[Federal Register Volume 86, Number 219 (Wednesday, November 17, 2021)]
[Proposed Rules]
[Pages 64115-64129]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-24785]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2021-0227; FRL-8985-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (21-2.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
pursuant to TSCA. The SNURs require persons who intend to manufacture
(defined by statute to include import) or process any of these chemical
substances for an activity that is proposed as a significant new use by
this rule to notify EPA at least 90 days before commencing that
activity. The required notification initiates EPA's evaluation of the
use, under the conditions of use for that chemical substance, within
the applicable review period. Persons may not commence manufacture or
processing for the significant new use until EPA has conducted a review
of the notice, made an appropriate determination on the notice, and has
taken such actions as are required by that determination.
DATES: Comments must be received on or before December 17, 2021.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0227, 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 December 17, 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
[[Page 64116]]
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-2021-0227, includes information considered by the Agency in
developing these proposed SNURs.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same significant new use notice (SNUN) requirements and EPA regulatory
procedures as submitters of PMNs under TSCA section 5(a)(1)(A). These
requirements include the information submission requirements of TSCA
sections 5(b) and 5(d)(1), the exemptions authorized by TSCA sections
5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part
720. Once EPA receives a SNUN and before the manufacture or processing
for the significant new use can commence, EPA must either determine
that the use is not likely to present an unreasonable risk of injury
under the conditions of use for the chemical substance or take such
regulatory action as is associated with an alternative determination.
If EPA determines that the use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
potential human exposures and environmental releases that may be
associated with possible uses of these chemical substances, in the
context of the four TSCA section 5(a)(2) factors listed in this unit.
The proposed rules include PMN substances that EPA has determined
``not likely'' to present an unreasonable risk under the conditions of
use. EPA is proposing to identify other circumstances that, while not
reasonably foreseen, would warrant further EPA review before
manufacture or processing for such a use is commenced.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for certain chemical substances in 40 CFR part 721, subpart E. In this
unit, EPA provides the following information for each chemical
substance that is identified in this unit as subject to this proposed
rule:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Potentially Useful Information.
CFR citation assigned in the regulatory text section of
the proposed rule.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P-15-632
Chemical Name: Mixed amine salt (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a salt for polymers. Based on the estimated physical/
chemical properties of the PMN substance, test data on components of
the PMN substance, and comparison to analogous aliphatic amines, EPA
has identified concerns for irritation, bladder effects,
carcinogenicity, developmental effects, corrosion, pulmonary effects,
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 use involving an application method that generates a
vapor, mist, aerosol, or dust.
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
reproductive/developmental toxicity, specific target organ toxicity,
and pulmonary effects testing may be potentially useful to characterize
the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11659.
PMN Number: P-17-233
Chemical Name: Oxyalkylene modified polyalkyl amine alkyl diacid
polymer with 2-(chloromethyl)oxirane (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as
[[Page 64117]]
a creping aid for Yankee dryers to manufacture tissue and towel paper.
Based on the 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 irritation and corrosion to eyes, lung, and skin, 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 manufacturing, processing, or use in any manner that
results in inhalation exposure; and
No release of the PMN substance resulting in surface water
concentrations that exceed 20 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 aquatic toxicity, specific target organ toxicity, and
pulmonary effects testing may be potentially useful to characterize the
health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11660.
PMN Number: P-17-298
Chemical Name: Formaldehyde, homopolymer, reaction products with N-
propyl-1-propanamine.
CAS Number: 1374859-50-3.
Basis for action: The PMN states that the use of the PMN substance
will be as a hydrogen sulfide scavenger used in controlling hydrogen
sulfide in the vapor space of fuel storage, shipping vessels, and
pipelines. Based on the estimated physical/chemical properties of the
PMN substance, available data on the PMN substance, available data on a
degradate of the PMN substance, and comparison to structurally
analogous chemical substances, EPA has identified concerns for
irritation to the skin, eyes, and lungs, skin and eye corrosion, dermal
sensitization, mutagenicity, carcinogenicity, systemic 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 other than as a hydrogen
sulfide scavenger used in controlling hydrogen sulfide in the vapor
space of fuel storage, shipping vessels, and pipelines; and
No release of the PMN substance resulting in surface water
concentrations that exceed 3 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
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
metabolism or pharmacokinetics, carcinogenicity, and specific target
organ toxicity testing may be potentially useful to characterize the
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11661.
PMN Number: P-17-325
Chemical Name: 2-Propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-
propen-1-yl)amino]-1-propanesulfonic acid.
CAS Number: 40623-75-4.
Basis for action: The PMN states that the use of the PMN substance
will be in the textile industry in bleaching and dyeing operations as a
dispersing agent and for professional use. Based on the estimated
physical/chemical properties of the PMN substance and comparison to
structurally analogous chemical substances, EPA has identified concerns
for aquatic toxicity if the new 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 50 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 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 aquatic
toxicity testing may be potentially useful to characterize the
environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11662.
PMN Number: P-17-355
Chemical Name: Benzoic acid, alkyl derivs. (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 site intermediate.
Based on the estimated physical/chemical properties of the PMN
substance, comparison to structurally analogous chemical substances,
and comparison to analogous phenols, EPA has identified concerns for
lung effects (lung surfactancy), dermal sensitization, and systemic 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:
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, specific target organ toxicity, and reproductive
toxicity (developmental effects) testing may be potentially useful to
characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11663.
PMN Number: P-17-396
Chemical Name: Aminoalkylated imidazole (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an intermediate for a polyurethane catalyst. Based on the
estimated physical/chemical properties of the PMN substance, available
data on a component of the PMN substance, and comparison to analogous
aliphatic amines and pyrroles/diazoles, EPA has identified concerns for
corrosion and severe irritation to the skin, eyes, lungs, and mucous
membranes, neurotoxicity, systemic 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:
Use of the PMN substance only for the confidential use
described in the PMN;
[[Page 64118]]
No use of the PMN substance in a consumer product; and
No release of the PMN substance resulting in surface water
concentrations that exceed 33 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 skin corrosion, eye damage, 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 721.11664.
PMN Number: P-18-29
Chemical Name: Fatty acids and fatty acid unsatd., reaction
products with ethyleneamines and maleic anhydride (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for industrial use in
oilfields. Based on the estimated physical/chemical properties of the
PMN substance, comparison to structurally analogous chemical
substances, and comparison to analogous anionic surfactants, EPA has
identified concerns for skin 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 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 pulmonary effects testing may be potentially useful
to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11665.
PMN Number: P-18-108
Chemical Name: Aromatic anhydride polymer with
bisalkylbiphenylbisamine compound with alkylamino acrylate ester
(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 ionic salt of a
polyamic acid for coatings, open, non-dispersive use. Based on the
estimated physical/chemical properties of the PMN substance, comparison
to structurally analogous chemical substances, and comparison to
analogous aliphatic amines, EPA has identified concerns for acute
toxicity, skin, eye, and respiratory tract irritation, dermal and
respiratory sensitization, developmental toxicity, neurotoxicity,
systemic toxicity, 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:
Use of the PMN substance only for the confidential use
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
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 sensitization, pulmonary effects, developmental
toxicity, 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 721.11666.
PMN Number: P-18-114
Chemical Name: Propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-,
polymer with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)]
ether with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester),
lithium salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol
monoacrylate-blocked (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as resin for industrial coatings. Based on the estimated
physical/chemical properties of the PMN substance, comparison to
analogous chemical substances, and comparison to analogous polyanionic
polymers, EPA has identified concerns for irritation and sensitization
(respiratory and skin), developmental toxicity, kidney toxicity,
thyroid toxicity, and neurotoxicity 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
specific target organ toxicity, skin sensitization, skin irritation,
eye irritation, and reproductive/developmental toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11667.
PMN Number: P-18-133
Chemical Name: Polyol adduct of bisaldehyde (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 component in
hydraulic fracturing fluids. Based on the estimated physical/chemical
properties of the PMN substance, comparison to analogous chemical
substances, and comparison to analogous neutral organics, EPA has
identified concerns for systemic toxicity, eye and skin irritation, and
skin 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 use of the PMN substance involving an application
method that generates a vapor, mist, or aerosol.
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
[[Page 64119]]
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 and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11668.
PMN Numbers: P-18-165 and P-18-166
Chemical Names: 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, sodium salts (generic) (P-18-165) and
2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy- substituted
butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic) (P-18-
166).
CAS Numbers: Not available.
Basis for action: The PMNs state that the use of the PMN substances
will be as chemical intermediates. Based on the estimated physical/
chemical properties of the PMN substances, comparison to structurally
analogous chemical substances, and comparison to analogous polyanionic
polymers and monomers, EPA has identified concerns for developmental
toxicity, systemic effects, irritation to eyes, lungs, and mucous
membranes, and aquatic toxicity if the new 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
measures:
No release of the PMN substances to water;
No use of the PMN substances in consumer products; and
No manufacturing, processing, or use of the PMN substances
in any manner that results in inhalation exposure.
The proposed SNURs would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substances if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by these SNURs. EPA has determined that the
results of reproductive (developmental) toxicity, specific target organ
toxicity, skin irritation, eye irritation, and aquatic toxicity testing
may be potentially useful to characterize the health and environmental
effects of the PMN substances.
CFR Citations: 40 CFR 721.11669 (P-18-165) and 40 CFR 721.11670 (P-
18-166).
PMN Number: P-18-167
Chemical Name: Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-
(2-methoxyphenyl)-3-oxo- (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 the estimated physical/
chemical properties of the PMN substance and comparison to structurally
analogous chemical substances, EPA has identified concerns for
irritation to the eyes, lungs, and skin, systemic 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;
No release of the PMN substance to water; 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
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, eye irritation, 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 721.11671.
PMN Numbers: P-18-214, P-18-215, and P-18-216
Chemical Names: Polycyclic substituted alkane, polymer with
cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction
products with dialkylamine substituted alkyl amine (generic) (P-18-
214); Polycyclic alkane, polymer with monocyclic amine, polycyclic
epoxide ether, reaction products with dialkylamine alkyl amine
(generic) (P-18-215); and Polycyclic substituted alkane, polymer with
epoxide, reaction products with cyclicalkylamine and dialkylamine
substituted alkyl amine (generic) (P-18-216).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as curing agents. Based
on the estimated physical/chemical properties of the PMN substances and
comparison to structurally analogous chemical substances, EPA has
identified concerns for systemic toxicity, lung toxicity, and
irritation 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 spray application of the PMN substances other than by
the method described in the spray analysis report submitted with the
PMNs.
The proposed SNURs 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 these SNURs. EPA has determined that the results of
pulmonary effects, absorption, specific target organ toxicity, skin
irritation/corrosion, and eye irritation testing may be potentially
useful to characterize the health effects of the PMN substances.
CFR Citations: 40 CFR 721.11672 (P-18-214), 40 CFR 721.11673 (P-18-
215), and 40 CFR 721.11674 (P-18-216).
PMN Number: P-18-329
Chemical Name: Substituted carbopolycyclic dicarboxylic acid
dialkyl ester, polymer with alkanediol and carbopolycyclic
bis(substituted carbopolycycle) bisalkanol (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 component of lenses
used in electronic applications. Based on the estimated physical/
chemical properties of the PMN substance and comparison to structurally
analogous chemical substances, EPA has identified concerns for lung
effects (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 manufacturing, processing, or use of the PMN substance
in any manner that results in inhalation exposure.
[[Page 64120]]
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 specific
target organ toxicity and pulmonary effects testing may be potentially
useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11675.
PMN Number: P-18-385
Chemical Name: D-Glucopyranose, oligomeric, Bu glycosides, polymers
with epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts.
CAS Number: 2139271-53-5.
Basis for action: The PMN states that the use of the PMN substance
will be for liquid laundry. Based on the estimated physical/chemical
properties of the PMN substance, comparison to structurally analogous
chemical substances, and comparison to analogous polyanionic polymers
and monomers, EPA has identified concerns for surfactant effects on the
lung 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
pulmonary toxicity testing may be potentially useful to characterize
the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11676.
PMN Number: P-19-135
Chemical Name: Alkyl polyoxyethylene ethers, carboxymethylated
(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 lubricant additive.
Based on the estimated physical/chemical properties of the PMN
substance, test data submitted on the PMN substance, comparison to
structurally analogous chemical substances, and comparison to analogous
anionic surfactants and nonionic surfactants, EPA has identified
concerns for lung effects (surfactancy), dermal and eye irritation,
systemic 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 manufacturing, processing, or use 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 60 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
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, eye damage, specific target organ toxicity, and pulmonary
effects testing may be potentially useful to characterize the health
effects of the PMN substance.
CFR Citation: 40 CFR 721.11677.
PMN Numbers: P-19-148, P-19-149, P-19-150, and P-19-151
Chemical Names: Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products,
potassium salts (generic) (P-19-148); Iron, complexes with
ethylenediamine-4-hydroxycarbomonocycle hetero-acid potassium salt
(1:1)-potassium 2-oxoacetate (1:1) reaction products, potassium salts
(generic) (P-19-149); Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products,
sodium salts (generic) (P-19-150); and Iron, complexes with
ethylenediamine-4-hydroxycarbomonocycle hetero-acid sodium salt (1:1)-
sodium 2-oxoacetate (1:1) reaction products, sodium salts (generic) (P-
19-151).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as fertilizer
ingredients. Based on the estimated physical/chemical properties of the
PMN substances, comparison to structurally analogous chemical
substances, and comparison to analogous polyanionic polymers and
monomers, EPA has identified concerns for systemic effects,
developmental effects, and aquatic toxicity if the new 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 measures:
Use of the PMN substances only for the confidential uses
described in the PMNs; and
No domestic manufacture of the PMN substances.
The proposed SNURs would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substances if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by these SNURs. EPA has determined that the
results of reproductive (developmental) toxicity, specific target organ
toxicity, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN
substances.
CFR Citations: 40 CFR 721.11678 (P-19-148), 40 CFR 721.11679 (P-19-
149), 40 CFR 721.11680 (P-19-150), and 40 CFR 721.11681 (P-19-151).
PMN Number: P-19-152
Chemical Name: Alkaneic acid, dialkyl ester polymer with
alkanediol, (isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate
(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 pre-polymer for
polyurethane roll covers. Based on estimated physical/chemical
properties of the PMN substance and comparison to structurally
analogous chemical substances, EPA has identified concerns for
respiratory and skin sensitization, carcinogenicity, thyroid effects,
and respiratory effects 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 manufacture of the PMN substance to contain greater
than 25% residual isocyanate by weight;
No use of the PMN substance in a consumer product; and
[[Page 64121]]
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
specific target organ toxicity and skin sensitization testing may be
potentially useful to characterize the health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11682.
PMN Numbers: P-19-155, P-19-156, and P-19-157
Chemical Names: Amides, from C8-18 and C18-unsatd. glycerides and
diethylenetriamine, ethoxylated (P-19-155); Amides, from
diethylenetriamine and palm kernel-oil, ethoxylated (P-19-156); and
Amides, from coconut oil and diethylenetriamine, ethoxylated (P-19-
157).
CAS Numbers: 2173332-72-2 (P-19-155), 2173332-69-7 (P-19-156), and
2173332-70-0 (P-19-157).
Basis for action: The PMNs state that the use of the PMN substances
will be as adjuvants in agrochemical formulations. Based on the
estimated physical/chemical properties of the PMN substances, submitted
test data on the new chemical substances, comparison to structurally
analogous chemical substances, and comparison to analogous amphoteric
surfactants, EPA has identified concerns for lung effects
(surfactancy), skin corrosion, skin sensitization, systemic effects,
and aquatic toxicity if the new 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
measures:
No manufacturing or processing of the PMN substances in a
manner that results in inhalation exposure;
No release of the PMN substances resulting in surface
water concentrations that exceed 2 ppb;
Use of the PMN substances only as adjuvants for industrial
herbicide agrochemical formulations; and
No use of the PMN substances in consumer products.
The proposed SNURs would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substances if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by these SNURs. EPA has determined that the
results of pulmonary effects, specific target organ toxicity, and
aquatic toxicity testing may be potentially useful to characterize the
health and environmental effects of the PMN substances.
CFR Citations: 40 CFR 721.11683 (P-19-155), 40 CFR 721.11684 (P-19-
156), and 40 CFR 721.11685 (P-19-157).
PMN Number: P-20-24
Chemical Name: Phenol-formaldehyde polymer with amino-oxirane
copolymer and benzoates (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 dispersant polymer
for coatings. Based on the 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 (surfactancy), irritation to the
skin, eyes, and respiratory tract, 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 for the confidential use
described in the PMN; and
No use of the PMN substance in a final product formulation
at concentration greater than 8%.
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, aquatic toxicity, skin irritation, eye
irritation, and specific target organ toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11686.
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
[[Page 64122]]
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 November 17, 2021 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach is to ensure that a person cannot defeat a SNUR by initiating
a significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of that date would have to cease any such activity upon
the effective date of the final rule. To resume their activities, these
persons would have to first comply with all applicable SNUR
notification requirements and wait until EPA has conducted a review of
the notice, made an appropriate determination on the notice, and has
taken such actions as are required with that determination.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, TSCA
Order or consent agreement under TSCA section 4, then TSCA section
5(b)(1)(A) requires such information to be submitted to EPA at the time
of submission of the SNUN.
In the absence of a rule, TSCA Order, or consent agreement under
TSCA section 4 covering the chemical substance, persons are required
only to submit information in their possession or control and to
describe any other information known or reasonably ascertainable (see
40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has
the authority to require appropriate testing. Unit IV. lists
potentially useful information for all SNURs listed here. Descriptions
of this information is provided for informational purposes. The
potentially useful information identified in Unit IV. of the proposed
rule will be useful to EPA's evaluation in the event that someone
submits a SNUN for the significant new use.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency. Furthermore, pursuant to TSCA section 4(h),
which pertains to reduction of testing in vertebrate animals, EPA
encourages consultation with the Agency on the use of alternative test
methods and strategies (also called New Approach Methodologies, or
NAMs), if available, to generate the recommended test data. EPA
encourages dialog with Agency representatives to help determine how
best the submitter can meet both the data needs and the objective of
TSCA section 4(h). For more information on alternative test methods and
strategies to reduce vertebrate animal testing, visit https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce.
The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. However, submitting a SNUN without any test data or other
information may increase the likelihood that EPA will take action under
TSCA section 5(e) or 5(f). EPA recommends that potential SNUN
submitters contact EPA early enough so that they will be able to
conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40. E-PMN software is available electronically
at https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket for this rulemaking.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This proposed rule would establish SNURs for several new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection activities related to this action have
already been approved by OMB under the PRA under OMB control number
2070-0012 (EPA ICR No. 574). This proposed rule does not contain any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average between
30 and 170 hours per response. This burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including using
automated collection techniques, to the
[[Page 64123]]
Director, Regulatory Support Division, Office of Mission Support
(2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001. Please remember to include the OMB control
number in any correspondence, but do not submit any completed forms to
this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNURs would not have
a significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018
and only a fraction of these were from small businesses. In addition,
the Agency currently offers relief to qualifying small businesses by
reducing the SNUN submission fee from $16,000 to $2,800. This lower fee
reduces the total reporting and recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying small firms. Therefore, the
potential economic impacts of complying with this proposed SNUR are not
expected to be significant or adversely impact a substantial number of
small entities. In a SNUR that published in the Federal Register of
June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency presented its
general determination that final SNURs are not expected to have a
significant economic impact on a substantial number of small entities,
which was provided to the Chief Counsel for Advocacy of the Small
Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this proposed rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action would not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action would not significantly nor uniquely affect the communities of
Indian Tribal governments, nor would it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply
to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This proposed rule is not subject to Executive Order 13045 (62 FR
19885, April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this proposed rule is not expected to
affect energy supply, distribution, or use.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: October 26, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, EPA proposes to
amend 40 CFR chapter I as follows:
PART 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, and 2625(c).
0
2. Add Sec. Sec. 721.11659 through 721.11686 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec.
* * * * *
721.11659 Mixed amine salt (generic).
721.11660 Oxyalkylene modified polyalkyl amine alkyl diacid polymer
with 2-(chloromethyl)oxirane (generic).
721.11661 Formaldehyde, homopolymer, reaction products with N-
propyl-1-propanamine.
721.11662 2-Propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-
propen-1-yl)amino]-1-propanesulfonic acid.
721.11663 Benzoic acid, alkyl derivs. (generic).
721.11664 Aminoalkylated imidazole (generic).
721.11665 Fatty acids and fatty acid unsatd., reaction products with
ethyleneamines and maleic anhydride (generic).
721.11666 Aromatic anhydride polymer with bisalkylbiphenylbisamine
compound with alkylamino acrylate ester (generic).
721.11667 Propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, polymer
with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether
with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester), lithium
salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol
monoacrylate-blocked (generic).
721.11668 Polyol adduct of bisaldehyde (generic).
[[Page 64124]]
721.11669 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-
substituted butyl amide, sodium salts (generic).
721.11670 2,5-Furandione, polymer with ethenylbenzene, 4-hydroxy-
substituted butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic).
721.11671 Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-
methoxyphenyl)-3-oxo- (generic).
721.11672 Polycyclic substituted alkane, polymer with
cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction
products with dialkylamine substituted alkyl amine (generic).
721.11673 Polycyclic alkane, polymer with monocyclic amine,
polycyclic epoxide ether, reaction products with dialkylamine alkyl
amine (generic).
721.11674 Polycyclic substituted alkane, polymer with epoxide,
reaction products with cyclicalkylamine and dialkylamine substituted
alkyl amine (generic).
721.11675 Substituted carbopolycyclic dicarboxylic acid dialkyl
ester, polymer with alkanediol and carbopolycyclic bis(substituted
carbopolycycle) bisalkanol (generic).
721.11676 D-Glucopyranose, oligomeric, Bu glycosides, polymers with
epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts.
721.11677 Alkyl polyoxyethylene ethers, carboxymethylated (generic).
721.11678 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction
products, potassium salts (generic).
721.11679 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-
oxoacetate (1:1) reaction products, potassium salts (generic).
721.11680 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction
products, sodium salts (generic).
721.11681 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-
oxoacetate (1:1) reaction products, sodium salts (generic).
721.11682 Alkaneic acid, dialkyl ester polymer with alkanediol,
(isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate
(generic).
721.11683 Amides, from C8-18 and C18-unsatd. glycerides and
diethylenetriamine, ethoxylated.
721.11684 Amides, from diethylenetriamine and palm kernel-oil,
ethoxylated.
721.11685 Amides, from coconut oil and diethylenetriamine,
ethoxylated.
721.11686 Phenol-formaldehyde polymer with amino-oxirane copolymer
and benzoates (generic).
* * * * *
Sec. 721.11659 Mixed amine salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as mixed
amine salt (PMN P-15-632) 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(y)(1) and (2).
(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. 721.11660 Oxyalkylene modified polyalkyl amine alkyl diacid
polymer with 2-(chloromethyl)oxirane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
oxyalkylene modified polyalkyl amine alkyl diacid polymer with 2-
(chloromethyl)oxirane (PMN P-17-233) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=20.
(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. 721.11661 Formaldehyde, homopolymer, reaction products with N-
propyl-1-propanamine.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as formaldehyde,
homopolymer, reaction products with N-propyl-1-propanamine (PMN P-17-
298; CAS No. 1374859-50-3) 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 other than as a hydrogen
sulfide scavenger used in controlling hydrogen sulfide in the vapor
space of fuel storage, shipping vessels, and pipelines.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=3.
(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. 721.11662 2-Propenoic acid, polymer with 2-methyl-2-[(1-oxo-2-
propen-1-yl)amino]-1-propanesulfonic acid.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic
acid (PMN P-17-325; CAS No. 40623-75-4) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=50.
(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. 721.11663 Benzoic acid, alkyl derivs. (generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 64125]]
(1) The chemical substance identified generically as benzoic acid,
alkyl derivs. (PMN P-17-355) 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. 721.11664 Aminoalkylated imidazole (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aminoalkylated imidazole (PMN P-17-396) 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) and (o).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=33.
(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.
(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. 721.11665 Fatty acids and fatty acid unsatd., reaction products
with ethyleneamines and maleic anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids and fatty acid unsatd., reaction products with ethyleneamines and
maleic anhydride (PMN P-18-29) 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. 721.11666 Aromatic anhydride polymer with
bisalkylbiphenylbisamine compound with alkylamino acrylate ester
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aromatic anhydride polymer with bisalkylbiphenylbisamine compound with
alkylamino acrylate ester (PMN P-18-108) 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, 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. 721.11667 Propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-,
polymer with 1,6-diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)]
ether with alkyl (hydroxyalkyl)- alkanediol, 2-propenoate (ester),
lithium salt, glycerol monoacrylate 1-neodecanoate- and alkylene glycol
monoacrylate-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
propanoic acid, hydroxyl- (hydroxyalkyl)-alkyl-, polymer with 1,6-
diisocyanatoalkane and poly[oxy(alkyl-alkanediyl)] ether with alkyl
(hydroxyalkyl)- alkanediol, 2-propenoate (ester), lithium salt,
glycerol monoacrylate 1-neodecanoate- and alkylene glycol monoacrylate-
blocked (PMN P-18-114) 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 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. 721.11668 Polyol adduct of bisaldehyde (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as polyol
adduct of bisaldehyde (PMN P-18-133) 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(y)(1).
(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
[[Page 64126]]
provisions of Sec. 721.185 apply to this section.
Sec. 721.11669 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2,5-
furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl
amide, sodium salts (PMN P-18-165) 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
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.11670 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy- substituted butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-
2-oxopropyl]diazenyl]phenyl]substituted, sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2,5-
furandione, polymer with ethenylbenzene, 4-hydroxy- substituted
butyl[3-[2-[1-[[(2-methoxyphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]substituted, sodium salts (PMN P-18-166) 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
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.11671 Butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-
methoxyphenyl)-3-oxo- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
butanamide, 2-[2-[(substituted phenyl)diazenyl]-N-(2-methoxyphenyl)-3-
oxo- (PMN P-18-167) 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
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.11672 Polycyclic substituted alkane, polymer with
cyclicalkylamine, epoxide, and polycyclic epoxide ether, reaction
products with dialkylamine substituted alkyl amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polycyclic substituted alkane, polymer with cyclicalkylamine, epoxide,
and polycyclic epoxide ether, reaction products with dialkylamine
substituted alkyl amine (PMN P-18-214) 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 a spray application
method other than the method described in the spray analysis report
submitted with 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.
Sec. 721.11673 Polycyclic alkane, polymer with monocyclic amine,
polycyclic epoxide ether, reaction products with dialkylamine alkyl
amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polycyclic alkane, polymer with monocyclic amine, polycyclic epoxide
ether, reaction products with dialkylamine alkyl amine (PMN P-18-215)
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 a spray application
method other than the method described in the spray analysis report
submitted with 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.
Sec. 721.11674 Polycyclic substituted alkane, polymer with epoxide,
reaction products with cyclicalkylamine and dialkylamine substituted
alkyl amine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polycyclic substituted alkane, polymer with epoxide, reaction products
with cyclicalkylamine and dialkylamine substituted alkyl amine (PMN P-
18-216) is subject to reporting
[[Page 64127]]
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 a spray application
method other than the method described in the spray analysis report
submitted with 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.
Sec. 721.11675 Substituted carbopolycyclic dicarboxylic acid dialkyl
ester, polymer with alkanediol and carbopolycyclic bis(substituted
carbopolycycle) bisalkanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted carbopolycyclic dicarboxylic acid dialkyl ester, polymer
with alkanediol and carbopolycyclic bis(substituted carbopolycycle)
bisalkanol (PMN P-18-329) 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. 721.11676 D-Glucopyranose, oligomeric, Bu glycosides, polymers
with epichlorohydrin, 2-hydroxy-3-sulfopropyl ethers, sodium salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as D-glucopyranose,
oligomeric, Bu glycosides, polymers with epichlorohydrin, 2-hydroxy-3-
sulfopropyl ethers, sodium salts (PMN P-18-385; CAS No. 2139271-53-5)
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. 721.11677 Alkyl polyoxyethylene ethers, carboxymethylated
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
polyoxyethylene ethers, carboxymethylated (PMN P-19-135) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=60.
(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. 721.11678 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products,
potassium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as iron,
complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-
oxoacetic acid reaction products, potassium salts (PMN P-19-148) 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 (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. 721.11679 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid potassium salt (1:1)-potassium 2-
oxoacetate (1:1) reaction products, potassium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as iron,
complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid
potassium salt (1:1)-potassium 2-oxoacetate (1:1) reaction products,
potassium salts (PMN P-19-149) 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 (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
[[Page 64128]]
of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.
Sec. 721.11680 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid-2-oxoacetic acid reaction products,
sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as iron,
complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid-2-
oxoacetic acid reaction products, sodium salts (PMN P-19-150) 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 (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. 721.11681 Iron, complexes with ethylenediamine-4-
hydroxycarbomonocycle hetero-acid sodium salt (1:1)-sodium 2-oxoacetate
(1:1) reaction products, sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as iron,
complexes with ethylenediamine-4-hydroxycarbomonocycle hetero-acid
sodium salt (1:1)-sodium 2-oxoacetate (1:1) reaction products, sodium
salts (PMN P-19-151) 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 (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. 721.11682 Alkaneic acid, dialkyl ester polymer with alkanediol,
(isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkaneic acid, dialkyl ester polymer with alkanediol,
(isocyanatocarbomonocycle) alkyl)carbomonocycle) carbamate (PMN P-19-
152) 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
manufacture the PMN substance with greater than 25.0% residual
isocyanate by weight. 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. 721.11683 Amides, from C8-18 and C18-unsatd. glycerides and
diethylenetriamine, ethoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, from C8-18
and C18-unsatd. glycerides and diethylenetriamine, ethoxylated (PMN P-
19-155; CAS No. 2173332-72-2) 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. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture or process the PMN substance in any manner that results in
inhalation exposure. It is a significant new use to use the PMN
substance other than as an adjuvant for industrial herbicide
agrochemical formulations.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.11684 Amides, from diethylenetriamine and palm kernel-oil,
ethoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, from
diethylenetriamine and palm kernel-oil, ethoxylated (PMN P-19-156; CAS
No. 2173332-69-7) 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) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to
manufacture or process the PMN substance in any manner that results in
inhalation exposure. It is a significant new use to use the PMN
substance other than as an adjuvant for industrial herbicide
agrochemical formulations.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.11685 Amides, from coconut oil and diethylenetriamine,
ethoxylated.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as amides, from
coconut oil and
[[Page 64129]]
diethylenetriamine, ethoxylated (PMN P-19-157; CAS No. 2173332-70-0) 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
manufacture or process the PMN substance in any manner that results in
inhalation exposure. It is a significant new use to use the PMN
substance other than as an adjuvant for industrial herbicide
agrochemical formulations.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=2.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in 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. 721.11686 Phenol-formaldehyde polymer with amino-oxirane
copolymer and benzoates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol-
formaldehyde polymer with amino-oxirane copolymer and benzoates (PMN P-
20-24) 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) and (o). It is a significant new use to
use the PMN substance in final product formulation at a concentration
greater than 8%.
(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. 2021-24785 Filed 11-16-21; 8:45 am]
BILLING CODE 6560-50-P