[Federal Register Volume 84, Number 213 (Monday, November 4, 2019)]
[Proposed Rules]
[Pages 59335-59349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23388]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2019-0494; FRL-10000-54]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-4.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 26 chemical substances which
were the subject of premanufacture notices (PMNs). Five of these
chemical substances are subject to Orders issued by EPA pursuant to
TSCA, and the remaining 21 of these chemical substances received a
``not likely to present an unreasonable risk'' determination pursuant
to TSCA. This action would require persons who intend to manufacture
(defined by statute to include import) or process any of these 26
chemical substances for an activity that is proposed as a significant
new use to notify EPA at least 90 days before commencing that activity.
The required notification initiates EPA's evaluation of the use, under
the conditions of use for that chemical substance, within the
applicable review period. Persons may not commence manufacture or
processing for the significant new use until EPA has conducted a review
of the notice, made an appropriate determination on the notice, and has
taken such actions as are required by that determination.
DATES: Comments must be received on or before December 4, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0494, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: For technical information contact:
Kenneth Moss, Chemical Control Division (7405M), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-9232; email address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you manufacture,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances
[[Page 59336]]
(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
certification requirements 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. Importers of chemicals subject to final SNURs must certify
their compliance with the SNUR requirements. The EPA policy in support
of import certification appears at 40 CFR part 707, subpart B. In
addition, any persons who export or intend to export a chemical
substance that is the subject of this proposed rule on or after
December 4, 2019 are subject to the export notification provisions of
TSCA section 12(b) (15 U.S.C. 2611(b)) (see 40 CFR 721.20), and must
comply with the export notification requirements in 40 CFR part 707,
subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at http://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(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 a chemical substance for any 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. Additional background regarding SNURs is
more fully set out in the preamble to EPA's first direct final SNUR
published in the Federal Register issue of April 24, 1990 (55 FR
17376). Consult that preamble for further general information on the
objectives, rationale, and procedures for SNURs and on the basis for
significant new use designations, including provisions for developing
test data.
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 bulleted 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 proposed rule,
recordkeeping requirements, and exemptions to reporting requirements,
and applicability of the rule to uses occurring before the effective
date of the rule. Provisions relating to user fees appear at 40 CFR
part 700. Pursuant to 40 CFR 721.1(c), persons subject to SNURs must
comply with the same SNUN requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A) (15 U.S.C.
2604(a)(1)(A)). In particular, these requirements include the
information submission requirements of TSCA sections 5(b) and 5(d)(1)
(15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA
section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40
CFR part 720. Once EPA receives a SNUN, 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
before the manufacture or processing for the significant new use can
commence. In the case of a determination other than not likely to
present unreasonable risk, the applicable review period must also
expire before manufacturing or processing for the new use may commence.
If EPA determines that the use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining significant new uses for the 26 chemical substances
that are the subject of these SNURs, EPA considered relevant
information about the toxicity of the chemical substances and potential
human exposures and environmental releases that may be associated with
the substances, in addition to the factors in TSCA section 5(a)(2).
Consistent with TSCA section 5(f)(4), for the five chemical substances
subject to an order under TSCA section 5(e), EPA is proposing to
identify any use not conforming to the restrictions of the order as a
significant new use. For the 21 chemical 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 26 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the SNUR or basis for the TSCA 5(e) Order.
Potentially Useful Information. This is information
identified by EPA that
[[Page 59337]]
would help characterize the potential health and/or environmental
effects of the chemical substance in support of a request by the PMN
submitter to modify the Order, or if a manufacturer or processor is
considering submitting a SNUN for a significant new use designated by
the SNUR.
CFR citation assigned in the regulatory text section of
the proposed rule. The regulatory text section of each proposed rule
specifies the activities that would be designated as significant new
uses. Certain new uses, including exceedance of production volume
limits (i.e., limits on manufacture volume) and other uses designated
in this proposed rule, may be claimed as CBI.
These proposed rules include five PMN substances that are subject
to Orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under section 5(a)(3)(B). Those Orders require
protective measures to limit exposures or otherwise mitigate the
potential unreasonable risk. The proposed SNURs would identify as
significant new uses any manufacturing, processing, use, distribution
in commerce, or disposal that does not conform to the restrictions
imposed by the underlying Orders, consistent with TSCA section 5(f)(4).
These proposed rules also include 21 PMN substances that received
``not likely to present an unreasonable risk'' determination in TSCA
section 5(a)(3)(c). However, during the course of these reviews, EPA
identified concerns for certain health and/or environmental risks if
the chemicals were not used following the limitations identified by the
submitters in the notices, but the TSCA section 5(a)(3)(C)
determinations did not deem such uses as reasonably foreseen. The
proposed SNURs would identify as significant new uses any
manufacturing, processing, use, distribution in commerce, or disposal
that does not conform to those same limitations.
The chemicals subject to these proposed SNURs are as follows:
PMN Number: P-16-548
Chemical Name: Triarylsulfonium salt (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: July 22, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the PMN substance will be as a resin
catalyst. Based on physical/chemical properties of the PMN substance
(as described in the New Chemical Program's PBT category at 64 FR
60194; November 1999), the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical. EPA estimates that that PMN
substance will persist in the environment for more than 2 months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Based on comparison to structurally analogous chemical substances, the
estimated physical/chemical properties of the PMN, and test data for
the PMN substance, EPA has identified concerns for eye irritation,
systemic, developmental, blood, and reproductive effects. The Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the Order requires:
1. Refraining from domestic manufacture in the United States (i.e.,
import only);
2. Use of the PMN substance only for the confidential use specified
in the Order;
3. No manufacture (including import) of the PMN substance beyond
the confidential annual manufacture volume specified in the Order;
4. Refraining from processing or using the PMN substance in any
manner that generates a mist, vapor, or aerosol; and
5. No release of the PMN substance into the waters of the United
States.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health effects of the PMN substance may be
potentially useful in support of a request by the PMN submitter to
modify the TSCA section 5(e) Order, or if a manufacturer or processor
is considering submitting a SNUN for a significant new use that would
be designated by this SNUR. EPA has determined that the results of
specific target organ toxicity and reproductive/developmental toxicity
testing would help characterize the potential health effects of the PMN
substance. Although the TSCA section 5(e) Order does not require this
information, the TSCA section 5(e) Order's restrictions remain in
effect until the TSCA section 5(e) Order is modified or revoked by EPA
based on submission of this or other relevant information.
CFR Citation: 40 CFR 721.11383.
PMN Numbers: P-17-312, P-17-313, P-17-314, P-17-315, P-17-316, and P-
17-317
Chemical Names: Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic) (P-17-312); Phenol, 4,4'-(1-methylethylidene)bis-,
polymer with 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-
omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction
products with disubstituted amine and disubstituted polypropylene
glycol, organic acid salts (generic) (P-17-313); Organic acid, 2-
substituted-, compds. with bisphenol A-epichlorohydrin-polypropylene
glycol diglycidyl ether polymer-disubstituted aminedisubstituted
polypropylene glycol reaction products (generic) (P-17-314); Phenol,
4,4'-(1-methylethylidene)bis-, polymer with alpha-(2-substituted-
methylethyl)-omega-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-
ethanediyl)], 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-
omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl
ethers, reaction products with disubstituted amine, organic acid salts
(generic) (P-17-315); Organic acid, compds. with bisphenol A-
epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol
diglycidyl ether polymer alkylphenyl ethers-disubstituted amine
reaction products (generic) (P-17-316); Organic acid, compds. with
bisphenol A-epichlorohydrin-polypropylene glycol diglycidyl ether
polymer-disubstituted polypropylene glycol reaction products (generic)
(P-17-317).
CAS Numbers: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as additives for
electrocoat. Based on the estimated physical/chemical properties of the
PMN substances, comparison with structurally analogous substances, and
Structural Activity Relationships (SAR) analysis on analogous
polycationic polymers, EPA has identified concerns for lung effects,
nasal epithelial damage, skin and eye irritation, 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
PMNs include the following protective measures:
1. No modification of the manufacturing, processing, or use of the
PMN substances that result in the
[[Page 59338]]
generation of a dust, mist, or aerosol; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 78 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 health and
environmental effects of the PMN substances if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of pulmonary effects, skin irritation/corrosion, eye
damage, and acute aquatic toxicity testing would help characterize the
potential health effects of the PMN substances.
CFR Citations: 40 CFR 721.11384 (P-17-312), 40 CFR 721.11385 (P-17-
313), 40 CFR 721.11386 (P-17-314), 40 CFR 721.11387 (P-17-315), 40 CFR
721.11388 (P-17-316), and 40 CFR 721.11389 (P-17-317).
PMN Numbers: P-17-398, P-17-399, P-18-1, and P-18-28
Chemical names: Branched cyclic and linear hydrocarbons from
plastic depolymerization (generic) (P-17-398), Alkane, alkene, styrenic
compounds derived from plastic depolymerization (generic) (P-17-399),
Carbon compound derived from plastic depolymerization (generic) (P-18-
1), and Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic) (P-18-28).
CAS numbers: Not available.
Effective date of TSCA section 5(e) Order: June 10, 2019.
Basis for TSCA section 5(e) Order: The PMNs state that the use of
P-17-398 and P-17-399 will be as a refinery feedstock or fuel blending
additive, the generic use of P-18-1 will be as an additive, and the use
of P-18-28 will be as a chemical feedstock. Based on the physical/
chemical properties of the PMN substances and comparison to
structurally analogous chemical substances, EPA has identified concerns
for neurological impairment, and hematological effects including
aplastic anemia and acute myelogenous leukemia for PMN substance P-18-
28. There is concern for lung effects for P-18-1, if respirable, based
on the respirable, poorly soluble particles category. Based on SAR
analysis on analogous substances, EPA predicts toxicity to aquatic
organisms may occur at concentrations that exceed 1 ppb for P-17-398
and P-17-399, and 15 ppb for P-18-28. The Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a finding
that in the absence of sufficient information to permit a reasoned
evaluation, the substances may present an unreasonable risk of injury
to human health and the environment. The Order was also issued under
TSCA sections 5(a)(3)(B)(ii)(II) and 5(e)(1)(A)(ii)(II), based on a
finding that the substances are or will be produced in substantial
quantities and that the substances either enter or may reasonably be
anticipated to enter the environment in substantial quantities, or
there is or may be significant (or substantial) human exposure to the
substances. To protect against these risks, the Order requires:
1. Refraining from manufacturing, processing, or using P-17-398 and
P-17-399 other than as a refinery feedstock or a fuel blending additive
and refrain from manufacturing, processing, and using P-18-28 other
than as a chemical feedstock or a fuel blending additive;
2. Manufacture of P-18-1 via the enclosed manufacturing process
described in the PMN; and
3. Manufacture of P-18-1 according to the particle sizes described
in the PMN: 1% or less of the particles at less than 75 microns.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health and environmental effects of the PMN
substances may be potentially useful in support of a request by the PMN
submitter to modify the TSCA section 5(e) Order, or if a manufacturer
or processor is considering submitting a SNUN for a significant new use
that would be designated by this SNUR. EPA has determined that the
results of additional particle size characterization testing for P-18-1
and acute and chronic aquatic toxicity testing for P-17-398, P-17-399,
and P-18-28 would help EPA determine the potential human and
environmental effects of the PMN substances. Although the TSCA section
5(e) Order does not require this information, the Order's restrictions
remain in effect until the Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR citations: 40 CFR 721.11390 (P-17-398), 40 CFR 721.11391 (P-17-
399), 40 CFR 721.11392 (P-18-1), and 40 CFR 721.11393 (P-18-28).
PMN Number: P-18-9
Chemical Name: Phosphonic acid, dimethyl ester, polymer with alkyl
diols (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a lubricant additive.
Based on estimated physical/chemical properties of the PMN substance,
test data on the PMN substance, comparison to structurally analogous
chemical substances, and SAR analysis of test data on analogous esters,
EPA has identified concerns for gastrointestinal and kidney effects,
reproductive/developmental toxicity, and aquatic toxicity if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
1. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 300 ppb; and
2. No manufacture, process, or use of the PMN substance that
generates a dust, mist, or aerosol.
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 health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of aquatic toxicity, specific target organ toxicity, and
reproductive/developmental toxicity testing would help characterize the
potential health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11394.
PMN Number: P-18-11
Chemical Name: 1H-Imidazole, 1,2,4,5-tetramethyl-.
CAS Number: 1739[hyphen]83[hyphen]9.
Basis for action: The PMN states that the use of the PMN substance
will be as a chemical intermediate in the synthesis of a polymer. Based
on estimated physical/chemical properties of the PMN substance, test
data on analogous chemical substances, comparison to structurally
analogous chemical substances, and SAR analysis of test data on
analogous pyrroles/diazoles, EPA has identified concerns for irritation
and corrosion to all tissues,
[[Page 59339]]
developmental effects, liver toxicity, and aquatic toxicity if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
1. Refraining from domestic manufacture in the United States (i.e.,
import only);
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 7 ppb; and
3. No use of the PMN substance other than as a chemical
intermediate.
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 health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of skin corrosion, developmental/reproductive toxicity,
specific target organ toxicity, and aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11395.
PMN Number: P-18-170
Chemical Name: 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
CAS Number: 96320-92-2.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for use in textile
treatment. Based on the physical/chemical properties of the PMN
substance, comparison of structurally analogous chemical substances,
and SAR analysis on cationic surfactants, EPA has identified concerns
for surfactant effects on the lungs, developmental effects,
mutagenicity, carcinogenicity, systemic toxicity, skin and respiratory
sensitization, liver and kidney toxicity and aquatic toxicity if the
chemical substance is not used following the limitations noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measures:
1. No manufacturing, processing, or use of the PMN substance that
results in inhalation exposures; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 164 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 health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific target organ toxicity, reproductive/
developmental toxicity, and chronic aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11396.
PMN Number: P-18-185
Chemical Name: Fatty acid, polymer with alkanedioic acid dialkyl
ester, hydroxyl alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted alkane (generic). Polymer
exemption flag: The chemical must be manufactured such that it meets
the polymer exemption criteria as described under 40 CFR 723.250(e)(1),
in addition to meeting the definition of polymer at 40 CFR 723.250(b).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an adhesion-enhancing resin for wood applications for
industrial and commercial use. Based on estimated physical/chemical
properties of the PMN substance and comparison to structurally
analogous chemical substances, EPA has identified concerns for
developmental and reproductive effects if the chemical substance is not
used following the limitation noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measure:
No use of the PMN substance in a consumer product.
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 health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that reproductive/
developmental toxicity testing would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11397.
PMN Numbers: P-18-190 and P-18-191
Chemical Names: 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, polymers with epichlorohydrin and
trimethylolpropane, sodium salts (generic) (P-18-190); 2,5-Furandione,
polymer with ethenylbenzene, 4-hydroxy-substitutedbutyl [3-[2-[1-
[[(substitutedphenyl)amino]carbonyl]-2-oxopropyl]diazenyl]phenyl]methyl
amide, polymers with epichlorohydrin and trimethylolpropane, sodium
salts (generic) (P-18-191).
CAS Numbers: Not available.
Basis for action: The PMNs state that the use of the substances
will be as a pigment dispersing aid for pigments in inkjet printing
inks. Based on the estimated physical/chemical properties, high pH,
chelating potential of the polyanionic groups and comparison with
structurally analogous chemical substances, EPA has identified concerns
for developmental and blood effects, and eye, skin, and lung irritation
if the chemical substances are not used following the limitation noted.
The conditions of use of the PMN substances as described in the PMNs
include the following protective measure:
Use of the PMN substances only as pigment dispersing aids
for pigments in inkjet printing inks.
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 health
effects of the PMN substances if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of reproduction/developmental toxicity, skin irritation, and eye damage
testing would help characterize the potential health effects of the PMN
substances.
CFR Citations: 40 CFR 721.11398 (P-18-190) and 40 CFR 721.11399 (P-
18-191).
PMN Number: P-18-223
Chemical Name: Alkane, bis(alkoxymethyl)-dimethyl- (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a selectivity improver for catalysts used in polyolefin
production. Based on estimated physical/chemical properties, comparison
to structurally analogous chemical substances, test data on the PMN
substance, and SAR analysis on analogous neutral organics, EPA has
[[Page 59340]]
identified concerns for eye irritation, systemic and developmental
toxicity, neurotoxicity and aquatic toxicity if the chemical substance
is not used following the limitation noted. The conditions of use of
the PMN substance as described in the PMN include the following
protective measure:
No manufacture of the PMN substance beyond the
confidential annual production volume specified 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 health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of toxicokinetics, specific organ toxicity, irritation,
neurotoxicity, systemic toxicity, reproductive/developmental toxicity,
and aquatic toxicity testing would help characterize the potential
health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11400.
PMN Number: P-18-285
Chemical Name: Butanedioic acid, 2-methylene-, polymer with 2-
methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium
zinc salt.
CAS Number: 2220235-78-7.
Basis for action: The PMN states that the use of the PMN substance
will be for odor neutralization for pet litter and cleaning/deodorizing
hard surfaces, fabrics, skin and hair, odor neutralization for air
care, and odor neutralization for waste processing and solid waste
management in paper, oil, gas, mining, agriculture, and food and
municipal industries. Based on SAR analysis on analogous polyanionic
polymers, EPA has identified concerns for aquatic toxicity if the
chemical substance is not used following the limitation noted. The
conditions of use of the PMN substance as described in the PMN include
the following protective measure:
No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 143 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the environmental
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of chronic aquatic toxicity testing would help characterize the
potential environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11404.
PMN Number: P-18-300
Chemical Name: Heteromonocycle, alkenoic 1:1 salt, polymer with
alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega-methoxypoly(oxy-1,2-
ethanediyl) and methyl-alkenoic acid (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an additive for automatic dishwashing detergent. Based on
the estimated physical/chemical properties of the PMN substance,
comparison with structurally analogous chemical substances, and
available data on the new chemical substance, EPA has identified
concerns for lung effects if the chemical substance is not used
following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measures:
1. No manufacturing, processing, or use that results in particles
less than 50 microns; and
2. No use that results in consumer inhalation or dermal exposure
and use only in sealed, single-use packets.
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 health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of pulmonary effects, specific target organ effects, and developmental/
reproductive toxicity testing would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11405.
PMN Number: P-18-394
Chemical Name: Substituted benzylic ether polyethylene glycol alkyl
ether derivative (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 chemical
intermediate. Based on estimated physical/chemical properties of the
PMN substance, comparison to structurally analogous chemical
substances, and test data on the PMN substance, and SAR analysis on
analogous nonionic surfactants, EPA has identified concerns for ocular,
lung and mucous membrane irritation, lung effects, skin and respiratory
sensitization, systemic effects, neurotoxicity, immunotoxicity, and
aquatic toxicity if the chemical substance is not used following the
limitation noted. The condition of use of the PMN substance as
described in the PMN includes the following protective measures:
1. No use of the PMN substance involving application methods that
generate a vapor, mist, or aerosol; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 4 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 health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific target organ toxicity, neurotoxicity,
sensitization, eye damage, skin irritation, and algal toxicity testing
would help characterize the potential health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11406.
PMN Number: P-18-404
Chemical Name: Alkylmultiheteroatom, 2-functionalisedalkyl-2-
hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised
carbomonocycleheteroatom and multiglycidylether difunctionalised
polyalkylene glycol (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an epoxy curing agent used in molding formulations for the
manufacture of wind turbine blades. Based on estimated physical/
chemical properties of the PMN substance and comparison of structurally
analogous chemical substances, EPA has identified concerns for
pulmonary effects, skin corrosion, eye irritation, skin sensitization,
and kidney toxicity if the chemical substance is not used following the
limitations noted. The conditions of use
[[Page 59341]]
of the PMN substance as described in the PMN include the following
protective measures:
1. No manufacturing (including import), processing, or use of the
PMN substance that results in inhalation exposures; and
2. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that pulmonary toxicity,
specific target organ toxicity, and skin sensitization testing using
the reconstructed human cornea-like epithelium test method would help
characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11407.
PMN Number: P-19-12
Chemical Name: Benzenedicarboxylic acid, reaction products with
isobenzofurandione and diethylene glycol (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a resin component for polyisocyanurate resins and specialty
polyurethane kits and systems for aerospace and military applications.
Based on comparison to structurally analogous chemical substances, EPA
has identified concerns for bladder, kidney, and reproductive/
developmental toxicity if the chemical substance is not used following
the limitation noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
No manufacturing, processing, or use of the substance that
results in inhalation exposures.
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 about the health effects of the PMN substance may be
potentially useful if a manufacturer or processor is considering
submitting a SNUN for a significant new use that would be designated by
this proposed SNUR. EPA has determined that the results of
developmental/reproductive toxicity, specific target organ toxicity,
and eye and skin irritation testing would help characterize the
potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11408.
PMN Number: P-19-31
Chemical Name: Formaldehyde, polymer with N1-(2-aminoethyl)-
alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-
(chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[Phenol] and alpha-
hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a curing agent for epoxy coating systems. Based on the
estimated physical/chemical properties of the PMN substance, comparison
with structurally analogous chemical substances, and SAR analysis on
analogous polycationic polymers, EPA has identified concerns for
irritation, lung effects, carcinogenicity, systemic toxicity,
neurotoxicity, 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:
1. No release of a manufacturing, processing, or use stream
associated with any use of the PMN substance into the waters of the
United States exceeding a surface water concentration of 1 ppb; and
2. No manufacturing, processing, or use of the substance that
results in inhalation exposures.
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 health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific target organ toxicity, skin irritation,
neurotoxicity, carcinogenicity and aquatic toxicity testing would help
characterize the potential health and environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11409.
PMN Number: P-19-71
Chemical Name: 2,4-Hexadienoic acid, 1,1'-[2-ethyl-2-[(1-oxo-2,4-
hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.
CAS Number: 2307636-51-5.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a physical property
modifier for polymers. Based on estimated physical/chemical properties,
the comparison of structurally analogous chemical substances and SAR
analysis on esters, EPA has identified concerns for liver,
developmental, 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
measures:
1. Use of the PMN substance only for the confidential use specified
in the PMN; and
2. No manufacture of the PMN substance beyond the confidential
annual production volume specified 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 health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of reproductive toxicity, specific target organ toxicity,
and aquatic toxicity testing would help characterize the potential
health and environmental effects of the PMN substance.
CFR Citation: 40 CFR 721.11410.
PMN Number: P-19-72
Chemical Name: 1-Butanol, reaction products with 2-[(2-propen-1-
yloxy)methyl]oxirane.
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a raw material used
in chemical manufacture. Based on available data on the PMN substance,
EPA has identified concerns for acute toxicity, corrosion to all
exposed tissues, sensitization, and hematological and skin changes if
the chemical substance is not used following the limitation noted. The
condition of use of the PMN substance as described in the PMN includes
the following protective measure:
Use of the PMN substance only for the confidential use
specified 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
[[Page 59342]]
the health effects of the PMN substance if a manufacturer or processor
is considering submitting a SNUN for a significant new use that would
be designated by this proposed SNUR. EPA has determined that the
results of acute toxicity, sensitization, and systemic effects would
help characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11411.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these proposed SNURs, EPA concluded that for five
chemical substances regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) Orders requiring the use of
appropriate exposure controls were negotiated with the PMN submitters.
As a general matter, EPA believes it is necessary to follow TSCA
section 5(e) Orders with a SNUR that identifies the absence of those
protective measures as Significant New Uses to ensure that all
manufacturers and processors--not just the original submitter--are held
to the same standard.
During review of the other 21 chemical substances that are the
subject of these SNURs and as further discussed in Unit IV, EPA
identified certain circumstances that raised potential risk concerns.
EPA determined that deviations from the limitations identified in the
submissions could result in changes in the type or form of exposure to
the chemical substances and/or increased exposures to the chemical
substances and/or changes in the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and
disposal of the chemical substances, and therefore warranted SNURs. The
SNURs would identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to the certain limitations in the submission.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants:
To receive notice of any person's intent to manufacture or
process a listed chemical substance for the described significant new
use before that activity begins.
To review and evaluate data submitted in a SNUN before the
notice submitter begins manufacturing or processing a listed chemical
substance for the described significant new use.
To 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.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
http://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/index.html.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. However, TSCA section 5(e) Orders have been
issued for five of the 26 chemical substances, and the PMN submitters
are prohibited by the TSCA section 5(e) Orders from undertaking
activities which would be designated as significant new uses. The
identities of 21 of the 26 chemical substances subject to this proposed
rule have been claimed as confidential (per 40 CFR 720.85) for a
chemical substance covered by this action. Based on this, the Agency
believes that it is highly unlikely that any of the significant new
uses described in the regulatory text of this proposed rule are
ongoing.
Therefore, EPA designates November 4, 2019 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.
Persons who begin 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.
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: development of test data
is required where the chemical substance subject to the SNUR is also
subject to a rule, order or consent agreement under TSCA section 4 (see
TSCA section 5(b)(1)).
In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required only to submit information in their
possession or control and to describe any other information known to or
reasonably ascertainable by them (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
identified by EPA that would help characterize the potential health
and/or environmental effects of the PMN/SNUN substance for all of the
listed SNURs. EPA recognizes that the 2016 Lautenberg Amendments have
led to modifications in our approach to testing requirements, including
an increased consideration of alternatives to vertebrate testing.
Descriptions of tests/information needs are provided for informational
purposes only and EPA strongly encourages persons, before performing
any testing, to consult with the Agency pertaining to protocol
selection. 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 potentially useful information. EPA encourages dialogue with Agency
representatives to help determine how best the submitter
[[Page 59343]]
can meet both the data needs and the objective of TSCA section 4(h). To
access the OCSPP test guidelines referenced in this document
electronically, please go to http://www.epa.gov/ocspp and select ``Test
Methods and Guidelines.'' The Organisation for Economic Co-operation
and Development test guidelines are available from the OECD Bookshop at
http://www.oecdbookshop.org or SourceOECD at http://www.sourceoecd.org.
The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at http://www.epa.gov/opptintr/newchems.
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 under docket ID number EPA-HQ-OPPT-
2019-0494.
X. Statutory and Executive Order Reviews
Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations-and-executive-orders.
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This proposed rule would establish SNURs for several new chemical
substances that were the subject of PMNs and TSCA section 5(e) Orders.
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 the 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 in this proposed rule have
already been approved by OMB pursuant to the PRA under OMB control
number 2070-0012 (EPA ICR No. 574). This action does not impose 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
through the use of 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 RFA section 605(b) (5 U.S.C. 601 et seq.), the Agency
hereby certifies that promulgation of this proposed SNUR 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. Although some small entities may decide to pursue a
significant new use in the future, EPA cannot presently determine how
many, if any, there may be. However, EPA's experience to date is that,
in response to the promulgation of SNURs covering over 1,000 chemicals,
the Agency receives only a small number of notices per year. For
example, the number of SNUNs received was seven in Federal fiscal year
(FY) 2013, 13 in FY2014, six in FY2015, 10 in FY2016, 14 in FY2017, and
18 in FY2018 and only a fraction of these were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
proposed SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this proposed rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
[[Page 59344]]
E. Executive Order 11632: Federalism
This proposed rule 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 proposed rule would not have Tribal implications because it is
not expected to have substantial direct effects on Indian Tribes. This
proposed rule 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 and because this proposed
rule is not a significant regulatory action under Executive Order
12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this proposed rule would not involve any
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note) does not
apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This proposed rule does not entail special considerations of
environmental justice related issues as delineated by Executive Order
12898 (59 FR 7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: October 18, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PARTS 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
2. Add Sec. Sec. 721.11383 through 721.11411 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
* * * * *
Secs.
Sec. 721.11383 Triarylsulfonium salt (generic).
Sec. 721.11384 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic).
Sec. 721.11385 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products
with disubstituted amine and disubstituted polypropylene glycol,
organic acid salts (generic).
Sec. 721.11386 Organic acid, 2-substituted-, compds. with bisphenol
A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted aminedisubstituted polypropylene glycol reaction
products (generic).
Sec. 721.11387 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
alpha-(2-substituted-methylethyl)-omega-(2-substituted-
methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-
(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl
ethers, reaction products with disubstituted amine, organic acid
salts (generic).
Sec. 721.11388 Organic acid, compds. with bisphenol A-
epichlorohydrin-disubstituted polypropylene glycol-polypropylene
glycol diglycidyl ether polymer alkylphenyl ethers-disubstituted
amine reaction products (generic).
Sec. 721.11389 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted polypropylene glycol reaction products (generic).
Sec. 721.11390 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
Sec. 721.11391 Alkane, alkene, styrenic compounds derived from
plastic depolymerization (generic).
Sec. 721.11392 Carbon compound derived from plastic
depolymerization (generic).
Sec. 721.11393 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
Sec. 721.11394 Phosphonic acid, dimethyl ester, polymer with alkyl
diols (generic).
Sec. 721.11395 1H-Imidazole, 1,2,4,5-tetramethyl-.
Sec. 721.11396 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
Sec. 721.11397 Fatty acid, polymer with alkanedioic acid dialkyl
ester, hydroxyl alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted alkane (generic).
Sec. 721.11398 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, polymers with epichlorohydrin and
trimethylolpropane, sodium salts (generic).
Sec. 721.11399 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substitutedbutyl [3-[2-[1-
[[(substitutedphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]methyl amide, polymers with
epichlorohydrin and trimethylolpropane, sodium salts (generic).
Sec. 721.11400 Alkane, bis(alkoxymethyl)-dimethyl- (generic).
Sec. 721.11401 [Reserved]
Sec. 721.11402 [Reserved]
Sec. 721.11403 [Reserved]
Sec. 721.11404 Butanedioic acid, 2-methylene-, polymer with 2-
methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium
zinc salt.
Sec. 721.11405 Heteromonocycle, alkenoic (1:1) salt, polymer with
alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-
ethanediyl) and methyl-alkenoic acid (generic).
Sec. 721.11406 Substituted benzylic ether polyethylene glycol alkyl
ether derivative (generic).
Sec. 721.11407 Alkylmultiheteroatom, 2-functionalisedalkyl-2-
hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised
carbomonocycleheteroatom and multiglycidylether difunctionalised
polyalkylene glycol (generic).
Sec. 721.11408 Benzenedicarboxylic acid, reaction products with
isobenzofurandione and diethylene glycol (generic).
Sec. 721.11409 Formaldehyde, polymer with N1-(2-aminoethyl)-
alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-
(chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[Phenol] and
alpha-hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (generic).
Sec. 721.11410 2,4-Hexadienoic acid, 1,1'-[2-ethyl-2-[(1-oxo-2,4-
hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.
[[Page 59345]]
Sec. 721.11411 1-Butanol, reaction products with 2-[(2-propen-1-
yloxy)methyl]oxirane.
* * * * *
Sec. 721.11383 Triarylsulfonium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
triarylsulfonium salt (PMN P-16-548) 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), (k), and (t). It is a significant new
use to process or use the substance in a manner that generates a vapor,
mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) and (k) 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.
(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. 721.11384 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted amine-disubstituted polypropylene glycol reaction
products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted amine-disubstituted
polypropylene glycol reaction products (PMN P-17-312) 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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11385 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with 2-
(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-omega-(2-
oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], reaction products
with disubstituted amine and disubstituted polypropylene glycol,
organic acid salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
4,4'-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane and
alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-
ethanediyl)], reaction products with disubstituted amine and
disubstituted polypropylene glycol, organic acid salts (PMN P-17-313)
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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11386 Organic acid, 2-substituted-, compds. with bisphenol
A-epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted aminedisubstituted polypropylene glycol reaction products
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, 2-substituted-, compds. with bisphenol A-epichlorohydrin-
polypropylene glycol diglycidyl ether polymer-disubstituted
aminedisubstituted polypropylene glycol reaction products (PMN P-17-
314) 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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11387 Phenol, 4,4'-(1-methylethylidene)bis-, polymer with
alpha-(2-substituted-methylethyl)-omega-(2-substituted-
methylethoxy)poly[oxy(methyl-1,2-ethanediyl)], 2-(chloromethyl)oxirane
and alpha-(2-oxiranylmethyl)-omega-(2-oxiranylmethoxy)poly[oxy(methyl-
1,2-ethanediyl)], alkylphenyl ethers, reaction products with
disubstituted amine, organic acid salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol,
4,4'-(1-methylethylidene)bis-, polymer with alpha-(2-substituted-
methylethyl)-omega-(2-substituted-methylethoxy)poly[oxy(methyl-1,2-
ethanediyl)], 2-(chloromethyl)oxirane and alpha-(2-oxiranylmethyl)-
omega-(2-oxiranylmethoxy)poly[oxy(methyl-1,2-ethanediyl)], alkylphenyl
ethers, reaction products with disubstituted amine, organic acid salts
(PMN P-17-315) is subject to reporting under this section for the
significant new uses
[[Page 59346]]
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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11388 Organic acid, compds. with bisphenol A-
epichlorohydrin-disubstituted polypropylene glycol-polypropylene glycol
diglycidyl ether polymer alkylphenyl ethers-disubstituted amine
reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, compds. with bisphenol A-epichlorohydrin-disubstituted
polypropylene glycol-polypropylene glycol diglycidyl ether polymer
alkylphenyl ethers-disubstituted amine reaction products (PMN P-17-316)
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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11389 Organic acid, compds. with bisphenol A-
epichlorohydrin-polypropylene glycol diglycidyl ether polymer-
disubstituted polypropylene glycol reaction products (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as organic
acid, compds. with bisphenol A-epichlorohydrin-polypropylene glycol
diglycidyl ether polymer-disubstituted polypropylene glycol reaction
products (PMN P-17-317) 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 modify the manufacture, process, or use of the
substance that results in the generation of a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 78.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11390 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched cyclic and linear hydrocarbons from plastic depolymerization
(PMN P-17-398) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k)(other than as a refinery feedstock or
a fuel blending additive).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11391 Alkane, alkene, styrenic compounds derived from
plastic depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkane,
alkene, styrenic compounds derived from plastic depolymerization (PMN
P-17-399) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (other than as a refinery feedstock or
a fuel blending additive).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11392 Carbon compound derived from plastic depolymerization
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as carbon
compound derived from plastic depolymerization (PMN P-18-1) 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 substance containing more than
1% of the particles less than 75 microns. It is a significant new use
to manufacture the substance other than by the enclosed process
described in the premanufacture notice.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
[[Page 59347]]
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11393 Branched cyclic and linear hydrocarbons from plastic
depolymerization (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
branched cyclic and linear hydrocarbons from plastic depolymerization
(PMN P-18-28) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section. The
requirements of this section do not apply to quantities of the
substance that have been refined or blended into other chemical or fuel
formulations.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (other than as a refinery feedstock or
a fuel blending additive).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(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.
Sec. 721.11394 Phosphonic acid, dimethyl ester, polymer with alkyl
diols (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
phosphonic acid, dimethyl ester, polymer with alkyl diols (PMN P-18-9)
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. It is a
significant new use to manufacture, process, or use the PMN substance
in a manner that generates a dust, mist, or aerosol.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 300.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11395 1H-Imidazole, 1,2,4,5-tetramethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-Imidazole,
1,2,4,5-tetramethyl- (PMN P-18-11, CAS No. 1739-83-9) 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 (f) and (g).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 7.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11396 1-Propanaminium, N,N'-(oxydi-2,1-ethanediyl)bis[3-
chloro-2-hydroxy-N,N-dimethyl-, chloride (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-propanaminium,
N,N'-(oxydi-2,1-ethanediyl)bis[3-chloro-2-hydroxy-N,N-dimethyl-,
chloride (1:2) (PMN P-18-170, CAS No. 96320-92-2) 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 substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 164.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11397 Fatty acid, polymer with alkanedioic acid dialkyl
ester, hydroxyl alkyl substituted alkanediol, substituted
carbomonocycle and alkylol substituted alkane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid, polymer with alkanedioic acid dialkyl ester, hydroxyl alkyl
substituted alkanediol, substituted carbomonocycle and alkylol
substituted alkane (PMN P-18-185) 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).
(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.
Sec. 721.11398 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substituted butyl amide, polymers with epichlorohydrin and
trimethylolpropane, sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as 2,5-
furandione, polymer with ethenylbenzene, 4-hydroxy-substituted butyl
amide, polymers with epichlorohydrin and trimethylolpropane, sodium
salts (PMN P-18-190) 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 other than as a pigment
dispersing aid for pigments in inkjet printing inks.
[[Page 59348]]
(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 these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11399 2,5-Furandione, polymer with ethenylbenzene, 4-
hydroxy-substitutedbutyl [3-[2-[1-[[(substitutedphenyl)amino]carbonyl]-
2-oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin
and trimthylolpropane, sodium salts (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as 2,5-
furandione, polymer with ethenylbenzene, 4-hydroxy-substitutedbutyl [3-
[2-[1-[[(substitutedphenyl)amino]carbonyl]-2-
oxopropyl]diazenyl]phenyl]methyl amide, polymers with epichlorohydrin
and trimthylolpropane, sodium salts (PMN P-18-191) 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 other than as a pigment
dispersing aid for pigments in inkjet printing inks.
(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 these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11400 Alkane, bis(alkoxymethyl)-dimethyl-0 ((generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alkane,
bis(alkoxymethyl)-dimethyl- (PMN P-18-223) 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 substance greater than the
confidential annual production volume specified 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) Limitations 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. 721.11401 [Reserved]
Sec. 721.11402 [Reserved]
Sec. 721.11403 [Reserved]
Sec. 721.11404 Butanedioic acid, 2-methylene-, polymer with 2-methyl-
2-[(1-oxo-2-propen-1-yl)amino]-1-propanesulfonic acid, sodium zinc
salt.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as butanedioic acid,
2-methylene-, polymer with 2-methyl-2-[(1-oxo-2-propen-1-yl)amino]-1-
propanesulfonic acid, sodium zinc salt (PMN P-18-285, CAS No. 2220235-
78-7) 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) Releases to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N = 143.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11405 Heteromonocycle, alkenoic 1:1 salt, polymer with
alpha-(2-methyl-1-oxo-2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-
ethanediyl) and methyl-alkenoic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
heteromonocycle, alkenoic 1:1 salt, polymer with alpha-(2-methyl-1-oxo-
2-propen-1-y)l-omega.-methoxypoly(oxy-1,2-ethanediyl) and methyl-
alkenoic acid (PMN P-18-300) 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 particles less than 50 microns. It is a
significant new use to use the PMN substance in a manner that results
in consumer inhalation or dermal exposure, and use other than as
sealed, single-use packets.
(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.
Sec. 721.11406 Substituted benzylic ether polyethylene glycol alkyl
ether derivative (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted benzylic ether polyethylene glycol alkyl ether derivative
(PMN P-18-394) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1).
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 4.
(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) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[[Page 59349]]
Sec. 721.11407 Alkylmultiheteroatom, 2-functionalisedalkyl-2-
hydroxyalkyl-, polymer with alkylheteroatom-multialkylfunctionalised
carbomonocycleheteroatom and multiglycidylether difunctionalised
polyalkylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylmultiheteroatom, 2-functionalisedalkyl-2-hydroxyalkyl-, polymer
with alkylheteroatom-multialkylfunctionalised carbomonocycleheteroatom
and multiglycidylether difunctionalised polyalkylene glycol (PMN P-18-
404) 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 substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11408 Benzenedicarboxylic acid, reaction products with
isobenzofurandione and diethylene glycol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenedicarboxylic acid, reaction products with isobenzofurandione and
diethylene glycol (PMN P-19-12) 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 substance in
any manner that results in inhalation exposures.
(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.
Sec. 721.11409 Formaldehyde, polymer with N1-(2-aminoethyl)-
alkanediamine, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-
(chloromethyl)oxirane, 4,4'-(1-methylethylidene)bis[Phenol] and alpha-
hydro-omega-hydroxypoly(oxy-1,2-ethanediyl) (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
formaldehyde, polymer with N1-(2-aminoethyl)-alkanediamine, 5-amino-
1,3,3-trimethylcyclohexanemethanamine, 2-(chloromethyl)oxirane, 4,4'-
(1-methylethylidene)bis[Phenol] and alpha-hydro-omega-hydroxypoly(oxy-
1,2-ethanediyl) (PMN P-19-31) 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 substance in
any manner that results in inhalation exposures.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) where N = 1.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) 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.
Sec. 721.11410 2,4-Hexadienoic acid, 1,1'-[2-ethyl-2-[(1-oxo-2,4-
hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,4-hexadienoic
acid, 1,1'-[2-ethyl-2-[(1-oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3-
propanediyl] ester (PMN P-19-71, CAS No. 2307636-51-5) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s).
(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.
(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. 721.11411 1-Butanol, reaction products with 2-[(2-propen-1-
yloxy)methyl]oxirane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1-butanol, reaction
products with 2-[(2-propen-1-yloxy)methyl]oxirane (PMN P-19-72) 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) Limitations 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).
[FR Doc. 2019-23388 Filed 11-1-19; 8:45 am]
BILLING CODE 6560-50-P