Proposed Rule2021-21872
Significant New Use Rules on Certain Chemical Substances (21-1.F)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 12, 2021
Issuing agencies
Environmental Protection Agency
Abstract
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for chemical substances that were the subject of premanufacture notices (PMNs). The chemical substances received "not likely to present an unreasonable risk" determinations under TSCA. The SNURs require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity that is proposed as a significant new use by this rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the use, under the conditions of use for that chemical substance, within the applicable review period. Persons may not commence manufacture or processing for the significant new use until EPA has conducted a review of the notice, made an appropriate determination on the notice, and has taken such actions as are required by that determination.
Full Text
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<title>Federal Register, Volume 86 Issue 194 (Tuesday, October 12, 2021)</title>
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[Federal Register Volume 86, Number 194 (Tuesday, October 12, 2021)]
[Proposed Rules]
[Pages 56664-56679]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-21872]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2021-0220; FRL-8804-01-OCSPP]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (21-1.F)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for chemical substances that were
the subject of premanufacture notices (PMNs). The chemical substances
received ``not likely to present an unreasonable risk'' determinations
under TSCA. The SNURs require persons who intend to manufacture
(defined by statute to include import) or process any of these chemical
substances for an activity that is proposed as a significant new use by
this rule to notify EPA at least 90 days before commencing that
activity. The required notification initiates EPA's evaluation of the
use, under the conditions of use for that chemical substance, within
the applicable review period. Persons may not commence manufacture or
processing for the significant new use until EPA has conducted a review
of the notice, made an appropriate determination on the notice, and has
taken such actions as are required by that determination.
DATES: Comments must be received on or before November 12, 2021.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2021-0220, through the Federal eRulemaking
Portal at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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 <a href="https://www.epa.gov/dockets">https://www.epa.gov/dockets</a>.
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:
<a href="/cdn-cgi/l/email-protection#acdbd5dfc3c2cb82dbc5c0c0c5cdc1ecc9dccd82cbc3da"><span class="__cf_email__" data-cfemail="66111f1509080148110f0a0a0f070b2603160748010910">[email protected]</span></a>.
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: <a href="/cdn-cgi/l/email-protection#c591968684e88daab1a9acaba085a0b5a4eba2aab3"><span class="__cf_email__" data-cfemail="c692958587eb8ea9b2aaafa8a386a3b6a7e8a1a9b0">[email protected]</span></a>.
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:
<bullet> Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
provisions promulgated at 19 CFR 12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify that the shipment of the
chemical substance complies with all applicable rules and Orders under
TSCA, which would include the SNUR requirements should these proposed
rules be finalized. The EPA policy in support of import certification
appears at 40 CFR part 707, subpart B. In addition, pursuant to 40 CFR
721.20 any persons who export or intend to export a chemical substance
that is the subject of this proposed rule on or after November 12, 2021
are subject to the export notification provisions of TSCA section 12(b)
(15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must comply with the
export notification requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
<a href="http://regulations.gov">regulations.gov</a> or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at <a href="https://www.epa.gov/dockets/commenting-epa-dockets">https://www.epa.gov/dockets/commenting-epa-dockets</a>.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) (15 U.S.C.
2604(a)(2)) for chemical substances that were the subject of PMNs.
These proposed SNURs would require persons to notify EPA at least 90
days before commencing the manufacture or processing of any of these
chemical substances for an activity proposed as a significant new use.
Receipt of such notices would allow EPA to assess risks and, if
appropriate, to regulate the significant new use before it may occur.
The docket for these proposed SNURs, identified as docket ID number
EPA-HQ-OPPT-2021-0220, includes information considered by the Agency in
developing these proposed SNURs.
B. What is the Agency's authority for taking this action?
TSCA section 5(a)(2) (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the
[[Page 56665]]
rule. Provisions relating to user fees appear at 40 CFR part 700.
Pursuant to 40 CFR 721.1(c), persons subject to these SNURs must comply
with the same significant new use notice (SNUN) requirements and EPA
regulatory procedures as submitters of PMNs under TSCA section
5(a)(1)(A). These requirements include the information submission
requirements of TSCA sections 5(b) and 5(d)(1), the exemptions
authorized by TSCA sections 5(h)(1), (h)(2), (h)(3), and (h)(5), and
the regulations at 40 CFR part 720. Once EPA receives a SNUN and before
the manufacture or processing for the significant new use can commence,
EPA must either determine that the use is not likely to present an
unreasonable risk of injury under the conditions of use for the
chemical substance or take such regulatory action as is associated with
an alternative determination. If EPA determines that the use is not
likely to present an unreasonable risk, EPA is required under TSCA
section 5(g) to make public, and submit for publication in the Federal
Register, a statement of EPA's findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
<bullet> The projected volume of manufacturing and processing of a
chemical substance.
<bullet> The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
<bullet> The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
<bullet> 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:
<bullet> PMN number.
<bullet> Chemical name (generic name, if the specific name is
claimed as CBI).
<bullet> Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
<bullet> Potentially Useful Information.
<bullet> CFR citation assigned in the regulatory text section of
the proposed rule.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P-16-420
Chemical Name: Dimethyl cyclohexenyl propanol (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a fragrance ingredient, being blended (mixed) with other
fragrance ingredients to make fragrance oils that will be sold to
industrial and commercial customers for their incorporation into soaps,
detergents, cleaners and other similar household and consumer products.
Based on the estimated physical/chemical properties of the PMN
substance, comparison to structurally analogous chemical substances,
and submitted test data on the PMN substance, EPA has identified
concerns for eye irritation, systemic toxicity, and aquatic toxicity if
the chemical substance is not used following the limitation noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measure:
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 55 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that the
results of specific target organ toxicity and aquatic toxicity testing
may be potentially useful to characterize the health and environmental
effects of the PMN substance.
CFR Citation: 40 CFR 721.11604.
PMN Number: P-16-446
Chemical Name: Fatty acids, polymers with substituted
carbomonocycle, substituted alkylamines, heteromonocycle, fatty acid
and alkylamine, lactates (salts) (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a resin in architectural primer coatings. Based on the
estimated physical/chemical properties of the PMN substance and
comparison to structurally analogous chemical substances, EPA has
identified concerns for irritation to all tissues and aquatic toxicity
if the chemical substance is not used following the limitation noted.
The conditions of use of the PMN substance as described in the PMN
include the following protective measure:
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 38 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that the
results of skin irritation and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11605.
PMN Number: P-16-602
Chemical Name: Carbonic acid, dialkyl ester, polymers with 5-amino-
1,3,3-trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-
diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolalkane
(generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ingredient in
paints. Based on the estimated physical/chemical properties of the PMN
substance and comparison to structurally analogous chemical substances,
EPA has identified concerns
[[Page 56666]]
for lung effects if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measures:
<bullet> Application method during use other than the confidential
method described in the PMN; and
<bullet> No manufacturing, processing, or use of the PMN substance
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11606.
PMN Number: P-17-284
Chemical Name: 2-Heptanone, 4-hydroxy-.
CAS Number: 25290-14-6.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an in-process
intermediate. Based on the estimated physical/chemical properties of
the PMN substance and comparison to structurally analogous chemical
substances, EPA has identified concerns for solvent neurotoxicity and
irritation, sensitization, mutagenicity, neurotoxicity, reproductive
toxicity, developmental toxicity, systemic toxicity, and aquatic
toxicity if the chemical substance is not used following the limitation
noted. The conditions of use of the PMN substance as described in the
PMN include the following protective measure:
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 1,000 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that the
results of specific target organ toxicity, reproductive/developmental
toxicity, irritation, sensitization, and aquatic toxicity testing may
be potentially useful to characterize the health and environmental
effects of the PMN substance.
CFR Citation: 40 CFR 721.11607.
PMN Number: P-17-285
Chemical Name: 4-Hepten-2-one.
CAS Number: 24332-22-7.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an in-process
intermediate. Based on the estimated physical/chemical properties of
the PMN substance and comparison to structurally analogous chemical
substances, EPA has identified concerns for solvent neurotoxicity and
irritation, eye and skin irritation, developmental, liver, and kidney
toxicities, sensitization, and aquatic toxicity if the PMN substance is
not used following the limitation noted. The conditions of use of the
chemical substance as described in the PMN include the following
protective measure:
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 730 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that the
results of specific target organ toxicity, reproductive/developmental
toxicity, sensitization, and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11608.
PMN Number: P-17-360
Chemical Names: 2-Propanol, 1-amino-, compd. with .alpha.-
sulfo-.omega.-(octyloxy)poly(oxy-1,2-ethanediyl) (1:1) (P-17-360,
chemical A) and 2-Propanol, 1-amino-, compd. with
.alpha.-.sulfo-.omega.-(decyloxy)poly(oxy-1,2-ethanediyl) (1:1) (P-17-
360, chemical B).
CAS Numbers: 2098904-74-4 (P-17-360, chemical A) and 2098904-80-2
(P-17-360, chemical B).
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substances will be as surfactants for oil
and gas recovery. Based on the estimated physical/chemical properties
of the PMN substances, comparison to structurally analogous chemical
substances, comparison to analogous anionic surfactant substances, and
submitted test data on the PMN substances, EPA has identified concerns
for lung effects (surfactancy), irritation to the skin, eye, mucous
membranes, and lungs, and systemic (kidney, liver, and thymus) effects
if the chemical substances are not used following the limitation noted.
The conditions of use of the PMN substances as described in the PMN
include the following protective measure:
<bullet> No manufacturing, processing, or use of the PMN substances
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substances if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity, skin irritation, eye irritation, and
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substances.
CFR Citations: 40 CFR 721.11609 (P-17-360, chemical A) and 40 CFR
721.11610 (P-17-360, chemical B).
PMN Number: P-18-19
Chemical Name: Substituted benzene, 4-[2-[2-hydroxy-3-[[(3-
nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt
(1:1) (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a dispersive pigment. Based on estimated physical/chemical
properties of the PMN substance, comparison to structurally analogous
chemical substances, comparison to analogous acid dyes and amphoteric
dyes, and submitted test data on the PMN substance, EPA has identified
concerns for eye irritation, skin sensitization, and aquatic toxicity
if the chemical substance is not used following the limitations noted.
The conditions of use of the PMN substance as described in the PMN
include the following protective measures:
<bullet> No use of the PMN substance in a consumer product;
<bullet> No domestic manufacture (i.e., import only); and
[[Page 56667]]
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 260 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that the
results of eye irritation, skin sensitization, and aquatic toxicity
testing may be potentially useful to characterize the health and
environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11611.
PMN Number: P-18-34
Chemical Name: Polyetheramine carboxylate salt (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a dispersing agent for pigments in industrial paints and
coatings. Based on estimated physical/chemical properties of the PMN
substance, comparison to structurally analogous chemical substances,
and comparison to analogous polycationic polymers, EPA has identified
concerns for lung effects and aquatic toxicity if the chemical
substance is not used following the limitations noted. The conditions
of use of the PMN substance as described in the PMN include the
following protective measures:
<bullet> No use of the PMN substance in a consumer product;
<bullet> Use of the PMN substance only as a dispersing agent for
pigments in industrial paints and coatings;
<bullet> No processing beyond a maximum concentration of 1% in the
formulation of the final product;
<bullet> No manufacture or processing of the PMN substance in any
manner that results in inhalation exposure; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 45 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that the
results of pulmonary effects and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11612.
PMN Number: P-18-121
Chemical Name: Benzene, 1,1'- oxybis-, branched eicosyl derivs.
CAS Number: 1800419-55-9.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an additive for
lubricating grease. Based on estimated physical/chemical properties of
the PMN substance and submitted test data on the PMN substance, EPA has
identified concerns for neurotoxicity, kidney effects, and blood
effects if the chemical substance is not used following the limitation
noted. The conditions of use of the PMN substance as described in the
PMN include the following protective measure:
<bullet> Use of the PMN substance only for the confidential use
described in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
workplace exposure monitoring may be potentially useful to characterize
the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11613.
PMN Number: P-18-168
Chemical Name: Alkoxylated triaryl methane (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a color additive.
Based on estimated physical/chemical properties of the PMN substance,
comparison to structurally analogous chemical substances, and test data
submitted on the PMN substance, EPA has identified concerns for lung
surfactancy if the chemical substance is not used following the
limitation noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11614.
PMN Numbers: P-18-179, P-18-180, and P-18-181
Chemical Names: Phenolic resin, alkali, polymer with formaldehyde
and phenol, sodium salt (generic) (P-18-179), Phenol, polymer with
formaldehyde and phenolic resin, potassium salt (generic) (P-18-180),
and Phenol, polymer with formaldehyde and phenolic resin, potassium
sodium salt (generic) (P-18-181).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as adhesives. Based on
the estimated physical/chemical properties of the PMN substances,
comparison to structurally analogous chemical substances, and
comparison to analogous polyanionic polymers, EPA has identified
concerns for irritation, corrosion, and aquatic toxicity if the
chemical substances are not used following the limitations noted. The
conditions of use of the PMN substances as described in the PMN include
the following protective measures:
<bullet> No manufacture (including import) of the PMN substances to
contain greater than 0.1% unbound formaldehyde residuals by weight;
<bullet> No use of the PMN substances other than for the
confidential uses described in the PMNs;
<bullet> No manufacture of the PMN substances such that the weight
percent of low molecular weight species below 1000 daltons exceeds the
confidential value specified in the PMNs; and
<bullet> No manufacture, processing, or use of the PMN substances
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substances if a manufacturer or
processor is
[[Page 56668]]
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
absorption, distribution, metabolism, and excretion (ADME), repeated
dose, and aquatic toxicity testing may be potentially useful to
characterize the health and environmental effects of the PMN
substances.
CFR Citations: 40 CFR 721.11615 (P-18-179), 40 CFR 721.11616 (P-18-
180), and 40 CFR 721.11617 (P-18-181).
PMN Number: P-18-192
Chemical Name: Benzenesulfonic acid,
(alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-
yl]amino]-, N-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-
substituted(alkanol) (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an optical brightener for use in paper applications. Based
on estimated physical/chemical properties of the PMN substance and
comparison to structurally analogous chemical substances, EPA has
identified concerns for respiratory tract effects, systemic toxicity,
developmental effects, and irritation to the skin, eye, and mucous
membranes if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measures:
<bullet> Use of the PMN substance only as an optical brightener for
use in paper applications; and
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
specific target organ toxicity testing may be potentially useful to
characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11618.
PMN Number: P-18-197
Chemical Name: Metal, alkylcarboxylate oxo complexes (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a polymer composite
additive. Based on estimated physical/chemical properties of the PMN
substance and comparison to structurally analogous chemical substances,
EPA has identified concerns for lung overload and respiratory
irritation if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measures:
<bullet> No use of the PMN substance other than for the
confidential use described in the PMN; and
<bullet> No manufacture or processing of the PMN substance without
the confidential engineering controls described in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11619.
PMN Number: P-18-221
Chemical Name: Polyglycerol reaction product with acid anhydride,
etherified (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a binder for wood panels. Based on estimated physical/
chemical properties of the PMN substance, identified structural alerts,
and comparison to structurally analogous chemical substances, EPA has
identified concerns for skin and lung sensitization, germ cell
mutagenicity, carcinogenicity, and developmental, reproductive, liver,
and kidney toxicity if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
<bullet> No manufacturing, processing, or use of the PMN substance
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
absorption, specific target organ toxicity, irritation, sensitization,
and developmental toxicity testing may be potentially useful to
characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11620.
PMN Numbers: P-18-258 and P-18-259
Chemical Names: Dioic acids, polymers with caprolactam and
alkyldiamines (generic) (P-18-258) and Fatty acids, dimers,
hydrogenated, polymers with caprolactam and alkyldiamine (generic) (P-
18-259).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the PMN substances will be as copolyamides for
packaging films. Based on estimated physical/chemical properties of the
PMN substances and comparison to structurally analogous chemical
substances, EPA has identified concerns for lung toxicity if the
chemical substances are not used following the limitations noted. The
conditions of use of the PMN substances as described in the PMNs
include the following protective measure:
<bullet> No manufacturing, processing, or use of the PMN substances
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substances if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results pulmonary
effects testing may be potentially useful to characterize the health
effects of the PMN substances.
CFR Citations: 40 CFR 721.11621 (P-18-258) and 40 CFR 721.11622 (P-
18-259).
PMN Number: P-18-277
Chemical Name: Poly[2-(Dimethylamino)ethyl acrylate chloride salt,
vinyl acetate, methacrylic acid and alkyl acrylates] (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the
[[Page 56669]]
PMN substance will be as an adhesive. Based on estimated physical/
chemical properties of the PMN substance, comparison to structurally
analogous chemical substances, and comparison to analogous amphoteric
polymers, EPA has identified concerns for lung surfactancy if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measure:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11623.
PMN Number: P-18-278
Chemical Name: Isophthalic acid, polymer with terephthalic acid and
C4 and C6 dialkyl amines (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a resin for molded automotive parts and electrical and
electronic equipment. Based on estimated physical/chemical properties
of the PMN substance, comparison to structurally analogous chemical
substances, and comparison to analogous high molecular weight polymers,
EPA has identified concerns for lung overload if the chemical substance
is not used following the limitations noted. The conditions of use of
the PMN substance as described in the PMN include the following
protective measure:
<bullet> No manufacture (including import) of the PMN substance
with particle sizes less than 10 microns.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11624.
PMN Number: P-18-299
Chemical Name: Alkenoic acid, alkyl-, polymers with alkyl
methacrylate, cycloalkyl methacrylate, alkylene dimethacrylate, and
polyalkene glycol hydrogen sulfate [(branched alkyloxy)alkyl]-
(alkenyloxy)alkyl ethers ammonium salts, metal salts (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an ink additive.
Based on estimated physical/chemical properties of the PMN substance,
comparison to structurally analogous chemical substances, and submitted
test data on the PMN substance, EPA has identified concerns for lung
toxicity and lung cancer if the chemical substance is not used
following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measure:
<bullet> No manufacturing, processing, or use of the PMN substance
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects testing may be potentially useful to characterize the
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11625.
PMN Number: P-18-375
Chemical Name: Fats and Glyceridic oils, vegetable, sulfonated,
sodium salts.
CAS Number: 97489-04-8.
Basis for action: The PMN states that the use of the PMN substance
will be in the fat liquoring stage in the production of leather as part
of an aqueous emulsion containing about 10 to 25 percent PMN substance
with lubricant oils, nonionic surfactants and anionic surfactants.
Based on estimated physical/chemical properties of the PMN substance
and comparison to structurally analogous chemical substances, EPA has
identified concerns for irritation, corrosion, and lung effects if the
chemical substance is not used following the limitation noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measure:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
irritation and pulmonary effects testing may be potentially useful to
characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11626.
PMN Number: P-18-379
Chemical Name: Cashew nutshell liq., polymer with bisphenol A,
epichlorohydrin, amines, formaldehyde, and glycol (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a hardener for
waterborne epoxy systems. Based on estimated physical/chemical
properties of the PMN substance and comparison to structurally
analogous chemical substances, EPA has identified concerns for cationic
binding to the lungs, irritation to the eyes and skin, and
sensitization if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measures:
<bullet> No manufacture (including import) of the PMN substance
such that the weight percent of low molecular weight species below 500
daltons exceeds 1% and the weight percent of low molecular weight
species below 1,000 daltons exceeds 6%; and
<bullet> No manufacturing, processing, or use of the PMN substance
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
pulmonary effects, skin irritation/
[[Page 56670]]
corrosion, eye irritation/corrosion, and skin sensitization testing may
be potentially useful to characterize the health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11627.
PMN Number: P-18-401
Chemical Name: Glycerides, C16-18 and C18-unsatd. mono- and di-,
citrates.
CAS Number: 91052-16-3.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an additive. Based on
estimated physical/chemical properties of the PMN substance, comparison
to structurally analogous chemical substances, comparison to analogous
anionic surfactants, and submitted test data on the PMN substance, EPA
has identified concerns for lung effects and aquatic toxicity if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
<bullet> No use of the PMN substance in formulations greater than
0.01% in a manner that results in inhalation exposure; and
<bullet> No release of the PMN substance resulting in surface water
concentrations that exceed 12 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
and environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that will be designated by this SNUR. EPA has determined that the
results of pulmonary effects and aquatic toxicity testing may be
potentially useful to characterize the health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11628.
PMN Number: P-19-3
Chemical Name: Polyaromatic ether symmetrical dicarboxylic
anhydride (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a chemical intermediate. Based on estimated physical/
chemical properties of the PMN substance, comparison to structurally
analogous chemical substances, and comparison to analogous anhydrides,
carboxylic acids, EPA has identified concerns for cardiac, blood,
muscle, reproductive, and developmental toxicity, skin and eye
irritation, and respiratory sensitization. if the chemical substance is
not used following the limitation noted. The conditions of use of the
PMN substance as described in the PMN include the following protective
measure:
<bullet> No manufacturing, processing, or use of the PMN substance
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of
sensitization, reproductive and developmental effects, and specific
organ toxicity testing may be potentially useful to characterize the
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11629.
PMN Number: P-19-28
Chemical Name: Alkyl salicylate, metal salts (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will as a lubricating oil
additive. Based on the estimated physical/chemical properties of the
PMN substance and submitted test data on the PMN substance, EPA has
identified concerns for lung surfactancy and sensitization if the
chemical substance is not used following the limitation noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measure:
<bullet> No manufacturing, processing, or use of the PMN substance
in any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
sensitization and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11630.
PMN Number: P-19-40
Chemical Name: Alkyl bis(dialkylamino alkyl) amide (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an intermediate.
Based on comparison to structurally analogous chemical substances and
metabolites, EPA has identified concerns for corrosion and irritation
for the lungs, skin, and eyes, lung damage, systemic effects,
reproductive/developmental toxicity, and sensitization if the chemical
substance is not used following the limitation noted. The conditions of
use of the PMN substance as described in the PMN include the following
protective measure:
<bullet> No manufacture, processing, or use of the PMN substance in
any manner that results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of skin
sensitization and specific target organ toxicity testing may be
potentially useful to characterize the health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11631.
PMN Number: P-19-117
Chemical Name: Polycyclic amine, reaction products with
polyalkylalkene, polymers (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an additive. Based on
estimated physical/chemical properties of the PMN substance, comparison
to structurally analogous chemical substances, and submitted test data
on the PMN substance, EPA has identified concerns for liver effects and
developmental toxicity if the chemical substance is not used following
the limitation noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
<bullet> Use of the PMN substance only for the confidential use
described in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information
[[Page 56671]]
may be potentially useful to characterize the human health effects of
the PMN substance if a manufacturer or processor is considering
submitting a SNUN for a significant new use that will be designated by
this SNUR. EPA has determined that the results of developmental and
specific target organ toxicity testing may be potentially useful to
characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11632.
PMN Number: P-19-121
Chemical Name: Plant based oils, polymer with 1,1'-methylenebis[4-
isocyanatobenzene], pentaerythritol, phthalic esters, polypropylene
glycol and polypropylene glycol ether with glycerol (3:1) (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an industrial adhesive. Based on estimated physical/chemical
properties of the PMN substance and comparison to structurally
analogous chemical substances, EPA has identified concerns for
irritation to all exposed tissues, dermal and respiratory
sensitization, and lung effects if the chemical substance is not used
following the limitation noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measure:
<bullet> No use of the PMN substance in spray applications.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
damage, skin irritation, skin sensitization, and pulmonary effects
testing may be potentially useful to characterize the health effects of
the PMN substance.
CFR Citation: 40 CFR 721.11633.
PMN Number: P-19-130
Chemical Name: Aminohydroxy naphthalenesulfonic acid, coupled with
diazotized[(aminophenyl)sulfonyl]ethyl hydrogen sulfate and diazotized
amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid, salts (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a dye. Based on
estimated physical/chemical properties of the PMN substance, comparison
to structurally analogous chemical substances, analysis of analogous
acid dyes and amphoteric dyes and vinyl sulfones, and submitted test
data on the PMN substance, EPA has identified concerns for irreversible
damage to eyes and irritation to mucous membranes if the chemical
substance is not used following the limitation noted. The conditions of
use of the PMN substance as described in the PMN include the following
protective measure:
<bullet> Use of the PMN substance only for the confidential use
described in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially Useful Information: EPA has determined that certain
information may be potentially useful to characterize the human health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that will be
designated by this SNUR. EPA has determined that the results of eye
damage and specific target organ toxicity testing may be potentially
useful to characterize the health effects of the PMN substance.
CFR Citation: 40 CFR 721.11634.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the chemical substances that are the subject of
these SNURs and as further discussed in Unit IV, EPA identified certain
circumstances that raised potential risk concerns. EPA determined that
deviations from the limitations identified in the submissions could
result in changes in the type or form of exposure to the chemical
substances and/or increased exposures to the chemical substances and/or
changes in the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
the chemical substances, and therefore warranted SNURs. The SNURs would
identify as significant new uses any manufacturing, processing, use,
distribution in commerce, or disposal that does not conform to the
certain limitations in the submission.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants:
<bullet> 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.
<bullet> To be able to either determine that the prospective
manufacture or processing is not likely to present an unreasonable
risk, or to take necessary regulatory action associated with any other
determination, before the described significant new use of the chemical
substance occurs.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted, EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. The identities of many of the chemical
substances subject to this proposed rule have been claimed as
confidential per 40 CFR 720.85. Based on this, the Agency believes that
it is highly unlikely that any of the significant new uses described in
the regulatory text of this proposed rule are ongoing.
Therefore, EPA designates October 12, 2021 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach is to ensure that a person cannot defeat a SNUR by initiating
a significant new use before the effective date of the final rule.
In the unlikely event that a person began commercial manufacture or
processing of the chemical substances for a significant new use
identified as of that date would have to cease any such activity upon
the effective date of the final rule. To resume their activities, these
persons would have to first comply with all applicable SNUR
notification requirements and wait until EPA has conducted a review of
the notice, made an appropriate determination on the notice, and has
taken such actions as are required with that determination.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the
[[Page 56672]]
TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to
determine if a chemical substance is on the TSCA Inventory is available
on the internet at <a href="http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html">http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html</a>.
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 <a href="https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce">https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/alternative-test-methods-and-strategies-reduce</a>.
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:
<bullet> 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 <a href="https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca">https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca</a>.
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 <a href="https://www.epa.gov/laws-regulations-and-executive-orders">https://www.epa.gov/laws-regulations-and-executive-orders</a>.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This proposed rule would establish SNURs for several new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA (44 U.S.C. 3501 et seq.), an agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection activities related to this action have
already been approved by OMB under the PRA under OMB control number
2070-0012 (EPA ICR No. 574). This proposed rule does not contain any
burden requiring additional OMB approval. If an entity were to submit a
SNUN to the Agency, the annual burden is estimated to average between
30 and 170 hours per response. This burden estimate includes the time
needed to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including using
automated collection techniques, to the Director, Regulatory Support
Division, Office of Mission Support (2822T), Environmental Protection
Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001. Please
remember to include the OMB control number in any correspondence, but
do not submit any completed forms to this address.
C. Regulatory Flexibility Act (RFA)
Pursuant to the RFA section 605(b) (5 U.S.C. 601 et seq.), the
Agency hereby certifies that promulgation of these SNURs would not have
a significant adverse economic impact on a substantial number of small
entities. The requirement to submit a SNUN applies to any person
(including small or large entities) who intends to engage in any
activity described in the final rule as a ``significant new use.''
Because these uses are ``new,'' based on all information currently
available to EPA, it appears that no small or large entities presently
engage in such activities. A SNUR requires that any person who intends
to engage in such activity in the future must first notify EPA by
submitting a SNUN. EPA's experience to date is that, in response to the
promulgation of SNURs covering over 1,000 chemicals, the Agency
receives only a small number of notices per year. For example, the
number of SNUNs received was seven in Federal fiscal year (FY) 2013, 13
in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and 18 in FY2018
and only a fraction of
[[Page 56673]]
these were from small businesses. In addition, the Agency currently
offers relief to qualifying small businesses by reducing the SNUN
submission fee from $16,000 to $2,800. This lower fee reduces the total
reporting and recordkeeping of cost of submitting a SNUN to about
$10,116 for qualifying small firms. Therefore, the potential economic
impacts of complying with this proposed SNUR are not expected to be
significant or adversely impact a substantial number of small entities.
In a SNUR that published in the Federal Register of June 2, 1997 (62 FR
29684) (FRL-5597-1), the Agency presented its general determination
that final SNURs are not expected to have a significant economic impact
on a substantial number of small entities, which was provided to the
Chief Counsel for Advocacy of the Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this proposed rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action would not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action would not significantly nor uniquely affect the communities of
Indian Tribal governments, nor would it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175 (65 FR 67249, November 9, 2000), do not apply
to this action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This proposed rule is not subject to Executive Order 13045 (62 FR
19885, April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This proposed rule is not subject to Executive Order 13211 (66 FR
28355, May 22, 2001), because this proposed rule is not expected to
affect energy supply, distribution, or use.
I. National Technology Transfer and Advancement Act (NTTAA)
This action does not involve any technical standards subject to
NTTAA section 12(d) (15 U.S.C. 272 note).
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 28, 2021.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, for the reasons stated in the preamble, it is proposed
that 40 CFR chapter I be amended as follows:
PARTS 721--SIGNIFICANT NEW USES OF CHEMICAL SUBSTANCES
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625(c).
0
2. Add Sec. Sec. 721.11604 through 721.11634 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
721.11604 Dimethyl cyclohexenyl propanol (generic).
721.11605 Fatty acids, polymers with substituted carbomonocycle,
substituted alkylamines, heteromonocycle, fatty acid and alkylamine,
lactates (salts) (generic).
721.11606 Carbonic acid, dialkyl ester, polymers with 5-amino-1,3,3-
trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-
diisocyanatoalkane homopolymer and 1,6-alkanediol and
trimethylolalkane (generic).
721.11607 2-Heptanone, 4-hydroxy-.
721.11608 4-Hepten-2-one.
721.11609 2-Propanol, 1-amino-, compd. with .alpha.-sulfo-.omega.-
(octyloxy)poly(oxy-1,2-ethanediyl) (1:1).
721.11610 2-Propanol, 1-amino-, compd. with .alpha.-.sulfo-.omega.-
(decyloxy)poly(oxy-1,2-ethanediyl) (1:1).
721.11611 Substituted benzene, 4-[2-[2-hydroxy-3-[[(3-
nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt
(1:1) (generic).
721.11612 Polyetheramine carboxylate salt (generic).
721.11613 Benzene, 1,1'-oxybis-, branched eicosyl derivs.
721.11614 Alkoxylated triaryl methane (generic).
721.11615 Phenolic resin, alkali, polymer with formaldehyde and
phenol, sodium salt (generic).
721.11616 Phenol, polymer with formaldehyde and phenolic resin,
potassium salt (generic).
721.11617 Phenol, polymer with formaldehyde and phenolic resin,
potassium sodium salt (generic).
721.11618 Benzenesulfonic acid,
(alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-
yl]amino]-, N-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-
substituted(alkanol) (generic).
721.11619 Metal, alkylcarboxylate oxo complexes (generic).
721.11620 Polyglycerol reaction product with acid anhydride,
etherified (generic).
721.11621 Dioic acids, polymers with caprolactam and alkyldiamines
(generic).
721.11622 Fatty acids, dimers, hydrogenated, polymers with
caprolactam and alkyldiamine (generic).
721.11623 Poly[2-(Dimethylamino)ethyl acrylate chloride salt, vinyl
acetate, methacrylic acid and alkyl acrylates] (generic).
721.11624 Isophthalic acid, polymer with terephthalic acid and C4
and C6 dialkyl amines (generic).
721.11625 Alkenoic acid, alkyl-, polymers with alkyl methacrylate,
cycloalkyl methacrylate, alkylene dimethacrylate, and polyalkene
glycol hydrogen sulfate [(branched alkyloxy)alkyl]-(alkenyloxy)alkyl
ethers ammonium salts, metal salts (generic).
721.11626 Fats and Glyceridic oils, vegetable, sulfonated, sodium
salts.
721.11627 Cashew nutshell liq., polymer with bisphenol A,
epichlorohydrin, amines, formaldehyde, and glycol (generic).
721.11628 Glycerides, C16-18 and C18-unsatd. mono- and di-,
citrates.
721.11629 Polyaromatic ether symmetrical dicarboxylic anhydride
(generic).
721.11630 Alkyl salicylate, metal salts (generic).
[[Page 56674]]
721.11631 Alkyl bis(dialkylamino alkyl) amide (generic).
721.11632 Polycyclic amine, reaction products with polyalkylalkene,
polymers (generic).
721.11633 Plant based oils, polymer with 1,1'-methylenebis[4-
isocyanatobenzene], pentaerythritol, phthalic esters, polypropylene
glycol and polypropylene glycol ether with glycerol (3:1) (generic).
721.11634 Aminohydroxy naphthalenesulfonic acid, coupled with
diazotized[(aminophenyl)sulfonyl]ethyl hydrogen sulfate and
diazotized amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid,
salts (generic).
* * * * *
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Sec. 721.11604 Dimethyl cyclohexenyl propanol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
dimethyl cyclohexenyl propanol (PMN P-16-420) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=55.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11605 Fatty acids, polymers with substituted
carbomonocycle, substituted alkylamines, heteromonocycle, fatty acid
and alkylamine, lactates (salts) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, polymers with substituted carbomonocycle, substituted
alkylamines, heteromonocycle, fatty acid and alkylamine, lactates
(salts) (PMN P-16-446) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=38.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11606 Carbonic acid, dialkyl ester, polymers with 5-amino-
1,3,3-trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-
diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolalkane
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
carbonic acid, dialkyl ester, polymers with 5-amino-1,3,3-
trimethylcycloalkanemethanamine, 2-ethyl-1-alcohol-blocked 1,6-
diisocyanatoalkane homopolymer and 1,6-alkanediol and trimethylolalkane
(PMN P-16-602) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use an application method during use other than
the confidential method described in the PMN. It is a significant new
use to manufacture, process, or use the PMN substance in any manner
that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11607 2-Heptanone, 4-hydroxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-heptanone, 4-
hydroxy-. (PMN P-17-284; CAS No. 25290-14-6) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=1,000.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11608 4-Hepten-2-one.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 4-hepten-2-one (PMN
P-17-285; CAS No. 24332-22-7) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=730.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11609 2-Propanol, 1-amino-, compd. with .alpha.-
sulfo-.omega.-(octyloxy)poly(oxy-1,2-ethanediyl) (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propanol, 1-
amino-, compd. with .alpha.-sulfo-.omega.-(octyloxy)poly(oxy-1,2-
ethanediyl) (1:1) (PMN P-17-360, chemical A; CAS No. 2098904-74-4) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
[[Page 56675]]
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11610 2-Propanol, 1-amino-, compd. with
.alpha.-.sulfo-.omega.-(decyloxy)poly(oxy-1,2-ethanediyl) (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propanol, 1-
amino-, compd. with .alpha.-.sulfo-.omega.-(decyloxy)poly(oxy-1,2-
ethanediyl) (1:1) (PMN P-17-360, chemical B; CAS No. 2098904-80-2) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11611 Substituted benzene, 4-[2-[2-hydroxy-3-[[(3-
nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt
(1:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzene, 4-[2-[2-hydroxy-3-[[(3-
nitrophenyl)amino]carbonyl]-1-naphthalenyl]diazenyl]-, sodium salt
(1:1) (PMN P-18-19) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(f) and (o).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=260.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11612 Polyetheramine carboxylate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyetheramine carboxylate salt (PMN P-18-34) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to use the
PMN substance other than as a dispersing agent for pigments in
industrial paints and coatings. It is a significant new use to process
the PMN substance to greater than 1% by weight in the formulation of
the final product. It is a significant new use to manufacture or
process the PMN substance in any manner that results in inhalation
exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4), where N=45.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11613 Benzene, 1,1'-oxybis-, branched eicosyl derivs.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzene, 1,1'-
oxybis-, branched eicosyl derivs. (PMN P-18-121; CAS No. 1800419-55-9)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11614 Alkoxylated triaryl methane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkoxylated triaryl methane (PMN P-18-168) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in a manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11615 Phenolic resin, alkali, polymer with formaldehyde and
phenol, sodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phenolic resin, alkali, polymer with formaldehyde and phenol, sodium
salt (PMN P-18-179) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as
[[Page 56676]]
specified in Sec. 721.80(j). It is a significant new use to
manufacture the PMN substance to contain greater than 0.1% unbound
formaldehyde residuals by weight. It is a significant new use to
manufacture or process the PMN substance such that the weight percent
of low molecular weight species below 1,000 Daltons exceeds the
confidential value specified in the PMN. It is a significant new use to
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11616 Phenol, polymer with formaldehyde and phenolic resin,
potassium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
polymer with formaldehyde and phenolic resin, potassium salt (PMN P-18-
180) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j). It is a significant new use to
manufacture the PMN substance to contain greater than 0.1% unbound
formaldehyde residuals by weight. It is a significant new use to
manufacture or process the PMN substance such that the weight percent
of low molecular weight species below 1000 Daltons exceeds the
confidential value specified in the PMN. It is a significant new use to
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11617 Phenol, polymer with formaldehyde and phenolic resin,
potassium sodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
polymer with formaldehyde and phenolic resin, potassium sodium salt
(PMN P-18-181) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j). It is a significant new use to
manufacture the PMN substance to contain greater than 0.1% unbound
formaldehyde residuals by weight. It is a significant new use to
manufacture or process the PMN substance such that the weight percent
of low molecular weight species below 1000 Daltons exceeds the
confidential value specified in the PMN. It is a significant new use to
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11618 Benzenesulfonic acid,
(alkenediyl)bis[[[(hydroxyalkyl)amino]-(phenylamino)-triazin-2-
yl]amino]-, N-(hydroxyalkyl) derivs., salts, compds. with polyalkyl-
substituted(alkanol) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenesulfonic acid, (alkenediyl)bis[[[(hydroxyalkyl)amino]-
(phenylamino)-triazin-2-yl]amino]-, N-(hydroxyalkyl) derivs., salts,
compds. with polyalkyl-substituted(alkanol) (PMN P-18-192) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use the PMN substance other than as an optical
brightener for use in paper applications. It is a significant new use
to manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11619 Metal, alkylcarboxylate oxo complexes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as metal,
alkylcarboxylate oxo complexes (PMN P-18-197) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j). It is a significant new use to
manufacture or process the PMN substance without the confidential
engineering controls described in the PMN.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
[[Page 56677]]
Sec. 721.11620 Polyglycerol reaction product with acid anhydride,
etherified (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyglycerol reaction product with acid anhydride, etherified (PMN P-
18-221) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11621 Dioic acids, polymers with caprolactam and
alkyldiamines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as dioic
acids, polymers with caprolactam and alkyldiamines (PMN P-18-258) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11622 Fatty acids, dimers, hydrogenated, polymers with
caprolactam and alkyldiamine (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, dimers, hydrogenated, polymers with caprolactam and alkyldiamine
(PMN P-18-259) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11623 Poly[2-(Dimethylamino)ethyl acrylate chloride salt,
vinyl acetate, methacrylic acid and alkyl acrylates] (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as poly[2-
(Dimethylamino)ethyl acrylate chloride salt, vinyl acetate, methacrylic
acid and alkyl acrylates] (PMN P-18-277) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11624 Isophthalic acid, polymer with terephthalic acid and
C4 and C6 dialkyl amines (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isophthalic acid, polymer with terephthalic acid and C4 and C6 dialkyl
amines (PMN P-18-278) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture the PMN substance with particle
sizes less 10 microns.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11625 Alkenoic acid, alkyl-, polymers with alkyl
methacrylate, cycloalkyl methacrylate, alkylene dimethacrylate, and
polyalkene glycol hydrogen sulfate [(branched alkyloxy)alkyl]-
(alkenyloxy)alkyl ethers ammonium salts, metal salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically alkenoic
acid, alkyl-, polymers with alkyl methacrylate, cycloalkyl
methacrylate, alkylene dimethacrylate, and polyalkene glycol hydrogen
sulfate [(branched alkyloxy)alkyl]-(alkenyloxy)alkyl ethers ammonium
salts, metal salts (PMN P-18-299) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i), are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 56678]]
Sec. 721.11626 Fats and glyceridic oils, vegetable, sulfonated,
sodium salts.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as fats and glyceridic
oils, vegetable, sulfonated, sodium salts (PMN P-18-375; CAS No. 97489-
04-8) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11627 Cashew nutshell liq., polymer with bisphenol A,
epichlorohydrin, amines, formaldehyde, and glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as cashew
nutshell liq., polymer with bisphenol A, epichlorohydrin, amines,
formaldehyde, and glycol (PMN P-18-379) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture (including import) the PMN substance
such that the weight percent of low molecular weight species below 500
daltons exceeds 1% and the weight percent of low molecular weight
species below 1,000 daltons exceeds 6%. It is a significant new use to
manufacture, process, or use the PMN substance in any manner that
results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11628 Glycerides, C16-18 and C18-unsatd. mono- and di-,
citrates.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as glycerides, C16-18
and C18-unsatd. mono- and di-, citrates (PMN P-18-401; CAS No. 91052-
16-3) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use the PMN substance in formulations greater
than 0.01% in a manner that results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4) and (c)(4), where N=12.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11629 Polyaromatic ether symmetrical dicarboxylic anhydride
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyaromatic ether symmetrical dicarboxylic anhydride (PMN P-19-3) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11630 Alkyl salicylate, metal salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
salicylate, metal salts (PMN P-19-28) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11631 Alkyl bis(dialkylamino alkyl) amide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
bis(dialkylamino alkyl) amide (PMN P-19-40) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11632 Polycyclic amine, reaction products with
polyalkylalkene, polymers (generic).
(a) Chemical substance and significant new uses subject to
reporting.
[[Page 56679]]
(1) The chemical substance identified generically as polycyclic amine,
reaction products with polyalkylalkene, polymers (PMN P-19-117) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11633 Plant based oils, polymer with 1,1'-methylenebis[4-
isocyanatobenzene], pentaerythritol, phthalic esters, polypropylene
glycol and polypropylene glycol ether with glycerol (3:1) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as plant
based oils, polymer with 1,1'-methylenebis[4-isocyanatobenzene],
pentaerythritol, phthalic esters, polypropylene glycol and
polypropylene glycol ether with glycerol (3:1) (PMN P-19-121) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to use the substance in spray applications.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11634 Aminohydroxy naphthalenesulfonic acid, coupled with
diazotized [(aminophenyl)sulfonyl]ethyl hydrogen sulfate and diazotized
amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid, salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
aminohydroxy naphthalenesulfonic acid, coupled with
diazotized[(aminophenyl)sulfonyl]ethyl hydrogen sulfate and diazotized
amino[[(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid, salts (PMN P-19-
130) is subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitation or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
* * * * *
[FR Doc. 2021-21872 Filed 10-8-21; 8:45 am]
BILLING CODE 6560-50-P
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