN substance is less than 3% (by weight) in the consumer product;

• No use of the PMN substance in a commercial or industrial product unless the concentration of the PMN substance in the product does not exceed the confidential percentage (by weight) listed in the Order;

• No spray application of the PMN substance unless done in an enclosed process;

• Use of a NIOSH-certified 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; and

• Establishment of a hazard communication program, including human health precautionary st

in the Order;

• No spray application of the PMN substance unless done in an enclosed process;

• Use of a NIOSH-certified 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; 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, skin 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-23-127 (40 CFR 721.12128)

Chemical name: Polysaccharide lyase (generic).

CASRN or Accession No.: Not available.

Effective date of TSCA Order: December 6, 2024.

Basis for TSCA Order: The PMN states that the use will be as an ingredient in laundry detergent that is used for degradation of stains on fabric. Based on comparison to analogous chemical substances, EPA has identified concerns for respiratory sensitization. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 98 ppb if not deactivated

fects, skin irritation, skin sensitization, 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-23-133 (40 CFR 721.12130)

Chemical name: Fatty acids reaction products with alcoholamine reaction by-products, salts (generic).

CASRN or Accession No.: Not available.

Effective date of TSCA Order: January 16, 2025.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a component in asphalt. 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 PMN substance is a potentially 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 1,000. Based on structure and intended use, EPA has identified concerns for lung toxicity (surfactant effects). Based on comparison to analogous chemical substances, EPA has also identified concerns for eye irritation, skin corrosion, skin sensitization, and systemic effects. Based on comparison to analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.039 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

on to analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.039 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 processing for use or use of the PMN substance in a consumer product;

• Manufacture, processing, or use of the PMN substance only in liquid or asphalt formulation;

• No release of the PMN substance, or any waste stream containing the PMN substance, into waters of the United States; 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, eye irritation, pulmonary effects, skin corrosion, skin sensitization, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the fate, 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

skin corrosion, skin sensitization, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the fate, 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-23-134 (40 CFR 721.12131)

Chemical name: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-hydro-.omega.-[[2-[(1-chloro-9-oxo-9H-thioxanthen-4-yl)oxy]acetyl]oxy]-, ether with 2,2-bis(hydroxymethyl)-1,3-propanediol (4:1).

CASRN: 1003567-83-6.

Effective date of TSCA Order: July 15, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a photoinitiator for UV curing of monomeric and oligomeric acrylate-based printing inks. Based on comparison to analogous chemical substances to the residual, EPA has identified concerns for eye corrosion. 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 of the PMN substance only below a molecular weight of 10,000 Daltons;

• 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

. Based on submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 405 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 the environment. To protect against these risks, the Order requires:

• No release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 405 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 aquatic toxicity testing may be potentially useful to characterize the 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-23-149 (40 CFR 721.12133)

Chemical name: Dialkyltin fatty acids ester (generic).

CASRN or Accession No.: Not available.

Effective date of TSCA Order: November 18, 2024.

Basis for TSCA Order: The PMN states that the use will be as a catalyst. Based on comparison to analogous organotins, EPA has identified concerns for systemic effects (including neurological and immunological) and acute toxicity. Based on comparison to analogous chemical substances, EPA has also identified concerns for developmental effects

ble.

Effective date of TSCA Order: November 18, 2024.

Basis for TSCA Order: The PMN states that the use will be as a catalyst. Based on comparison to analogous organotins, EPA has identified concerns for systemic effects (including neurological and immunological) and acute toxicity. Based on comparison to analogous chemical substances, EPA has also identified concerns for developmental effects. Based on comparison to analogous organotin compounds, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 47 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 or processing of the PMN substance only in a manner that does not generate vapor, mist, dust, or aerosol containing the PMN substance;

• Use of the PMN substance only if the concentration of the PMN substance does not exceed 1.0% by weight in formulation;

• Use of a NIOSH-certified 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, into waters of the United States; 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

e 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, neurological effects, reproductive/developmental toxicity, specific target organ toxicity, toxicokinetics, 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-23-166 (40 CFR 721.12134)

Chemical name: Polypropylene glycol allyloxymethyl acrylate (generic).

CASRN or Accession No.: Not available.

Effective date of TSCA Order: January 8, 2025.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a monomer for UV curable application. Based on submitted test data on the PMN substance, EPA has identified concerns for skin irritation. Based on comparison to analogous chemical substances, EPA has also identified concerns for acute toxicity, skin sensitization, systemic effects, and respiratory sensitization. Based on comparison to analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 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

n comparison to analogous acrylates, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 10 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 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, resulting in surface water concentrations that exceed 10 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 skin sensitization, acute 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-23-167 (40 CFR 721.12135)

Chemical name: Bisalkyldiacid fluorophosphate salt (generic).

Accession No.: 302773.

Effective date of TSCA Order: July 15, 2024

o analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 53 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;

• Notwithstanding the disposal restriction in the order, no release of the PMN substance, or any waste stream containing the PMN substance, resulting in surface water concentrations that exceed 53 ppb;

• 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; 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 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

ated by this SNUR. EPA has determined that the results of 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-23-168 (40 CFR 721.12136)

Chemical name: Sulfamide fluorophosphate salt (generic).

Accession No.: 303038.

Effective date of TSCA Order: August 9, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be in battery production. 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 PMN substance hydrolysis product is a potentially PBT chemical. EPA estimates that the PMN substance hydrolysis product will persist in the environment for more than six months and has unknown bioaccumulation potential. Based on submitted test data on the PMN substance, EPA has identified concerns for acute toxicity and skin, eye, and respiratory tract corrosion. Based on comparison to analogous chemical substances, EPA has also identified concerns for neurotoxicity, systemic effects, and reproductive and developmental effects for the hydrolysis products. Based on comparison to analogous phosphates inorganic and submitted test data on the PMN substance, 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

itted test data on the PMN substance, 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;

• Disposal of the PMN substance, or any waste stream containing the PMN substance, 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, into waters of the United States; 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, eye irritation/corrosion, neurotoxicity, pulmonary effects, reproductive toxicity, developmental 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 Order is modified or revoked by EPA based on submission of this or other relevant information

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; 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, eye irritation, pulmonary effects, and skin sensitization 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-24-18 (40 CFR 721.12139)

Chemical name: 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-dodecylhexadecyl 2-methyl-2-propenoate, 2-oxepanone homopolymer, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester and 2-tetradecyloctadecyl 2-methyl-2-propenoate.

CASRN: 2854367-08-9.

Effective date of TSCA Order: November 18, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an additive for lubricating oil. Based on comparison to analogous chemical substances, EPA has identified concerns for lung effects (lung overload) and eye irritation. 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

icating oil. Based on comparison to analogous chemical substances, EPA has identified concerns for lung effects (lung overload) and eye irritation. 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:

• Manufacture, processing, or use of the PMN substance only in a liquid formulation;

• Use of the PMN substance only as an additive for lubricating oil;

• 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 eye irritation 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-24-36 (40 CFR 721.12140)

Chemical name: Poly(oxy-alkylene), .alpha.-alkenyl-.omega.-hydroxy- (generic).

Accession No.: 303050.

Effective date of TSCA Order: October 17, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an intermediate

ing 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-24-67 (40 CFR 721.12141)

Chemical name: Methanethioic acid, 1,1′-tetrathiobis-, O1,O1′-bis(1-methylethyl) ester.

CASRN: 69303-50-0.

Effective date of TSCA Order: November 26, 2024.

Basis for TSCA Order: The PMN states that the use will be as a rubber accelerator. Based on submitted test data on the PMN substance, EPA has identified concerns for acute toxicity and skin irritation. Based on comparison to analogous chemical substances, EPA has also identified concerns for acute toxicity, skin irritation, skin sensitization, and systemic effects. Based on comparison to analogous neutral organics, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 330 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 use of the PMN substance in a spray application;

• 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, in surface water concentrations that exceed 169 ppb;

• Use of a NIOSH-certified 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; 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

n 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; 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 sensitization, 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-24-69 (40 CFR 721.12142)

Chemical name: Oxa-thiaspiro alkane, oxide (generic).

CASRN or Accession No.: Not available.

Effective date of TSCA Order: December 16, 2024.

Basis for TSCA Order: The PMN states that the use will be as an additive for use in battery electrolyte formulations. Based on submitted test data on the PMN substance, EPA has identified concerns for acute toxicity and respiratory tract irritation. Based on alkylation potential, substructure, and comparison to analogous chemical substances, EPA has also identified concerns for genetic toxicity and 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

otential, substructure, and comparison to analogous chemical substances, EPA has also identified concerns for genetic toxicity and 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;

• Manufacture, processing, and use of the PMN substance only in an enclosed process;

• No processing for use or use of the PMN substance in a consumer product;

• Disposal of the PMN substance, or waste streams containing the PMN substance, only by incineration;

• No release of the PMN substance, or any waste stream containing the PMN substance, into waters of the United States; 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 genetic toxicity, carcinogenicity, 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

ated by this SNUR. EPA has determined that the results of genetic toxicity, carcinogenicity, 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-24-100 (40 CFR 721.12143) and P-24-101 (40 CFR 721.12144)

Chemical names: Sulfonyl carbamate of propoxylated alkyl alcohol (generic) (P-24-100) and Sulfonyl carbamate of ethoxy/propoxylated alkyl alcohol ethoxy (generic) (P-24-101).

CASRNs or Accession Nos.: Not available.

Effective date of TSCA Order: November 4, 2024.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as wetting agents. Based on the structure of the PMN substances, EPA has identified concerns for lung effects (surfactancy). Based on comparison to analogous chemical substances and test data on a feedstock residual of P-24-100, EPA has also identified concerns for skin, eye, and respiratory tract irritation, systemic effects, developmental and reproductive effects, acute toxicity, and neurotoxicity. Based on comparison to analogous carbamate esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 41 ppb (P-24-100) and 1,000 ppb (P-24-101). 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

e/developmental toxicity, skin irritation, specific target organ toxicity, and aquatic 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-24-160 (40 CFR 721.12145)

Chemical name: Iodonium, bis(dialkyl carbomonocycle) salt with alkyl carbomonocycle hetero-acid (generic).

Accession No.: 303107

Effective date of TSCA Order: November 26, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be for photoacid generator use at customer sites. 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 PMN substance is a potentially PBT chemical. EPA estimates that the PMN substance will persist in the environment for more than six months and has unknown bioaccumulation potential. EPA estimates that the PMN substance 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. Based on comparison to analogous chemical substances, EPA identified concerns for skin irritation, genetic toxicity, and systemic effects. Based on the photoreactivity of the PMN substance, EPA has also identified concerns for photosensitization. Due to a lack of scientific data/information, EPA is unable to characterize the environmental hazards 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

ion. Due to a lack of scientific data/information, EPA is unable to characterize the environmental hazards 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, unless in sealed containers weighing 5 kilograms or less; and

• No exceedance of the confidential annual importation volume listed the Order.

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

on: 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.

P-24-190 (40 CFR 721.12146)

Chemical name: Aromatic sulfonium tricyclo salt with alkyl carbomonocycle hetero-acid (generic).

Accession No.: 303049.

Effective date of TSCA Order: November 26, 2024.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be for photoacid generator use at customer sites. 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 PMN substance is a potentially PBT chemical. EPA estimates that the PMN substance anion will persist in the environment for more than six months and has unknown bioaccumulation potential. EPA also estimates that the PMN substance cation photodegradation product 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 comparison to analogous sulfonium compounds, EPA has identified concerns for acute toxicity, irritation to the skin and respiratory tract, eye corrosion, neurological effects, 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 genetic toxicity

ll 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

112 Alkane diglycidyl ether, polymer with alkyl-cycloalkane diamines (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkane diglycidyl ether, polymer with alkyl-cycloalkane diamines (PMN P-20-138) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, serious eye damage, skin corrosion, skin sensitization, reproductive toxicity, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (o). It is a significant new use to use the substance in any manner that is a spray application.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=1.

.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, skin sensitization, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (o).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12114 2-Propanamine, 1,1′-[(1-methylethylidene)bis(oxy)]bis-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propanamine, 1,1′-[(1-methylethylidene)bis(oxy)]bis- (PMN P-22-68; CASRN 2267262-12-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

ical substance identified as 2-propanamine, 1,1′-[(1-methylethylidene)bis(oxy)]bis- (PMN P-22-68; CASRN 2267262-12-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators

must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50, or 1,000 if spray applied.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, serious eye damage, respiratory sensitization, skin sensitization, reproductive toxicity, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (o).

(iv) Disposal. It is a significant new use to dispose of the substance, or waste steams containing the substance, other than by hazardous waste incineration.

(v) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=60.

g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for the substance. The NCEL is 0.0078 mg/m 3 in aggregate as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: eye irritation and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. It is a significant new use to process for use or use the substance in consumer products at a concentration of 3% or greater by weight in formulation. It is a significant new use to use the substance for commercial or industrial use at greater than the confidential percentage by weight in formulation listed in the Order. It is a significant new use to use the substance in spray applications unless contained in an enclosed process, other than for the confidential use listed in the Order.

a concentration of 3% or greater by weight in formulation. It is a significant new use to use the substance for commercial or industrial use at greater than the confidential percentage by weight in formulation listed in the Order. It is a significant new use to use the substance in spray applications unless contained in an enclosed process, other than for the confidential use listed in the Order.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed 550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99, and P-22-100. For purposes of 721.91(a)(7), the control technology is primary and secondary wastewater treatment as defined in 40 CFR part 133 and the percentage removal of the substance resulting from use of the specified control technology is 90%.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12116 Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates (PMN P-22-96) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

carbohydrates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates (PMN P-22-98) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA section 5(e) Order for the substance. The NCEL is 0.0078 mg/m 3 in aggregate as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order.

(B) [Reserved]

ied in § 721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed 550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99, and P-22-100. For purposes of 721.91(a)(7), the control technology is primary and secondary wastewater treatment as defined in 40 CFR part 133 and the percentage removal of the substance resulting from use of the specified control technology is 90%.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12119 Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates (PMN P-22-99) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000

0078 mg/m 3 in aggregate as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to § 721.63 respirator requirements may request to do so under § 721.30. Persons whose § 721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA section 5(e) Order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: eye irritation and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. It is a significant new use to process for use or use the substance in consumer products at a concentration of 3% or greater by weight in formulation. It is a significant new use to use the substance for commercial or industrial use at greater than the confidential percentage by

weight in formulation listed in the Order. It is a significant new use to use the substance in spray applications unless contained in an enclosed process, other than for the confidential use listed in the Order.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where release to water may not exceed 550 ppb in aggregate of P-22-95, P-22-96, P-22-97, P-22-98, P-22-99, and P-22-100. For purposes of 721.91(a)(7), the control technology is primary and secondary wastewater treatment as defined in 40 CFR part 133 and the percentage removal of the substance resulting from use of the specified control technology is 90%.

(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12122 Acetamide, N-[3-[alkyl(carbomonocyclic) substituted]carbomonocycle]-, coupled with diazotized 2-substituted-3-halo-5-nitrobenzonitrile (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acetamide, N-[3-[alkyl(carbomonocyclic) substituted]carbomonocycle]-, coupled with diazotized 2-substituted-3-halo-5-nitrobenzonitrile (PMN P-22-143) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: specific target organ toxicity, genetic toxicity, and carcinogenicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

ed in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: eye irritation, skin irritation, reproductive toxicity, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(y)(1) and (2). It is a significant new use to manufacture or process the substance in a manner that generates a dust, vapor, mist, or aerosol containing the substance. It is a significant new use to process for use or use the substance in a consumer product unless the concentration of the substance does not exceed the confidential concentration by weight listed in the Order in the consumer product.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=32.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

se to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=32.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12125 2-Propanol, 1,3-bis[(3-methyl-2-buten-1-yl)oxy]-. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propanol, 1,3-bis[(3-methyl-2-buten-1-yl)oxy]- (PMN P-23-16; CASRN 2337348-25-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, skin sensitization, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

nication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, skin sensitization, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. It is a significant new use to process for use or use the substance in a consumer product unless the concentration of the substance is less than 1% by weight in the consumer product. It is a significant new use to process for use or use the substance in an industrial or commercial product unless the concentration of the substance is less than or equal to 2% by weight in the industrial or commercial product.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=230.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12126 Heteromonocyclic, dialkyl amide, substituted alkyl salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteromonocyclic, dialkyl amide, substituted alkyl salt (PMN P-23-47) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

bstance may cause: reproductive

toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o).

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=1600.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12127 Oxirane, 2-methyl-, polymer with 2-[[3-(triethoxysilyl)propoxy]methyl]oxirane, monoether with .alpha.-butyl-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)]. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as oxirane, 2-methyl-, polymer with 2-[[3-(triethoxysilyl)propoxy]methyl]oxirane, monoether with .alpha.-butyl-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)] (PMN P-23-87; CASRN 1973415-03-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when completely reacted or cured.

(2) The significant new uses are:

ropoxy]methyl]oxirane, monoether with .alpha.-butyl-.omega.-hydroxypoly[oxy(methyl-1,2-ethanediyl)] (PMN P-23-87; CASRN 1973415-03-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through(d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, eye irritation, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. It is a significant new use to process for use or use the substance in a consumer product unless the concentration of the substance is less than 3% (by weight) in the consumer product. It is a significant new use to use the substance in a commercial or industrial product unless the concentration of the substance in the product does not exceed the confidential percentage (by weight) listed in the Order. It is a significant new use to spray apply the substance unless done in an enclosed process.

e concentration of the substance is less than 3% (by weight) in the consumer product. It is a significant new use to use the substance in a commercial or industrial product unless the concentration of the substance in the product does not exceed the confidential percentage (by weight) listed in the Order. It is a significant new use to spray apply the substance unless done in an enclosed process.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12128 Polysaccharide lyase (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polysaccharide lyase (PMN P-23-127) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3))iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: respiratory sensitization. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(ii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(v)(1), (v)(2), (v)(4), (w)(1), (w)(2), (w)(4), and (x)(1), (x)(2), and (x)(4). It is a significant new use to process for use or use the substance other than as an ingredient in laundry detergent that is used for degradation of stains on fabric.

ical substance identified generically as fatty acids reaction products with polyalkylpolyamines, salts (PMN P-23-130) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, skin sensitization, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to manufacture, process, or use the substance other than in a liquid or asphalt formulation. It is a significant new use to manufacture, process, or use the substance in any

manner that results in inhalation exposure to the substance.

(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

-23-133) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured ( i.e. the chemical has been reacted or cured to the extent that no release of the chemical can be detected).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: skin corrosion, eye irritation, skin sensitization, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to manufacture, process, or use the substance other than in a liquid or asphalt formulation. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.

(iv) Release to water. Requirements as specified in § 721.90(a)(1), (b)(1), and (c)(1).

gnificant new use to manufacture the substance at a molecular weight of 10,000 Daltons or greater.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12132 L-Lysine, N-(3-carboxy-1-oxopropyl) derivs., calcium salts. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as L-Lysine, N-(3-carboxy-1-oxopropyl) derivs., calcium salts (PMN P-23-144; CASRN 1917323-93-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated as part of an “article” as defined at 40 CFR 720.3(c).

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(3)(iii), and (5). Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=405.

ed in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, skin sensitization, respiratory sensitization, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=10.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

1.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, reproductive toxicity, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance.

(iv) Disposal. Requirements as specified in § 721.85(a)(1), (b)(1), and (c)(1).

(v) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=53.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12136 Sulfamide fluorophosphate salt (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfamide fluorophosphate salt (PMN P-23-168; Accession No. 303038) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when completely sealed within an article such as a battery.

(2) The significant new uses are:

-181) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured ( i.e., the substance has been reacted or cured to the extent that no release of the substance can be detected).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, eye irritation, respiratory sensitization, skin sensitization, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o), (y)(1), and (y)(2). It is a significant new use to manufacture or process the substance in a manner that generates a dust, vapor, mist, or aerosol containing the substance.

warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o), (y)(1), and (y)(2). It is a significant new use to manufacture or process the substance in a manner that generates a dust, vapor, mist, or aerosol containing the substance.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12139 2-Propenoic acid, 2-methyl-, butyl ester, polymer with 2-dodecylhexadecyl 2-methyl-2-propenoate, 2-oxepanone homopolymer, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester and 2-tetradecyloctadecyl 2-methyl-2-propenoate. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propenoic acid, 2-methyl-, butyl ester, polymer with 2-dodecylhexadecyl 2-

methyl-2-propenoate, 2-oxepanone homopolymer, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester and 2-tetradecyloctadecyl 2-methyl-2-propenoate (PMN P-24-18; CASRN 2854367-08-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

acid, 2-methyl-, butyl ester, polymer with 2-dodecylhexadecyl 2-

methyl-2-propenoate, 2-oxepanone homopolymer, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester and 2-tetradecyloctadecyl 2-methyl-2-propenoate (PMN P-24-18; CASRN 2854367-08-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: eye irritation and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(v)(1), (v)(2), (v)(4), (w)(1), (w)(2), (w)(4), (x)(1), (x)(2), and (x)(4). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to use the substance other than as an additive for lubricating oil.

Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(v)(1), (v)(2), (v)(4), (w)(1), (w)(2), (w)(4), (x)(1), (x)(2), and (x)(4). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure to the substance. It is a significant new use to use the substance other than as an additive for lubricating oil.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12140 Poly(oxy-alkylene), .alpha.-alkenyl-.omega.-hydroxy- (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as poly(oxy-alkylene), .alpha.-alkenyl-.omega.-hydroxy- (PMN P-24-36; Accession No. 303050) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

ed in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g).

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12141 Methanethioic acid, 1,1′-tetrathiobis-, O1,O1′-bis(1-methylethyl) ester. (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as methanethioic acid, 1,1′-tetrathiobis-, O1,O1′-bis(1-methylethyl) ester (PMN P-24-67; CASRN 69303-50-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance when completely reacted or cured ( i.e., the substance has been reacted or cured to the extent that no release of the substance can be detected).

(2) The significant new uses are:

uses subject to reporting. (1) The chemical substance identified generically as sulfonyl carbamate of propoxylated alkyl alcohol (PMN P-24-100) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been entrained in cured resin or destroyed.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, eye irritation, reproductive toxicity, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (o), (y)(1), and (y)(2). It is a significant new use to manufacture or process the substance in a manner that generates a dust, vapor, mist, or aerosol containing the substance.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=41 in aggregate of P-24-100 and P-24-101.

trial, commercial, and consumer activities. Requirements as specified in § 721.80 (o), (y)(1), and (y)(2). It is a significant new use to manufacture or process the substance in a manner that generates a dust, vapor, mist, or aerosol containing the substance.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=41 in aggregate of P-24-100 and P-24-101.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12144 Sulfonyl carbamate of ethoxy/propoxylated alkyl alcohol ethoxy (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonyl carbamate of ethoxy/propoxylated alkyl alcohol ethoxy (PMN P-24-101) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been entrained in cured resin or destroyed.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

ed in § 721.63(a)(1), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), (g)(1), (g)(3)(iii), and (g)(5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, eye irritation, reproductive toxicity, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80 (o), (y)(1), and (y)(2). It is a significant new use to manufacture or process the substance in a manner that generates a dust, vapor, mist, or aerosol containing the substance.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=41 in aggregate of P-24-100 and P-24-101.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

in § 721.90(a)(4), (b)(4), and (c)(4), where N=41 in aggregate of P-24-100 and P-24-101.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i), and (k) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12145 Iodonium, bis(dialkyl carbomonocycle) salt with alkyl carbomonocycle hetero-acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as iodonium, bis(dialkyl carbomonocycle) salt with alkyl carbomonocycle hetero-acid (PMN P-24-160; Accession No. 303107) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures)

shall be considered and implemented to prevent exposure, where feasible.

(2)(i) and (iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures)

shall be considered and implemented to prevent exposure, where feasible.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), (g)(1), (g)(2)(i) through (iii) and (v), (g)(3)(i) and (ii), and (g)(5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: skin irritation, skin sensitization, genetic toxicity, and specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 18 months.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.

-enclosed process. It is a significant new use to manufacture the substance longer than 18 months.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b).

(1) Recordkeeping. Recordkeeping requirements as specified in § 721.125(a) through (i) are applicable to manufacturers, importers, and processors of this substance.

(2) Limitation or revocation of certain notification requirements. The provisions of § 721.185 apply to this section.

§ 721.12146 Aromatic sulfonium tricyclo salt with alkyl carbomonocycle hetero-acid (generic). (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic sulfonium tricyclo salt with alkyl carbomonocycle hetero-acid (PMN P-24-190; Accession No. 303049) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (a)(2)(i) and (2)(iii), (a)(3), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible.