[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Proposed Rules]
[Pages 56664-56679]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-21872]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 721

[EPA-HQ-OPPT-2021-0220; FRL-8804-01-OCSPP]
RIN 2070-AB27


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

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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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: (202) 564-4163; email address: 
[email protected].
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; email address: [email protected].

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

[[Page 56665]]

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

[[Page 56666]]

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

[[Page 56667]]

     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

[[Page 56668]]

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

[[Page 56669]]

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/

[[Page 56670]]

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

[[Page 56671]]

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

[[Page 56672]]

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

[[Page 56673]]

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

0
1. The authority citation for part 721 continues to read as follows:

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

0
2. Add Sec. Sec.  721.11604 through 721.11634 to subpart E to read as 
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
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).

[[Page 56674]]

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

* * * * *


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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.

[[Page 56675]]

    (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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  721.80(f) and (o).
    (ii) Release to water. Requirements as specified in Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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

[[Page 56676]]

specified in Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.

[[Page 56677]]

Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.

[[Page 56678]]

Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  721.11632   Polycyclic amine, reaction products with 
polyalkylalkene, polymers (generic).

    (a) Chemical substance and significant new uses subject to 
reporting.

[[Page 56679]]

(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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.


Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.


Sec.  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 Sec.  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 Sec.  
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 Sec.  721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section. 
The provisions of Sec.  721.1725(b)(1) apply to paragraph (a)(2)(i) of 
this section.
* * * * *
[FR Doc. 2021-21872 Filed 10-8-21; 8:45 am]
BILLING CODE 6560-50-P


