87 FR 121 pgs. 37783-37807 - Significant New Use Rules on Certain Chemical Substances (21-3.5e)

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Type: PRORULEVolume: 87Number: 121Pages: 37783 - 37807

Docket number: [EPA-HQ-OPPT-2021-0568; FRL-9779-01-OCSPP]

FR document: [FR Doc. 2022-13360 Filed 6-23-22; 8:45 am]

Agency: Environmental Protection Agency

Official PDF Version: PDF Version

Pages: 37783, 37784, 37785, 37786, 37787, 37788, 37789, 37790, 37791, 37792, 37793, 37794, 37795, 37796, 37797, 37798, 37799, 37800, 37801, 37802, 37803, 37804, 37805, 37806, 37807

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2021-0568; FRL-9779-01-OCSPP]

RIN 2070-AB27

Significant New Use Rules on Certain Chemical Substances (21-3.5e)

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Proposed rule.

SUMMARY:

EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs) and are also subject to Orders issued by EPA pursuant to TSCA. 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 use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.

DATES:

Comments must be received on or before July 25, 2022.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0568, through the Federal eRulemaking Portal 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 or visiting the docket, along with more information about dockets generally, is available at http://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 Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: (202) 564-4163; email address: wysong.william@epa.gov.

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

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

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

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

This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and Orders under TSCA, which would include the SNUR requirements should these proposed rules be finalized. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR 721.20, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after July 25, 2022 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.

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

1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2.

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

A. What action is the Agency taking?

[top] EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) for certain chemical substances that were the subject of PMNs. These proposed SNURs would require persons to notify EPA at least 90 days before commencing the manufacture or processing of any of these chemical substances for an activity proposed as a significant new use. Receipt of such notices would allow EPA to assess risks and, if

appropriate, to regulate the significant new use before it may occur.

The docket for these proposed SNURs, identified as docket ID number EPA-HQ-OPPT-2021-0568, includes information considered by the Agency in developing these proposed SNURs.

B. 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 four TSCA section 5(a)(2) factors listed in Unit III.

C. Applicability of General Provisions

General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the rule. Provisions relating to user fees appear at 40 CFR part 700. Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply with the same significant new use notice (SNUN) requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). 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), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN and before the manufacture or processing for the significant new use can commence, EPA must either determine that the 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. If EPA determines that the use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the Federal Register , a statement of EPA's findings.

III. Significant New Use Determination

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, potential human exposures and environmental releases that may be associated with possible uses of these chemical substances, in the context of the four TSCA section 5(a)(2) factors listed in this unit.

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

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

IV. Substances Subject to This Proposed Rule

EPA is proposing significant new use and recordkeeping requirements for certain chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance that is identified in this unit as subject to this proposed rule:

• PMN number.

• Chemical name (generic name, if the specific name is claimed as CBI).

• Chemical Abstracts Service (CAS) Registry number (if assigned for non-confidential chemical identities).

• Effective date of and basis for the TSCA Order.

• Potentially Useful Information.

• CFR citation assigned in the regulatory text section of the proposed rule.

The chemicals subject to these proposed SNURs are as follows:

PMN Number: P-18-143

Chemical Name: Fatty acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino) alkyl] phenol (generic).

CAS Number: Not available.

Effective Date of TSCA Order: April 27, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be as an anti-corrosive primer for outdoor industrial applications. Based on available data on an analogue, EPA has identified concerns for systemic effects and reproduction/developmental toxicity. Based on analogue data for the low molecular weight fraction and information in the Safety Data Sheet, EPA has also identified concerns for corrosion to all tissues and skin sensitization. Based on comparison to analogous aliphatic amines, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb; and

• No use of the PMN substance in a consumer product.

[top] 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.

CFR Citation: 40 CFR 721.11687.

PMN Number: P-18-154

Chemical Name: Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked (generic).

CAS Number: Not available.

Effective Date of TSCA Order: August 2, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use will be as a crosslinking agent for coatings. Based on the expected function of the PMN substance as a crosslinking agent that can crosslink proteins and bind to DNA, EPA has identified concerns for skin sensitization, respiratory sensitization, and genotoxicity. Based on comparison to analogous carbamate esters, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• No 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;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb.

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

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

CFR Citation: 40 CFR 721.11688.

PMN Number: P-18-273

Chemical Name: 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) ester.

CAS Number: 84731-70-4.

Effective Date of TSCA Order: June 9, 2021.

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

• No use of the PMN substance other than the confidential use allowed in the Order;

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

• Use of personal protective equipment where there is a potential for dermal exposure; and

• Establishment of a hazard communication program, including human health 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 toxicokinetics 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.

CFR Citation: 40 CFR 721.11689.

PMN Number: P-18-290

Chemical Name: Carbomonocylic-oxazolidine (generic).

CAS Number: Not available.

Effective Date of TSCA Order: August 19, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be for gas scrubbing and wastewater deodorizing. Based on the potential release of a hydrolysis product of the PMN substance, EPA has identified concerns for systemic effects. Based on comparison to analogous chemical substances, EPA has identified concerns for eye and respiratory tract irritation. Based on test data on the PMN substance, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 285 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified respirator with an APF of at least 10 where there is a potential for inhalation exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substance resulting in surface water concentrations that exceed 285 ppb.

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

[top] 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, specific target organ toxicity, and chronic 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.

CFR Citation: 40 CFR 721.11690.

PMN Number: P-19-73

Chemical Name: Propoxylated, ethoxylated alkoxyalkyl ether (generic).

CAS Number: Not available.

Effective Date of TSCA Order: April 22, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be as a polymer coatings additive-low foaming wetting agent. Based on the surfactant properties and submitted test data on the PMN substance, EPA has identified concerns for irritation to the eyes, skin, lungs, and mucous membranes; skin sensitization; and lung effects. Based on comparison to structurally analogous chemical substances, EPA has also identified concerns for systemic toxicity. Based on submitted test data on the PMN substance and comparison to analogous nonionic surfactants, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 24 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;

• No processing of the PMN substance for use in consumer products unless the concentration in consumer formulations is less than 1%;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substance resulting in surface water concentrations that exceed 24 ppb.

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

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

CFR Citation: 40 CFR 721.11691.

PMN Number: P-19-98

Chemical Name: Phosphoric acid, polymer with (hydroxyalkyl)-alkanediol and alkanediol (generic).

CAS Number: Not available.

Effective Date of TSCA Order: May 28, 2021.

Basis for TSCA Order: The PMN states that use of the substance will be as a flame retardant additive for intumescent coatings. Based on available data on a residual substance, EPA has identified concerns for neurotoxicity, developmental effects, and systemic effects. Based on phosphate esters, EPA has also identified concerns for reproductive toxicity, neurotoxicity, and systemic effects. Based on phosphoric acid residual, EPA has also identified concerns for corrosion 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 or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified respirator with an APF of at least 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;

• Use of the PMN substance only as a flame retardant additive for intumescent coatings;

• No use of the PMN substance in a consumer product; and

• No release of the PMN substance resulting in surface water concentrations that exceed 500 ppb.

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

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

CFR Citation: 40 CFR 721.11692.

PMN Numbers: P-19-122 and P-20-83

Chemical Names: 2-Propenoic acid, 2-(hydrogenated animal-based nitrogen-substituted)ethyl ester (generic) (P-19-122) and 2-propenoic acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (generic) (P-20-83).

CAS Number: Not available.

Effective Date of TSCA Order: March 17, 2021.

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

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;

• No domestic manufacture ( i.e., import only);

• No use of the PMN substances in consumer applications;

[top] • Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substances resulting in surface water concentrations that exceed 1 ppb.

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

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

CFR Citations: 40 CFR 721.11693 (P-19-122) and 40 CFR 721.11694 (P-20-83).

PMN Number: P-20-5

Chemical Name: Modified graphene (generic).

CAS Number: Not available.

Effective Date of TSCA Order: August 13, 2021.

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

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified particulate respirator with an APF of at least 50 where there is a potential for inhalation exposure;

• Implementation of dust controls that demonstrate an exposure reduction of at least 90% where workers are reasonably expected to be exposed by inhalation to dust from the substance;

• No processing or use of the PMN substance other than for the confidential use allowed in the Order;

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

• No use of the PMN substance in an application method that results in inhalation exposure to workers;

• No direct release of the PMN substance to air;

• Disposal of the PMN substance only by incineration or landfill; and

• No release of the PMN substance to water.

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

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

CFR Citation: 40 CFR 721.11695.

PMN Number: P-20-58

Chemical Name: Polysaccharide, polymer with unsaturated carboxylic acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt initiated (generic).

CAS Number: Not available.

Effective Date of TSCA Order: September 9, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be as an additive for automatic dishwashing and hard surface cleaners. Based on comparison to analogous chemical substances, EPA has identified concerns for systemic effects. Based on comparison to analogous chemical substances, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 102 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substance resulting in surface water concentrations that exceed 102 ppb.

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

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

CFR Citation: 40 CFR 721.11696.

PMN Numbers: P-20-112, P-20-113, P-20-114, P-20-115, P-20-116, and P-20-117

Chemical Names: Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112), Ashes (residues), reactions products with substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3- (trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-113), Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114), Ashes (residues), reactions products with substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3- (trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-115), Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116), and Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117).

CAS Numbers: Not available.

[top] Effective Date of TSCA Order: June 15, 2021.

Basis for TSCA Order: The PMNs state that the use of the substances will be as additives for polymers ( e.g., rubber, plastics, adhesives, coatings and sealants). Based on the metal content of the PMN substances, EPA has identified concerns for lung toxicity, acute toxicity, lung effects, systemic effects, developmental effects, carcinogenicity, and mutagenicity. Based on silica and metal components (nickel and vanadium), acid groups, and information in the SDS, EPA has identified concerns for irritation and sensitization. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• Submittal to EPA of metals content analysis of the confidential immediate precursor used to manufacture the PMN substances;

• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure or compliance with a NCEL of 0.05 mg/m ³ as an 8-hour time-weighted average to prevent inhalation exposure;

• No manufacture, processing, or use of the PMN substances other than at facilities equipped with pollution controls, such as a bag house, that remove particulates from the air at 99% or greater efficiency and ensure all air releases from each facility, including fugitive releases, are filtered through these pollution controls;

• Use of the PMN substances only for the uses described in the PMNs; 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. The submitter has agreed not to exceed the time limits in the Order without sampling and analyzing the confidential immediate precursor used to manufacture the PMN substances via EPA Method 6010B for the following elements: arsenic, barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, mercury, nickel, selenium, silver, vanadium, and zinc.

CFR Citations: 40 CFR 721.11697 (P-20-112), 40 CFR 721.11698 (P-20-113), 40 CFR 721.11699 (P-20-114), 40 CFR 721.11700 (P-20-115), 40 CFR 721.11701 (P-20-116), and 40 CFR 721.11702 (P-20-117).

PMN Number: P-20-173

Chemical Name: Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated (generic).

CAS Number: Not available.

Effective Date of TSCA Order: June 10, 2021.

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

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified respirator with an APF of at least 10 where there is a potential for inhalation exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb.

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

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

CFR Citation: 40 CFR 721.11703.

PMN Number: P-21-10

Chemical Name: 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)- 1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-trimethyl-5-[[[[2-[(1-oxo-2-propen-1- yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate

CAS Number: 2460376-09-2.

Effective Date of TSCA Order: July 1, 2021.

Basis for TSCA Order: The PMN states that the use of the substance will be in 3D printing. Based on structural alerts for acrylates, EPA has identified concerns for irritation to the skin, eyes, and respiratory tract; and skin sensitization. Based on structural alerts for bifunctional acrylates, EPA has identified a concern for respiratory sensitization for the low molecular weight species. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure;

• No use of the PMN substance in a consumer product; and

• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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

CFR Citation: 40 CFR 721.11704.

PMN Number: P-21-13

Chemical Name: Methyl phenylethyl cyclopropanemethanol (generic).

CAS Number: Not available.

Effective Date of TSCA Order: May 20, 2021.

Basis for TSCA Order: The PMN states that use of the substance will be as a fragrance in fine fragrances; shampoos and body washes; household products such as laundry detergents and air fresheners; and deodorants and cosmetics. Based on submitted test data and comparison to analogous chemical substances, EPA has identified concerns for skin sensitization and irritation to the eyes and respiratory tract. Based on comparison to analogous neutral organic chemicals, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 1 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified respirator with an APF of at least 50 where there is a potential for inhalation exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;

• Use of the PMN substance in a consumer product only if the concentration of the PMN substance is less than 1%; and

• No release of the PMN substance resulting in surface water concentrations that exceed 1 ppb.

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

CFR Citation: 40 CFR 721.11705.

PMN Number: P-21-17

Chemical Name: [(Substituted-carbomonocyclic)amino] oxoalkenoic acid, inorganic salt (generic).

CAS Number: Not available.

Effective Date of TSCA Order: June 16, 2021.

Basis for TSCA Order: The PMN states that the use of the substance will be to improve physical properties in rubber products. Based on submitted test data, EPA has identified concerns for systemic effects and skin sensitization. Based on submitted test data, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 590 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified particulate respirator with an APF of at least 50 where there is a potential for inhalation exposure;

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

• No use of the PMN substance other than as an additive to improve physical properties in rubber products; and

• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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

CFR Citation: 40 CFR 721.11706.

PMN Number: P-21-18

Chemical Name: Sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1) (generic).

CAS Number: Not available.

Effective Date of TSCA Order: March 24, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be for contained use for microlithography for electronic device manufacturing. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on the photoreactivity of the PMN substance, EPA has identified concerns for photosensitization. Based on comparison to analogous substances, EPA has identified concerns for eye corrosion, irritation, acute toxicity, liver toxicity, neurotoxicity, and reproductive (developmental) toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance beyond the time limits specified in the Order without submittal to EPA the results of certain testing described in the Testing section of the Order;

• Use of personal protective equipment where there is a potential for dermal exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;

• No modification of the processing or use of the PMN substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;

[top] • Use of the PMN substance only as described in the PMN;

• 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.

CFR Citation: 40 CFR 721.11707.

PMN Numbers: P-21-23 and P-21-64

Chemical Names: Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic) (P-21-23) and sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic acid (1:1) (generic) (P-21-64).

CAS Numbers: Not available.

Effective Date of TSCA Order: April 20, 2021.

Basis for TSCA Order: The PMNs state that the generic (non-confidential) use of the substances will be for photolithography. Based on the physical/chemical properties of the PMN substances (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999) and test data on structurally similar substances, the PMN substances are potentially persistent, bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN substances will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on the photoreactivity of the PMN substances, EPA has identified concerns for photosensitization. Based on comparison to analogous substances, EPA has identified concerns for eye corrosion, irritation, acute toxicity, liver toxicity, and neurotoxicity. Based on positive mutagenicity and the perfluoro anion analogue, EPA has identified concerns for reproductive (developmental) toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substances may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substances beyond the time limits specified in the Order without submittal to EPA the results of certain testing described in the Testing section of the Order;

• Use of personal protective equipment where there is a potential for dermal exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;

• No modification of the processing or use of the PMN substances in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;

• Use of the PMN substances only as described in the PMNs;

• 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.

CFR Citations: 40 CFR 721.11708 (P-21-23) and 40 CFR 721.11709 (P-21-64).

PMN Number: P-21-27

Chemical Name: Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic salt (generic).

CAS Number: Not available.

Effective Date of TSCA Order: April 20, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be as an ingredient used in the manufacture of photoresists. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on the photoreactivity of the PMN substance, EPA has identified concerns for photosensitization. Based on comparison to analogous substances, EPA has identified concerns for eye corrosion, irritation, acute toxicity, liver toxicity, neurotoxicity, and reproductive (developmental) toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance beyond the time limits specified in the Order without submittal to EPA the results of certain testing described in the Testing section of the Order;

• Use of personal protective equipment where there is a potential for dermal exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;

• No modification of the processing or use of the PMN substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;

• Use of the PMN substance only as described in the PMN;

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

[top] • 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.

CFR Citation: 40 CFR 721.11710.

PMN Number: P-21-42

Chemical Name: Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).

CAS Number: Not available.

Effective Date of TSCA Order: April 1, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be for photolithography. Based on the physical/chemical properties of the PMN substance (as described in the New Chemical Program's PBT category at 64 FR 60194; November 1999) and test data on structurally similar substances, the PMN substance is a potentially persistent, bioaccumulative, and toxic (PBT) chemical. EPA estimates that the PMN substance will persist in the environment for more than 2 months and estimates a bioaccumulation factor of greater than or equal to 1,000. Based on the photoreactivity of the PMN substance, EPA has identified concerns for photosensitization. Based on comparison to analogous substances, EPA has identified concerns for eye corrosion, irritation, acute toxicity, liver toxicity, neurotoxicity, and reproductive (developmental) toxicity. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• No manufacture of the PMN substance beyond the time limits specified in the Order without submittal to EPA the results of certain testing described in the Testing section of the Order;

• Use of personal protective equipment where there is a potential for dermal exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS;

• No modification of the processing or use of the PMN substance in any way that generates a vapor, dust, mist, or aerosol in a non-enclosed process;

• Use of the PMN substance only as described in the PMN;

• 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.

CFR Citation: 40 CFR 721.11711.

PMN Number: P-21-54

Chemical Name: 2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts) (generic).

CAS Number: Not available.

Effective Date of TSCA Order: July 23, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be as a carpet treatment additive. Based on structure alerts, EPA has identified concerns for lung waterproofing and irritation to the skin, eyes, and respiratory tract. Based on comparison to analogous polycationic polymers, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 52 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• No use of the PMN substance in a product that is applied by a consumer;

• No manufacture or processing of the PMN substance in any manner that results in inhalation exposure;

• No use of the PMN substance in an application method that results in inhalation exposure;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substance resulting in surface water concentrations that exceed 52 ppb.

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

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

CFR Citation: 40 CFR 721.11712.

PMN Number: P-21-63

Chemical Name: Heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-polyalkyl ester (generic).

CAS Number: Not available.

Effective Date of TSCA Order: August 10, 2021.

[top] Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be as a component in herbicides. Based on test data on the PMN substance, EPA has identified concerns for acute toxicity, phototoxicity (skin irritation), reproductive effects, and developmental effects. Based on test data on the PMN substance, EPA predicts that toxicity to

aquatic organisms may occur at concentrations that exceed 18 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

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

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substance to water.

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

CFR Citation: 40 CFR 721.11713.

PMN Number: P-21-65

Chemical Name: Alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-alkanediol] (generic).

CAS Number: Not available.

Effective Date of TSCA Order: June 21, 2021.

Basis for TSCA Order: The PMN states that the use of the substance will be to improve the reactivity of ink formulation when cured under LED UV light. Based on structural alerts for cationic binding and for acrylates, EPA has identified concerns for lung effects and skin and eye irritation. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified particulate respirator with an APF of at least 1,000 where there is a potential for inhalation exposure;

• No use of the PMN substance in a spray application;

• No use of the PMN substance in a consumer product; and

• Establishment of a hazard communication program, including human health precautionary statements on each label and in the SDS.

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

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

CFR Citation: 40 CFR 721.11714.

PMN Number: P-21-125

Chemical Name: Nonane, branched.

CAS Number: 85408-10-2.

Effective Date of TSCA Order: September 17, 2021.

Basis for TSCA Order: The PMN states that the generic (non-confidential) use of the substance will be for contained use for microlithography for electronic device manufacturing. Based on the physical/chemical properties of an analogue, isooctane, EPA has identified concerns for aspiration. Based on test data for an analogue of a potential metabolite, EPA has identified concerns for skin irritation, eye irritation, and systemic, reproductive, and developmental effects. Based on comparison to analogous neutral organic substances, EPA predicts that toxicity to aquatic organisms may occur at concentrations that exceed 5 ppb. The Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient information to permit a reasoned evaluation, the substance may present an unreasonable risk of injury to human health or the environment. To protect against these risks, the Order requires:

• Use of personal protective equipment where there is a potential for dermal exposure;

• Use of a NIOSH-certified particulate respirator with an APF of at least 50 where there is a potential for inhalation exposure or compliance with a NCEL of 0.72 mg/m3 as an 8-hour time-weighted average to prevent inhalation exposure;

• No use of the PMN substance other than for the confidential use allowed in the Order;

• Establishment of a hazard communication program, including human health and environmental precautionary statements on each label and in the SDS; and

• No release of the PMN substance to water.

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

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

CFR Citation: 40 CFR 721.11715.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

[top] During review of the PMNs submitted for the chemical substances that are the subject to these proposed SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) Orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. As a general matter, EPA believes it is necessary to follow the TSCA Orders with a SNUR that identifies the absence of those protective measures as

significant new uses to ensure that all manufacturers and processors-not just the original submitter-are held to the same standard.

B. Objectives

EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review 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 notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.

• To be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.

VI. Applicability of the Proposed Significant New Use Designation

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. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.

When chemical substances identified in this proposed rule 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. However, TSCA Orders have been issued for these chemical substances, and the PMN submitters are prohibited by the TSCA Orders from undertaking activities which would be designated as significant new uses. The identities of many of the chemical substances subject to this proposed rule have been claimed as confidential per 40 CFR 720.85. Based on this, the Agency believes that it is highly unlikely that any of the significant new uses described in the regulatory text of this proposed rule are ongoing.

Therefore, EPA designates June 24, 2022 as the cutoff date for determining whether the new use is ongoing. The objective of EPA's approach is to ensure that a person cannot defeat a SNUR by initiating a significant new use before the effective date of the final rule.

In the unlikely event that a person began commercial manufacture or processing of the chemical substances for a significant new use identified as of that cutoff date, they 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 wait until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required with that determination.

Issuance of a 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 on the internet at https://www.epa.gov/tsca-inventory.

VII. Development and Submission of Information

EPA recognizes that TSCA section 5 does not require developing 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, TSCA Order or consent agreement under TSCA section 4, then TSCA section 5(b)(1)(A) requires such information to be submitted to EPA at the time of submission of the SNUN.

In the absence of a rule, TSCA Order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known or reasonably ascertainable (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Unit IV. lists potentially useful information for the SNURs listed in this document. Descriptions of this information is provided for informational purposes. The potentially useful information identified in Unit IV. will be useful to EPA's evaluation in the event that someone submits a SNUN for the significant new use.

EPA strongly encourages persons, before performing any testing, to consult with the Agency. Furthermore, pursuant to TSCA section 4(h), which pertains to reduction of testing in vertebrate animals, EPA encourages dialog 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.

In some of the TSCA Orders for the chemical substances identified in this proposed rule, EPA has established time limits in view of the lack of data on the potential health and environmental risks that may be posed by the significant new uses or increased exposure to the chemical substances. These limits cannot be exceeded unless the PMN submitter first submits the results of specified tests that would permit a reasoned evaluation of the potential risks posed by these chemical substances. The SNURs contain the same time limits as the TSCA Orders. Exceeding these production limits is defined as a significant new use. Persons who intend to exceed the time limit must notify the Agency by submitting a SNUN at least 90 days in advance of commencement of non-exempt commercial manufacture or processing.

Any request by EPA for the triggered and pended testing described in the TSCA Orders was made based on EPA's consideration of available screening-level data, if any, as well as other available information on appropriate testing for the PMN substances. Further, any such testing request on the part of EPA that includes testing on vertebrates was made after consideration of available toxicity information, computational toxicology and bioinformatics, and high-throughput screening methods and their prediction models.

[top] The potentially useful information listed in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN without any test data or other information may increase the likelihood that EPA will take action under TSCA section 5(e) or 5(f). EPA recommends that potential SNUN submitters contact EPA early enough so that they will be able to conduct the appropriate tests.

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

• Human exposure and environmental release that may result from the significant new use of the chemical substances.

• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.

VIII. SNUN Submissions

According to 40 CFR 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. 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. E-PMN software is available electronically at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.

IX. Economic Analysis

EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule. EPA's complete economic analysis is available in the docket for this rulemaking.

X. 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 13563: Improving Regulations and Regulatory Review

This action proposes to establish SNURs for several new chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011).

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 activities associated with SNURs have already been approved by OMB under the PRA and assigned OMB control number 2070-0012 (EPA ICR No. 574). This proposed rule does not contain 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 response. 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.

Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including using automated collection techniques, to the Director, Regulatory Support Division, Office of Mission Support (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.

C. Regulatory Flexibility Act (RFA)

Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq. ), the Agency hereby certifies that promulgation of these SNURs would not have a significant adverse economic impact on a substantial number of small entities. 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, it appears 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. 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 seven in Federal fiscal year (FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018 and only a fraction of these were from small businesses. In addition, the Agency currently offers relief to qualifying small businesses by reducing the SNUN submission fee from $16,000 to $2,800. This lower fee reduces the total reporting and recordkeeping of cost of submitting a SNUN to about $10,116 for qualifying small firms. Therefore, the potential economic impacts of complying with this proposed SNUR 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 final 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)

Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government will be impacted by this action. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq. ).

E. Executive Order 13132: Federalism

This action would not 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, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999).

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

[top] This action would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This action would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175 (65 FR 67249, November 9, 2000), 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 this is not an economically significant regulatory action as defined by Executive Order 12866, and this action does not address environmental health or safety risks disproportionately affecting children.

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

This action is not subject to Executive Order 13211 (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use.

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

This action does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898 (59 FR 7629, February 16, 1994).

List of Subjects in 40 CFR Part 721

Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.

Dated: June 15, 2022.

Tala Henry,

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 set forth below:

PART 721-SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES

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

Authority:

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

2. Add §§?721.11687 through 721.11715 to subpart E to read as follows:

Subpart E-Significant New Uses for Specific Chemical Substances

Sec. 721.11687 Fatty acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino) alkyl] phenol (generic).721.11688 Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked (generic).721.11689 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) ester.721.11690 Carbomonocylic-oxazolidine (generic).721.11691 Propoxylated, ethoxylated alkoxyalkyl ether (generic).721.11692 Phosphoric acid, polymer with (hydroxyalkyl)-alkanediol and alkanediol (generic).721.11693 2-Propenoic acid, 2-(hydrogenated animal-based nitrogen-substituted)ethyl ester.721.11694 2-Propenoic acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (generic).721.11695 Modified graphene (generic).721.11696 Polysaccharide, polymer with unsaturated carboxylic acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt initiated (generic).721.11697 Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112)721.11698 Ashes (residues), reactions products with substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-113)721.11699 Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114)721.11700 Ashes (residues), reactions products with substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-115)721.11701 Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116)721.11702 Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117)721.11703 Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated (generic).721.11704 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)- 1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-trimethyl-5-[[[[2-[(1-oxo-2-propen-1- yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.721.11705 Methyl phenylethyl cyclopropanemethanol (generic).721.11706 [(Substituted-carbomonocyclic)amino] oxoalkenoic acid, inorganic salt (generic).721.11707 Sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1) (generic).721.11708 Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic).721.11709 Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic acid (1:1) (generic).721.11710 Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic salt (generic).721.11711 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).721.11712 2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts) (generic).721.11713 Heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-polyalkyl ester (generic).721.11714 Alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-alkanediol] salt (generic).721.11715 Nonane, branched.

§?721.11687 Fatty acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino) alkyl] phenol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, tall-oil polymers with aminoalkyl, dialkyl alkane diamine, polyalkylene polyamine alkanepolyamine fraction, and tris-[(alkylamino) alkyl] phenol (PMN P-18-143) 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) Industrial, commercial, and consumer activities. Requirements as specified in §?721.80(o).

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

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

[top] (1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (c), (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.

§?721.11688 Isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isocyanic acid, polyalkylenepolycycloalkylene ester, 2-alkoxy alkanol and 1-alkoxy alkanol and alkylene diol blocked (PMN P-18-154) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) Hazard communication. Requirements as specified in §?721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of §?721.72(g)(1), this substance may cause: skin sensitization; respiratory sensitization; germ cell mutagenicity. 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=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.

§?721.11689 1,4-Cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,4-cyclohexanedicarboxylic acid, 1,4-bis(2-ethylhexyl) ester (PMN P-18-273; CAS No. 84731-70-4) 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) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(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), (g)(1), and (g)(5). For purposes of §??721.72(e), the concentration is set at 1.0%. For purposes of §?721.72(g)(1), this substance may cause: specific target organ toxicity. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

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

(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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11690 Carbomonocylic-oxazolidine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbomonocylic-oxazolidine (PMN P-18-290) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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), (g)(1), (g)(3), and (g)(5). For purposes of §??721.72(e), the concentration is set at 1.0%. For purposes of §?721.72(g)(1), this substance may cause: 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) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4) where N=285.

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

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

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

§?721.11691 Propoxylated, ethoxylated alkoxyalkyl ether (generic).

[top] (a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as propoxylated, ethoxylated alkoxyalkyl ether (PMN P-19-73) 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) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §?721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000. For purposes of §?721.63(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets).

(ii) Hazard communication. Requirements as specified in §?721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of §?721.72(g)(1), this substance may cause: skin irritation; serious eye damage; 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 process the substance for use in a consumer product where the concentration of the substance is 1% or greater in the consumer product formulation.

(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4) where N=24.

(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.

§?721.11692 Phosphoric acid, polymer with (hydroxyalkyl)-alkanediol and alkanediol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phosphoric acid, polymer with (hydroxyalkyl)-alkanediol and alkanediol (PMN P-19-98) 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 (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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%. For purposes of §?721.63(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets).

(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), and (g)(5). For purposes of §??721.72(e), the concentration is set at 1.0%. For purposes of §?721.72(g)(1), this substance may cause: skin corrosion; severe eye damage; 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. Requirements as specified in §?721.80(o). It is a significant new use to use the substance other than as a flame retardant additive for intumescent coatings.

(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4) where N=500.

(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.

§?721.11693 2-Propenoic acid, 2-(hydrogenated animal-based nitrogen-substituted)ethyl ester.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, 2-(hydrogenated animal-based nitrogen-substituted)ethyl ester (PMN P-19-122) 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 (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets).

(ii) Hazard communication. Requirements as specified in §?721.72(a) through (d), (f), (g)(1), (g)(3), and (g)(5). For purposes of §?721.72(g)(1), this substance may cause: skin corrosion; serious eye damage; 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. Requirements as specified in §?721.80(f). It is a significant new use to use the substance in consumer applications.

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

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

[top] (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.

§?721.11694 2-Propenoic acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, nitrogen-substituted alkyl, N-C16-18-acyl derivs. (PMN P-20-83) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets).

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

(iii) Industrial, commercial, and consumer activities. Requirements as specified in §?721.80(f). It is a significant new use to use the substance in consumer applications.

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

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

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

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

§?721.11695 Modified graphene (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as modified graphene (PMN P-20-5) 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), embedded into a thermoset polymer resin as an intermediate step before curing, or 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), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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. Where workers are reasonably expected to be exposed by inhalation to dust from the substance, dust controls shall be implemented that demonstrate an exposure reduction of at least 90%. 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(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets).

(ii) Industrial, commercial, and consumer activities. Requirements as specified in §?721.80(f) and (k). It is a significant new use to use the substance in an application method that results in inhalation exposure to workers.

(iii) Disposal. Requirements as specified in §?721.85(a)(1), (a)(2), (b)(1), (b)(2), (c)(1), and (c)(2). It is a significant new use to release the substance directly to air.

(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 (e) and (i) 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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(ii) of this section.

§?721.11696 Polysaccharide, polymer with unsaturated carboxylic acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt initiated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polysaccharide, polymer with unsaturated carboxylic acid and methacryloxyethyltrimethyl ammonium chloride, sodium salt, acid salt initiated (PMN P-20-58) 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:

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

System and OSHA Hazard Communication Standard may be used.

(iii) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4) where N=102.

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

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

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

§?721.11697 Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-112).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (PMN P-20-112) 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 incorporated into a polymer matrix.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63(a)(4) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(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(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets). For purposes of §?721.63(b), the concentration is set at 0.1%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA Order for this substance. The NCEL is 0.05 mg/m ³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to §?721.63 respirator requirements may request to do so under §?721.30. Persons whose §?721.30 requests to use the NCEL approach are approved by EPA will be required to follow NCEL provisions comparable to those contained in the corresponding TSCA Order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For purposes of §?721.72(e), the concentration is set at 0.1%. For purposes of §?721.72(g)(2), avoid skin contact; avoid breathing substance; avoid ingestion; use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.05 mg/m ³ ; use skin protection. 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). It is a significant new use to manufacture the substances without sampling and analyzing the immediate precursor used to manufacture the substances according to the terms specified in the TSCA Order for the following elements: arsenic, barium, beryllium, cadmium, chromium, cobalt, copper, lead, manganese, mercury, nickel, selenium, silver, vanadium, and zinc. It is a significant new use to manufacture the substances at facilities other than those equipped with pollution controls, such as a bag house, that remove particulates from the air at 99% or greater efficiency. It is a significant new use to process the substances other than in an enclosed system that does not allow for the release of particulates or at facilities equipped with pollution controls, such as a bag house, that remove particulates from the air at 99% or greater efficiency.

(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 (d) 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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11698 Ashes (residues), reactions products with substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-113).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ashes (residues), reactions products with substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (PMN P-20-113) 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 incorporated into a polymer matrix.

(2) The significant new uses are:

(B) [Reserved]

[top] (ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1)(ii) through (ix), (g)(2) and (g)(5). For purposes of §?721.72(e),

the concentration is set at 0.1%. For purposes of §?721.72(g)(2), avoid skin contact; avoid breathing substance; avoid ingestion; use respiratory protection or maintain workplace airborne concentrations at or below an 8-hour time-weighted average of 0.05 mg/m ³ ; use skin protection. Alternative hazard and warning statements that meet the criteria of the Globally Harmonized System and OSHA Hazard Communication Standard may be used.

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

(1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (d) 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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11699 Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-114).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (PMN P-20-114) 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 incorporated into a polymer matrix.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63 (a)(4) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets). For purposes of §?721.63(b), the concentration is set at 0.1%.

(B) [Reserved]

(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 (d) 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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11700 Ashes (residues), reactions products with substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (P-20-115).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ashes (residues), reactions products with substituted tricarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl] oxirane (generic) (PMN P-20-115) 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 incorporated into a polymer matrix.

(2) The significant new uses are:

[top] (i) Protection in the workplace. Requirements as specified in §?721.63(a)(4) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(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(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets). For purposes of §?721.63(b), the concentration is set at 0.1%.

(B) [Reserved]

(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 (d) 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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11701 Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-116).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (PMN P-20-116) 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 incorporated into a polymer matrix.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63(a)(4) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(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(a)(6), the airborne form(s) of the substance include. For purposes of §?721.63(b), the concentration is set at 0.1%.

(B) [Reserved]

(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 (d) and (f) through (i) are applicable to manufacturers, importers, and processors of this substance.

[top] (2) Limitation or revocation of certain notification requirements. The

provisions of §?721.185 apply to this section.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11702 Ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (P-20-117).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as ashes (residues), reactions products with dicarboxylic acid, silicic acid (H4SiO4) tetra-Et ester and 2-[[3-(trialkoxysilyl)alkoxy]methyl]oxirane (generic) (generic) (PMN P-20-117) 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 incorporated into a polymer matrix.

(2) The significant new uses are:

(B) [Reserved]

(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 (d) 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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11703 Silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as silsesquioxanes, alkyl, alkoxy- and hydroxy- terminated (PMN P-20-173) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (6), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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%. For purposes of §??721.63(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets).

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

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

[top]

§?721.11704 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)- 1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-trimethyl-5-[[[[2-[(1-oxo-2-propen-1- yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 1,3-benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2- (hydroxymethyl)-1,3-propanediol, hexanedioic acid, 1,6-hexanediol and 1,3-isobenzofurandione, N-[[1,3,3-trimethyl-5-[[[2-[(1-oxo-2- propen-1-yl)oxy]ethoxy]carbonyl]amino]cyclohexyl]methyl]carbamate N-[3,3,5-trimethyl-5-[[[[2-[(1-oxo-2-propen-1-yl)oxy]ethoxy]carbonyl]amino]methyl]cyclohexyl]carbamate (PMN P-21-10; CAS No. 2460376-09-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted (cured).

(2) The significant new uses are:

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

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

(1) Recordkeeping. Recordkeeping requirements as specified in §?721.125(a) through (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.

§?721.11705 Methyl phenylethyl cyclopropanemethanol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as methyl phenylethyl cyclopropanemethanol (PMN P-21-13) 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), (a)(3) through (5), (a)(6)(v) and (vi), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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), (g)(3), and (g)(5). For purposes of §?721.72(g)(1), this substance may cause: eye irritation; skin sensitization. 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 use the substance in consumer products unless the concentration of the substance is less than 1%.

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

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

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

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

§?721.11706 [(Substituted-carbomonocyclic)amino] oxoalkenoic acid, inorganic salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as [(substituted-carbomonocyclic)amino] oxoalkenoic acid, inorganic salt (PMN P-21-17) 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) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (6), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets).

(ii) Hazard communication. Requirements as specified in §?721.72(a) through (d), (f) (g)(1), and (g)(5). For purposes of §?721.72(g)(1), this substance may cause: skin 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(f). It is a significant new use to use the substance other than as an additive to improve physical properties in rubber products.

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

[top] (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.

§?721.11707 Sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, triphenyl-, heterocyclic compound-carboxylate (1:1) (PMN P-21-18) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section. The requirements of this section do not apply to quantities of the substance after they have been completely reacted or adhered (during photolithographic processes) onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

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

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

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

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

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

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

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11708 Sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, carbocyclic-, salt with 1-(alkyl) 2-[4-[polyhydro-2-carbomonocyclic-5-(polyfluoro-2-sulfoalkyl)-4,7-methano-1,3-benzodioxol-2-yl]carbomonocyclic oxy]acetate (1:1) (PMN P-21-23) 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 onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

(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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11709 Sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic acid (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, triphenyl-, polyfluoro-polyhydrospiro[9H-carbopolycyclic-9,2'-[4,7]methano[1,3]benzodioxole]-5'-alkenesulfonic acid (1:1) (PMN P-21-64) 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 onto a semiconductor wafer surface or similar manufactured article used in the production of semiconductor technologies.

(2) The significant new uses are:

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

(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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11710 Heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heteropolycyclic, trihaloalkyl carbomonocycle-, hydroxy carbomonocyclic salt (PMN P-21-27) 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:

(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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

§?721.11711 Sulfonium, tricarbocyclic-, 2-heteroatom-substituted-4-(alkyl)carbomonocyclic carboxylate (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as sulfonium, tricarbocyclic-,2-heteroatom-substituted-4-(alkyl)carbomonocyclic carboxylate (1:1) (PMN P-21-42) 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:

(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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

[top]

§?721.11712 2-Propenoic acid, 2-methyl-, aminoalkyl ester, polymer with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as 2-propenoic acid, 2-methyl-, aminoalkyl ester, polymer with hydroxyalkyl alkenoate and octadecyl alkenoate, acetate (salts) (PMN P-21-54) 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 incorporated into an article as defined at §?720.3(c).

(2) The significant new uses are:

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

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

(iv) Release to water. Requirements as specified in §?721.90(a)(4), (b)(4), and (c)(4) where N=52. Before totaling the releases of the substance to water from all operations at a site as described in 40 CFR 721.91(a)(5), you may subtract up to 90 percent for any releases that will be treated using primary and secondary wastewater treatment as defined in 40 CFR part 133.

(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.

§?721.11713 Heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-polyalkyl ester (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as heterocyclic-polycarboxylic acid, polyhaloaryl-polyhydro-alkyl-polyalkyl ester (PMN P-21-63) 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:

(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of §??721.72(e), the concentration is set at 1.0%. For purposes of §?721.72(g)(1), this substance may cause: skin irritation; acute 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(o).

(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.

§?721.11714 Alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-alkanediol] salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkenoic acid, reaction products with alkylamine-alkanediyl diacrylate polymer and [oxybis(alkylene)]bis[alkyl-alkanediol] (PMN P-21-65) 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) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (6) and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(4), engineering control measures ( e.g., enclosure or confinement of the operation, general and local ventilation) or administrative control measures ( e.g., workplace policies and procedures) shall be considered and implemented to prevent exposure, where feasible. For purposes of §?721.63(a)(5), respirators must provide a National Institute for Occupational Safety and Health (NIOSH) assigned protection factor (APF) of at least 1,000. For purposes of §??721.63(a)(6), the airborne form(s) of the substance include: particulate (including solids or liquid droplets).

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

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

[top] (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.

§?721.11715 Nonane, branched.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as nonane, branched (PMN P-21-125; CAS No. 85408-10-2) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Protection in the workplace. Requirements as specified in §?721.63(a)(1), (a)(3) through (5), (a)(6)(v) and (vi), (b), and (c). When determining which persons are reasonably likely to be exposed as required for §?721.63(a)(1) and (a)(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%.

(A) As an alternative to the respirator requirements in paragraph (a)(2)(i) of this section, a manufacturer or processor may choose to follow the new chemical exposure limit (NCEL) provision listed in the TSCA Order for this substance. The NCEL is 0.72 mg/m ³ as an 8-hour time weighted average. Persons who wish to pursue NCELs as an alternative to §??721.63 respirator requirements may request to do so under §??721.30. Persons whose §??721.30 requests to use the NCELs approach are approved by EPA will be required to follow NCELs provisions comparable to those contained in the corresponding TSCA Order.

(B) [Reserved]

(ii) Hazard communication. Requirements as specified in §?721.72(a) through (f), (g)(1), (g)(3), and (g)(5). For purposes of §??721.72(e), the concentration is set at 1.0%. For purposes of §?721.72(g)(1), this substance may cause: skin irritation; eye irritation; reproductive toxicity; specific target organ toxicity; aspiration hazard. 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).

(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.

(3) Determining whether a specific use is subject to this section. The provisions of §?721.1725(b)(1) apply to paragraph (a)(2)(iii) of this section.

[FR Doc. 2022-13360 Filed 6-23-22; 8:45 am]

BILLING CODE 6560-50-P