Significant New Uses Certain Chemical Substances (24-2.5e)

Significant New Use Rules on Certain Chemical Substances (24-2.5e)

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

C. Does this action apply to me?

1. General Applicability

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

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

2. Applicability to Importers and Exporters

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

Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements promulgated at 19 CFR 12.118 through 12.127, 19 CFR 127.28, and the EPA policy in support of import certification at 40 CFR part 707, subpart B. Chemical importers 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 January 2, 2025 are subject to TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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

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

1. Estimated Costs for SNUN Submissions

If a SNUN is submitted, costs are an estimated $45,000 per SNUN submission for large business submitters and $14,500 for small business submitters. These estimates include the cost to prepare and submit the SNUN (including registration for EPA's Central Data Exchange (CDX)), and the payment of a user fee. Businesses that submit a SNUN would be subject to either a $37,000 user fee required by 40 CFR 700.45(c)(2)(ii) and (d), or, if they are a small business as defined at 13 CFR 121.201, a reduced user fee of $6,480 (40 CFR 700.45(c)(1)(ii) and (d)) per fiscal year 2022. The costs of submission for SNUNs will not be incurred by any company unless a company decides to pursue a significant new use as defined in these SNURs. Additionally, these estimates reflect the costs and fees as they are known at the time of this rulemaking.

2. Estimated Costs for Export Notifications

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

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

1. Submitting CBI

Do not submit CBI to EPA through email or https://www.regulations.gov. If you wish to include CBI in your comment, please follow the applicable instructions at https://www.epa.gov/dockets/commenting-epa-dockets#rules and clearly mark the information that you claim to be CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR parts 2 and 703.

2. Tips for Preparing Your Comments

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

II. Background

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

A. Significant New Use Determination Factors

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

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

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

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

B. Rationale and Objectives of the SNURs

1. Rationale

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

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

2. Objectives

EPA is proposing these SNURs because the Agency wants:

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

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

C. Significant New Uses Claimed as CBI

EPA is proposing to establish certain significant new uses which have been claimed as CBI subject to Agency confidentiality regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with the situation where a specific significant new use is CBI. Under these procedures, a manufacturer or processor may request for EPA to identify the confidential significant new use under the rule. The manufacturer or processor must show that it has a bona fide intent to manufacture or process the chemical substance. If EPA concludes that the person has shown a bona fide intent to manufacture or process the chemical substance, EPA will identify the confidential significant new use to that person. Since most of the chemical identities of the chemical substances subject to these SNURs are also CBI, manufacturers and processors can combine the bona fide submission under the procedure in 40 CFR 721.11 into a single step.

D. Applicability of General Provisions

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

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

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

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

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

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

F. Important Information About SNUN Submissions

1. SNUN Submissions

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

2. Development and Submission of Information

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

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

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

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

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs that provide detailed information on the following:

• 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 determining whether the new use is ongoing for these chemical substances?

EPA designates December 2, 2024 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).
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service Registry Number (CASRN) (if assigned for non-confidential chemical identities).
• Basis for the action [Effective date of and basis for the TSCA Order].
• Potentially useful information.

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

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

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

C. Which chemical substances are subject to this proposed rule?

The substances subject to the proposed rules in this document are as follows:

PMN Numbers (Proposed CFR Citations): P-16-377 (40 CFR 721.11960) and P-16-378 (40 CFR 721.11961)

Chemical Names: Polyester polyol (generic).

CASRN: Not available.

Effective Date of TSCA Order: August 8, 2023.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as film components. Based on meeting the criteria of the PMN substances being insoluble in water, non-reactive, respirable, and being high molecular weight polymers, EPA has identified concerns for lung effects (lung overload). The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health.

To protect against these risks, the Order requires:

• No manufacture, processing, or use of the PMN substances in a manner that would result in respirable particle sizes below 10 microns; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity testing may be potentially useful to characterize the health 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.

PMN Number (Proposed CFR Citation): P-18-346 (40 CFR 721.11962)

Chemical Name: 2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane, 3,9-bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-tetramethylbutyl)phenoxy]-.

CASRN: 1507339-21-0.

Effective Date of TSCA Order: July 25, 2023.

Basis for TSCA Order: The PMN states that the use will be as an antioxidant compounded into various polymers to be used in extrusion processes to fabricate articles. Based on submitted test data on the PMN substance, EPA has identified concerns for eye irritation and skin sensitization. Based on comparison to analogous chemical substances, EPA has also identified concerns for neurotoxicity, liver, spleen, reproductive, and developmental effects. Based on comparison to analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 18 parts per billion (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 release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 18 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure; 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 neurotoxicity, specific target organ toxicity, reproductive toxicity, developmental toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-20-44 (40 CFR 721.11963)

Chemical Name: 1-Propanamine, 3-methoxy-N,N-dimethyl-.

CASRN: 20650-07-1.

Effective Date of Modified TSCA Order: June 14, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a curing additive for automotive paint, an additive for industrial polyurethane dispersions, a solubilizer for high acid value styrene acrylic polymers for use in ink applications, for neutralization, solubilization, and stability in commercial waterborne and solvent borne coatings and varnishes used for wood, metal, composites, and other substrates. Based on submitted test data on the new chemical substance, EPA has identified concerns for skin and respiratory irritation and serious eye damage. Based on comparison to structurally analogous chemical substances, EPA has also identified concerns for systemic toxicity, respiratory tract effects, and reproductive/developmental toxicity. Based on comparison to analogous aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1000 ppb. EPA issued an Order 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. The Order was also issued under TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a finding that the substance is or will be produced in substantial quantities and that the substance either enters or may reasonably be anticipated to enter the environment in substantial quantities, or there is or may be significant (or substantial) human exposure to the substance. The Order, effective October 1, 2020, required the submitter of P-20-44 to submit to EPA the results of certain toxicity testing before any manufacturing (which includes import), processing, or use of the PMN substance. On May 25, 2021, the PMN submitter provided the results of three environmental toxicity studies in accordance with the requirements of the Order. EPA reviewed those studies and determined the studies to be valid. EPA subsequently modified the terms of the Order to mitigate any unreasonable risks to human health and the environment and issued a modified Order, effective June 14, 2023. To protect against these potential risks, the modified Order requires:

• No use of the PMN substance in consumer products;
• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 1000 ppb;
• Use of a NIOSH-certified gas/vapor particulate respirator with an APF of at least 1000 where there is a potential for inhalation exposure or compliance with a NCEL of 1.1388mg/m3 as an 8-hour time-weighted average to prevent 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 irritation, serious eye damage, reproductive toxicity, 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.

PMN Number (Proposed CFR Citation): P-21-21 (40 CFR 721.11964)

Chemical Name: Soybean oil, mixed esters with diethylene glycol, phthalic acid and terephthalic acid.

CASRN: Not available.

Effective Date of TSCA Order: July 5, 2023.

Basis for TSCA Order: The PMN states that use will be as a raw material to be blended into R-side components of the polyurethane and polyisocyanurate industry (specifically used in slabstock/bunstock processing of foam). Based on the acid groups, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract. Based on test data for a feedstock and potential metabolite, diethylene glycol, EPA has also identified concerns for systemic (body weight, bladder, kidney) and developmental effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No use of the PMN substance in consumer products;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 3000 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 reproductive toxicity, skin irritation, eye damage, 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.

PMN Number (Proposed CFR Citation): P-21-151 (40 CFR 721.11965)

Chemical Name: Soybean oil, epoxidized, polymer with bisphenol A, alkyl glycidyl ether, epichlorohydrin, polyethylene glycol and trihydroxyalkane (generic).

CASRN: Not available.

Effective Date of TSCA Order: August 16, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be in polyurethane applications. Based on the surfactant properties of the PMN substance, EPA has identified concerns for lung effects (surfactancy) if inhaled. Based on the potential protein crosslinking of multifunctional reactive groups and epoxides present in the feedstocks, EPA has also identified concerns for dermal and respiratory sensitization. Based on comparison to analogous nonionic surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 140 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 for use in a consumer product;
• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 140 ppb;
• No processing or use of the PMN substance in a spray application;
• 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; 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, specific target organ toxicity, skin sensitization, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-21-168 (40 CFR 721.11966)

Chemical Name: Metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino] sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium salts (generic).

CASRN: Not available.

Effective Date of TSCA Order: September 22, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a colorant. Based on submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 178 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, in surface water concentrations that exceed 178 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 chronic 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.

PMN Number (Proposed CFR Citation): P-21-173 (40 CFR 721.11967)

Chemical Name: Siloxanes and silicones polyether, polymer with aliphatic isocyanate, 2-dimethylaminoethanol and polyglycol ether (generic).

CASRN: Not available.

Effective Date of TSCA Order: June 29, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an additive for finishing of textiles/fabrics. Based on structure, EPA has identified concerns for lung effects due to surfactancy. Based on comparison to analogous chemical substances, EPA has also identified concerns for developmental and systemic effects. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health 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;
• 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, in surface water concentrations that exceed 1 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 developmental toxicity, specific target organ toxicity, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-21-194 (40 CFR 721.11968)

Chemical Name: Siloxanes and Silicones, di-Me, [gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-terminated, (salts) (generic).

CASRN: Not available.

Effective Date of TSCA Order: September 15, 2023.

Basis for TSCA Order: The PMN states that the use will be as a textile softening agent. Based on the siloxane moieties, EPA has identified concerns for lung waterproofing. Based on comparison to analogous chemical substances, EPA has also identified concerns for irritation to skin and eyes. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 210 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance as a consumer product;
• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 210 ppb;
• No manufacture, processing, or use of the PMN substance in any manner that results in the generation of a vapor, mist, dust, or aerosol;
• 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 metabolism or pharmacokinetics, skin irritation, eye irritation/corrosion, specific target organ toxicity, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-21-202 (40 CFR 721.11969)

Chemical Name: Sulfonium, carbomonocycle bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester (generic).

CASRN: Not available.

Effective Date of TSCA Order: December 21, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as an ingredient used in the manufacture of photoresist. 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 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance's cation photolysis product will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000. EPA also estimates that the PMN substance's cation will persist in the environment for more than six months and estimates an unknown bioaccumulation potential based on uncertainty about bioaccumulation. Based on the photoreactivity of the PMN substance, EPA has identified concerns for photosensitization for the cation of the PMN substance. Based on comparison to chemical substances analogous to the sulfonium cation of the PMN substance and supported by information provided in the SDS, EPA has also identified concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, eye corrosion, ocular lethality, neurological effects, and systemic effects for the cation. Based on information provided in the SDS, EPA has also identified concerns for irritation to the skin, eyes, and respiratory tract and neurotoxicity. Based on comparison to analogous chemical substances, EPA has also identified concerns for mutagenicity for the cation. Based on a potential incineration by-product, EPA has also identified concerns for both local and systemic effects via inhalation exposure. Based on test data for salicylic acid and sodium salicylate, EPA has also identified concerns for acute toxicity (mortality), eye irritation, neurotoxicity, and reproductive and developmental effects for the anion. Based on potential for chelation and irritation based on acid groups, EPA has also identified concerns for developmental effects for the anion. 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 modification of the processing or use of the PMN substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substance only for the confidential use listed in the Order;

• No domestic manufacture of the PMN substance ( i.e., import only);

• Import of the PMN substance only in solution, or in any form 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. 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.

PMN Numbers (Proposed CFR Citations): P-21-208 (40 CFR 721.11970), P-21-209 (40 CFR 721.11971), and P-21-210 (40 CFR 721.11972)

Chemical Names: Aromatic diacids, polymer with alkyldiacids, alkyldiols, benzofurandione, caprolactone and 1,1′-methylenebis[4-isocyanatobenzene] (generic) (P-21-208), Aromatic diacid, polymer with alkyldiacid, alkyldiols, polypropylene glycol, benzofurandione, caprolactone and 1,1′-methylenebis[4-isocyanatobenzene] (generic) (P-21-209), and Aromatic diacids, polymer with alkyldiacids, alkyldiols, benzofurandione, polypropylene, alkylhydroxyacid glycolester, caprolactone and 1,1′-methylenebis[4- isocyanatobenzene] (generic) (P-21-210).

CASRN: Not available.

Effective Date of TSCA Order: May 26, 2023.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as adhesives for profile wrapping. Based on the structure of the PMN substances, EPA has identified concerns for skin sensitization, respiratory sensitization, and genotoxicity. Based on test data for a feedstock residual, EPA has also identified concerns for acute toxicity, acute neurotoxicity, irritation to the skin, eyes, and respiratory tracts, skin sensitization, respiratory sensitization, genotoxicity, carcinogenicity, and portal-of-entry systemic, reproductive, and developmental effects. Based on information provided in the SDSs for the feedstock residual, EPA also identified acute toxicity (inhalation), skin sensitization, respiratory sensitization, skin irritation, respiratory irritation, and eye corrosion. Based on Organisation for Economic Co-operation and Development (OECD Toolbox results for the feedstock residual, EPA also identified skin sensitization and respiratory sensitization. Based on test data for a hydrolysis product of feedstock residual, EPA also identified acute toxicity, genotoxicity, carcinogenicity, eye irritation, skin irritation, skin sensitization, and systemic and reproductive 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 substances may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No manufacture, processing, or use of the PMN substances in any manner that results in inhalation exposure;
• No release of the PMN substances, or any waste stream containing the PMN substances, into waters of the United States;
• No processing for use or use of the PMN substances in consumer products;
• 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, carcinogenicity, developmental toxicity, serious eye damage, genetic toxicity, reproductive toxicity, skin irritation, skin sensitization, pulmonary effects, and specific target organ toxicity testing may be potentially useful to characterize the health 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.

PMN Number (Proposed CFR Citation): P-21-212 (40 CFR 721.11973)

Chemical Name: Diketone compound metal complex (generic).

CASRN: Not available.

Effective Date of TSCA Order: August 2, 2023.

Basis for TSCA Order: The PMN states that the use will be as a luminescent material for security ink. Based on submitted test data, EPA has identified concerns for acute toxicity and neurotoxicity. Based on the structure as a europium complex, EPA has also identified concerns for chelation to nutrient metals. Based on test data for analogues of the cation, EPA has also identified concerns for eye irritation, irritation/hypersensitivity reactions, and systemic effects. Based on test data for analogues of the anion, EPA has also identified concerns for acute toxicity, neurotoxicity, and systemic and developmental effects. Based on test data for an incineration product, EPA has also identified concerns for neurotoxicity, portal-of-entry, and systemic effects. Based on comparison to analogous lanthanides or rare earth metals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 13 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance in exceedance of an annual volume of 1,000 kg/yr;
• 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 13 ppb;
• The PMN substance, or waste streams containing the PMN substance, must be disposed of by hazardous waste incineration;
• 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 10 where there is a potential for inhalation 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, skin irritation/corrosion, eye irritation, specific target organ toxicity, pulmonary effects, developmental toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-21-214 (40 CFR 721.11974)

Chemical Name: Poly(oxy-1,2-ethanedlyl), .alpha.,.alpha.′,.alpha."-(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (generic).

CASRN: Not available.

Effective Date of TSCA Order: June 29, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a textile finishing agent. Based on the structure and intended use as an emulsifier, EPA has identified concerns for lung toxicity (surfactant effects), and skin, eye, and respiratory tract irritation. Based on test data for alcohol ethoxylates, EPA has also identified concerns for developmental and systemic effects. Based on comparison to analogous aliphatic amines and polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 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;
• 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, in surface water concentrations that exceed 4 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 developmental toxicity, skin irritation, eye irritation, specific target organ toxicity, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-22-18 (40 CFR 721.11975)

Chemical Name: Substituted polyalkylenepoly, reaction products with substituted heteromonocycle substituted heteromonocycle polyalkylene derivs. (generic).

CASRN: Not available.

Effective Date of TSCA Order: June 23, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a component of a lubricant. Based on the structure of the PMN substance, EPA has identified concerns for lung toxicity via cationic binding. Based on the use of the PMN substance, EPA has also identified concerns for surfactant effects on the lungs. Based on comparison to analogous chemical substances, EPA has also identified concerns for 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:

• No processing for use or use of the PMN substance in consumer products at a concentration greater than 3%;
• No manufacture, processing, or use of the PMN substance in any manner that generates a dust, mist, or aerosol;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No use of the PMN substance other than for the confidential use listed in the Order; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin 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.

PMN Number (Proposed CFR Citation): P-22-21 (40 CFR 721.11976)

Chemical Name: Alkylphosphonic acid, calcium salt (generic).

CASRN: Not available.

Effective Date of TSCA Order: June 14, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a nucleating agent for polyolefins. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic (decreased body weight and blood effects) and reproductive (male) 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 and the environment. To protect against these risks, the Order requires:

• No use of the PMN substance in consumer products other than in plastic articles and other plastic parts;
• 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 10 where there is a potential for inhalation 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 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.

PMN Number (Proposed CFR Citation): P-22-32 (40 CFR 721.11977)

Chemical Name: Isocyanic acid, polymethylenepolyphenylene ester, polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1′-methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.-hydroxypoly[oxy(alkanediyl)]] (generic).

CASRN: Not available.

Effective Date of TSCA Order: October 5, 2023.

Basis for TSCA Order: The PMN states that the use will be as a reactive polymer for use in adhesives and sealants. Based on the weight of scientific evidence, EPA has identified concerns for skin and respiratory sensitization and lung toxicity for the PMN substance and the low molecular weight fraction. Based on test data for residuals and analogues of the residuals of the PMN substance, EPA has also identified concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, skin sensitization, respiratory sensitization, lung effects, systemic effects, reproductive and developmental effects, 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:

• No manufacture, processing, or use of the PMN substance in any manner that generates vapor, mist, aerosol, or dust;
• 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, into waters of the United States;

• 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 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.

PMN Number (Proposed CFR Citation): P-22-33 (40 CFR 721.11978)

Chemical Name: Alkylamine, alkoxysilyl-, hydrolyzed (generic).

CASRN: Not available.

Effective Date of TSCA Order: October 5, 2023.

Basis for TSCA Order: The PMN states that the use will be as an adhesion promoter for use in industrial manufacturing operations. Based on the amine content, EPA has identified concerns for irritation to the skin, eye, and respiratory tract. Based on potential for cationic binding to lung membranes, waterproofing, and comparison to analogous alkoxysilanes, EPA has also identified concerns for lung effects. Based on the expected release of a hydrolysis product, EPA has also identified concerns for neurotoxicity and developmental effects. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture, processing, or use of the PMN substance in any manner that generates vapor, mist, aerosol, or dust;
• 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, into waters of the United States;
• 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 specific target organ toxicity, pulmonary effects, skin irritation/corrosion, eye irritation/corrosion, reproductive/developmental toxicity, neurotoxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-22-34 (40 CFR 721.11979)

Chemical Name: Alkylphosphonic acid, disodium salt (generic).

CASRN: Not available.

Effective Date of TSCA Order: June 14, 2023.

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

• No 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;
• 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 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.

PMN Number (Proposed CFR Citation): P-22-35 (40 CFR 721.11980)

Chemical Name: Alkenoic acid, alkanediyl ester, polymer with bis(substituted alkyl)-alkanediol polymer with alkylene oxides alkenoate, and alkanamine (generic).

CASRN: Not available.

Effective Date of TSCA Order: June 1, 2023.

Basis for TSCA Order: The PMN states that the use will be as a component of flexographic ink formulations to improve reactivity when cured under LED UV light. Based on comparison to analogous acrylates/methacrylates and cross-linking potential, EPA has identified concerns for irritation to the skin, eyes and respiratory tract, and skin and respiratory sensitization. Based on the structure of the PMN substance, EPA has also identified concerns for lung effects (cationic binding). Based on comparison to analogues of both the low molecular weight fraction and the residual, EPA also identified concerns for acute toxicity, skin irritation/corrosion, eye irritation/corrosion, respiratory tract irritation/corrosion, skin sensitization, neurotoxicity, and systemic and reproductive (male) effects. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 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 consumer products;
• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 3 ppb;
• Use of a NIOSH-certified particulate respirator with an APF of at least 1000 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 aquatic toxicity, specific target organ toxicity, pulmonary effects, reproductive/developmental toxicity, skin sensitization, skin irritation/corrosion, eye irritation/corrosion, acute toxicity, and neurotoxicity 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.

PMN Number (Proposed CFR Citation): P-22-38 (40 CFR 721.11981)

Chemical Name: Siloxanes and silicones, di-Me, mixed (polyhydro-substituted heterocyclic) alkyl group and [(polyalkylsilyl)substituted]-terminated (generic).

CASRN: Not available.

Effective Date of TSCA Order: September 29, 2023.

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

• No processing for use or use of the PMN substance in a consumer product;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, into waters of the United States;
• 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, specific target organ toxicity, and reproductive toxicity testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-22-94 (40 CFR 721.11982)

Chemical Name: Cadmium tin oxide (Cd ₂ Sn0 ₄ ).

CASRN: 12185-56-7.

Effective Date of TSCA Order: October 25, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be for a contained use as a sputtering material. Based on comparison to analogous respirable, poorly soluble particulates, EPA has identified concerns for lung effects (lung overload and subsequent carcinogenicity). Based on test data for components and information provided in the SDS, EPA has also identified concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, systemic effects, reproductive and developmental effects, genotoxicity, and carcinogenicity. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.2 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 domestic manufacture of the PMN substance ( i.e., import only);

• No processing or use of the PMN substance in any manner that results in inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure;
• No use of the PMN substance other than for the confidential use listed in the Order;
• 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, sediment toxicity, specific target organ toxicity, acute toxicity, pulmonary effects, reproductive toxicity, developmental toxicity, skin irritation, eye damage, carcinogenicity, and genetic 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.

PMN Numbers (Proposed CFR Citations): P-22-119 (40 CFR 721.11983) and P-22-120 (40 CFR 721.11984)

Chemical Names: Polyhydroxyalkanoate (generic).

CASRN: Not applicable.

Effective Date of TSCA Order: September 29, 2023.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as resins for packaging materials and for use as binders. Based on comparison to analogous chemical substances, EPA has identified concerns for skin, eye, and respiratory tract 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 substances may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

Use of a NIOSH-certified particulate 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 eye irritation, pulmonary effects, and skin irritation testing may be potentially useful to characterize the health 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.

PMN Number (Proposed CFR Citation): P-22-151 (40 CFR 721.11985)

Chemical Name: Glycolipids, sophorose-contg., yeast-fermented, from glycerides and carbohydrates (generic).

CASRN: Not available.

Effective Date of TSCA Order: August 29, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a surfactant for commercial applications. Based on the intended use of the new chemical substance as well as submitted surface tension data, EPA has identified concerns for lung effects (surfactancy). Based on test data for components and information provided in the SDS, EPA has identified concerns for eye and respiratory tract irritation and systemic effects. Based on comparison to analogous aliphatic amines, 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 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;
• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 550 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 pulmonary effects, 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.

PMN Number (Proposed CFR Citation): P-22-178 (40 CFR 721.11986)

Chemical Name: Aromatic diacid, polymer with alkyldiols, hexanedioic acid, benzofurandione, and 1,1′- methylenebis[4-isocyanatobenzene] (generic).

CASRN: Not available.

Effective Date of TSCA Order: November 3, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an adhesive for lamination. Based on comparison to analogous diisocyanates, EPA has identified concerns for skin sensitization, respiratory sensitization, and pulmonary toxicity. Based on test data for the feedstock residual, EPA has also identified concerns for acute toxicity, skin and respiratory sensitization, irritation to the skin, eyes, and respiratory tract, and systemic, pulmonary, and developmental effects. Based on test data for a hydrolysis product of a residual, EPA has also identified concerns for genetic toxicity, carcinogenicity, and portal-of-entry, systemic, and reproductive 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 manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure;
• No manufacture, processing, or use of the PMN substance with residual MDI greater than 5% by weight;
• No processing for use or use of the PMN substance in consumer products;
• 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 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.

PMN Number (Proposed CFR Citation): P-23-13 (40 CFR 721.11987)

Chemical Name: Phenol, polymer with 4,4′- bis(chloromethyl)-1,1′-biphenyl.

CASRN: 208254-04-0.

Effective Date of TSCA Order: November 2, 2023.

Basis for TSCA Order: The PMN states that the use will be as an epoxy molding compound for electronic devices. Based on comparison to analogous chemical substances, EPA has identified concerns for portal-of-entry effects (GI 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:

• Manufacture of the PMN substance other than by import into the United States ( i.e., no domestic manufacture) at concentrations equal to or less than the confidential concentration percentage listed in the Order;

• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 260 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 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.

PMN Numbers (Proposed CFR Citations): P-23-49 (40 CFR 721.11988) and P-23-124 (40 CFR 721.11989)

Chemical Names: Sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (generic) (P-23-49) and Sulfonium, tricabocyclic-, 2-heteroatom-substituted-(halocarbocyclic)carboxylate (1:1) (generic) (P-23-124).

CASRN: Not available.

Effective Date of TSCA Order: September 25, 2023.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the PMN substances will be for photolithography. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999) and test data on structurally similar substances, the PMN substance are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on the presence of 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 substances. Based on comparison to analogous chemical substances, EPA has also identified concerns for genetic toxicity for the cation of the PMN substances. Based on the photoreactivity of the PMN substances, EPA has also identified concerns for photosensitization for the cation of the PMN substances. Based on a structural alert and OECD QSAR (Quantitative Structure-Activity Relationship) Toolbox results, EPA has also identified concerns for skin sensitization for the anion of P-23-124. Based on a potential incineration product, EPA has also identified concerns for local and systemic effects for the incineration product. 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 or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substances 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 modification of the processing of the PMN substances in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substances only for the confidential uses listed in the Order;

• No domestic manufacture of the PMN substances ( i.e., import only);

• Import of the PMN substances only in solution, or in sealed containers weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volumes 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 substances 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.

PMN Number (Proposed CFR Citation): P-23-50 (40 CFR 721.11990)

Chemical Name: Substitutedheterocyclic onium compound, salt with heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1), polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2′-(1,2-diazenediyl)bis[2- methylpropanoate]-initiated (generic).

CASRN: Not available.

Effective Date of TSCA Order: September 20, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be for contained use for microlithography for electronic device manufacturing. 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 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on comparison to chemical substances analogous to the cation compound s of the PMN substance and supported by information provided in the SDS, EPA has identified concerns for acute toxicity, irritation to the skin and respiratory tract, eye corrosion, neurological effects, and systemic effects for the cation of the PMN substance. Based on comparison to analogous chemical substances, EPA has also identified concerns for genetic toxicity for the cation of the PMN substance. Based on the photoreactivity of the PMN substance, EPA has also identified concerns for photosensitization for the cation of the PMN substance. Based on a potential incineration product, EPA has also identified concerns for local and systemic effects for the incineration product. 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 modification of the processing or use of the PMN substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substance only for the confidential use listed in the Order;

• No domestic manufacture of the PMN substance ( i.e., import only);

• Import of the PMN substance only in solution or in sealed containers weighing 5 kilograms or less; and
• No exceedance of 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. 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.

PMN Numbers (Proposed CFR Citations): P-23-83 (40 CFR 721.11991), P-23-125 (40 CFR 721.11992), and P-23-147 (40 CFR 721.11993)

Chemical Names: Sulfonium, tricarbocyclic-, [polyhydro-alkyl-(polyfluoro-2-heteroatom substituted)- alkano-heteromonocyclic] alkyl ester (1:1) (generic) (P-23-83), Sulfonium, tricarbocyclic-, polyfluoropolyhydro-heteroatom substituted carbomonocyclic-2-heteroatom substituted carbomonocyclic heteropolycycle-5-alkanesulfonate (1:1) (generic) (P-23-125), and Sulfonium, tris(heteroatom-substituted carbomonocyclic), salt with polyhydro-polyfluoro-heteroatom-substituted alkyl heteropolycyclic-heteroatom-substituted aryl heteroatom-substituted benzoate (1:1) (generic) (P-23-147).

CASRN: Not available.

Effective Date of TSCA Order: October 27, 2023.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the PMN substances will be for photolithography. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999) and test data on structurally similar substances, the PMN substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on the presence of 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 substances. Based on comparison to analogous chemical substances, EPA has also identified concerns for genetic toxicity for the sulfonium cation of the PMN substances. Based on the photoreactivity of the PMN substances, EPA has also identified concerns for photosensitization for the sulfonium cation of the PMN substances. Based on comparison to analogous chemical substances, EPA has also identified concerns for systemic and developmental effects for the anion component of the PMN substances. Based on a potential incineration product, EPA has also identified concerns for local and systemic effects via inhalation exposure for the incineration product of the PMN substances. Based on OECD Toolbox results, EPA also identified concerns for skin sensitization for the anion component of P-23-147. 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 or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substances 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 modification of the processing of the PMN substances in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substances only for the confidential uses listed in the Order;

• No domestic manufacture of the PMN substances ( i.e., import only);

• Import of the PMN substances only in solution, or in sealed containers weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volumes 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 substances 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.

PMN Number (Proposed CFR Citation): P-23-104 (40 CFR 721.11994)

Chemical Name: Sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester (generic).

CASRN: Not available.

Effective Date of TSCA Order: September 29, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be an ingredient used in the manufacture of photoresist. 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 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment for more than six months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on the presence of 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 cation of the PMN substance. Based on comparison to analogous chemical substances, EPA has also identified concerns for genetic toxicity for the cation of the PMN substance. Based on the photoreactivity of the PMN substance, EPA has also identified concerns for photosensitization for the cation of the PMN substance. Based on a potential incineration product, EPA has also identified concerns for local and systemic effects for the incineration product. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance beyond the time limits specified in the Order without submittal to EPA the results of certain testing described in the Testing section of the Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS;
• No processing of the PMN substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;
• Use of the PMN substance only for the confidential use listed in the Order;

• No domestic manufacture of the PMN substance ( i.e., import only);

• Import of the PMN substance only in solution, or in sealed containers weighing 5 kilograms or less; and
• No exceedance of 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. The submitter has agreed not to exceed the time limits specified in the Order without performing the required Tier I and Tier II testing outlined in the Testing section of the Order.

IV. Statutory and Executive Order Reviews

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

A. Executive Order 12866: Regulatory Planning and Review and Executive Order 14094: Modernizing Regulatory Review

This action proposes to establish SNURs for new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023).

B. Paperwork Reduction Act (PRA)

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

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

EPA always welcomes your feedback on the burden estimates. Send any comments about the accuracy of the burden estimate, and any suggested methods for improving the collection instruments or instruction or minimizing respondent burden, including through the use of automated collection techniques.

C. Regulatory Flexibility Act (RFA)

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

A SNUR requires that any person who intends to engage in such activity in the future must first notify EPA by submitting a SNUN. Although some small entities may decide to pursue a significant new use in the future, EPA cannot presently determine how many, if any, there may be. However, EPA's experience to date is that, in response to the promulgation of SNURs covering over 1,000 chemicals, the Agency receives only a small number of notices per year. For example, the number of SNUNs received was 16 in Federal fiscal year (FY) FY2018, five in FY2019, seven in FY2020, 13 in FY2021, 11 in FY2022, and 15 in FY2023, and only a fraction of these submissions were from small businesses.

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

D. 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.

E. 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.

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

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

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

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

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

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

I. National Technology Transfer and Advancement Act (NTTAA)

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

J. Executive Order 12898: Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations and Executive Order 14096: Revitalizing Our Nation's Commitment to Environmental Justice for All

EPA believes that this type of action does not concern human health or environmental conditions and therefore cannot be evaluated with respect to potentially disproportionate and adverse effects on communities with environmental justice concerns in accordance with Executive Orders 12898 (59 FR 7629, February 16, 1994) and 14096 (88 FR 25251, April 26, 2023). Although this action does not concern human health or environmental conditions, the premanufacture notifications required by these SNURs will allow EPA to assess the intended uses to identify potential disproportionate risks and take appropriate actions before the activities commence.

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

PART 721-SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

Subpart E-Significant New Uses for Specific Chemical Substances

Sec.

* * * * *

* * * * *

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyester polyol (PMN P-16-377) 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 (f), and (g)(1) and (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: 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.

(ii) Industrial, commercial, and consumer use. It is a significant new use to manufacture, process, or use the substance in any manner that would result in respirable particle sizes below 10 microns.

(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 (c), and (f) 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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyester polyol (PMN P-16-378) 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 (f), and (g)(1) and (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: 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.

(ii) Industrial, commercial, and consumer use. It is a significant new use to manufacture, process, or use the substance in any manner that would result in respirable particle sizes below 10 microns.

(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 (c), and (f) 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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane, 3,9-bis-[2-(1-methyl-1- phenylethyl)-4-(1,1,3,3-tetramethylbutyl)phenoxy]- (PMN P-18-346; CASRN 1507339-21-0) 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), (3) through (5), 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.

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

(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=18.

(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 (h), 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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1-propanamine, 3-methoxy-N,N-dimethyl- (PMN P-20-44; CASRN 20650-07-1) 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), (3) through (5), (b), 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 1000. For purposes of § 721.63(b), the concentration is set at 1.0%.

(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 this substance. The NCEL is 1.1388mg/m3 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 who § 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 (f), and (g)(1) and (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, serious eye damage, 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 use. 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=1000.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as soybean oil, mixed esters with diethylene glycol, phthalic acid and terephthalic acid (PMN P-21-21) 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 destroyed.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1) and (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, 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 use. 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.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=3000.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as soybean oil, epoxidized, polymer with bisphenol A, alkyl glycidyl ether, epichlorohydrin, polyethylene glycol and trihydroxyalkane (PMN P-21-151) 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) and (3) through (5), 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), and (g)(1) through (3), and (5). For purposes of § 721.72(g)(1), this substance may cause: respiratory sensitization, skin sensitization, and specific target organ toxicity. For purposes of § 721.72(g)(2), do not spray apply. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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 use. Requirements as specified in § 721.80(o). It is a significant new use to process or use the substance in a spray application.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=140.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as metal, [heteropolycyclic]-, [[[(hydroxyalkyl)amino] sulfonyl]alkyl]sulfonyl(sulfoalkyl)sulfonyl derivs., ammonium sodium salts (PMN P-21-168) 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 (f), and (g)(3) and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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=178.

(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 (c), (f) through (h), 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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as siloxanes and silicones polyether, polymer with aliphatic isocyanate, 2-dimethylaminoethanol and polyglycol ether (PMN P-21-173) 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 embedded into a textile fiber matrix.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3), and (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: reproductive toxicity and specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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 use. 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.

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as siloxanes and silicones, di-Me, [gluconoylamino)alkyl]dialkylammonio]- hydroxyalkoxy]alkyl group-terminated, (salts) (PMN P-21-194) 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 incorporated into a textile.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3), and (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, eye irritation, and specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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 use. 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 the generation of a vapor, mist, dust, or aerosol.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=210.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, carbomonocycle bis((trihaloalkyl)carbomonocycle), substituted carbomonocyclic ester (PMN P-21-202) 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), (2)(i) and (iii), (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), and (g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, 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), (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 9 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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic diacids, polymer with alkyldiacids, alkyldiols, benzofurandione, caprolactone and 1,1′-methylenebis[4-isocyanatobenzene] (PMN P-21-208) 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) and (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), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, 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 use. 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.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic diacid, polymer with alkyldiacid, alkyldiols, polypropylene glycol, benzofurandione, caprolactone and 1,1′-methylenebis[4-isocyanatobenzene] (PMN P-21-209) 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) and (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), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, 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 use. 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.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic diacids, polymer with alkyldiacids, alkyldiols, benzofurandione, polypropylene, alkylhydroxyacid glycolester, caprolactone and 1,1′-methylenebis[4- isocyanatobenzene] (PMN P-21-210) 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) and (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), and (f), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, 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 use. 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.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as diketone compound metal complex (PMN P-21-212) 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 entrained in dried/cured ink.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), 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), and (g)(1), (3), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin corrosion, serious eye damage, skin irritation, eye irritation, skin sensitization, reproductive toxicity, and specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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 use. Requirements as specified in § 721.80(o) and (t). It is a significant new use to manufacture the substance in excess of an annual volume of 1,000 kg/yr.

(iv) Disposal. It is a significant new use to dispose of the substance or waste streams 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=13.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as poly(oxy-1,2-ethanedlyl), alpha,alpha′,alpha″-(trialkylamino)tris[omega-hydroxy-, alkyl (ester) (PMN P-21-214) 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 embedded into a textile fiber matrix.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3), and (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, eye irritation, reproductive toxicity, and specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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 use. 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.

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

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted polyalkylenepoly, reaction products with substituted heteromonocycle substituted heteromonocycle polyalkylene derivs. (PMN P-22-18) 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) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1) and (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 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 use. Requirements as specified in § 721.80(k). It is a significant new use to process for use or use the substance in consumer products at a concentration greater than 3%. It is a significant new use to manufacture, process, or use the substance in any manner that results in a dust, mist, or aerosol.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylphosphonic acid, calcium salt (PMN P-22-21) 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 fully reacted, cured, destroyed, or entrained in a polymer matrix.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1) and (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: 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 use. It is a significant new use to use the substance in consumer products other than in plastic articles and other plastic parts.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polymethylenepolyphenylene ester, polymer with .alpha.-hydro-.omega.-hydroxypoly[oxy(alkanediyl)], 1,1′-methylenebis[4-isocyanatobenzene] and .alpha.-alkane[.omega.-hydroxypoly[oxy(alkanediyl)]] (PMN P-22-32) 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) and (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), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity (residual), skin irritation (residual), eye irritation (residual), skin sensitization, respiratory sensitization, genetic toxicity (residual), carcinogenicity (residual), reproductive toxicity (residual), 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 use. 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 a vapor, mist, aerosol, or dust.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylamine, alkoxysilyl-, hydrolyzed (PMN P-22-33) 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) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3) and (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, eye irritation, specific target organ toxicity, and reproductive toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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 use. 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 a vapor, mist, aerosol, or dust.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkylphosphonic acid, disodium salt (PMN P-22-34) 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 fully reacted, cured, destroyed, or entrained in a polymer matrix.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1) and (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: 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 use. 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.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, alkanediyl ester, polymer with bis(substituted alkyl)-alkanediol polymer with alkylene oxides alkenoate, and alkanamine (PMN P-22-35) 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), (3) through (5), 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 1000.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), and (g)(1), (3), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, eye irritation, skin corrosion, serious eye damage, respiratory sensitization, skin sensitization, reproductive toxicity, and specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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 use. 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=3.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as siloxanes and silicones, di-Me, mixed (polyhydro-substituted heterocyclic) alkyl group- and [(polyalkylsilyl)substituted]-terminated (PMN P-22-38) 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) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1) and (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: 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 use. 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.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as cadmium tin oxide (Cd ₂ Sn0 ₄ ) (PMN P-22-94; CASRN 12185-56-7) 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.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 0.1%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3), and (5). For purposes of § 721.72(e), the concentration is set at 0.1%. For purposes of § 721.72(g)(1), this substance may cause: skin irritation, eye irritation, genetic toxicity, specific target organ toxicity, acute toxicity, reproductive toxicity, and carcinogenicity. For purposes of § 721.72(g)(3), this substance may be: toxicity to aquatic life. 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 use. Requirements as specified in § 721.80(f) and (k). It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyhydroxyalkanoate (PMN P-22-119) 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 plastic or when completely reacted or cured or when incorporated into an article.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1) and (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, 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.

(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 (h) 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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyhydroxyalkanoate (PMN P-22-120) 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 plastic or when completely reacted or cured or when incorporated into an article.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1) and (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, 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.

(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 (h) 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.

(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-22-151) 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) and (3), (b), 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. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3), and (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: eye irritation and specific target organ toxicity. %. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. 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 use. 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.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=550.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aromatic diacid, polymer with alkyldiols, hexanedioic acid, benzofurandione, and 1,1′- methylenebis[4-isocyanatobenzene] (PMN P-22-178) 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) and (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), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, eye irritation, respiratory sensitization, skin sensitization, genetic toxicity, carcinogenicity, 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 use. 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. It is a significant new use to manufacture, process, or use the substance with residual MDI greater than 5% by weight.

(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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as phenol, polymer with 4,4′- bis(chloromethyl)-1,1′-biphenyl (PMN P-23-13; CASRN 208254-04-0) 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 after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1) and (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: 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.

(ii) Industrial, commercial, and consumer use. It is a significant new use to manufacture the substance other than by import into the United States ( i.e., no domestic manufacture) at concentrations equal to or greater than the confidential concentration percentage listed in the Order.

(iii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=260.

(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 (c), (f) 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.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-23-49) 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), (2)(i) and (iii), (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), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, 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, or in sealed containers weighing 5 kilograms or less. It is a significant new use to modify the processing of 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.

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, tricabocyclic-, 2-heteroatom-substituted-(halocarbocyclic)carboxylate (1:1) (generic) (PMN P-23-124) 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), (2)(i) and (iii), (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), and (g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, 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, or in sealed containers weighing 5 kilograms or less. It is a significant new use to modify the processing of 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.

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substitutedheterocyclic onium compound, salt with heteropolysubstitutedalkyl substitutedtricycloalkanecarboxylate (1:1), polymer with 3-ethenylphenol and heterosubstitutedaromaticalkyl 2-methyl-2-propenoate, di-Me 2,2′-(1,2-diazenediyl)bis[2- methylpropanoate]-initiated (PMN P-23-50) 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), (2)(i) and (iii), (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), and (g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, 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, or in sealed containers weighing 5 kilograms or less. It is a significant new use to modify the processing or use 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.

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, tricarbocyclic-, 2-aryl- polyfluoropolyhydro-alkano -heteropolycycle-alkanesulfonate (1:1), polymer with heteroatom substituted aryl and carbomonocyclic 2-alkyl-2-alkanoate, di-Me 2,2-(1,2-diazenediyl)bis[2-methylpropanoate]-initiated (PMN P-23-83) 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), (2)(i) and (iii), (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), and (g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, 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), (k), and (t). It is a significant new use to import the substance other than in solution, or in sealed containers weighing 5 kilograms or less. It is a significant new use to modify the processing of 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.

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, tricarbocyclic-, polyfluoropolyhydro-heteroatom substituted carbomonocyclic-2-heteroatom substituted carbomonocyclic heteropolycycle-5-alkanesulfonate (1:1) (PMN P-23-125) 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), (2)(i) and (iii), (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), and (g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, 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), (k), and (t). It is a significant new use to import the substance other than in solution, or in sealed containers weighing 5 kilograms or less. It is a significant new use to modify the processing of 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.

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, tris(heteroatom-substituted carbomonocyclic), salt with polyhydro-polyfluoro-heteroatom-substituted alkyl heteropolycyclic-heteroatom-substituted aryl heteroatom-substituted benzoate (1:1) (PMN P-23-147) 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), (2)(i) and (iii), (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), and (g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, skin sensitization, genetic toxicity, 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), (k), and (t). It is a significant new use to import the substance other than in solution, or in sealed containers weighing 5 kilograms or less. It is a significant new use to modify the processing of 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.

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

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, carbomonocycle bis[(trihaloalkyl)carbomonocycle], disubstituted carbomonocyclic ester (PMN P-23-104) 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), (2)(i) and (iii), (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), and (g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity, skin irritation, serious eye damage, 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, or 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 9 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.

[FR Doc. 2024-27912 Filed 11-29-24; 8:45 am]

BILLING CODE 6560-50-P