2024-18259. Significant New Use Rules on Certain Chemical Substances (24-1.5e)

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Environmental Protection Agency

1. 40 CFR Parts 721 and 725
2. [EPA-HQ-OPPT-2024-0074; FRL-11916-01-OCSPP]
3. RIN 2070-AB27

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 a Microbial Commercial Activity Notice (MCAN) and are also subject to a TSCA Order. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the conditions of use for that chemical substance. 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 September 19, 2024.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2024-0074, 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 contact: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental ( print page 67369) Protection Agency, 1200 Pennsylvania Ave., NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

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

SUPPLEMENTARY INFORMATION:

I. Executive Summary

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

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

B. What action is the Agency taking?

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

C. Does this action apply to me?

1. General Applicability

This action applies to you if you manufacture, process, or use the chemical substances identified in Unit III. This may include entities in North American Industrial Classification System (NAICS) codes 325 and 324110, e.g., chemical manufacturing and petroleum refineries.

2. Applicability to Importers and Exporters

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

Chemical importers are subject to TSCA section 13 (15 U.S.C. 2612), the requirements promulgated at 19 CFR 12.118 through 12.127 (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 Title IV.

Pursuant to 40 CFR 721.20, or 40 CFR 725.920 (for the microorganism), any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after September 19, 2024 are subject to TSCA section 12(b) (15 U.S.C. 2611(b)) and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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

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

1. Estimated Costs for SNUN Submissions

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

2. Estimated Costs for Export Notifications

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

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

1. Submitting CBI

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

2. Tips for Preparing Your Comments

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

II. Background

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

A. Significant New Use Determination Factors

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

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

In determining what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, and potential human exposures and environmental releases that may be associated with the substances, in the context of the four bulleted TSCA section 5(a)(2) factors ( print page 67370) listed in this unit and discussed in Unit III.

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

B. Rationale and Objectives of the SNURs

1. Rationale

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

During review of the PMN/MCAN submitted for these 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 these chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA Orders requiring the use of appropriate exposure controls were negotiated with the PMN/MCAN 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, 40 CFR part 720, subpart E. Absent a final determination or other disposition of the confidentiality claim under 40 CFR part 2 procedures, EPA is required to keep this information confidential. EPA promulgated a procedure at 40 CFR 721.11 to deal with the situation where a specific significant new use is CBI.

Under these procedures, a manufacturer or processor may request 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 request if a substance is subject to a SNUR and whether a specific use would be a significant new use under the rule in a single bona fide submission.

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 significant new use is not likely to present an unreasonable risk of injury under the conditions of use for the chemical substance or take such regulatory action as is associated with an alternative determination under TSCA section 5 before the manufacture (including import) or processing for the significant new use can commence. If EPA determines that the 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 ( print page 67371) TSCA section 12(b), and persons who import a chemical substance identified in a final SNUR are subject to the TSCA section 13 import certification requirements. See also https://www.epa.gov/​tsca-import-export-requirements.

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

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

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

F. Important Information About SNUN Submissions

1. SNUN Submissions

SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available 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 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/MCANs 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 August 20, 2024, as the cutoff date for determining whether the new use is ongoing. This designation is explained in more detail in Unit II.E.

B. What information is provided for each chemical substance?

For each chemical substance identified in Unit III.C., EPA provides the following information:

• PMN or MCAN 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 and MCAN 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 this proposed rule?

The substances subject to the proposed rules in this document are as follows: ( print page 67372)

PMN Numbers: P-18-356 (40 CFR 721.11894) and P-18-357 (40 CFR 721.11895)

Chemical Names: Sulfonated phenolic resin salt, polymer with acetone-phenol reaction products, formaldehyde and phenol, sodium salt (generic) (P-18-356) and Sulfonated phenolic resin salt, polymer with acetone-phenol reaction products, formaldehyde and phenol, potassium salt (generic) (P-18-357).

CASRN: Not available.

Effective Date of TSCA Order: May 2, 2023.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as adhesives. Based on comparison to analogous chemical substances, EPA has identified concerns for reproductive and developmental effects, systemic effects, and corrosion to the eyes, skin, and respiratory tract. Based on comparison to analogous polyanionic polymers and monomers, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 6 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture, processing, or use of the PMN substances in any manner that results in inhalation exposure;
• No processing for use or use of the PMN substances in consumer products;
• No release of the PMN substances, or any waste stream containing the PMN substances, in surface water concentrations that exceed 6 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin corrosion, eye damage, specific target organ toxicity, reproductive toxicity, developmental toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN 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: P-19-188 (40 CFR 721.11896)

Chemical Name: Octadecanamide, N,N-dialkyl, salts (generic).

CASRN: Not available.

Effective Date of TSCA Order: December 5, 2022.

Basis for TSCA Order: The PMN states that the use will be as a wetting agent and lubricant. Based on the surfactant properties of the PMN substance, EPA has identified concerns for irritation and lung effects (surfactancy). Based on amines, EPA has also identified concerns for irritation to the skin, eyes, and respiratory tract. Based on submitted test data on the PMN substance, EPA has also identified concerns for severe skin and eye irritation, skin corrosion, and scabbing. Based on submitted test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 34 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• No use of the PMN substance in a consumer product;
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure;
• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 34 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, 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 Numbers: P-20-175 (40 CFR 721.11897), P-20-176 (40 CFR 721.11898), and P-20-178 (40 CFR 721.11899)

Chemical Names: Acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, methyl ester (generic) (P-20-175); Acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl ester (generic) (P-20-176); and Carbopolycyclic alkenyl, 2-carboxylic acid, 2-[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (generic) (P-20-178).

CASRNs: Not available.

Effective Date of TSCA Order: May 15, 2023.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) uses will be as proprietary additive for formulations. Based on the structure alert for isocyanates, EPA has identified concerns for irritation to the eyes, skin, and respiratory tract. Based on comparison to analogous chemical substances, EPA has also identified concerns for respiratory effects and skin and respiratory sensitization for the residual. For the hydrolysis product of the residual, EPA has also identified concerns for systemic effects and cancer. Based on comparison to analogous chemical substances, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 0.1 ppb for P-20-175 and P-20-176 and 0.2 ppb for P-20-178. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture, processing, or use of the PMN substances in any manner that results in inhalation exposure;
• No release of the PMN substances, or any waste stream containing the PMN substances, in surface water concentrations that exceed 0.1 ppb for P-20-175 and P-20-176 and 0.2 ppb for P-20-178;
• No use of the PMN substances in consumer products; ( print page 67373)
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of aquatic toxicity 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 Number: P-21-15 (40 CFR 721.11900)

Chemical Name: Amines, C36-alkylenedi-, polymers with 5,5′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].

CASRN: 2419899-87-7.

Effective Date of TSCA Order: May 19, 2021.

Basis for TSCA Order: The PMN states that the use will be as a raw material in a temporary bonding adhesive formulation. The adhesive is used to bond completed semiconductor wafers to a backing substrate to facilitate mechanical grinding of the wafer to reduce its thickness. Based on the high molecular weight and low water solubility of the PMN substance, EPA has identified concerns for lung effects (lung overload). Based on test data for the potential incineration product, EPA has also identified concerns for portal-of-entry effects (lesions in the upper respiratory tract and lungs), liver effects, kidney effects, body weight loss, and neurotoxicity.

The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No use of the PMN substance other than as a raw material in a temporary bonding adhesive formulation. The adhesive is used to bond completed semiconductor wafers to a backing substrate to facilitate mechanical grinding of the wafer to reduce its thickness;
• No manufacture, processing, or use of the PMN substance in any manner that results in worker inhalation exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, pulmonary effects, and neurotoxicity 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: P-21-32 (40 CFR 721.11901) and P-21-33 (40 CFR 721.11902)

Chemical Names: Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-(1-methylethoxy)- (P-21-32) and Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy- (P-21-33).

CASRNs: 2304726-48-3 (P-21-32) and 2304726-50-7 (P-21-33).

Effective Date of TSCA Order: April 27, 2023.

Basis for TSCA Order: The PMNs state that the uses will be as chemical intermediates for an asphalt emulsified (20%) and ore flotation (80%). Based on comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, skin and eye corrosion, skin sensitization, systemic effects, and lung effects. Based on comparison to analogous polycationic polymers and aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 220 ppb (P-21-32) and 110 ppb (P-21-33). The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing or use of the PMN substances in a formulation containing the PMN substances at greater than 4%;
• No processing or use of the PMN substances in consumer products;
• No release of the PMN substances, or any waste stream containing the PMN substances, in surface water concentrations that exceed 110 ppb of the PMN substances combined;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin corrosion, eye damage, skin sensitization, specific target organ toxicity, pulmonary effects, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN 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: P-21-75 (40 CFR 721.11903)

Chemical Name: Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and [oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with dialkyalkanamine (generic).

CASRN: Not available.

Effective Date of TSCA Order: May 24, 2023.

Basis for TSCA Order: The PMN states that the use will be as a curable resin for aqueous coatings. Based on the presence of acrylates, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract and skin and respiratory sensitization. Based on ( print page 67374) data for the counter ion of the PMN substance, EPA has also identified concerns for skin and eye corrosion, acute toxicity, systemic effects, male reproductive effects, and respiratory tract effects. Based on data for an analogue of the counter ion, EPA also identified concerns for neurotoxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No use of the PMN substance in consumer products;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure, or 1000 if spray applied;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of acute toxicity, specific toxic organ toxicity, pulmonary effects, skin sensitization, and reproductive/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 Number: P-21-80 (40 CFR 721.11904)

Chemical Name: Alkanedioic acid, polymers with alkanoic acid-dipentaerythritol reaction products, alkanedioc acid dihydrazide, hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (generic).

CASRN: Not available.

Effective Date of TSCA Order: May 24, 2023.

Basis for TSCA Order: The PMN states that the use will be as a binder for UV curable coating resin. Based on a structural alert for acrylates and information provided in the SDS, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract. Based on a structural alert for acrylates for the LMW fraction, EPA has also identified concerns for skin and respiratory sensitization. Based on multifunctional reactive groups, EPA has also identified concerns for respiratory sensitization. Based on comparison to analogous chemical substances, EPA has also identified concerns for skin irritation, clinical signs, systemic effects (decreased body weight and body weight gains, reduced food consumption, blood, adrenal, thymus, and brain effects), and irritation in the GI tract (stomach, cecum, colon, duodenum, ileum, and/or jejunum). The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No use of the PMN substance in consumer products;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure, or 1000 if spray applied;
• 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, specific toxic organ toxicity, eye damage, and skin sensitization testing may be potentially useful to characterize the health effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information.

PMN Number: P-21-96 (40 CFR 721.11905)

Chemical Name: Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2,2′-[(1-methylethylidene) bis (4,1-phenyleneoxymethylene)] bis [heteromonocycle], bis(2-methyl-2-propenoate) (generic).

CASRN: Not available.

Effective Date of TSCA Order: May 17, 2023.

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

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

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin sensitization, neurotoxicity, specific target organ toxicity, developmental toxicity, reproductive toxicity, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the ( print page 67375) 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: P-21-98 (40 CFR 721.11906)

Chemical Name: Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', .alpha.” -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (generic).

CASRN: Not available

Effective Date of TSCA Order: May 10, 2023.

Basis for TSCA Order: The PMN states that the use will be as a co-initiator for the curing of UV printing inks. Based on comparison to analogous chemical substances, EPA has identified concerns for skin sensitization and reproductive and systemic effects. Based on the surfactant properties of the PMN substance, EPA also identified concerns for lung effects and irritation to the skin, eyes, and respiratory tract. Based on comparison to analogous esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 12 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No use of the PMN substance in consumer products;
• No manufacture or processing of the PMN substance in any manner that results in inhalation exposure;
• No use of the PMN substance in formulations at concentrations greater than 4%;
• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 12 ppb;
• Use of a NIOSH-certified combination particulate and gas/vapor respirator with an APF of at least 10 where there is a potential for inhalation exposure;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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

PMN Number: P-21-126 (40 CFR 721.11907)

Chemical Name: Substituted heteromonocycle, polymer with haloalkyl substituted heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene) bis [hydroxycarbomonocycle] and oxybls[alkanol], reaction products with metal oxide and dialkanolamine (generic).

CASRN: Not available.

Effective Date of TSCA Order: May 1, 2023.

Basis for TSCA Order: The PMN states that the use will be as a component in several coating resin products that are only applied by cathodic electrodeposition and used as additives for corrosion protection. Based on submitted test data, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 230 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to the environment. To protect against these risks, the Order requires:

• No release of the PMN substance, or any waste stream containing the PMN substance, in surface water concentrations that exceed 230 ppb; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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: P-21-175 (40 CFR 721.11908)

Chemical Name: Carbonic acid, diphenyl ester, polymer with 1,4-butanediol and 1,10-decanediol.

CASRN: 1615685-41-0.

Effective Date of TSCA Order: March 1, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be as a raw material of polyurethane. Based on comparison to analogous esters and test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 22 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to the environment. To protect against these risks, the Order requires:

• No release of the PMN substance resulting in surface water concentrations that exceed 22 ppb; and
• Establishment of a hazard communication program, including precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of chronic aquatic toxicity testing may be potentially useful to characterize the environmental effects of the PMN substance. Although the Order does not require these tests, the Order's restrictions remain in effect until the Order is modified or revoked by EPA based on submission of this or other relevant information. ( print page 67376)

PMN Number: P-22-7 (40 CFR 721.11909)

Chemical Name: 3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).

CASRN: Not available.

Effective Date of TSCA Order: February 3, 2023.

Basis for TSCA Order: The PMN states that the use will be as a crosslinker in formulating general purpose sealants and adhesives for use in consumer and professional markets. Based on test data on the PMN substance, EPA has identified concerns for eye irritation. Based on comparison to analogous chemical substances, EPA has also identified concerns for systemic effects. Based on test data for hydrolysis products of the PMN substance, EPA has also identified concerns for respiratory tract irritation and reproductive and developmental effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;
• No processing or use of the PMN substance other than as a crosslinker in formulating general purpose sealants and adhesives;
• No processing for use or use of the PMN substance where the concentration of the PMN substance exceeds 6% by weight in consumer products;
• No processing for use or use of the PMN substance in consumer products other than in the form of a paste;
• 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 precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, pulmonary effects, 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 Number: P-22-8 (40 CFR 721.11910)

Chemical Name:.beta.-N-Acetylhexosaminidase (expressed in genetically modified Bacillus licheniformis strain ATJI0138).

CASRN: 9012-33-3.

Effective Date of TSCA Order: March 3, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a biocatalyst used in a variety of products. Based on comparison to analogous chemical substances, EPA has identified concerns for skin irritation, eye irritation, respiratory irritation, skin sensitization, respiratory sensitization, portal-of-entry (oral) effects, and systemic effects. Based on comparison to analogous polyamphoteric polymers and test data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 1,000 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure;
• No processing of the PMN substance to greater than 1% in formulation for use in a consumer product;
• Use of personal protective equipment where there is a potential for dermal exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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

PMN Number: P-22-9 (40 CFR 721.11911)

Chemical Name: Alkanes, C4-9-branched and linear.

CASRN: 2577172-51-9.

Effective Date of TSCA Order: January 24, 2023.

Basis for TSCA Order: The PMN states that the use will be as a gasoline blending component to reduce the average carbon intensity and subsequent CO2 emissions of fuel. Based on comparison to analogous chemical mixtures, EPA has identified concerns for respiratory tract irritation, carcinogenicity, neurotoxicity, ototoxicity, portal-of-entry (inhalation and oral), systemic (body weight, liver, kidney, blood, adrenal, and spleen) toxicity, developmental effects, reproductive effects, acute toxicity, skin irritation, eye irritation, and aspiration hazard. Based on the chemical composition (petroleum) and n-nonane, EPA also identified concerns for hydrocarbon pneumonia and aspiration hazard. Based on comparison to analogous neutral organic chemicals, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 3 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Manufacture, processing, and use of the PMN substance only as a fuel, refinery feedstock, a chemical feedstock, or a fuel blending additive or component;
• 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 ( print page 67377) 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, respiratory depression/irritation, hydrocarbon pneumonia/aspiration hazard, reproductive/developmental toxicity, systemic toxicity, genetic toxicity, carcinogenicity, and consumer inhalation exposures 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 Number: P-22-10 (40 CFR 721.11912)

Chemical Name: Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-(trimethoxysilyl)propyl ester (generic).

CASRN: Not available.

Effective Date of TSCA Order: March 16, 2023.

Basis for TSCA Order: The PMN states that the use will be as part of an industrial adhesive. Based on comparison to analogous alkoxysilanes, EPA has identified concerns for lung pathology and systemic effects. Based on comparison to analogous chemical substances, EPA has also identified concerns for mortality, skin irritation, eye corrosion, respiratory irritation, portal-of-entry, neurotoxicity, systemic, and reproductive effects. Based on a hydrolysis product, EPA has also identified concerns for systemic, neurotoxicity, and developmental effects. Based on comparison to analogous alkoxysilanes and aliphatic amines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 80 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No use of the PMN substance in consumer products;
• No 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 80 ppb;
• 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 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: P-22-13 (40 CFR 721.11913)

Chemical Name: 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo, aryl ester (generic).

CASRN: Not available.

Effective Date of TSCA Order: March 2, 2023.

Basis for TSCA Order: The PMN states that the use will be as a raw material/intermediate, site-limited, destructive use. Based on test data for the ester hydrolysis products, EPA has identified concerns for skin sensitization, eye irritation, and systemic and neurotoxicity effects. Based on comparison to analogous anilines and esters, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 4 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Manufacture, processing, and use of the PMN substance only in a solid form when using a dust collection system with a capture and control efficiency of at least 32% to control dust exposure;
• No use of the PMN substance other than as an intermediate;
• 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;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation 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 aquatic toxicity, neurotoxicity, eye irritation/corrosion, skin sensitization, specific target organ toxicity, and persistence and bioaccumulation testing may be potentially useful to characterize the health, environmental, and fate 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: P-22-15 (40 CFR 721.11914)

Chemical Name: 2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo (generic).

CASRN: Not available.

Effective Date of TSCA Order: March 6, 2023.

Basis for TSCA Order: The PMN states that the use will be as a raw material/intermediate, site-limited, destructive use. Based on comparison to analogous chemical substances, EPA has identified concerns for eye irritation and systemic effects. Based on comparison to analogous anilines, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 14 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• Manufacture, processing, and use of the PMN substance only in a solid form when using a dust collection system with a capture and control efficiency of at least 32% to control dust exposure;
• No use of the PMN substance other than as an intermediate; ( print page 67378)
• 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;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation 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 aquatic toxicity, eye irritation, specific target organ toxicity, and persistence and bioaccumulation testing may be potentially useful to characterize the health, environmental, and fate 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: P-22-37 (40 CFR 721.11915)

Chemical Name: Polyphosphoric acids, esters with heteromonocycle homopolymer (generic).

CASRN: Not available.

Effective Date of TSCA Order: April 3, 2023.

Basis for TSCA Order: The PMN states that the use will be as an adhesion promoter used in coatings for better adhesion to metals under high humidity conditions. Based on comparison to analogous chemical substances, EPA has identified concerns for irritation/corrosion to the skin, eyes, and respiratory tract, clinical signs, and systemic effects. Based on the surfactant-like properties of the PMN substance, EPA has also identified concerns for lung effects (surfactancy). Based on comparison to analogous phosphates—inorganic and polyanionic polymers (& monomers) and the standard toxicity profile for inorganic phosphate, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 2 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing of the PMN substance to greater than 1% in formulation;
• No use of the PMN substance in a formulation containing the PMN substance at a concentration greater than 1%;
• No processing for use or 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 2 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified combination particulate and gas/vapor respirator with an APF of at least 50 where there is a potential for inhalation exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, pulmonary effects, skin corrosion, eye irritation/corrosion, 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: P-22-44 (40 CFR 721.11916)

Chemical Name: Silica gel, reaction products with alkyl metal salt (generic).

CASRN: Not available.

Effective Date of TSCA Order: February 16, 2023.

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

• Manufacture, processing, and use of the PMN substance only in an enclosed process;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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

PMN Number: P-22-54 (40 CFR 721.11917)

Chemical Name: Graphene nanoplatelets (generic).

CASRN: Not available.

Effective Date of TSCA Order: March 17, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as an additive for paint coatings. Based on comparison to analogous chemical substances, EPA has identified concerns for lung effects and systemic effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable ( print page 67379) risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance other than by import into the United States in the form of a solution (i.e., no domestic manufacture);
• No processing of the PMN substance in any manner that results in inhalation exposure;
• No processing or use of the PMN substance other than in a liquid formulation;
• No use of the PMN substance other than for the confidential use listed in the Order;
• No use of the PMN substance in an application method where the concentration of the PMN substance in the formulation exceeds the confidential concentration 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;
• Use of a NIOSH-certified combination particulate and gas/vapor respirator with an APF of at least 50 where there is a potential for inhalation exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful in support of a request by the PMN submitter to modify the Order, or if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity, pulmonary effects, sediment 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 Numbers: P-22-86 (40 CFR 721.11918), P-22-122 (40 CFR 721.11919), P-22-179 (40 CFR 721.11920), and P-22-180 (40 CFR 721.11921)

Chemical Names: Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri-carbopolycycle, hetero-acid)benzenesulfonate (1:1) (generic) (P-22-86), Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium (1:1) (generic) (P-22-122), Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl trisubstitutedbenzoate (1:1) (generic) (P-22-179), and Dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1) (generic) (P-22-180).

CASRNs: Not available.

Effective Date of TSCA Order: January 24, 2023.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the PMN substances will be for contained used for microlithography for electronic device manufacturing. 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), 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 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 and irritation to the skin, eyes, and respiratory tract. Based on information provided in the SDS, EPA has also identified concerns for acute toxicity and irritation to the skin, eyes, and respiratory tract. Based on confidential analogous 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 confidential cation of the PMN substances. Based on comparison to analogous substances, EPA has also identified concerns for mutagenicity. Based on a potential incineration by-product, EPA has also identified concerns for local, neurotoxic, and systemic effects for P-22-122, P-22-179, and P-22-180. Based on OECD QSAR Toolbox results, EPA has also identified hazards for skin sensitization and carcinogenicity for the anion for P-22-179 and P-22-180. 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 precautionary statements on each label and in the SDS;
• No 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 listed the Order.

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

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

PMN Number: P-22-115 (40 CFR 721.11922)

Chemical Name:.beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers, chlorides.

CASRN: 2683011-63-2.

Effective Date of TSCA Order: May 9, 2023.

Basis for TSCA Order: The PMN states that the uses will be as a filter media integrated and encapsulated in block filter articles for consumer, industrial, and commercial applications, filter media integrated and encapsulated in filter articles for consumer applications, and filter media integrated and encapsulated in packed bed filters for industrial and commercial applications. ( print page 67380) Based on the high molecular weight polymer and low water solubility, EPA has identified concerns for lung effects (lung overload). Based on amine content, EPA has also identified concerns for irritation to the skin, eyes, and respiratory tract. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• No processing for use or use of the PMN substance in consumer products except when incorporated into an article;
• No manufacture, processing, or use of the PMN substance with a particle size less than 20 microns;
• 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 10 where there is a potential for inhalation exposure; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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

PMN Number: P-22-129 (40 CFR 721.11923)

Chemical Name: Substituted heterocyclic onium compound, salt with heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1), polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate, hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate and 4-hydroxyphenyl 2-methyl-2-propenoate (generic).

CASRN: Not available.

Effective Date of TSCA Order: April 24, 2023.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the PMN substance will be for contained use for microlithography for electronic device manufacturing. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194, November 4, 1999 (FRL-6097-7)), 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, and irritation to the skin, eyes, and respiratory tract. Based on the cation of the PMN substance 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. Based on comparison to analogous chemical substances, EPA has also identified concerns for mutagenicity. Based on a potential incineration by-product, EPA has also identified concerns for local, neurotoxic, and systemic effects. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

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

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

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

PMN Number: P-22-162 (40 CFR 721.11924)

Chemical Name: Haloalkylfurancarboxaldehyde (generic).

CASRN: Not available.

Effective Date of TSCA Order: May 8, 2023.

Basis for TSCA Order: The PMN states that the use will be as a chemical intermediate used in the production of para-xylene and in production of FDCA/PET and other specialty chemicals. Based on submitted test data on the PMN substance and comparison to analogous chemical substances, EPA has identified concerns for acute toxicity, skin and respiratory tract irritation, serious eye damage, skin sensitization, systemic effects, developmental effects, and genotoxicity. Based on comparison to analogous aldehydes and submitted acute toxicity data on the PMN substance, EPA predicts toxicity to aquatic organisms may occur at concentrations that exceed 540 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No processing or use of the PMN substance in consumer products;
• No manufacture, processing, or use of the substance in any manner that results in inhalation exposure;
• No release of the PMN substance, or any waste stream containing the PMN ( print page 67381) substance, in surface water concentrations that exceed 540 ppb;
• Use of personal protective equipment where there is a potential for dermal exposure;
• Disposal of the PMN substance, or any waste steams containing the PMN substance, only by hazardous waste incineration achieving at least 99.99% destruction of the PMN substance;
• Manufacture, processing, or use of the PMN substance only in an enclosed process; and
• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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

MCAN Number: J-23-3 (40 CFR 725.1082)

Chemical Name: Microorganism expressing enzymes (generic).

CASRN: Not available.

Effective Date of TSCA Order: April 21, 2023.

Basis for TSCA Order: The MCAN states that the generic (non-confidential) use of the microorganism will be for production of an enzyme mixture. EPA determined that certain fermentation conditions, other than the typical submerged standard industrial fermentation process for enzyme production, could result in increased exposures. Specifically, EPA is concerned that where growth on plant material or on solid substrates occur, the MCAN microorganism has been shown to produce a secondary metabolite known as paracelsin, which is associated with a variety of toxic effects to mammalian and bacterial cells. 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 microorganism may present an unreasonable risk of injury to human health and the environment. To protect against these risks, the Order requires:

• No manufacture, processing, or use of the microorganism other than in a fermentation system that meets all of the following conditions:

(1) Enzyme production is conducted under conditions of submerged fermentation ( i.e., growth of the microorganism occurs beneath the surface of the liquid growth medium); and

(2) Any fermentation of solid plant material or insoluble substrate, to which the fermentation broth is added after the submerged standard industrial fermentation operations used for enzyme production is completed, may be initiated only after the inactivation of the microorganism as delineated in 40 CFR 725.422(d).

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

Potentially Useful Information: EPA has determined that the results of the following studies would help characterize any potential human health and environmental effects of the MCAN microorganism if a manufacturer or processor is considering submitting a SNUN for a significant new use that would be designated by this SNUR:

• Investigation of whether paracelsin will be produced, and at what levels if the MCAN microorganism is grown on various plant biomass materials for different durations under various fermentation conditions in cellulosic biomass facilities.
• If paracelsin is produced, a study of whether paracelsin would be denatured/inactivated during production and processing.
• If paracelsin is released from the facility, a study of whether paracelsin would be degraded/inactivated during wastewater treatment.
• If released to the environment, studies on the persistence, stability, dissemination, accumulation, and the potential resulting biological activity of paracelsin with exposure to aquatic and terrestrial organisms in the environment.
• Studies to determine the ability of the MCAN microorganism to survive in the environment relative to the survival of the unmodified parent or recipient strain, and to assess its competitiveness with other fungi in the environment. This study may require some supplementation with one or more carbon sources and the use of various soil types.
• A study to determine survival of the MCAN microorganism during an anaerobic fermentation for production of ethanol by an ethanologen, and survival of the MCAN microorganism during ethanol distillation or at the distillation temperature for ethanol.

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.

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 or MCANs. 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 ( print page 67382) burden estimate, and any suggested methods for improving the collection instruments or instruction or minimizing respondent burden, including through the use of automated collection techniques.

C. Regulatory Flexibility Act (RFA)

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

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

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

D. Unfunded Mandates Reform Act (UMRA)

This action does not contain an unfunded mandate of $100 million or more (in 1995 dollars) in any one year as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by SNURs. 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 rule. 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 and 725

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

Dated: August 9, 2024.

Mark Hartman,

Deputy Director, Office of Pollution Prevention and Toxics.

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).

( print page 67383)

2. Add §§ 721.11894 through 721.11924 to subpart E to read as follows:

Subpart E—Significant New Uses for Specific Chemical Substances

* * * * *

721.11894

Sulfonated phenolic resin salt, polymer with acetone-phenol reaction products, formaldehyde and phenol, sodium salt (generic).

721.11895

Sulfonated phenolic resin salt, polymer with acetone-phenol reaction products, formaldehyde and phenol, potassium salt (generic).

721.11896

Octadecanamide, N,N-dialkyl, salts (generic).

721.11897

Acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, methyl ester (generic).

721.11898

Acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl ester (generic).

721.11899

Carbopolycyclic alkenyl, 2-carboxylic acid, 2-[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (generic).

721.11900

Amines, C36-alkylenedi-, polymers with 5,5′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].

721.11901

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-(1-methylethoxy)-.

721.11902

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy-.

721.11903

Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and [oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with dialkyalkanamine (generic).

721.11904

Alkanedioic acid, polymers with alkanoic acid-dipentaerythritol reaction products, alkanedioc acid dihydrazide, hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (generic).

721.11905

Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2,2′-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)] bis [heteromonocycle], bis(2-methyl-2-propenoate) (generic).

721.11906

Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', .alpha.” -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (generic).

721.11907

Substituted heteromonocycle, polymer with haloalkyl substituted heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene)bis[hydroxy-carbomonocycle] and oxybis[alkanol], reaction products with metal oxide and dialkanolamine (generic).

721.11908

Carbonic acid, diphenyl ester, polymer with 1,4-butanediol and 1,10-decanediol.

721.11909

3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).

721.11910

.beta.-N-Acetylhexosaminidase (expressed in genetically modified Bacillus licheniformis strain ATJI0138).

721.11911

Alkanes, C4-9-branched and linear.

721.11912

Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-(trimethoxysilyl)propyl ester (generic).

721.11913

2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo, aryl ester (generic).

721.11914

2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo- (generic).

721.11915

Polyphosphoric acids, esters with heteromonocycle homopolymer (generic).

721.11916

Silica gel, reaction products with alkyl metal salt (generic).

721.11917

Graphene nanoplatelets (generic)

721.11918

Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri-carbopolycycle, hetero-acid)benzenesulfonate (1:1) (generic).

721.11919

Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium (1:1) (generic).

721.11920

Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl trisubstitutedbenzoate (1:1) (generic).

721.11921

Dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1) (generic).

721.11922

.beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers, chlorides.

721.11923

Substituted heterocyclic onium compound, salt with heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1), polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate, hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate and 4-hydroxyphenyl 2-methyl-2-propenoate (generic).

721.11924

Haloalkylfurancarboxaldehyde (generic).

§ 721.11894

Sulfonated phenolic resin salt, polymer with acetone-phenol reaction products, formaldehyde and phenol, sodium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonated phenolic resin salt, polymer with acetone-phenol reaction products, formaldehyde and phenol, sodium salt (PMN P-18-356) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3) and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: skin corrosion; serious eye damage; reproductive toxicity; specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

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

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=6.

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

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

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

( print page 67384)

§ 721.11895

Sulfonated phenolic resin salt, polymer with acetone-phenol reaction products, formaldehyde and phenol, potassium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonated phenolic resin salt, polymer with acetone-phenol reaction products, formaldehyde and phenol, potassium salt (PMN P-18-357) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3) and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: skin corrosion; serious eye damage; reproductive toxicity; specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

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

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=6.

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

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

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

§ 721.11896

Octadecanamide, N,N-dialkyl, salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as octadecanamide, N,N-dialkyl, salts (PMN P-19-188) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(b), the concentration is set at 1.0%.

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

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

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=34.

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

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

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

§ 721.11897

Acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, methyl ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acid N-[4-(4-diarylalkyl]-, carbopolycyclic alkenyl, methyl ester (PMN P-20-175) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

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

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

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

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=0.1.

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

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

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

( print page 67385)

§ 721.11898

Acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as acid N-(diarylalkyl)-, carbopolycyclic alkenyl, methyl ester (PMN P-20-176) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

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

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

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

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=0.1.

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

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

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

§ 721.11899

Carbopolycyclic alkenyl, 2-carboxylic acid, 2-[[[(diarylalkyl)] carbonyl]oxy] ethyl ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbopolycyclic alkenyl, 2-carboxylic acid, 2-[[[(diarylalkyl)]carbonyl]oxy]ethyl ester (PMN P-20-178) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

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

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

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

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=0.2.

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

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

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

§ 721.11900

Amines, C36-alkylenedi-, polymers with 5,5′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol].

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as amines, C36-alkylenedi-, polymers with 5,5′-[(1-methylethylidene)bis(4,1-phenyleneoxy)]bis[1,3-isobenzofurandione] and 4,4′-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[2-aminophenol] (PMN P-21-15; CASRN 2419899-87-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

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

(ii) Industrial, commercial, and consumer activities. It is a significant new use to use the substance other than as a raw material in a temporary bonding adhesive formulation. The adhesive is used to bond completed semiconductor wafers to a backing substrate to facilitate mechanical grinding of the wafer to reduce its thickness. It is a significant new use to manufacture, process, or use the substance in any manner that results in worker inhalation exposure.

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

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

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

§ 721.11901

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-(1-methylethoxy)-.

(a) Chemical substance and significant new uses subject to reporting. ( print page 67386) (1) The chemical substance identified as poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-(1-methylethoxy)- (PMN P-21-32; CASRN 2304726-48-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or destroyed.

(2) The significant new uses are:

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

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to process or use the substance in any manner in formulation containing the substance at greater than 4%.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=110. Whenever the substance is released together with poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy- (PMN P-21-33; CASRN 2304726-50-7), N should be calculated using the combined number of kilograms of both substances released per site per day.

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

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

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

§ 721.11902

Poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-butoxy- (PMN P-21-33; CASRN 2304726-50-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or destroyed.

(2) The significant new uses are:

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

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to process or use the substance in any manner in formulation containing the substance at greater than 4%.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=110. Whenever the substance is released together with poly[oxy(methyl-1,2-ethanediyl)], .alpha.-(3-aminopropyl)-.omega.-(1-methylethoxy)- (PMN P-21-32; CASRN 2304726-48-3), N should be calculated using the combined number of kilograms of both substances released per site per day.

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

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

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

§ 721.11903

Alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and [oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with dialkyalkanamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanoic acid, hydroxy-(hydroxyalkyl)-alkyl-, polymer with .alpha.-[(hydroxyalkyl)alkyl]-.omega.-alkoxypoly(oxy-alkanediyl), dialkyl carbonate, alkanediol, alkylene[isocyanato-carbomonocycle] and [oxybis(alkylene)]bis[alkyl-alkanediole] alkenoate, compd. with dialkyalkanamine (PMN P-21-75) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50, or 1000 if spray applied.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), and (g)(1) and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity; skin corrosion; skin irritation; serious eye damage; eye irritation; respiratory sensitization; reproductive toxicity; specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used. ( print page 67387)

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

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

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

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

§ 721.11904

Alkanedioic acid, polymers with alkanoic acid-dipentaerythritol reaction products, alkanedioc acid dihydrazide, hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkanedioic acid, polymers with alkanoic acid-dipentaerythritol reaction products, alkanedioc acid dihydrazide, hydroxy-(hydroxyalkyl)-alkylalkanoic acid, isocyanato-(isocyanatoalkyl)-alkyl substituted carbomonocycle, dialkylalkanediol and polyalkylene glycol(hydroxyalkyl)alkyl alkyl ether (PMN P-21-80) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50, or 1000 if spray applied.

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

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

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

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

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

§ 721.11905

Phenol, 4,4′-(1-methylethylidene) bis-, polymer with 2,2′-[(1-methylethylidene) bis (4,1-phenyleneoxymethylene)] bis [heteromonocycle], bis (2-methyl-2-propenoate) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2,2′-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)] bis [heteromonocycle], bis (2-methyl-2-propenoate) (PMN P-21-96) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

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

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

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

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=2.

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

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

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

§ 721.11906

Poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', .alpha.” -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as poly(oxy-1,2-ethanediyl), .alpha.-hydro-.omega.-[2(or 3)-[[substituted benzoyl]oxy]hydroxypropoxyl]-, .alpha., .alpha.', .alpha.” -ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1) (PMN P-21-98) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. ( print page 67388)

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to manufacture or process the substance in any manner or method that results in inhalation exposure. It is a significant new use to use the substance in formulations at concentrations greater than 4%.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=12.

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

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

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

§ 721.11907

Substituted heteromonocycle, polymer with haloalkyl substituted heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene)bis[hydroxy-carbomonocycle] and oxybis[alkanol], reaction products with metal oxide and dialkanolamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted heteromonocycle, polymer with haloalkyl substituted heteromonocycle, dialkyl-alkanediamine, (alkylalkylidene)bis[hydroxy-carbomonocycle] and oxybis[alkanol], reaction products with metal oxide and dialkanolamine (PMN P-21-126) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely destroyed.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(3) and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

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

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

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

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

§ 721.11908

Carbonic acid, diphenyl ester, polymer with 1,4-butanediol and 1,10-decanediol.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as carbonic acid, diphenyl ester, polymer with 1,4-butanediol and 1,10-decanediol (PMN P-21-175; CASRN 1615685-41-0) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely destroyed.

(2) The significant new uses are:

(i) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(3) and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=22.

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

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

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

§ 721.11909

3,5,8-Trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 3,5,8-trioxa-4-silaalkanoic acid, 4-ethenyl-4-(2-alkoxy-1-alkyl-2-oxoethoxy)-2,6-dialkyl-7-oxo-, alkyl ester (PMN P-22-7) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or destroyed.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(b), the concentration is set at 1.0%.

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

(iii) Industrial, commercial, and consumer activities. It is a significant new use to process for use or use the substance other than as a crosslinker in formulating general purpose sealants and adhesives. It is a significant new use to process for use or use the substance in consumer products other than in the form of a paste. It is a significant new use to process for use or use the substance where the concentration of the substance exceeds 6% by weight in consumer products. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure.

(b) Specific requirements. The provisions of subpart A of this part ( print page 67389) apply to this section except as modified by this paragraph (b).

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

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

§ 721.11910

.beta.-N-Acetylhexosaminidase (expressed in genetically modified Bacillus licheniformis strain ATJI0138).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as .beta.-N-acetylhexosaminidase (expressed in genetically modified Bacillus licheniformis strain ATJI0138) (PMN P-22-8; CASRN 9012-33-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

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

(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance in any manner that results in inhalation exposure. It is a significant new use to process the substance to greater than 1% in formulation for use in a consumer product.

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

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

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

§ 721.11911

Alkanes, C4-9-branched and linear.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as alkanes, C4-9-branched and linear (PMN P-22-9; CASRN 2577172-51-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into a fuel or refined or blended into other chemical or fuel formulations.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(b), the concentration is set at 0.1%.

(ii) Hazard communication. Requirements as specified in § 721.72(a).

(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance other than as a fuel, a refinery feedstock, a chemical feedstock, or a fuel blending additive or component.

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

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

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

§ 721.11912

Amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-(trimethoxysilyl)propyl ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as amino alkanoic acid, N-[3-(trimethoxysilyl)propyl]-, 3-(trimethoxysilyl)propyl ester (PMN P-22-10) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1) and (3), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3) and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: skin irritation; serious eye damage; reproductive toxicity; specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

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

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=80.

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

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

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

§ 721.11913

2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo, aryl ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified ( print page 67390) generically as 2-pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo, aryl ester (PMN P-22-13) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50.

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g). It is a significant new use to manufacture, process, or use the substance unless in solid form when using a dust collection system with a capture and control efficient of at least 32%.

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

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

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

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

§ 721.11914

2-Pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo- (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-pyridinecarboxylic acid, 3-halo-4-nitrogen-substituted-5-halo-6-halo- (PMN P-22-15) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. For purposes of § 721.63(b), the concentration is set at 1.0%.

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(g). It is a significant new use to manufacture, process, or use the substance unless in solid form when using a dust collection system with a capture and control efficient of at least 32%.

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

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

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

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

§ 721.11915

Polyphosphoric acids, esters with heteromonocycle homopolymer (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyphosphoric acids, esters with heteromonocycle homopolymer (PMN P-22-37) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or cured.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. For purposes of § 721.63(b), the concentration is set at 1.0%.

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (f), and (g)(1), (3) and (5). For purposes of § 721.72(e), the concentration is set at 1.0%. For purposes of § 721.72(g)(1), this substance may cause: skin corrosion; skin irritation; serious eye damage; eye irritation; specific target organ toxicity. For purposes of § 721.72(g)(3), this substance may be: toxic to aquatic life. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to process the substance to greater than 1% in formulation. It is a significant new use to use the substance in a formulation containing the substance at a concentration greater than 1%.

(iv) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=2.

(b) Specific requirements. The provisions of subpart A of this part apply to this section except as modified by this paragraph (b). ( print page 67391)

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

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

§ 721.11916

Silica gel, reaction products with alkyl metal salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silica gel, reaction products with alkyl metal salt (PMN P-22-44) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely destroyed.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. For purposes of § 721.63(b), the concentration is set at 1.0%.

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

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

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

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

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

§ 721.11917

Graphene nanoplatelets (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as graphene nanoplatelets (PMN P-22-54) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been: (i) Completely reacted or cured; or (ii) Embedded into a permanent solid polymer form that is not intended to undergo further processing, except mechanical processing or physical blending.

(2) The significant new uses are: (i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 50. For purposes of § 721.63(b), the concentration is set at 1.0%.

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(k), (v)(3), and (x)(3). It is a significant new use to manufacture the substance other than by import into the United States in the form of a solution ( i.e., no domestic manufacture). It is a significant new use to process the substance in any manner that generates inhalation exposure. It is a significant new use to use the substance in an application method where the concentration of the substance in the formulation exceeds the confidential concentration listed in the Order.

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

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

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

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

§ 721.11918

Phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri-carbopolycycle, hetero-acid)benzenesulfonate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenoxathiinium, 10-phenyl-, 5-alkyl-2-alkyl-4-(2,4,6-substituted tri- carbopolycycle, hetero-acid)benzenesulfonate (1:1) (PMN P-22-86) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

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

(ii) Hazard communication. Requirements as specified in § 721.72(a) through (d), (f), and (g)(1), (2)(i) through (iii), (v), (3)(i) and (ii), and (5). For purposes of § 721.72(g)(1), this substance may cause: acute toxicity; skin irritation; serious eye damage; skin sensitization; genetic toxicity; specific ( print page 67392) target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 9 months.

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

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

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

§ 721.11919

Heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heterotrisubstituted-bile acid, 1-(difluorosulfomethyl)-2,2,2-trifluoroethyl ester, ion(1-), (5)-, 5-phenyldibenzothiophenium (1:1) (PMN P-22-122) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

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

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 9 months.

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

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

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

§ 721.11920

Sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl trisubstitutedbenzoate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, (alkylsubstitutedphenyl)diphenyl-, salt with 1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkyl trisubstitutedbenzoate (1:1) (PMN P-22-179) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

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

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 9 months.

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

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

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

§ 721.11921

Dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2-triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dibenzothiophenium, 5-phenyl-, 4-[1-(heterosubstitutedalkyl)-2,2,2- triheterosubstitutedalkoxy]-4-oxoalkyl trisubstitutedbenzoate (1:1) (PMN P-22-180) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar ( print page 67393) manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

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

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution or in sealed containers weighing 5 kilograms or less. It is a significant new use to process the substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 9 months.

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

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

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

§ 721.11922

.beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers, chlorides.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as .beta.-cyclodextrin, polymer with 2,3,5,6-tetrafluoro-1,4-benzenedicarbonitrile, hydrolyzed, 2-(trimethylammonio)ethyl ethers, chlorides (PMN P-22-115; CASRN 2683011-63-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been incorporated into an article.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in § 721.63(a)(1), (3) through (5), (b), and (c). When determining which persons are reasonably likely to be exposed as required for § 721.63(a)(1) and (4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of § 721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 10. For purposes of § 721.63(b), the concentration is set at 1.0%.

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

(iii) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the substance with particle size less than 20 microns. It is a significant new use to process for use or use the substance in consumer products except when incorporated into an article.

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

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

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

§ 721.11923

Substituted heterocyclic onium compound, salt with heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1), polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate, hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate and 4-hydroxyphenyl 2-methyl-2-propenoate (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted heterocyclic onium compound, salt with heteropolysubstitutedalkyl substitutedtricycloalkane carboxylate (1:1), polymer with 1-alkenyl-4-[(alkylcycloalkyl)oxy]carbomonocycle, 5-ethyloctahydro-4,7-methano-1H-inden-5-yl 2-methyl-2-propenoate, hexahydro-5-oxo-2,6-methanofuro[3,2-b]furan-3-yl 2-methyl-2-propenoate and 4-hydroxyphenyl 2-methyl-2-propenoate (PMN P-22-129) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

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

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f), (k), and (t). It is a significant new use to import the substance other than in solution, unless in sealed containers weighing 5 ( print page 67394) kilograms or less. It is a significant new use to process the substance in any way that generates dust, mist, or aerosol in a non-enclosed process. It is a significant new use to manufacture the substance longer than 18 months.

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

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

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

§ 721.11924

Haloalkylfurancarboxaldehyde (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as haloalkylfurancarboxaldehyde (PMN P-22-162) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (destroyed).

(2) The significant new uses are:

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

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

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

(iv) Disposal. It is a significant new use to dispose of the substance, or any waste streams containing the substance, other than by hazardous waste incineration achieving at least 99.99% destruction of the substance.

(v) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=540.

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

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

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

PART 725—REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS

3. The authority citation for part 725 continues to read as follows:

Authority: 15 U.S.C. 2604, 2607, 2613, and 2625.

4. Add §§ 725.1082 to subpart M to read as follows:

Subpart M—Significant New Uses for Specific Microorganisms

* * * * *

§ 725.1082

Microorganism expressing enzymes (generic).

(a) Microorganism and significant new uses subject to reporting. (1) The genetically-modified microorganism identified generically as microorganism expressing enzymes (MCAN J-23-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) It is a significant new use to manufacture, process, or use the microorganism other than in a fermentation system that meets all of the following conditions:

(A) Enzyme production occurs by submerged fermentation ( i.e., for enzyme production, growth of the microorganism occurs beneath the surface of the liquid growth medium); and

(B) Any fermentation of solid plant material or insoluble substrate to which the microorganism fermentation broth is added after the standard industrial fermentation is completed is initiated only after the inactivation of the microorganism as delineated in § 725.422(d).

(ii) [Reserved]

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

(1) Recordkeeping. Recordkeeping requirements as specified in § 725.950(b)(2) through (4) are applicable to manufacturers and processors of this microorganism.

(2) Modification or revocation of certain notification requirements. The provisions of § 725.984 apply to this section.