Significant New Use Rules on Certain Chemical Substances (23-3.5e)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to a TSCA Order. A SNUR requires persons who intend to manufacture (defined by statute to include import) or process a particular chemical substance for an activity that is identified as a significant new use in the SNUR to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of use identified in the notification to EPA. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination.

DATES:

Comments must be received on or before July 11, 2024.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2023-0328, online at https://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Additional instructions on commenting and visiting the docket, along with more information about dockets generally, is available at https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:

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

For general information: The TSCA-Hotline, ABVI-Goodwill, 422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 554-1404; email address: TSCA-Hotline@epa.gov.

SUPPLEMENTARY INFORMATION:

I. Executive Summary

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

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

B. What action is the Agency taking?

EPA is proposing SNURs for chemical substances that were the subject of PMNs as 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 rules under TSCA ( https://www.epa.gov/tsca-import-export-requirements ).

Chemical importers are subject to the import provisions in TSCA section 13 (15 U.S.C. 2612), the requirements promulgated at 19 CFR 12.118 through 12.127 (see also 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 TSCA 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 July 11, 2024 are subject to the export notification provisions of 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 significant new use notice (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 by EPA 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 for the chemical substances, 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. The basis for such findings is outlined in Unit IV. Based on these findings, 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 to deal with the situation where a specific significant new use is CBI, at 40 CFR 721.11.

Under these procedures a manufacturer or processor may request EPA to determine whether a specific use would be a 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 and must identify the specific use for which it intends 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 tell the person whether the use identified in the bona fide submission would be a significant new use under the rule. 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.

If EPA determines that the use identified in the bona fide submission would not be a significant new use, i.e., the use does not meet the criteria specified in the rule for a significant new use, that person can manufacture or process the chemical substance so long as the significant new use trigger is not met. In the case of a production volume trigger, this means that the aggregate annual production volume does not exceed that identified in the bona fide submission to EPA. Because of confidentiality concerns, EPA does not typically disclose the actual production volume that constitutes the use trigger. Thus, if the person later intends to exceed that volume, a new bona fide submission would be necessary to determine whether that higher volume would be a significant new use.

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 conditions of 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 conditions of use of the chemical substance is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to publish a statement of EPA's findings in the Federal Register .

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 substances and the PMN submitters are required by the TSCA Orders to submit a SNUN before undertaking activities which 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 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.C. for these chemical substances 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 information 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 to provide useful information with their SNUN submission.

SNUN submitters should be aware that EPA will be better able to evaluate SNUNs which 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 ongoing uses?

EPA designates June 11, 2024 as the cutoff date for determining whether the new use is ongoing. This designation is explained in more detail in Unit II.D.

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 this document).
• 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).
• 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).

C. Which chemical substances are subject to the proposed SNURs in this document?

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

PMN Number (Proposed CFR Citation): P-20-96 (40 CFR 721.11829)

Chemical Name: Unsaturated dicarboxylic acid polymer with 2-(dialkylamino)alkyl-alkyl-alkanoate, N,N-dialkyl-alkene amide, 2-propenamide and salt of alkyl-substituted alkene sulfonate (generic).

CASRN: Not available.

Effective Date of TSCA Order: November 8, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be in a papermaking process. Based on a structural alert for aliphatic amines, the acid moieties, and a confidential residual substance, EPA has identified concerns for skin, eye, and respiratory tract irritation. Based on comparison to analogous polyamphoteric polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 490 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified gas/vapor respirator with an APF of at least 10 where there is a potential for inhalation exposure;
• No manufacture of the PMN substance unless the percentage of the confidential reactant listed in the Order represents 10% or less (by weight) of the PMN substance;
• No release of the PMN substance resulting in surface water concentrations that exceed 490 ppb; and
• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.

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

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

PMN Number (Proposed CFR Citation): P-21-2 (40 CFR 721.11830)

Chemical Name: Octadecanoic acid, 12-hydroxy-, polymer with aziridine, 2-oxepanone and tetrahydro-2H-pyran-2-one, reaction products with disubstituted heteropolycycle (generic).

CASRN: Not available.

Effective Date of TSCA Order: October 4, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a polymer in coatings. Based on a structural alert for aliphatic amines, EPA has identified concerns for lung effects (cationic binding) and irritation to the skin, eyes, and respiratory tract. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 50 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• 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 50 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 during non-spray applications;
• Use of a NIOSH-certified respirator with an APF of at least 10,000 where there is a potential for inhalation exposure during spray applications;
• Establishment of a hazard communication program, including human health and environmental 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, eye irritation/corrosion, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-21-19 (40 CFR 721.11831)

Chemical Name: Ethyl 4-alkyl-2-oxocycloalkanecarboxylate (generic).

CASRN: Not available.

Effective Date of TSCA Order: November 17, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a fragrance ingredient. Based on submitted test data on PMN substance, EPA has identified concerns for acute neurotoxicity and kidney effects, and EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 460 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No use of the PMN substance other than as a fragrance ingredient for making fragrance oils by blending (mixing) with other fragrance ingredients;
• No use of the PMN substance at a concentration of 0.5% (by weight) or greater in consumer products;
• No domestic manufacture of the PMN substance (i.e., import only);
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity testing may be potentially useful to characterize the environmental effects of the PMN 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 Numbers (Proposed CFR Citations): P-21-48 (40 CFR 721.11832), P-21-130 (40 CFR 721.11833), P-21-131 (40 CFR 721.11834), P-21-177 (40 CFR 721.11835), P-21-204 (40 CFR 721.11836), and P-22-12 (40 CFR 721.11837)

Chemical Names: Sulfonium, tricarbocyclic-, polyfluoropolyhydro-2,2-dicarbocyclic -4,7-methano-1,3-benzodioxole-5-alkanesulfonate (1:1) (generic) (P-21-48), Sulfonium, tricarbocyclic-, 2-[3,5-bis(haloalkyl)phenyl]-.alpha., .alpha., .beta., .beta.-polyhalopolyhydro-2-alkyl-4,7-alkano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-21-130), Sulfonium, tricarbocyclic-, 2-(4-alkoxyhalocarbomonocyclic)-.alpha., .alpha., .beta., .beta.-polyhalopolyhydro-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-21-131), Sulfonium, monocarbocyclicbisarylpolyhaloalkyl, .alpha., .alpha., .beta., .beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-21-177), Sulfonium, bis(3,4-polyhalocarbocyclic)aryl-, .alpha., .alpha., .beta., .beta.-polyhalopolyhydro-2,2-diaryl-4,7-methano-1,3-heteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-21-204), and Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-(halocarbocyclic)carboxylate (1:1) (generic) (P-22-12).

CASRNs: Not available.

Effective Date of TSCA Order: December 22, 2022.

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 in the absence of data, the PMN substances and photolysis products are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment for more than two months and that their potential to bioaccumulate is unknown. EPA estimates that the photolysis products will persist in the environment for more than two months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on the reactivity of the PMN substances, EPA has identified concerns for photosensitization. Based on information provided in the SDS and data on analogues, EPA has also identified concerns for irritation to the skin, eyes, and respiratory tract. Based on data on sulfonium compounds, 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 sulfonium cation of the PMN substances. Based on comparison to analogous substances, EPA has also identified concerns for mutagenicity. Based on analogue data, EPA has also identified concerns for thyroid, liver, and reproductive (developmental) toxicity for the anion for PMNs P-21-48, P-21-130, P-21-131, P-21-177, and P-21-204. Based on test data on salicylic acid and sodium salicylate and a structural alert for phenols, EPA has also identified concerns for acute toxicity, eye irritation, neurotoxicity, reproductive and developmental effects for P-22-12. Based on protein binding alert for benzyl phenyl ethers, EPA has also identified concerns for skin sensitization for P-22-12. Based on data on a potential incineration product, EPA has identified concerns for local and systemic effects. Based on insufficient information, the PMN substance has unknown toxicity to aquatic organisms. 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 any 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 and environmental precautionary statements on each label and in the SDS;
• No modification of the processing or use 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 use stated in the Order;
• No domestic manufacture of the PMN substances (i.e., import only);
• Import of the PMN substances only in solution, or in any form in sealed containers weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volumes stated in 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-21-55 (40 CFR 721.11838)

Chemical Name: Fatty acids, reaction products with polyamine-polyacid polymer and fatty acid (generic).

CASRN: Not available.

Effective Date of TSCA Order: March 29, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an adhesive used for coating formulations. Based on structural alert for aliphatic amines, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract. Based on a potential metabolite and confidential residual, EPA has also identified concerns for systemic (body weight, adrenal, and clinical chemistry), reproductive, and developmental effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Manufacture of the PMN substance only in a manner that results in an amine value of no more than 127 mg KOH/g;
• 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 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 Numbers (Proposed CFR Citations): P-21-71 (40 CFR 721.11839) and P-21-72 (40 CFR 721.11840)

Chemical Names: Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-(1-methylethoxy)-, sodium salt (1:1) (P-21-71) and Poly[oxy(methyl-1,2-ethandiyl)], .alpha.-(dithiocarboxy)-.omega.-butoxy-, sodium salt (1:1) (P-21-72).

CASRNs: 2304726-53-0 (P-21-71) and 2304726-56-3 (P-21-72).

Effective Date of TSCA Order: October 5, 2022.

Basis for TSCA Order: The PMNs state that the uses will be as flotation aids in sulfide ore mining. Based on surfactant properties, EPA has identified concerns for lung effects and skin and eye irritation. Based on data on carbon disulfide, EPA has also identified concerns for neurotoxicity and systemic, reproductive, and developmental effects for the hydrolysis product. Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 350 ppb (P-21-71) and 150 ppb (P-21-72). 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:

• 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;
• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;
• No use of the PMN substances other than as flotation aids in sulfide ore mining at mines with valid permits (State, Federal, or Tribal) for operations and waste handling;
• No domestic manufacture of the PMN substances (i.e., import only); and
• No release of the PMN substances resulting in surface water concentrations that exceed 150 ppb.

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, developmental toxicity, eye damage, neurotoxicity, reproductive toxicity, skin irritation, specific target organ toxicity, and pulmonary effects testing may be potentially useful to characterize the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-21-73 (40 CFR 721. 11841)

Chemical Name: 1,4-Cyclohexanedicarboxylic acid, 1,4-dinonyl ester, branched and linear.

CASRN: 2449089-78-3.

Effective Date of TSCA Order: September 1, 2022.

Basis for TSCA Order: The PMN states that the use will be as a plasticizer in PVC articles like roofing membranes, flooring, or coated fabrics. Based on the potential hydrolysis product, EPA has identified concerns for reproductive and developmental effects. Based on test data on the PMN substance and comparison to neutral organic substances, EPA predicts the PMN substance may be toxic to aquatic organisms and has unknown toxicity to sediment dwelling environmental organisms. 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:

• Use of personal protective equipment where there is a potential for dermal exposure;
• No processing or use of the PMN substance in a consumer product;
• No processing or use of the PMN substance other than as a plasticizer in polyvinyl chloride (PVC) articles;
• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;
• No release of the PMN substance, or any waste stream containing the PMN substance, into water or into any environmental media destined for water.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity testing may be potentially useful to characterize the environmental effects of the PMN substance. Although the Order does not require this test, 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-21-74 (40 CFR 721.11842)

Chemical Name: 1,3-Butadiene, homopolymer, hydrogenated, 2-(ethenyloxy)ethyl-terminated.

CASRN: 2511154-73-5.

Effective Date of TSCA Order: March 28, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a resin component of an adhesive formulation. Based on potential epoxidation of the terminal C=C bonds, EPA has identified concerns for dermal and respiratory sensitization, reproductive and developmental effects, genotoxicity, 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 or the environment. 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;
• Use of the PMN substance only 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;
• 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.

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 sensitization, germ cell mutagenicity, specific target organ toxicity, reproductive toxicity, and developmental 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-21-89 (40 CFR 721.11843) and P-21-90 (40 CFR 721.11844)

Chemical Names: Lignin, modified, reaction products with alkylamine by-products, hydrochlorides (generic) (P-21-89) and Lignin, modified, reaction products with alkylamine by-products (generic) (P-21-90).

CASRNs: Not available.

Effective Date of TSCA Order: July 25, 2022.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as an emulsifier (P-21-89) and a component in paving formulations (P-21-90). Based on the cationic binding of amines to lung membranes, EPA has identified concerns for lung effects. Based on analogue data, EPA has also identified concerns for corrosion to the skin and eyes for P-21-90. Based on comparison to analogous polycationic polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb (P-21-89). Based on comparison to analogous polyamphoteric polymers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 12 ppb (P-21-90). 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:

• Use of personal protective equipment where there is a potential for dermal exposure to P-21-90;
• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;
• No manufacture, processing, or use in any manner that results in inhalation exposure;
• No manufacture, processing, or use in any manner that results in direct air releases to the environment except during loading or unloading of transport containers;
• No release of PMN P-21-89 resulting in surface water concentrations that exceed 2 ppb; and
• No release of PMN P-21-90 resulting in surface water concentrations that exceed 12 ppb.

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 and specific target organ toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances. EPA has also determined that the results of skin corrosion and serious eye damage testing may be potentially useful to characterize the health effects of P-21-90. 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-21-124 (40 CFR 721.11845)

Chemical Name: Sulfonium, triphenyl-, salt with fluoroalkyl 5- sulfobicyclo[2.2.1]heptane carboxylate (1:1) (generic).

CASRN: Not available.

Effective Date of TSCA Order: December 22, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be for photolithography. 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 in the absence of data, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance may potentially 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 reactivity of the PMN substance, EPA has identified concerns for photosensitization. Based on data on sulfonium compounds, 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 sulfonium cation of the PMN substance. Based on comparison to analogous substances, EPA has also identified concerns for genetic toxicity. Based on perfluoro analogue data, EPA has also identified concerns for thyroid, liver, and reproductive (developmental) toxicity for the anion. Based on data on a potential incineration product, EPA has also identified concerns for local and systemic effects. Based on insufficient information, the PMN substance has unknown toxicity to aquatic organisms. 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 and environmental 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 as an onium salt that generates strong or weak acid in lithography process;
• 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 in 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 Number (Proposed CFR Citation): P-21-137 (40 CFR 721.11846)

Chemical Name: Triazine-trione, tris(isocyanatoalkyl)-, polymer with substituted diisocyanato alkylcarbomonocycle, hydro-hydroxypoly(oxyalkanediyl)and hydro-hydroxypoly[oxy(alkyl-alkanediyl)], aliphatic alkyl amine-blocked (generic).

CASRN: Not available.

Effective Date of TSCA Order: August 3, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an industrial additive. Based on information in the SDS, comparison to analogous chemical substances, and test data on a residual, EPA has identified concerns for eye, skin, and respiratory irritation, eye and skin corrosion, acute toxicity, acute neurotoxicity, systemic effects, portal-of-entry effects, mutagenicity, and reproductive effects. Based on the potential of the PMN substance as a crosslinker, EPA has also identified concerns for skin sensitization. Based on comparison to analogous substituted ureas, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 15 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• 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 15 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health and environmental 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, specific target organ toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number (Proposed CFR Citation): P-21-138 (40 CFR 721.11847)

Chemical Name: Lithium metal oxide (generic).

CASRN: Not available.

Effective Date of TSCA Order: October 31, 2022.

Basis for TSCA Order: The PMN states that the use will be as an electrode material for use in the manufacture of batteries. Based on the physical/chemical properties of the PMN substance and comparison to analogous respirable, poorly soluble particulates, EPA has identified concerns for lung effects (lung overload). Based on comparison to analogous chemical substances, EPA has also identified concerns for systemic, reproductive, and developmental effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate respirator with an APF of at least 1,000 if the dust control capture and reduction rate is at less than 90% where there is a potential for inhalation exposure;
• Use of a NIOSH-certified particulate respirator with an APF of at least 50 if the dust control capture and reduction rate is at least 90% where there is a potential for inhalation exposure;
• No domestic manufacture of the PMN substance (i.e., import only);
• No disposal of the PMN substance or waste streams containing the PMN substance other than by landfill or incineration;
• No use of the PMN substance in a consumer product;
• No use of the PMN substance other than in the manufacture of batteries; 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 testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require this test, 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-21-140 (40 CFR 721.11848)

Chemical Name: Soybean oil, oleic acid-high, epoxidized.

CASRN: 2410202-82-1.

Effective Date of TSCA Order: September 1, 2022.

Basis for TSCA Order: The PMN states that the use will be as a chemical intermediate to prepare acrylate-containing oil, which is subsequently polymerized to prepare a viscosity modifier for asphalt. Based on analogous epoxides, EPA has identified concerns for reproductive effects and carcinogenicity. Based on OECD QSAR Toolbox results and test data for a functional analogue, 4-vinylcyclohexene diepoxide, EPA has also identified concerns for carcinogenicity. Based on test data for an analogue, epoxidized soybean oil, EPA has also identified concerns for systemic effects and reproductive effects. Based on OECD QSAR Toolbox identification as a respiratory sensitizer, the new chemical substance having bifunctional reactive groups which can crosslink proteins, and the respiratory tract not having a stratum corneum protective layer like the skin to inhibit absorption, EPA has also identified concerns for respiratory sensitization. Based on insufficient information, toxicity to sediment-dwelling organisms is unknown. 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:

• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste steam containing the PMN substance, into waters of the United States;
• No use of the PMN substance other than as a chemical intermediate to prepare acrylate-containing oil, which is subsequently polymerized to prepare a viscosity modifier for asphalt;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure; and
• Establishment of a hazard communication program, including human health and environmental 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, skin irritation, eye irritation/corrosion, reproductive toxicity, developmental toxicity, carcinogenicity, and sediment organism 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-21-180 (40 CFR 721.11849)

Chemical Name: Sulfonium, (halocarbomonocycle)diphenyl-, salt with 1-heterosubstituted-2-methylalkyl trihalobenzoate (1:1) (generic).

CASRN: Not available.

Effective Date of TSCA Order: December 20, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be 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 the absence of data, 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 the bioaccumulation potential is unknown and that the cation photolysis product has the potential to bioaccumulate and be persistent in the environment. Based on the reactivity of the PMN substance, EPA has identified concerns for photosensitization. Based on data on sulfonium compounds and 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 sulfonium cation of the PMN substance. Based on comparison to analogous substances, EPA has also identified concerns for mutagenicity. Based on analogue data and the OECD QSAR Toolbox, EPA has also identified concerns for thyroid, liver, and reproductive (developmental) toxicity and skin sensitization for the anion. Based on data on a potential incineration product, EPA has identified concerns for local and systemic effects. Based on insufficient information, the PMN substance has unknown toxicity to aquatic organisms. 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 and environmental 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 stated 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 in 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 Number (Proposed CFR Citation): P-21-199 (40 CFR 721.11850)

Chemical Name: 1,6-Disubstituted hexane (generic).

CASRN: Not available.

Effective Date of TSCA Order: November 7, 2022.

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

• Use of personal protective equipment where there is a potential for dermal exposure;
• No release of the PMN substance, or any waste steam containing the PMN substance, into waters of the United States;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure;
• No disposal of the PMN substance or waste streams containing the PMN substance other than by hazardous waste incineration;
• No use of the PMN substance in a consumer product; and
• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.

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

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

PMN Number (Proposed CFR Citation): P-21-201 (40 CFR 721.11851)

Chemical Name: 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-tetradecyl-, chloride (1:2); 1,3-Propanediaminium, N1-hexadecyl-2-hydroxy-N1,N1,N3,N3,N3-pentamethyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecyl-, chloride (1:2); 1,3-Propanediaminium, 2-hydroxy-N1,N1,N1,N3,N3-pentamethyl-N3-octadecen-1-yl, chloride (1:2).

CASRNs: 1622255-87-1; 63560-76-9; 197862-16-1; and 2748681-38-9.

Effective Date of TSCA Order: April 12, 2022.

Basis for TSCA Order: The PMN states that the use will be as a surfactant in a cationic latex asphalt emulsion formulation. Based on the intended use and structure, EPA has identified concerns for surfactant effects of the lung. Based on comparison to analogous chemical substances, EPA also identified concerns for skin irritation/corrosion, eye irritation/corrosion, mortality, systemic, and neurotoxic, and developmental effects. Based on comparison to analogous cationic (quaternary ammonium) surfactants, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 21 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No use of the PMN substance in consumer products;
• No manufacture, processing, or use of the PMN substance in any manner or method 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 21 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity, acute toxicity, neurotoxicity, specific target organ toxicity, pulmonary effects, developmental toxicity, skin irritation, skin corrosion, and eye damage 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-21-206 (40 CFR 721.11852)

Chemical Name: Alkanes, branched and linear (generic).

CASRN: Not available.

Effective Date of TSCA Order: March 25, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a component of gasoline. Based on data on analogous mixtures, EPA has identified concerns for skin irritation, neurotoxicity, systemic toxicity, developmental toxicity, portal-of-entry effects via the inhalation route, and carcinogenicity. Based on data on representative constituents of the PMN substance, EPA has also identified concerns for eye irritation, acute toxicity, acute neurotoxicity, reproductive toxicity, portal-of-entry effects via the oral route, aspiration hazard, and genetic toxicity. Based on information provided in the SDS, EPA has also identified concerns for aspiration hazard, flammability, skin irritation, eye irritation, and acute neurotoxicity. Based on the chemical composition, EPA has also identified hydrocarbon pneumonia/aspiration hazard. EPA also assumes respiratory tract irritation is a hazard. Based on comparison to analogous neutral organic substances, 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 or the environment. To protect against these risks, the Order requires:

• No manufacture, processing, or use of the PMN substance other than for use as a fuel, fuel additive, or regulated blendstock subject to40 CFR part 79 or 1090, including as a component of gasoline or ethanol base fuel (E85);
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program.

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, eye irritation, respiratory depression/irritation, hydrocarbon pneumonia/aspiration hazard, reproductive developmental toxicity, systemic toxicity, genetic toxicity, carcinogenicity, aquatic toxicity, and consumer inhalation exposure at gas stations 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-22-29 (40 CFR 721.11853), P-22-30 (40 CFR 721.11854), and P-22-31 (40 CFR 721.11855)

Chemical Names: Polyester with 1,4-benzenedicarboxylic acid, 1,4- dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3- hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1′-methylenebis[isocyanatobenzene] (generic) (P-22-29), Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 3- hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1′-methylenebis[4- isocyanatobenzene] (generic) (P-22-30), and Polyester with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, 1,2-ethanediol, aliphatic polyester, 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione and 1,1′- methylenebis[isocyanatobenzene] (generic) (P-22-31).

CASRNs: Not available.

Effective Date of TSCA Order: January 6, 2023.

Basis for TSCA Order: The PMNs state that the uses will be as industrial adhesives. Based on comparison to analogous diisocyanates, EPA has identified concerns for irritation to skin, eyes, and respiratory tract, skin and respiratory sensitization, and pulmonary toxicity for the low molecular weight species present in the PMN substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. 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 use of the PMN substances in consumer products;
• 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.

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, skin irritation, eye irritation, skin sensitization, 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-22-55 (40 CFR 721.11856)

Chemical Name: Aromatic sulfonium tricyclo fluoroalkyl sulfonic acid salt (generic).

CASRN: Not available.

Effective Date of TSCA Order: October 31, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a photoacid generator (PAG) for use in electronics industry. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999) and in the absence of data, 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 reactivity of the PMN substance, EPA has identified concerns for photosensitization. Based on test data on the PMN substance and information provided in the SDS, EPA has also identified concerns for eye irritation and corrosion, skin and eye corrosion, and corrosion to mucous membranes. Based on data on sulfonium compounds, 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 sulfonium cation of the PMN substance. Based on comparison to analogous substances, EPA has also identified concerns for genetic and acute toxicity, eye irritation and corrosion, and systemic effects. Based on perfluoro analogue data, EPA has also identified concerns for thyroid, liver, and reproductive (developmental) toxicity for the anion of the PMN substance. Based on data on a potential incineration product, EPA identified hazards for local and systemic effects. EPA was unable to estimate the environmental hazard of this substance. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance beyond the time limits specified in the Order without submittal to EPA the results of certain testing described in the Testing section of the Order;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Establishment of a hazard communication program, including human health and environmental 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 as a photoacid generator;
• 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 in 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 Number (Proposed CFR Citation): P-22-69 (40 CFR 721.11857)

Chemical Name: Fluoroheteroacid, metal salt (generic).

CASRN: Not available.

Effective Date of TSCA Order: November 24, 2022.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a component in batteries. Based on submitted test data on the PMN substance, EPA has identified concerns for acute toxicity, skin, respiratory and eye corrosion, skin sensitization, and systemic effects. Based on data on the hydrolysis product, EPA has also identified concerns for systemic, reproductive, and developmental effects. Based on submitted test data on the PMN substance and comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 380 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified particulate respirator with an APF of at least 50 where there is a potential for inhalation exposure;
• No use of the PMN substance in a consumer product;
• No release of the PMN substance resulting in surface water concentrations that exceed 380 ppb; and
• Establishment of a hazard communication program, including human health and environmental 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, developmental effects, specific target organ toxicity, and chronic fish 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-22-147 (40 CFR 721.11858)

Chemical Name: Hydrocarbons, C5-10.

CASRN: 2779559-23-6.

Effective Date of TSCA Order: November 2, 2022.

Basis for TSCA Order: The PMN states that the use will be as a feedstock for gasoline for racing fuels. Based on comparison to analogous chemical mixtures and data on the worst case constituents of the PMN substance, EPA has identified concerns for irritation to the skin, eye, and respiratory tract, acute toxicity, developmental and reproductive effects, systemic effects, aspiration hazard, genetic toxicity, and carcinogenicity. Based on data on constituents of the mixture, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 25 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:

• Import, processing, and use of the PMN substance only as a feedstock for gasoline containing no more than 64% of the PMN substance where the imported gasoline mixture is regulated under applicable EPA regulations for fuels, fuel additives, and regulated blendstocks (40 CFR part 1090), fuel additives, and regulated blendstocks (40 CFR part 1090), registration of fuels and fuel additives (40 CFR part 79).
• No domestic manufacture of the PMN substance (i.e., import only);
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program.

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, skin irritation, eye irritation, reproductive/developmental toxicity, systemic toxicity, genetic toxicity, and carcinogenicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Numbers (Proposed CFR Citations): P-22-150 (40 CFR 721.11859), P-22-152 (40 CFR 721.11860), P-22-161 (40 CFR 721.11861), and P-22-177 (40 CFR 721.11862).

Chemical Names: Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-22-150), Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-alkylcarbomonocyclecarboxylate (1:1) (generic) (P-22-152), Sulfonium, tricarbocyclic-, salt with [polyhydro-2-alkyl-5-(polyhalo-2-heteroalkyl)- alkano-1,3-hetropolycyclic]alkyl polyhaloaryl ester (1:1) (generic) (P-22-161), and Sulfonium, tricarbocyclic-, alpha, alpha, beta, beta-polyhalopolyhydro-heteropolycyclic-5-alkanesulfonate (1:1) (generic) (P-22-177).

CASRNs: Not available.

Effective Date of TSCA Order: February 6, 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 in the absence of data, 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 have unknown bioaccumulation potential. EPA also estimates that the cation photodegradation products will persist in the environment for more than two months and have bioaccumulation factors over 1000. Based on data on sulfonium compounds, EPA has identified concerns for acute toxicity, irritation to the skin, eyes, and respiratory tract, eye corrosion, ocular lethality, neurological effects, and systemic effects for the sulfonium cations of the PMN substances. Based on the photoreactivity of the PMN substances, EPA has also identified concerns for photosensitization. Based on the reactivity of the PMN substances, EPA has also identified irritation to the skin, eyes, and respiratory tract. Based on comparison to analogous substances, EPA has also identified concerns for mutagenicity. Based on OECD QSAR Toolbox results, EPA has also identified hazards for skin sensitization for P-22-150, P-22-161, and P-22-177, and carcinogenicity for P-22-161 and P-22-177, and skin sensitization and carcinogenicity for the anion of P-22-161. Based on anion analogue data, EPA has also identified concerns for acute toxicity, skin irritation, eye corrosion, GI tract irritation, and systemic, reproductive and developmental effects for P-22-150, P-22-161, and P-22-177. Based on data on a potential incineration by-product, EPA has also identified concerns for local, neurotoxic, and systemic effects. EPA was unable to estimate the environmental hazard of these substances. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No manufacture of any 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 and environmental precautionary statements on each label and in the SDS;
• No 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 use stated in the Order;
• No domestic manufacture of the PMN substances (i.e., import only);
• Import of the PMN substances only in solution, or in any form in sealed containers weighing 5 kilograms or less; and
• No exceedance of the confidential annual importation volumes listed in 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.

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 any one year (in 1995 dollars) 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. 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 human health, 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 conditions of use 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

This action does not concern human health or environmental conditions and therefore cannot be evaluated with respect to the potential for disproportionate impacts on non-white and low-income populations in accordance with Executive Order 12898 (59 FR 7629, February 16, 1994) and Executive Order 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 allow EPA to assess the conditions of use to identify potential disproportionate risks and take appropriate actions before the activities commence.

List of Subjects in 40 CFR Part 721

• Environmental protection
• Chemicals
• Hazardous substances
• Reporting and recordkeeping requirements

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

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

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

2. Add §§ 721.11829 through 721.11862 to subpart E to read as follows:

Subpart E—Significant New Uses for Specific Chemical Substances