2021-21872. Significant New Use Rules on Certain Chemical Substances (21-1.F)

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). The chemical substances received “not likely to present an unreasonable risk” determinations under 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 November 12, 2021.

ADDRESSES:

Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2021-0220, 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.

Due to the public health concerns related to COVID-19, the EPA Docket Center (EPA/DC) and Reading Room is closed to visitors with limited exceptions. The staff continues to provide remote customer service via email, phone, and webform. For the latest status information on EPA/DC services and docket access, visit https://www.epa.gov/​dockets.

FOR FURTHER INFORMATION CONTACT:

 

For technical information contact: William Wysong, New Chemicals Division (7405M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: [phone]; email address: [e-mail].

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

SUPPLEMENTARY INFORMATION:

I. 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 November 12, 2021 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?

EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) for 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-2021-0220, 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 EPA has determined “not likely” to present an unreasonable risk under the conditions of use, EPA is proposing to identify other circumstances that, while not reasonably foreseen, would warrant further EPA review before manufacture or processing for such a use is commenced.

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).
• 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-16-420

Chemical Name: Dimethyl cyclohexenyl propanol (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a fragrance ingredient, being blended (mixed) with other fragrance ingredients to make fragrance oils that will be sold to industrial and commercial customers for their incorporation into soaps, detergents, cleaners and other similar household and consumer products. Based on the estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and submitted test data on the PMN substance, EPA has identified concerns for eye irritation, systemic toxicity, and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No release of the PMN substance resulting in surface water concentrations that exceed 55 ppb.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance 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.

CFR Citation: 40 CFR 721.11604.

PMN Number: P-16-446

Chemical Name: Fatty acids, polymers with substituted carbomonocycle, substituted alkylamines, heteromonocycle, fatty acid and alkylamine, lactates (salts) (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a resin in architectural primer coatings. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation to all tissues and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No release of the PMN substance resulting in surface water concentrations that exceed 38 ppb.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11605.

PMN Number: P-16-602

Chemical Name: Carbonic acid, dialkyl ester, polymers with 5-amino-1,3,3-trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolalkane (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an ingredient in paints. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for lung effects if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• Application method during use other than the confidential method described in the PMN; and
• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

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 to characterize the human health effects of the PMN substance 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 testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11606.

PMN Number: P-17-284

Chemical Name: 2-Heptanone, 4-hydroxy-.

CAS Number: 25290-14-6.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an in-process intermediate. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for solvent neurotoxicity and irritation, sensitization, mutagenicity, neurotoxicity, reproductive toxicity, developmental toxicity, systemic toxicity, and aquatic toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No release of the PMN substance resulting in surface water concentrations that exceed 1,000 ppb.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance 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, reproductive/developmental toxicity, irritation, sensitization, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11607.

PMN Number: P-17-285

Chemical Name: 4-Hepten-2-one.

CAS Number: 24332-22-7.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an in-process intermediate. Based on the estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for solvent neurotoxicity and irritation, eye and skin irritation, developmental, liver, and kidney toxicities, sensitization, and aquatic toxicity if the PMN substance is not used following the limitation noted. The conditions of use of the chemical substance as described in the PMN include the following protective measure:

• No release of the PMN substance resulting in surface water concentrations that exceed 730 ppb.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance 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, reproductive/developmental toxicity, sensitization, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11608.

PMN Number: P-17-360

Chemical Names: 2-Propanol, 1-amino-, compd. with .alpha.-sulfo-.omega.-(octyloxy)poly(oxy-1,2-ethanediyl) (1:1) (P-17-360, chemical A) and 2-Propanol, 1-amino-, compd. with .alpha.-.sulfo-.omega.-(decyloxy)poly(oxy-1,2-ethanediyl) (1:1) (P-17-360, chemical B).

CAS Numbers: 2098904-74-4 (P-17-360, chemical A) and 2098904-80-2 (P-17-360, chemical B).

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substances will be as surfactants for oil and gas recovery. Based on the estimated physical/chemical properties of the PMN substances, comparison to structurally analogous chemical substances, comparison to analogous anionic surfactant substances, and submitted test data on the PMN substances, EPA has identified concerns for lung effects (surfactancy), irritation to the skin, eye, mucous membranes, and lungs, and systemic (kidney, liver, and thymus) effects if the chemical substances are not used following the limitation noted. The conditions of use of the PMN substances as described in the PMN include the following protective measure:

• No manufacturing, processing, or use of the PMN substances in any manner that results in inhalation exposure.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substances 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 pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substances.

CFR Citations: 40 CFR 721.11609 (P-17-360, chemical A) and 40 CFR 721.11610 (P-17-360, chemical B).

PMN Number: P-18-19

Chemical Name: Substituted benzene, 4-[2-[2-hydroxy-3-[[(3-nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt (1:1) (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a dispersive pigment. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, comparison to analogous acid dyes and amphoteric dyes, and submitted test data on the PMN substance, EPA has identified concerns for eye irritation, skin sensitization, and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

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

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

• No release of the PMN substance resulting in surface water concentrations that exceed 260 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 to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of eye irritation, skin sensitization, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11611.

PMN Number: P-18-34

Chemical Name: Polyetheramine carboxylate salt (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a dispersing agent for pigments in industrial paints and coatings. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous polycationic polymers, EPA has identified concerns for lung effects and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No use of the PMN substance in a consumer product;
• Use of the PMN substance only as a dispersing agent for pigments in industrial paints and coatings;
• No processing beyond a maximum concentration of 1% in the formulation of the final product;
• No manufacture or processing of the PMN substance in any manner that results in inhalation exposure; and
• No release of the PMN substance resulting in surface water concentrations that exceed 45 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 to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11612.

PMN Number: P-18-121

Chemical Name: Benzene, 1,1′-oxybis-, branched eicosyl derivs.

CAS Number: 1800419-55-9.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an additive for lubricating grease. Based on estimated physical/chemical properties of the PMN substance and submitted test data on the PMN substance, EPA has identified concerns for neurotoxicity, kidney effects, and blood effects if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• Use of the PMN substance only for the confidential use described in the PMN.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance 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 workplace exposure monitoring may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11613.

PMN Number: P-18-168

Chemical Name: Alkoxylated triaryl methane (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a color additive. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and test data submitted on the PMN substance, EPA has identified concerns for lung surfactancy if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

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

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance 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 testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11614.

PMN Numbers: P-18-179, P-18-180, and P-18-181

Chemical Names: Phenolic resin, alkali, polymer with formaldehyde and phenol, sodium salt (generic) (P-18-179), Phenol, polymer with formaldehyde and phenolic resin, potassium salt (generic) (P-18-180), and Phenol, polymer with formaldehyde and phenolic resin, potassium sodium salt (generic) (P-18-181).

CAS Numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the PMN substances will be as adhesives. Based on the estimated physical/chemical properties of the PMN substances, comparison to structurally analogous chemical substances, and comparison to analogous polyanionic polymers, EPA has identified concerns for irritation, corrosion, and aquatic toxicity if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMN include the following protective measures:

• No manufacture (including import) of the PMN substances to contain greater than 0.1% unbound formaldehyde residuals by weight;
• No use of the PMN substances other than for the confidential uses described in the PMNs;
• No manufacture of the PMN substances such that the weight percent of low molecular weight species below 1000 daltons exceeds the confidential value specified in the PMNs; and
• No manufacture, processing, or use of the PMN substances in any manner that results in inhalation exposure.

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 to characterize the human health and environmental effects of the PMN substances 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 absorption, distribution, metabolism, and excretion (ADME), repeated dose, and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substances.

CFR Citations: 40 CFR 721.11615 (P-18-179), 40 CFR 721.11616 (P-18-180), and 40 CFR 721.11617 (P-18-181).

PMN Number: P-18-192

Chemical Name: Benzenesulfonic acid, (alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-yl]amino]-, N-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-substituted(alkanol) (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as an optical brightener for use in paper applications. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for respiratory tract effects, systemic toxicity, developmental effects, and irritation to the skin, eye, and mucous membranes if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• Use of the PMN substance only as an optical brightener for use in paper applications; and
• No manufacture, processing, or use of the PMN substance in any manner that results in inhalation exposure.

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 to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11618.

PMN Number: P-18-197

Chemical Name: Metal, alkylcarboxylate oxo complexes (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a polymer composite additive. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for lung overload and respiratory irritation if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No use of the PMN substance other than for the confidential use described in the PMN; and
• No manufacture or processing of the PMN substance without the confidential engineering controls described in the PMN.

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 to characterize the human health effects of the PMN substance 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 testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11619.

PMN Number: P-18-221

Chemical Name: Polyglycerol reaction product with acid anhydride, etherified (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a binder for wood panels. Based on estimated physical/chemical properties of the PMN substance, identified structural alerts, and comparison to structurally analogous chemical substances, EPA has identified concerns for skin and lung sensitization, germ cell mutagenicity, carcinogenicity, and developmental, reproductive, liver, and kidney toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

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

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance 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 absorption, specific target organ toxicity, irritation, sensitization, and developmental toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11620.

PMN Numbers: P-18-258 and P-18-259

Chemical Names: Dioic acids, polymers with caprolactam and alkyldiamines (generic) (P-18-258) and Fatty acids, dimers, hydrogenated, polymers with caprolactam and alkyldiamine (generic) (P-18-259).

CAS Numbers: Not available.

Basis for action: The PMNs state that the generic (non-confidential) use of the PMN substances will be as copolyamides for packaging films. Based on estimated physical/chemical properties of the PMN substances and comparison to structurally analogous chemical substances, EPA has identified concerns for lung toxicity if the chemical substances are not used following the limitations noted. The conditions of use of the PMN substances as described in the PMNs include the following protective measure:

• No manufacturing, processing, or use of the PMN substances in any manner that results in inhalation exposure.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substances 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 pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substances.

CFR Citations: 40 CFR 721.11621 (P-18-258) and 40 CFR 721.11622 (P-18-259).

PMN Number: P-18-277

Chemical Name: Poly[2-(Dimethylamino)ethyl acrylate chloride salt, vinyl acetate, methacrylic acid and alkyl acrylates] (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an adhesive. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous amphoteric polymers, EPA has identified concerns for lung surfactancy if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

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

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance 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 testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11623.

PMN Number: P-18-278

Chemical Name: Isophthalic acid, polymer with terephthalic acid and C4 and C6 dialkyl amines (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a resin for molded automotive parts and electrical and electronic equipment. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous high molecular weight polymers, EPA has identified concerns for lung overload if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No manufacture (including import) of the PMN substance with particle sizes less than 10 microns.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance 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 testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11624.

PMN Number: P-18-299

Chemical Name: Alkenoic acid, alkyl-, polymers with alkyl methacrylate, cycloalkyl methacrylate, alkylene dimethacrylate, and polyalkene glycol hydrogen sulfate [(branched alkyloxy)alkyl]-(alkenyloxy)alkyl ethers ammonium salts, metal salts (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an ink additive. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and submitted test data on the PMN substance, EPA has identified concerns for lung toxicity and lung cancer if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

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

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 to characterize the human health effects of the PMN substance 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 testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11625.

PMN Number: P-18-375

Chemical Name: Fats and Glyceridic oils, vegetable, sulfonated, sodium salts.

CAS Number: 97489-04-8.

Basis for action: The PMN states that the use of the PMN substance will be in the fat liquoring stage in the production of leather as part of an aqueous emulsion containing about 10 to 25 percent PMN substance with lubricant oils, nonionic surfactants and anionic surfactants. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation, corrosion, and lung effects if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

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

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin irritation and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11626.

PMN Number: P-18-379

Chemical Name: Cashew nutshell liq., polymer with bisphenol A, epichlorohydrin, amines, formaldehyde, and glycol (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a hardener for waterborne epoxy systems. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for cationic binding to the lungs, irritation to the eyes and skin, and sensitization if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No manufacture (including import) of the PMN substance such that the weight percent of low molecular weight species below 500 daltons exceeds 1% and the weight percent of low molecular weight species below 1,000 daltons exceeds 6%; and
• No manufacturing, processing, or use of the PMN substance in any manner that results in inhalation exposure.

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 to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects, skin irritation/ corrosion, eye irritation/corrosion, and skin sensitization testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11627.

PMN Number: P-18-401

Chemical Name: Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates.

CAS Number: 91052-16-3.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an additive. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, comparison to analogous anionic surfactants, and submitted test data on the PMN substance, EPA has identified concerns for lung effects and aquatic toxicity if the chemical substance is not used following the limitations noted. The conditions of use of the PMN substance as described in the PMN include the following protective measures:

• No use of the PMN substance in formulations greater than 0.01% in a manner that results in inhalation exposure; and
• No release of the PMN substance resulting in surface water concentrations that exceed 12 ppb.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health and environmental effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of pulmonary effects and aquatic toxicity testing may be potentially useful to characterize the health and environmental effects of the PMN substance.

CFR Citation: 40 CFR 721.11628.

PMN Number: P-19-3

Chemical Name: Polyaromatic ether symmetrical dicarboxylic anhydride (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as a chemical intermediate. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and comparison to analogous anhydrides, carboxylic acids, EPA has identified concerns for cardiac, blood, muscle, reproductive, and developmental toxicity, skin and eye irritation, and respiratory sensitization. if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

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

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of sensitization, reproductive and developmental effects, and specific organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11629.

PMN Number: P-19-28

Chemical Name: Alkyl salicylate, metal salts (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will as a lubricating oil additive. Based on the estimated physical/chemical properties of the PMN substance and submitted test data on the PMN substance, EPA has identified concerns for lung surfactancy and sensitization if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

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

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin sensitization and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11630.

PMN Number: P-19-40

Chemical Name: Alkyl bis(dialkylamino alkyl) amide (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an intermediate. Based on comparison to structurally analogous chemical substances and metabolites, EPA has identified concerns for corrosion and irritation for the lungs, skin, and eyes, lung damage, systemic effects, reproductive/developmental toxicity, and sensitization if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

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

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of skin sensitization and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11631.

PMN Number: P-19-117

Chemical Name: Polycyclic amine, reaction products with polyalkylalkene, polymers (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as an additive. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, and submitted test data on the PMN substance, EPA has identified concerns for liver effects and developmental toxicity if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• Use of the PMN substance only for the confidential use described in the PMN.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance if a manufacturer or processor is considering submitting a SNUN for a significant new use that will be designated by this SNUR. EPA has determined that the results of developmental and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11632.

PMN Number: P-19-121

Chemical Name: Plant based oils, polymer with 1,1′-methylenebis[4-isocyanatobenzene], pentaerythritol, phthalic esters, polypropylene glycol and polypropylene glycol ether with glycerol (3:1) (generic).

CAS Number: Not available.

Basis for action: The PMN states that the use of the PMN substance will be as an industrial adhesive. Based on estimated physical/chemical properties of the PMN substance and comparison to structurally analogous chemical substances, EPA has identified concerns for irritation to all exposed tissues, dermal and respiratory sensitization, and lung effects if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• No use of the PMN substance in spray applications.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance 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, skin irritation, skin sensitization, and pulmonary effects testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11633.

PMN Number: P-19-130

Chemical Name: Aminohydroxy naphthalenesulfonic acid, coupled with diazotized[(aminophenyl)sulfonyl]ethyl hydrogen sulfate and diazotized amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid, salts (generic).

CAS Number: Not available.

Basis for action: The PMN states that the generic (non-confidential) use of the PMN substance will be as a dye. Based on estimated physical/chemical properties of the PMN substance, comparison to structurally analogous chemical substances, analysis of analogous acid dyes and amphoteric dyes and vinyl sulfones, and submitted test data on the PMN substance, EPA has identified concerns for irreversible damage to eyes and irritation to mucous membranes if the chemical substance is not used following the limitation noted. The conditions of use of the PMN substance as described in the PMN include the following protective measure:

• Use of the PMN substance only for the confidential use described in the PMN.

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

Potentially Useful Information: EPA has determined that certain information may be potentially useful to characterize the human health effects of the PMN substance 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 and specific target organ toxicity testing may be potentially useful to characterize the health effects of the PMN substance.

CFR Citation: 40 CFR 721.11634.

V. Rationale and Objectives of the Proposed Rule

A. Rationale

During review of the chemical substances that are the subject of these SNURs and as further discussed in Unit IV, EPA identified certain circumstances that raised potential risk concerns. EPA determined that deviations from the limitations identified in the submissions could result in changes in the type or form of exposure to the chemical substances and/or increased exposures to the chemical substances and/or changes in the reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of the chemical substances, and therefore warranted SNURs. The SNURs would identify as significant new uses any manufacturing, processing, use, distribution in commerce, or disposal that does not conform to the certain limitations in the submission.

B. Objectives

EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants:

• 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. 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 October 12, 2021 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 date 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 http://www.epa.gov/​opptintr/​existingchemicals/​pubs/​tscainventory/​index.html.

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 all SNURs listed here. Descriptions of this information is provided for informational purposes. The potentially useful information identified in Unit IV. of the proposed rule 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 consultation with the Agency on the use of alternative test methods and strategies (also called New Approach Methodologies, or NAMs), if available, to generate the recommended test data. EPA encourages dialog with Agency representatives to help determine how best the submitter can meet both the data needs and the objective of TSCA section 4(h). For more information on alternative test methods and strategies to reduce vertebrate animal testing, visit https://www.epa.gov/​assessing-and-managing-chemicals-under-tsca/​alternative-test-methods-and-strategies-reduce.

The potentially useful information 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.

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 proposed rule would 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 related to this action have already been approved by OMB under the PRA under 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

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 proposed rule 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 proposed rule 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: September 28, 2021.

Tala Henry,

Deputy Director, Office of Pollution Prevention and Toxics.

Therefore, for the reasons stated in the preamble, it is proposed that 40 CFR chapter I be amended as follows:

PARTS 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, 2613, and 2625(c).

2. Add §§ 721.11604 through 721.11634 to subpart E to read as follows:

Subpart E—Significant New Uses for Specific Chemical Substances

721.11604

Dimethyl cyclohexenyl propanol (generic).

721.11605

Fatty acids, polymers with substituted carbomonocycle, substituted alkylamines, heteromonocycle, fatty acid and alkylamine, lactates (salts) (generic).

721.11606

Carbonic acid, dialkyl ester, polymers with 5-amino-1,3,3-trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolalkane (generic).

721.11607

2-Heptanone, 4-hydroxy-.

721.11608

4-Hepten-2-one.

721.11609

2-Propanol, 1-amino-, compd. with .alpha.-sulfo-.omega.-(octyloxy)poly(oxy-1,2-ethanediyl) (1:1).

721.11610

2-Propanol, 1-amino-, compd. with .alpha.-.sulfo-.omega.-(decyloxy)poly(oxy-1,2-ethanediyl) (1:1).

721.11611

Substituted benzene, 4-[2-[2-hydroxy-3-[[(3-nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt (1:1) (generic).

721.11612

Polyetheramine carboxylate salt (generic).

721.11613

Benzene, 1,1′-oxybis-, branched eicosyl derivs.

721.11614

Alkoxylated triaryl methane (generic).

721.11615

Phenolic resin, alkali, polymer with formaldehyde and phenol, sodium salt (generic).

721.11616

Phenol, polymer with formaldehyde and phenolic resin, potassium salt (generic).

721.11617

Phenol, polymer with formaldehyde and phenolic resin, potassium sodium salt (generic).

721.11618

Benzenesulfonic acid, (alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-yl]amino]-, N-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-substituted(alkanol) (generic).

721.11619

Metal, alkylcarboxylate oxo complexes (generic).

721.11620

Polyglycerol reaction product with acid anhydride, etherified (generic).

721.11621

Dioic acids, polymers with caprolactam and alkyldiamines (generic).

721.11622

Fatty acids, dimers, hydrogenated, polymers with caprolactam and alkyldiamine (generic).

721.11623

Poly[2-(Dimethylamino)ethyl acrylate chloride salt, vinyl acetate, methacrylic acid and alkyl acrylates] (generic).

721.11624

Isophthalic acid, polymer with terephthalic acid and C4 and C6 dialkyl amines (generic).

721.11625

Alkenoic acid, alkyl-, polymers with alkyl methacrylate, cycloalkyl methacrylate, alkylene dimethacrylate, and polyalkene glycol hydrogen sulfate [(branched alkyloxy)alkyl]-(alkenyloxy)alkyl ethers ammonium salts, metal salts (generic).

721.11626

Fats and Glyceridic oils, vegetable, sulfonated, sodium salts.

721.11627

Cashew nutshell liq., polymer with bisphenol A, epichlorohydrin, amines, formaldehyde, and glycol (generic).

721.11628

Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates.

721.11629

Polyaromatic ether symmetrical dicarboxylic anhydride (generic).

721.11630

Alkyl salicylate, metal salts (generic).

721.11631

Alkyl bis(dialkylamino alkyl) amide (generic).

721.11632

Polycyclic amine, reaction products with polyalkylalkene, polymers (generic).

721.11633

Plant based oils, polymer with 1,1′-methylenebis[4-isocyanatobenzene], pentaerythritol, phthalic esters, polypropylene glycol and polypropylene glycol ether with glycerol (3:1) (generic).

721.11634

Aminohydroxy naphthalenesulfonic acid, coupled with diazotized[(aminophenyl)sulfonyl]ethyl hydrogen sulfate and diazotized amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid, salts (generic).

* * * * *

Subpart E—Significant New Uses for Specific Chemical Substances

* * * * *

§ 721.11604

Dimethyl cyclohexenyl propanol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dimethyl cyclohexenyl propanol (PMN P-16-420) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=55.

(ii) [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 (c) and (k) are applicable to manufacturers and processors of this substance.

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

§ 721.11605

Fatty acids, polymers with substituted carbomonocycle, substituted alkylamines, heteromonocycle, fatty acid and alkylamine, lactates (salts) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, polymers with substituted carbomonocycle, substituted alkylamines, heteromonocycle, fatty acid and alkylamine, lactates (salts) (PMN P-16-446) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=38.

(ii) [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 (c) and (k) are applicable to manufacturers and processors of this substance.

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

§ 721.11606

Carbonic acid, dialkyl ester, polymers with 5-amino-1,3,3-trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolalkane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as carbonic acid, dialkyl ester, polymers with 5-amino-1,3,3-trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolalkane (PMN P-16-602) 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) Industrial, commercial, and consumer activities. It is a significant new use to use an application method during use other than the confidential method described in the PMN. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c), and (i) are applicable to manufacturers 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)(i) of this section.

§ 721.11607

2-Heptanone, 4-hydroxy-.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-heptanone, 4-hydroxy-. (PMN P-17-284; CAS No. 25290-14-6) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=1,000.

(ii) [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 (c) and (k) are applicable to manufacturers and processors of this substance.

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

§ 721.11608

4-Hepten-2-one.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 4-hepten-2-one (PMN P-17-285; CAS No. 24332-22-7) 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) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=730.

(ii) [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 (c) and (k) are applicable to manufacturers and processors of this substance.

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

§ 721.11609

2-Propanol, 1-amino-, compd. with .alpha.-sulfo-.omega.-(octyloxy)poly(oxy-1,2-ethanediyl) (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propanol, 1-amino-, compd. with .alpha.-sulfo-.omega.-(octyloxy)poly(oxy-1,2-ethanediyl) (1:1) (PMN P-17-360, chemical A; CAS No. 2098904-74-4) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11610

2-Propanol, 1-amino-, compd. with .alpha.-.sulfo-.omega.-(decyloxy)poly(oxy-1,2-ethanediyl) (1:1).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as 2-propanol, 1-amino-, compd. with .alpha.-.sulfo-.omega.-(decyloxy)poly(oxy-1,2-ethanediyl) (1:1) (PMN P-17-360, chemical B; CAS No. 2098904-80-2) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11611

Substituted benzene, 4-[2-[2-hydroxy-3-[[(3-nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt (1:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as substituted benzene, 4-[2-[2-hydroxy-3-[[(3-nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt (1:1) (PMN P-18-19) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(f) and (o).

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

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

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

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

§ 721.11612

Polyetheramine carboxylate salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyetheramine carboxylate salt (PMN P-18-34) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(o). It is a significant new use to use the PMN substance other than as a dispersing agent for pigments in industrial paints and coatings. It is a significant new use to process the PMN substance to greater than 1% by weight in the formulation of the final product. It is a significant new use to manufacture or process the PMN substance in any manner that results in inhalation exposure.

(ii) Release to water. Requirements as specified in § 721.90(a)(4), (b)(4), and (c)(4), where N=45.

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

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

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

§ 721.11613

Benzene, 1,1′-oxybis-, branched eicosyl derivs.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as benzene, 1,1′-oxybis-, branched eicosyl derivs. (PMN P-18-121; CAS No. 1800419-55-9) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [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 (c) and (i) are applicable to manufacturers 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)(i) of this section.

§ 721.11614

Alkoxylated triaryl methane (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkoxylated triaryl methane (PMN P-18-168) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11615

Phenolic resin, alkali, polymer with formaldehyde and phenol, sodium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenolic resin, alkali, polymer with formaldehyde and phenol, sodium salt (PMN P-18-179) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j). It is a significant new use to manufacture the PMN substance to contain greater than 0.1% unbound formaldehyde residuals by weight. It is a significant new use to manufacture or process the PMN substance such that the weight percent of low molecular weight species below 1,000 Daltons exceeds the confidential value specified in the PMN. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers 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)(i) of this section.

§ 721.11616

Phenol, polymer with formaldehyde and phenolic resin, potassium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol, polymer with formaldehyde and phenolic resin, potassium salt (PMN P-18-180) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j). It is a significant new use to manufacture the PMN substance to contain greater than 0.1% unbound formaldehyde residuals by weight. It is a significant new use to manufacture or process the PMN substance such that the weight percent of low molecular weight species below 1000 Daltons exceeds the confidential value specified in the PMN. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c), and (i) are applicable to manufacturers 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)(i) of this section.

§ 721.11617

Phenol, polymer with formaldehyde and phenolic resin, potassium sodium salt (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as phenol, polymer with formaldehyde and phenolic resin, potassium sodium salt (PMN P-18-181) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j). It is a significant new use to manufacture the PMN substance to contain greater than 0.1% unbound formaldehyde residuals by weight. It is a significant new use to manufacture or process the PMN substance such that the weight percent of low molecular weight species below 1000 Daltons exceeds the confidential value specified in the PMN. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers 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)(i) of this section.

§ 721.11618

Benzenesulfonic acid, (alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-yl]amino]-, N-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-substituted(alkanol) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as benzenesulfonic acid, (alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-yl]amino]-, N-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-substituted(alkanol) (PMN P-18-192) 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) Industrial, commercial, and consumer activities. It is a significant new use to use the PMN substance other than as an optical brightener for use in paper applications. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11619

Metal, alkylcarboxylate oxo complexes (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as metal, alkylcarboxylate oxo complexes (PMN P-18-197) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j). It is a significant new use to manufacture or process the PMN substance without the confidential engineering controls described in the PMN.

(ii) [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 (c) and (i) are applicable to manufacturers 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)(i) of this section.

§ 721.11620

Polyglycerol reaction product with acid anhydride, etherified (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyglycerol reaction product with acid anhydride, etherified (PMN P-18-221) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11621

Dioic acids, polymers with caprolactam and alkyldiamines (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as dioic acids, polymers with caprolactam and alkyldiamines (PMN P-18-258) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11622

Fatty acids, dimers, hydrogenated, polymers with caprolactam and alkyldiamine (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as fatty acids, dimers, hydrogenated, polymers with caprolactam and alkyldiamine (PMN P-18-259) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11623

Poly[2-(Dimethylamino)ethyl acrylate chloride salt, vinyl acetate, methacrylic acid and alkyl acrylates] (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as poly[2-(Dimethylamino)ethyl acrylate chloride salt, vinyl acetate, methacrylic acid and alkyl acrylates] (PMN P-18-277) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11624

Isophthalic acid, polymer with terephthalic acid and C4 and C6 dialkyl amines (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as isophthalic acid, polymer with terephthalic acid and C4 and C6 dialkyl amines (PMN P-18-278) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture the PMN substance with particle sizes less 10 microns.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11625

Alkenoic acid, alkyl-, polymers with alkyl methacrylate, cycloalkyl methacrylate, alkylene dimethacrylate, and polyalkene glycol hydrogen sulfate [(branched alkyloxy)alkyl]-(alkenyloxy)alkyl ethers ammonium salts, metal salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically alkenoic acid, alkyl-, polymers with alkyl methacrylate, cycloalkyl methacrylate, alkylene dimethacrylate, and polyalkene glycol hydrogen sulfate [(branched alkyloxy)alkyl]-(alkenyloxy)alkyl ethers ammonium salts, metal salts (PMN P-18-299) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c), and (i), are applicable to manufacturers and processors of this substance.

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

§ 721.11626

Fats and glyceridic oils, vegetable, sulfonated, sodium salts.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as fats and glyceridic oils, vegetable, sulfonated, sodium salts (PMN P-18-375; CAS No. 97489-04-8) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11627

Cashew nutshell liq., polymer with bisphenol A, epichlorohydrin, amines, formaldehyde, and glycol (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as cashew nutshell liq., polymer with bisphenol A, epichlorohydrin, amines, formaldehyde, and glycol (PMN P-18-379) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture (including import) the PMN substance such that the weight percent of low molecular weight species below 500 daltons exceeds 1% and the weight percent of low molecular weight species below 1,000 daltons exceeds 6%. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11628

Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates.

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified as glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (PMN P-18-401; CAS No. 91052-16-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

(i) Industrial, commercial, and consumer activities. It is a significant new use to use the PMN substance in formulations greater than 0.01% in a manner that results in inhalation exposure.

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

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

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

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

§ 721.11629

Polyaromatic ether symmetrical dicarboxylic anhydride (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polyaromatic ether symmetrical dicarboxylic anhydride (PMN P-19-3) is subject to reporting under this section for the significant new uses described in paragraph (a)(2) of this section.

(2) The significant new uses are:

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

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11630

Alkyl salicylate, metal salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl salicylate, metal salts (PMN P-19-28) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11631

Alkyl bis(dialkylamino alkyl) amide (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as alkyl bis(dialkylamino alkyl) amide (PMN P-19-40) 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) Industrial, commercial, and consumer activities. It is a significant new use to manufacture, process, or use the PMN substance in any manner that results in inhalation exposure.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11632

Polycyclic amine, reaction products with polyalkylalkene, polymers (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as polycyclic amine, reaction products with polyalkylalkene, polymers (PMN P-19-117) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [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 (c) and (i) are applicable to manufacturers 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)(i) of this section.

§ 721.11633

Plant based oils, polymer with 1,1′-methylenebis[4-isocyanatobenzene], pentaerythritol, phthalic esters, polypropylene glycol and polypropylene glycol ether with glycerol (3:1) (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as plant based oils, polymer with 1,1′-methylenebis[4-isocyanatobenzene], pentaerythritol, phthalic esters, polypropylene glycol and polypropylene glycol ether with glycerol (3:1) (PMN P-19-121) 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) Industrial, commercial, and consumer activities. It is a significant new use to use the substance in spray applications.

(ii) [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 (c) and (i) are applicable to manufacturers and processors of this substance.

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

§ 721.11634

Aminohydroxy naphthalenesulfonic acid, coupled with diazotized [(aminophenyl)sulfonyl]ethyl hydrogen sulfate and diazotized amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid, salts (generic).

(a) Chemical substance and significant new uses subject to reporting. (1) The chemical substance identified generically as aminohydroxy naphthalenesulfonic acid, coupled with diazotized[(aminophenyl)sulfonyl]ethyl hydrogen sulfate and diazotized amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid, salts (PMN P-19-130) 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) Industrial, commercial, and consumer activities. Requirements as specified in § 721.80(j).

(ii) [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 (c) and (i) are applicable to manufacturers 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)(i) of this section.

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