Significant New Use Rules on Certain Chemical Substances (19-4.B), 40371-40381 [2019-17148]
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Proposed Rules
CCR, and handling equipment within
the structure;
(3) Is designed and operated to ensure
containment and prevent fugitive dust
emissions from openings, such as doors,
windows and vents, and the tracking of
CCR from the structure by personnel or
equipment.
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Temporary accumulation means an
accumulation on the land that is neither
permanent nor indefinite. To
demonstrate that the accumulation on
the land is temporary, all CCR must be
removed from the pile at the site. The
entity engaged in the activity must have
a record in place, such as a contract,
purchase order, facility operation and
maintenance, or fugitive dust control
plan, documenting that all of the CCR in
the pile will be completely removed
according to a specific timeline.
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■ 4. In § 257.90 add paragraph (e)(6) to
read as follows:
§ 257.90
Applicability.
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(e) * * *
(6) A section at the beginning of the
annual report that provides an overview
of the current status of groundwater
monitoring and corrective action
programs for the CCR unit. At a
minimum, the summary must specify:
(i) At the start of the current annual
reporting period, whether the CCR unit
was operating under the detection
monitoring program in § 257.94 or the
assessment monitoring program in
§ 257.95;
(ii) At the end of the current annual
reporting period, whether the CCR unit
was operating under the detection
monitoring program in § 257.94 or the
assessment monitoring program in
§ 257.95;
(iii) If it was determined that there
was a statistically significant increase
over background levels for one or more
constituents listed in appendix III to
this part pursuant to § 257.94(e):
(A) Identify those constituents listed
in appendix III to this part and the
names of the monitoring wells
associated with such an increase; and
(B) Provide the date when the
assessment monitoring program was
initiated for the CCR unit.
(iv) If it was determined that there
was a statistically significant increase
above the groundwater protection
standard for one or more constituents
listed in appendix IV to this part
pursuant to § 257.95(g):
(A) Identify those constituents listed
in appendix IV to this part and the
names of the monitoring wells
associated with such an increase;
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(B) Provide the date when the
assessment of corrective measures was
initiated for the CCR unit; and
(C) Provide the date when the
assessment of corrective measures was
completed for the CCR unit.
(v) Whether a remedy was selected
pursuant to § 257.97 during the current
annual reporting period, and if so, the
date of remedy selection; and
(vi) Whether remedial activities were
initiated or are ongoing pursuant to
§ 257.98 during the current annual
reporting period.
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■ 5. In § 257.107 revise paragraph (a) to
read as follows:
§ 257.107 Publicly accessible internet site
requirements.
(a) Each owner or operator of a CCR
unit subject to the requirements of this
subpart must maintain a publicly
accessible internet site (CCR website)
containing the information specified in
this section. The owner or operator’s
website must be titled ‘‘CCR Rule
Compliance Data and Information.’’ The
website must ensure that all information
required to be posted is immediately
available to anyone visiting the site,
without requiring any prerequisite, such
as registration or a requirement to
submit a document request. All required
information must be clearly identifiable
and must be able to be printed and
downloaded by anyone accessing the
site. If the owner/operator changes the
URL at any point, they must notify EPA
via the ‘‘contact us’’ form on EPA’s CCR
website within 14 days of making the
change.
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[FR Doc. 2019–16916 Filed 8–13–19; 8:45 am]
BILLING CODE 6560–50–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2019–0442; FRL–9997–73]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (19–4.B)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for 17
chemical substances which are the
subject of premanufacture notices
(PMNs). This action would require
persons to notify EPA at least 90 days
SUMMARY:
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40371
before commencing manufacture
(defined by statute to include import) or
processing of any of these 17 chemical
substances for an activity that is
designated as a significant new use by
this proposed rule. This action would
further require that persons not
commence manufacture or processing
for the significant new use until they
have submitted a Significant New Use
Notice, and EPA has conducted a review
of the notice, made an appropriate
determination on the notice under
TSCA 5(a)(3), and has taken any risk
management actions as are required as
a result of that determination.
DATES: Comments must be received on
or before September 13, 2019.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2019–0442, by
one of the following methods:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the online
instructions for submitting comments.
Do not submit electronically any
information you consider to be
Confidential Business Information (CBI)
or other information whose disclosure is
restricted by statute.
• 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 https://
www.epa.gov/dockets/contacts.html.
Additional instructions on
commenting or visiting the docket,
along with more information about
dockets generally, is available at https://
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: moss.kenneth@epa.gov.
For general information contact: The
TSCA-Hotline, ABVI-Goodwill, 422
South Clinton Ave., Rochester, NY
14620; telephone number: (202) 554–
1404; email address: TSCA-Hotline@
epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by
this action if you manufacture
(including import), process, or use the
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Federal Register / Vol. 84, No. 157 / Wednesday, August 14, 2019 / Proposed Rules
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 (including
importers) or processors of one or more
subject chemical substances (NAICS
codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import 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 these proposed
SNURs would need to certify their
compliance with the SNUR
requirements should these proposed
rules be finalized. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20,
any persons who export or intend to
export a chemical substance that is the
subject of this proposed rule on or after
September 13, 2019 are subject to the
export notification provisions of TSCA
section 12(b) (15 U.S.C. 2611(b)) and
must comply with the export
notification requirements in 40 CFR part
707, subpart D.
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B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit CBI
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
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https://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 17 chemical
substances which were the subjects of
PMNs P–16–92, P–17–346, P–17–347/
348/349/350/351/352, P–17–395, P–18–
35, P–18–103, P–18–155/156, P–18–286,
P–18–392, P–19–29, and P–19–62.
These proposed SNURs would require
persons who intend to manufacture or
process any of these chemical
substances for an activity that is
designated as a significant new use to
notify EPA at least 90 days before
commencing that activity.
The record for the proposed SNURs
on these chemicals was established as
docket EPA–HQ–OPPT–2019–0442.
That record includes information
considered by the Agency in developing
these proposed SNURs.
B. What is the Agency’s authority for
taking this action?
Section 5(a)(2) of TSCA (15 U.S.C.
2604(a)(2)) authorizes EPA to determine
that a use of a chemical substance is a
‘‘significant new use.’’ EPA must make
this determination by rule after
considering all relevant factors,
including the four TSCA section 5(a)(2)
factors listed in Unit III. Once EPA
determines through rulemaking that a
use of a chemical substance is a
significant new use, TSCA section
5(a)(1)(B)(i) (15 U.S.C. 2604(a)(1)(B)(i))
requires persons to submit a significant
new use notice (SNUN) to EPA at least
90 days before they manufacture or
process the chemical substance for that
use. TSCA prohibits such
manufacturing or processing from
commencing until EPA has conducted a
review of the SNUN, made an
appropriate determination on the
SNUN, and taken such actions as are
required in association with that
determination (15 U.S.C.
2604(a)(1)(B)(ii)). 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. As described in Unit V., the
general SNUR provisions are found at
40 CFR part 721, subpart A.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
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and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to
these SNURs must comply with the
same 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
sections 5(h)(1), 5(h)(2), 5(h)(3), and
5(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. If
EPA determines that the use is not
likely to present an unreasonable risk,
EPA is required under TSCA section
5(g) to make public, and submit for
publication in the Federal Register, a
statement of EPA’s findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA’s
determination that a use of a chemical
substance is a significant new use must
be made after consideration of all
relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In determining what would constitute
a significant new use for the chemical
substances that are the subject of these
SNURs, EPA considered relevant
information about the toxicity of the
chemical substances, and potential
human exposures and environmental
releases that may be associated with the
conditions of use of the substances, in
the context of the four bulleted TSCA
section 5(a)(2) factors listed in this unit.
During its review of these chemicals,
EPA identified certain conditions of use
that are not intended by the submitters,
but reasonably foreseen to occur. EPA is
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proposing to designate those reasonably
foreseen conditions of use as significant
new uses.
IV. Substances Subject to This Proposed
Rule
EPA is proposing significant new use
and recordkeeping requirements for 17
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 nonconfidential chemical identities).
• Basis for the SNUR.
• Information identified by EPA that
would help characterize the potential
health and/or environmental effects of
the chemical substances if a
manufacturer or processor is
considering submitting a SNUN for a
significant new use designated by the
SNUR.
This information may include testing
not required to be conducted but which
would help characterize the potential
health and/or environmental effects of
the PMN substance. Any
recommendation for information
identified by EPA was made based on
EPA’s consideration of available
screening-level data, if any, as well as
other available information on
appropriate testing for the chemical
substance. Further, any such testing
identified by EPA that includes testing
on vertebrates was made after
consideration of available toxicity
information, computational toxicology
and bioinformatics, and highthroughput screening methods and their
prediction models. EPA also recognizes
that whether testing/further information
is needed will depend on the specific
exposure and use scenario in the SNUN.
EPA encourages all SNUN submitters to
contact EPA to discuss any potential
future testing. See Unit VII. for more
information.
• CFR citation assigned in the
regulatory text section of these proposed
rules.
The regulatory text section of these
proposed rules specifies the activities
designated as significant new uses.
Certain new uses, including production
volume limits and other uses designated
in the proposed rules, may be claimed
as CBI.
The chemical substances that are the
subject of these proposed SNURs are
undergoing premanufacture review. In
addition to those conditions of use
intended by the submitter, EPA has
identified certain other reasonably
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foreseen conditions of use. EPA has
preliminarily determined that the
chemicals under their intended
conditions of use are not likely to
present an unreasonable risk. However,
EPA has not assessed risks associated
with the reasonably foreseen conditions
of use for these chemicals. EPA is
proposing to designate these reasonably
foreseen and other potential conditions
of use as significant new uses. As a
result, those conditions of use are no
longer reasonably foreseen to occur
without first going through a separate,
subsequent EPA review and
determination process associated with a
SNUN.
The substances subject to these
proposed rules are as follows:
PMN Number: P–16–92
Chemical name: Polymeric polyamine
(generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as industrial coatings,
open non-dispersive use. Based on the
physical/chemical properties of the
PMN substance and Structure Activity
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for irritation,
corrosion, sensitization and lung effects
(based on cationic binding to lung
tissues), and toxicity to aquatic
organisms at surface water
concentrations exceeding 10 ppb, if the
chemical substance is used in ways
other than as intended by the PMN
submitter. Other conditions of use of the
PMN substance that EPA intends to
assess before they occur include the
following:
• Use of the PMN substance for other
than for the confidential use described
in the PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
about the human health and
environmental toxicity of the PMN
substance 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 sensitization and
environmental toxicity testing and
pulmonary effects would help
characterize the potential health and
environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.11330.
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PMN Number: P–17–346
Chemical name: Triarylalkyl
phosphonium halide salt (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a destructive use.
Based on the physical/chemical
properties of the PMN substance and
Structure Activity Relationships (SAR)
analysis of test data on analogous
substances, EPA has identified concerns
for Acute toxicity, irritation/corrosion
effects to the skin, eyes, and respiratory
tract, systemic toxicity, and
environmental toxicity if the chemical
substance is used in ways other than as
intended by the PMN submitter. Other
conditions of use of the PMN substance
that EPA intends to assess before they
occur include the following:
1. Use for other than the confidential
uses identified in the PMN.
2. Release of the PMN substance into
the waters of the United States resulting
in surface water concentrations
exceeding 5 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
about the human health and
environmental toxicity of the PMN
substance 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 acute
toxicity, specific target organ toxicity,
irritation, and environmental toxicity
testing would help characterize the
potential health and environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.11331.
PMN Numbers: P–17–347, P–17–348, P–
17–349, P–17–350, P–17–351 and P–17–
352
Chemical names: Oxirane, 2-methyl-,
polymer with oxirane, mono(2butyloctyl) ether (P–17–347); Oxirane,
2-methyl-, polymer with oxirane,
mono(2-hexyldecyl) ether (P–17–348);
Oxirane, 2-methyl-, polymer with
oxirane, mono(2-octyldodecyl) ether (P–
17–349); Oxirane, 2-methyl-, polymer
with oxirane, mono(2-decyltetradecyl)
ether (P–17–350); Oxirane, 2-methyl-,
polymer with oxirane, mono(2dodecylhexadecyl) ether (P–17–351);
Oxirane, 2-methyl-, polymer with
oxirane, mono(2-tetradecyloctadecyl)
ether (P–17–352).
CAS numbers: 252756–20–0 (P–17–
347); 125005–52–9 (P–17–348); 102640–
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44–8 (P–17–349); 72484–69–6 (P–17–
350); 102640–42–6 (P–17–351); and
102640–46–0 (P–17–352).
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be as an oilfield
surfactant. Based on the physical/
chemical properties of the PMN
substances and Structure Activity
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for lung toxicity and
toxicity to aquatic organisms, if the
chemical substances are used in ways
other than as intended by the PMN
submitter. Other conditions of use of the
PMN substances that EPA intends to
assess before they occur include the
following:
1. Use of the PMN substances other
than for the confidential use described
in the PMNs.
2. Any manufacture, processing or use
of the PMN substances that results in
inhalation exposure.
3. Annual production volume
exceeding 5,000 kilograms of the PMN
substances in aggregate.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
about the human health and
environmental toxicity of the PMN
substances 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 and
environmental toxicity testing would
help characterize the potential health
and environmental effects of the PMN
substances.
CFR Citations: 40 CFR 721.11332 (P–
17–347), 40 CFR 721.11333 (P–17–348),
40 CFR 721.11334 (P–17–349), 40 CFR
721.11335 (P–17–350), 40 CFR
721.11336 (P–17–351), and 40 CFR
721.11337 (P–17–352).
PMN Number: P–17–395
Chemical name: Alkyl tri
dithiocarbamate tri salt (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a water treatment
additive. Based on the physical/
chemical properties of the PMN
substance and Structure Activity
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for developmental
toxicity, neurotoxicity, carcinogenicity,
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and skin sensitization, and toxicity to
aquatic organisms, if the chemical
substance is used in ways other than as
intended by the PMN submitter. Other
conditions of use of the PMN substance
that EPA intends to assess before they
occur include the following:
1. Use of the PMN substance other
than for the confidential uses described
in the PMN.
2. Any manufacture, processing or use
of the PMN substance that results in
inhalation exposure.
3. Release to the PMN substance into
the waters of the United States resulting
in surface water concentrations
exceeding 1 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
about the human health and
environmental toxicity of the PMN
substance 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
sensitization, reproductive/
developmental toxicity, specific target
organ toxicity, and environmental
toxicity testing would help characterize
the potential health and environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.11338.
PMN Number: P–18–35
Chemical name: Methacrylic acid
heterocyclic alkyl ester (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a monomer for
polymer applications. Based on the
physical/chemical properties of the
PMN substance and Structure Activity
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for skin and eye
irritation and reproductive/
developmental toxicity if the chemical
substance is used in ways other than as
intended by the PMN submitter. Other
conditions of use of the PMN substance
that EPA intends to assess before they
occur include the following:
• Uses other than the confidential
uses identified in the PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ this
condition of use.
Potentially useful information: EPA
has determined that certain information
about the human health toxicity of the
PMN substance may be potentially
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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 genetic toxicology testing
would help characterize the potential
health effects of the PMN substance.
CFR citation: 40 CFR 721.11339.
PMN Number: P–18–103
Chemical name: Alkylnitrile
imidazole (generic).
CAS number: Not available.
Basis for action: The PMN states that
the use of the substance will be as an
intermediate for amine manufacture.
Based on the physical/chemical
properties of the PMN substance and
Structure Activity Relationships (SAR)
analysis of test data on analogous
substances, EPA has identified concerns
for eye irritation, reproductive/
developmental toxicity, and specific
target organ toxicity if the chemical
substance is used in ways other than as
intended by the PMN submitter. Other
conditions of use of the PMN substance
that EPA intends to assess before they
occur include the following:
1. Use for other than an intermediate
for amine manufacture.
2. Any manufacture, processing or use
of the PMN substance that results in
inhalation exposure.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
about the human health toxicity of the
PMN substance 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 specific target organ toxicity,
reproductive/developmental toxicity,
and eye irritation testing would help
characterize the potential health effects
of the PMN substance.
CFR citation: 40 CFR 721.113340.
PMN Numbers: P–18–155 and P–18–156
Chemical names: Crosslinked
polymer of alkyl acrylamides, acrylate
esters, and alkyl acrylamide sulfonate
salt (generic).
CAS number: Not available.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substance will be as a component in
cement. Based on the physical/chemical
properties of the PMN substances and
Structure Activity Relationships (SAR)
analysis of test data on analogous
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substances, EPA has identified concerns
for lung effects and carcinogenicity if
the chemical substance is used in ways
other than as intended by the PMN
submitter. Other conditions of use of the
PMN substances that EPA intends to
assess before they occur include the
following:
1. Use of the PMN substances other
than for the confidential uses described
in the PMNs.
2. Manufacture (including import) of
the PMN substances with greater than
10% of particles <10 microns.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
about the human health toxicity of the
PMN substances 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 pulmonary effects testing
would help characterize the potential
health effects of the PMN substances.
CFR citation: 40 CFR 721.11341 (P–
18–155 and P–18–156).
PMN Number: P–18–286
Chemical name: Propane, 1,1,1,3,3,3hexafluoro-2-methoxy-.
CAS number: 13171–18–1.
Basis for action: The PMN states that
the use of the substance will be as
solvent in vapor degreasing/vapor
cleaning and other confidential uses
generically described as heat transfer
fluid and additive contained/sealed in
low voltage electronics. Based on the
physical/chemical properties of the
PMN substance and Structure Activity
Relationships (SAR) analysis of test data
on analogous substances, EPA has
identified concerns for irritation and
developmental neurotoxicity effects, if
the chemical substance is used in ways
other than as intended by the PMN
submitter. Other conditions of use of the
PMN substance that EPA intends to
assess before they occur include the
following:
1. Use of the PMN substance other
than as a solvent in vapor degreasing/
vapor cleaning or additional
confidential uses described in the PMN.
2. Manufacture (including import),
processing or use of the PMN substance
without the transport container loading
process described in the PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
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about the human health toxicity of the
PMN substance 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 skin irritation and
developmental neurotoxicity testing
would help characterize the potential
health effects of the PMN substance.
CFR citation: 40 CFR 721.11342.
PMN Number: P–18–392
Chemical name: Heteromonocycle,
alkenyl alkyl (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an intermediate
chemical. Based on the physical/
chemical properties of and test data on
the PMN substance and Structure
Activity Relationships (SAR) analysis of
test data on analogous substances, EPA
has identified concerns for irritation/
corrosion and carcinogenicity if the
chemical substance is used in ways
other than as intended by the PMN
submitter. Other conditions of use of the
PMN substance that EPA intends to
assess before they occur include the
following:
• No use other than the confidential
uses identified in the PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
about the human health toxicity of the
PMN substance 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 absorption, skin and eye
irritation/corrosion, and carcinogenicity
testing would help characterize the
potential health effects of the PMN
substance.
CFR citation: 40 CFR 721.11343.
PMN Number: P–19–29
Chemical name: Phosphonium,
tributylethyl-, diethyl phosphate (1:1).
CAS number: 20445–94–7.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a catalyst. Based on
the physical/chemical properties of and
available data on the PMN substance
and Structure Activity Relationships
(SAR) analysis of test data on analogous
substances, EPA has identified concerns
for irritation, corrosion, neurotoxicity,
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reproductive toxicity, liver toxicity, and
toxicity to aquatic organisms at surface
water concentrations exceeding 51 ppb,
if the chemical substance is used in
ways other than as intended by the PMN
submitter. Other conditions of use of the
PMN substance that EPA intends to
assess before they occur include the
following:
1. Use of the PMN substance other
than for the confidential uses described
in the PMN.
2. Release to the PMN substance into
the waters of the United States resulting
in surface water concentrations
exceeding 51 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ these
conditions of use.
Potentially useful information: EPA
has determined that certain information
about the human health and
environmental fate of the PMN
substance 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 irritation, specific target organ
toxicity, neurotoxicity, and reproductive
toxicity, and environmental fate testing
would help characterize the potential
health and environmental effects of the
PMN substance.
CFR citation: 40 CFR 721.11344.
PMN Number: P–19–62
Chemical name:
Hydrochlorofluoroolefin (generic).
CAS number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as an industrial
solvent. Based on the physical/chemical
properties of the PMN substance and
Structure Activity Relationships (SAR)
analysis of test data on analogous
substances, EPA has identified concerns
for neurotoxicity, systemic toxicity,
reproductive toxicity, and lung effects if
the chemical substance is used in ways
other than as intended by the PMN
submitter. Other conditions of use of the
PMN substance that EPA intends to
assess before they occur include the
following:
• Use other than for the confidential
uses identified in the PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ this
condition of use.
Potentially useful information: EPA
has determined that certain information
about the human health toxicity of the
PMN substance may be potentially
useful to characterize the health effects
of the PMN substance if a manufacturer
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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
and neurotoxicity testing would help
characterize the potential health effects
of the PMN substance.
CFR citation: 40 CFR 721.11345.
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are the
subject of these proposed SNURs and as
further discussed in Unit IV, EPA
identified certain other reasonably
foreseen conditions of use, in addition
to those conditions of use intended by
the submitter. EPA has preliminarily
determined that the chemical under the
intended conditions of use is not likely
to present an unreasonable risk.
However, EPA has not assessed risks
associated with the reasonably foreseen
conditions of use. EPA is proposing to
designate these conditions of use as
significant new uses to ensure that they
are no longer reasonably foreseen to
occur without first going through a
separate, subsequent EPA review and
determination process associated with a
SNUN.
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B. Objectives
EPA is proposing SNURs for 17
specific chemical substances which are
undergoing premanufacture review
because the Agency wants to achieve
the following objectives with regard to
the significant new uses that would be
designated in this proposed rule:
• EPA would have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing or processing a
listed chemical substance for the
described significant new use.
• EPA would be obligated to make a
determination under TSCA section
5(a)(3) regarding the use described in
the SNUN, under the conditions of use.
The Agency will either determine under
TSCA section 5(a)(3)(C) that the
significant new use is not likely to
present an unreasonable risk, including
an unreasonable risk to a potentially
exposed or susceptible subpopulation
identified as relevant by the
Administrator under the conditions of
use, or make a determination under
TSCA section 5(a)(3) (A) or (B) and take
the required regulatory action associated
with the determination, before
manufacture or processing for the
significant new use of the chemical
substance can occur.
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• EPA would be able to complete its
review and determination on each of the
PMN substances, while deferring
analysis on the significant new uses
proposed in these rules unless and until
the Agency receives a SNUN.
Issuance of a proposed SNUR for a
chemical substance does not signify that
the chemical substance is listed on the
TSCA Inventory. Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
internet at https://www.epa.gov/tscainventory.
VI. Applicability of the Proposed Rules
to Uses Occurring Before the Effective
Date of the Final Rule
To establish a significant new use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this proposed rule were
undergoing premanufacture review at
the time of signature of this proposed
rule and were not on the TSCA
Inventory. 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 the chemical
substances subject to these proposed
SNURs, EPA concludes that the
proposed significant new uses are not
ongoing.
EPA designates August 1, 2019 (date
of web posting) 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 on or after 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 EPA would have to
take action under section 5 allowing
manufacture or processing to proceed.
In developing this proposed rule, EPA
has recognized that, given EPA’s general
practice of posting proposed rules on its
website a week or more in advance of
Federal Register publication, this
objective could be thwarted even before
Federal Register publication of the
proposed rule.
VII. Development and Submission of
Information
EPA recognizes that TSCA section 5
does not require development of any
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particular new information (e.g.,
generating test data) before submission
of a SNUN. There is an exception: If a
person is required to submit information
for a chemical substance pursuant to a
rule, order or consent agreement under
TSCA section 4 (15 U.S.C. 2603), then
TSCA section 5(b)(1)(A) (15 U.S.C.
2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of
submission of the SNUN.
In the absence of a rule, order, or
consent agreement under TSCA section
4 covering the chemical substance,
persons are required only to submit
information in their possession or
control and to describe any other
information known 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 for all SNURs listed here.
Descriptions are provided for
informational purposes. The potentially
useful information identified in Unit IV.
will be useful to EPA’s evaluation in the
event that someone submits a SNUN for
the significant new use. Companies who
are considering submitting a SNUN are
encouraged, but not required, to develop
the information on the substance, which
may assist with EPA’s analysis of the
SNUN.
EPA strongly encourages persons,
before performing any testing, to consult
with the Agency pertaining to protocol
selection. Furthermore, pursuant to
TSCA section 4(h), which pertains to
reduction of testing in vertebrate
animals, EPA encourages consultation
with the Agency on the use of
alternative test methods and strategies
(also called New Approach
Methodologies, or NAMs), if available,
to generate the recommended test data.
EPA encourages dialog with Agency
representatives to help determine how
best the submitter can meet both the
data needs and the objective of TSCA
section 4(h).
The potentially useful information
described in Unit IV. may not be the
only means of providing information to
evaluate the chemical substance
associated with the significant new
uses. However, submitting a SNUN
without any test data may increase the
likelihood that EPA will take action
under TSCA section 5(e) or 5(f). EPA
recommends that potential SNUN
submitters contact EPA early enough so
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
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• 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 https://
www.epa.gov/reviewing-new-chemicalsunder-toxic-substances-control-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this proposed rule. EPA’s complete
economic analysis is available in the
docket under docket ID number EPA–
HQ–OPPT–2019–0263.
X. Statutory and Executive Order
Reviews
Additional information about these
statutes and Executive Orders can be
found at https://www.epa.gov/lawsregulations-and-executive-orders.
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A. Executive Order 12866: Regulatory
Planning and Review and Executive
Order 13563: Improving Regulations
and Regulatory Review
This proposed rule would establish
SNURs for 8 new chemical substances
that were the subject of PMNs. The
Office of Management and Budget
(OMB) has exempted these types of
actions from review under Executive
Order 12866 (58 FR 51735, October 4,
1993) and 13563 (76 FR 3821, January
21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501
et seq., an Agency may not conduct or
sponsor, and a person is not required to
respond to a collection of information
that requires OMB approval under PRA,
unless it has been approved by OMB
and displays a currently valid OMB
control number. The OMB control
numbers for EPA’s regulations in title 40
of the CFR, after appearing in the
Federal Register, are listed in 40 CFR
part 9, and included on the related
collection instrument or form, if
applicable.
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The information collection
requirements related to this action have
already been approved by OMB
pursuant to 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 section 605(b) of the RFA,
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, 12 in FY2016, 13 in FY2017,
and 11 in FY2018, 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
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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
proposed rule. As such, EPA has
determined that this proposed rule does
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. 1531–1538 et seq.).
E. Executive Order 13132: Federalism
This action would not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999).
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This 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 does 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 proposed rule.
G. Executive Order 13045: Protection of
Children From Environmental Health
and Safety Risks
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
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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 action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
I. National Technology Transfer and
Advancement Act (NTTAA)
In addition, since this action does 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 action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898 (59 FR 7629,
February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: July 31, 2019.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, it is proposed that 40 CFR
part 721 is amended as follows:
PART 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
2. Add §§ 721.11330 through
721.11345 to subpart E to read as
follows:
■
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Subpart E—Significant New Uses for
Specific Chemical Substances
Sec.
§ 721.11330 Polymer of polyethylene
polyamine and alkanediol diglycidyl
ether (generic).
§ 721.11331 Triarylalkyl phosphonium
halide salt (generic).
§ 721.11332 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-butyloctyl) ether.
§ 721.11333 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-hexyldecyl) ether.
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§ 721.11334 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-octyldodecyl)
ether.
§ 721.11335 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-decyltetradecyl)
ether.
§ 721.11336 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-dodecylhexadecyl)
ether.
§ 721.11337 Oxirane, 2-methyl-, polymer
with oxirane, mono(2tetradecyloctadecyl) ether.
§ 721.11338 Alkyl tri dithiocarbamate tri
salt (generic).
§ 721.11339 Methacrylic acid heterocyclic
alkyl ester (generic).
§ 721.11340 Alkylnitrile imidazole
(generic).
§ 721.11341 Crosslinked polymer of alkyl
acrylamides, acrylate esters, and alkyl
acrylamide sulfonate salt (generic).
§ 721.11342 Propane, 1,1,1,3,3,3hexafluoro-2-methoxy-.
§ 721.11343 Heteromonocycle, alkenyl alkyl
(generic).
§ 721.11344 Phosphonium, tributylethyl-,
diethyl phosphate (1:1).
§ 721.11345 Hydrochlorofluoroolefin
(generic).
Subpart E—Significant New Uses for
Specific Chemical Substances
§ 721.11330 Polymer of polyethylene
polyamine and alkanediol diglycidyl ether
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as polymer of polyethylene
polyamine and alkanediol diglycidyl
ether (PMN P–16–92) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11331 Triarylalkyl phosphonium
halide salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
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(1) The chemical substance generically
identified as triarylalkyl phosphonium
halide salt (PMN P–17–346) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N = 5.
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11332 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-butyloctyl) ether.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-methyl-, polymer with
oxirane, mono(2-butyloctyl) ether. (P–
17–347, CASRN 252756–20–0) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (s) (5,000
kilograms, aggregate of PMN substances
P–17–347, P–17–348, P–17–349, P–17–
350, P–17–351 and P–17–352). It is a
significant new use to manufacture,
process or use the PMN substances in a
manner that results in inhalation
exposure.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
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of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11333 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-hexyldecyl) ether.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-methyl-, polymer with
oxirane, mono(2-hexyldecyl) ether (P–
17–348, CASRN 125005–52–9) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (s) (5,000
kilograms, aggregate of PMN substances
P–17–347, P–17–348, P–17–349, P–17–
350, P–17–351 and P–17–352). It is a
significant new use to manufacture,
process or use the PMN substances in a
manner that results in inhalation
exposure.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
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§ 721.11334 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-octyldodecyl) ether.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-methyl-, polymer with
oxirane, mono(2-octyldodecyl) ether (P–
17–349, CASRN 102640–44–8) is subject
to reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (s) (5,000
kilograms, aggregate of PMN substances
P–17–347, P–17–348, P–17–349, P–17–
350, P–17–351 and P–17–352). It is a
significant new use to manufacture,
process or use the PMN substances in a
manner that results in inhalation
exposure.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
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apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11335 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-decyltetradecyl) ether.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-methyl-, polymer with
oxirane, mono(2-decyltetradecyl) ether
(P–17–350, CASRN 72484–69–6) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (s) (5,000
kilograms, aggregate of PMN substances
P–17–347, P–17–348, P–17–349, P–17–
350, P–17–351 and P–17–352). It is a
significant new use to manufacture,
process or use the PMN substances in a
manner that results in inhalation
exposure.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11336 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-dodecylhexadecyl)
ether.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
Oxirane, 2-methyl-, polymer with
oxirane, mono(2-dodecylhexadecyl)
ether (P–17–351, CASRN 102640–42–6)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
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(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (s) (5,000
kilograms, aggregate of PMN substances
P–17–347, P–17–348, P–17–349, P–17–
350, P–17–351 and P–17–352). It is a
significant new use to manufacture,
process or use the PMN substances in a
manner that results in inhalation
exposure.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11337 Oxirane, 2-methyl-, polymer
with oxirane, mono(2-tetradecyloctadecyl)
ether.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
oxirane, 2-methyl-, polymer with
oxirane, mono(2-tetradecyloctadecyl)
ether (P–17–352, CASRN 102640–46–0)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j) and (s) (5,000
kilograms, aggregate of PMN substances
P–17–347, P–17–348, P–17–349, P–17–
350, P–17–351 and P–17–352). It is a
significant new use to manufacture,
process or use the PMN substances in a
manner that results in inhalation
exposure.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
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(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11338 Alkyl tri dithiocarbamate tri
salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as alkyl tri dithiocarbamate tri
salt (PMN P–17–395) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j). It is a significant
new use to manufacture, process, or use
the substance in a manner that results
in inhalation exposure.
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N = 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
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
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§ 721.11339 Methacrylic acid heterocyclic
alkyl ester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as methacrylic acid
heterocyclic alkyl ester (PMN P–18–35)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
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§ 721.11340
(generic).
Alkylnitrile imidazole
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
alkylnitrile imidazole (P–18–103) 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 for use other than as
an intermediate for amine manufacture.
It is a significant new use to
manufacture, process or use the PMN
substance in a manner that results in
inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11341 Crosslinked polymer of alkyl
acrylamides, acrylate esters, and alkyl
acrylamide sulfonate salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances generically
identified as crosslinked polymer of
alkyl acrylamides, acrylate esters, and
alkyl acrylamide sulfonate salt (PMNs
P–18–155 and P–18–156) are subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j). It is a significant
new use to manufacture the PMN
substances with greater than 10% of the
particles less than 10 microns.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
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(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11342 Propane, 1,1,1,3,3,3hexafluoro-2-methoxy-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
propane, 1,1,1,3,3,3-hexafluoro-2methoxy- (PMN P–18–286, CASRN
13171–18–1) 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. Requirements as
specified in § 721.80(j). It is a significant
new use to manufacture, process or use
the substance without the transport
container loading process described in
the PMN.
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11343 Heteromonocycle, alkenyl
alkyl (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as heteromonocycle, alkenyl
alkyl (PMN P–18–392) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved].
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
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applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11344 Phosphonium, tributylethyl-,
diethyl phosphate (1:1).
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phosphonium, tributylethyl-, diethyl
phosphate (1:1) (PMN P–19–29, CASRN
20445–94–7) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N = 51.
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(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers, importers,
and processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
§ 721.11345
(generic).
Hydrochlorofluoroolefin
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance generically
identified as hydrochlorofluoroolefin
(P–19–62) is subject to reporting under
this section for the significant new uses
described in paragraph (a)(2) of this
section.
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(2) The significant new uses are:
(i) Industrial, Commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), (i), (j) and (k)
are applicable to manufacturers,
importers, and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
[FR Doc. 2019–17148 Filed 8–13–19; 8:45 am]
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 84, Number 157 (Wednesday, August 14, 2019)]
[Proposed Rules]
[Pages 40371-40381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17148]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2019-0442; FRL-9997-73]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-4.B)
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: EPA is proposing significant new use rules (SNURs) under the
Toxic Substances Control Act (TSCA) for 17 chemical substances which
are the subject of premanufacture notices (PMNs). This action would
require persons to notify EPA at least 90 days before commencing
manufacture (defined by statute to include import) or processing of any
of these 17 chemical substances for an activity that is designated as a
significant new use by this proposed rule. This action would further
require that persons not commence manufacture or processing for the
significant new use until they have submitted a Significant New Use
Notice, and EPA has conducted a review of the notice, made an
appropriate determination on the notice under TSCA 5(a)(3), and has
taken any risk management actions as are required as a result of that
determination.
DATES: Comments must be received on or before September 13, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0442, by one of the following methods:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
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 https://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at https://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
(including import), process, or use the
[[Page 40372]]
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 (including importers) or processors of one
or more subject chemical substances (NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
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 these proposed SNURs
would need to certify their compliance with the SNUR requirements
should these proposed rules be finalized. The EPA policy in support of
import certification appears at 40 CFR part 707, subpart B. In
addition, pursuant to 40 CFR 721.20, any persons who export or intend
to export a chemical substance that is the subject of this proposed
rule on or after September 13, 2019 are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) 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 CBI to EPA through regulations.gov
or email. Clearly mark the part or all of the information that you
claim to be CBI. For CBI information in a disk or CD-ROM that you mail
to EPA, mark the outside of the disk or CD-ROM as CBI and then identify
electronically within the disk or CD-ROM the specific information that
is claimed as CBI. In addition to one complete version of the comment
that includes information claimed as CBI, a copy of the comment that
does not contain the information claimed as CBI must be submitted for
inclusion in the public docket. Information so marked will not be
disclosed except in accordance with procedures set forth in 40 CFR part
2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at https://www.epa.gov/dockets/comments.html.
II. Background
A. What action is the Agency taking?
EPA is proposing these SNURs under TSCA section 5(a)(2) for 17
chemical substances which were the subjects of PMNs P-16-92, P-17-346,
P-17-347/348/349/350/351/352, P-17-395, P-18-35, P-18-103, P-18-155/
156, P-18-286, P-18-392, P-19-29, and P-19-62. These proposed SNURs
would require persons who intend to manufacture or process any of these
chemical substances for an activity that is designated as a significant
new use to notify EPA at least 90 days before commencing that activity.
The record for the proposed SNURs on these chemicals was
established as docket EPA-HQ-OPPT-2019-0442. That record includes
information considered by the Agency in developing these proposed
SNURs.
B. What is the Agency's authority for taking this action?
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to
determine that a use of a chemical substance is a ``significant new
use.'' EPA must make this determination by rule after considering all
relevant factors, including the four TSCA section 5(a)(2) factors
listed in Unit III. Once EPA determines through rulemaking that a use
of a chemical substance is a significant new use, TSCA section
5(a)(1)(B)(i) (15 U.S.C. 2604(a)(1)(B)(i)) requires persons to submit a
significant new use notice (SNUN) to EPA at least 90 days before they
manufacture or process the chemical substance for that use. TSCA
prohibits such manufacturing or processing from commencing until EPA
has conducted a review of the SNUN, made an appropriate determination
on the SNUN, and taken such actions as are required in association with
that determination (15 U.S.C. 2604(a)(1)(B)(ii)). 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. As described in Unit V., the
general SNUR provisions are found at 40 CFR part 721, subpart A.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to these SNURs must comply with the
same 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 sections 5(h)(1),
5(h)(2), 5(h)(3), and 5(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. If EPA determines
that the use is not likely to present an unreasonable risk, EPA is
required under TSCA section 5(g) to make public, and submit for
publication in the Federal Register, a statement of EPA's findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining what would constitute a significant new use for the
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances, and
potential human exposures and environmental releases that may be
associated with the conditions of use of the substances, in the context
of the four bulleted TSCA section 5(a)(2) factors listed in this unit.
During its review of these chemicals, EPA identified certain conditions
of use that are not intended by the submitters, but reasonably foreseen
to occur. EPA is
[[Page 40373]]
proposing to designate those reasonably foreseen conditions of use as
significant new uses.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for 17 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.
Information identified by EPA that would help characterize
the potential health and/or environmental effects of the chemical
substances if a manufacturer or processor is considering submitting a
SNUN for a significant new use designated by the SNUR.
This information may include testing not required to be conducted
but which would help characterize the potential health and/or
environmental effects of the PMN substance. Any recommendation for
information identified by EPA was made based on EPA's consideration of
available screening-level data, if any, as well as other available
information on appropriate testing for the chemical substance. Further,
any such testing identified by EPA that includes testing on vertebrates
was made after consideration of available toxicity information,
computational toxicology and bioinformatics, and high-throughput
screening methods and their prediction models. EPA also recognizes that
whether testing/further information is needed will depend on the
specific exposure and use scenario in the SNUN. EPA encourages all SNUN
submitters to contact EPA to discuss any potential future testing. See
Unit VII. for more information.
CFR citation assigned in the regulatory text section of
these proposed rules.
The regulatory text section of these proposed rules specifies the
activities designated as significant new uses. Certain new uses,
including production volume limits and other uses designated in the
proposed rules, may be claimed as CBI.
The chemical substances that are the subject of these proposed
SNURs are undergoing premanufacture review. In addition to those
conditions of use intended by the submitter, EPA has identified certain
other reasonably foreseen conditions of use. EPA has preliminarily
determined that the chemicals under their intended conditions of use
are not likely to present an unreasonable risk. However, EPA has not
assessed risks associated with the reasonably foreseen conditions of
use for these chemicals. EPA is proposing to designate these reasonably
foreseen and other potential conditions of use as significant new uses.
As a result, those conditions of use are no longer reasonably foreseen
to occur without first going through a separate, subsequent EPA review
and determination process associated with a SNUN.
The substances subject to these proposed rules are as follows:
PMN Number: P-16-92
Chemical name: Polymeric polyamine (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as industrial coatings, open
non-dispersive use. Based on the physical/chemical properties of the
PMN substance and Structure Activity Relationships (SAR) analysis of
test data on analogous substances, EPA has identified concerns for
irritation, corrosion, sensitization and lung effects (based on
cationic binding to lung tissues), and toxicity to aquatic organisms at
surface water concentrations exceeding 10 ppb, if the chemical
substance is used in ways other than as intended by the PMN submitter.
Other conditions of use of the PMN substance that EPA intends to assess
before they occur include the following:
Use of the PMN substance for other than for the
confidential use described in the PMN.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substance 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 sensitization and environmental toxicity testing and pulmonary
effects would help characterize the potential health and environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.11330.
PMN Number: P-17-346
Chemical name: Triarylalkyl phosphonium halide salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a destructive use. Based
on the physical/chemical properties of the PMN substance and Structure
Activity Relationships (SAR) analysis of test data on analogous
substances, EPA has identified concerns for Acute toxicity, irritation/
corrosion effects to the skin, eyes, and respiratory tract, systemic
toxicity, and environmental toxicity if the chemical substance is used
in ways other than as intended by the PMN submitter. Other conditions
of use of the PMN substance that EPA intends to assess before they
occur include the following:
1. Use for other than the confidential uses identified in the PMN.
2. Release of the PMN substance into the waters of the United
States resulting in surface water concentrations exceeding 5 ppb.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substance 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 acute toxicity, specific target organ toxicity,
irritation, and environmental toxicity testing would help characterize
the potential health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.11331.
PMN Numbers: P-17-347, P-17-348, P-17-349, P-17-350, P-17-351 and P-17-
352
Chemical names: Oxirane, 2-methyl-, polymer with oxirane, mono(2-
butyloctyl) ether (P-17-347); Oxirane, 2-methyl-, polymer with oxirane,
mono(2-hexyldecyl) ether (P-17-348); Oxirane, 2-methyl-, polymer with
oxirane, mono(2-octyldodecyl) ether (P-17-349); Oxirane, 2-methyl-,
polymer with oxirane, mono(2-decyltetradecyl) ether (P-17-350);
Oxirane, 2-methyl-, polymer with oxirane, mono(2-dodecylhexadecyl)
ether (P-17-351); Oxirane, 2-methyl-, polymer with oxirane, mono(2-
tetradecyloctadecyl) ether (P-17-352).
CAS numbers: 252756-20-0 (P-17-347); 125005-52-9 (P-17-348);
102640-
[[Page 40374]]
44-8 (P-17-349); 72484-69-6 (P-17-350); 102640-42-6 (P-17-351); and
102640-46-0 (P-17-352).
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as an oilfield surfactant.
Based on the physical/chemical properties of the PMN substances and
Structure Activity Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for lung toxicity and
toxicity to aquatic organisms, if the chemical substances are used in
ways other than as intended by the PMN submitter. Other conditions of
use of the PMN substances that EPA intends to assess before they occur
include the following:
1. Use of the PMN substances other than for the confidential use
described in the PMNs.
2. Any manufacture, processing or use of the PMN substances that
results in inhalation exposure.
3. Annual production volume exceeding 5,000 kilograms of the PMN
substances in aggregate.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substances 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 and environmental toxicity testing
would help characterize the potential health and environmental effects
of the PMN substances.
CFR Citations: 40 CFR 721.11332 (P-17-347), 40 CFR 721.11333 (P-17-
348), 40 CFR 721.11334 (P-17-349), 40 CFR 721.11335 (P-17-350), 40 CFR
721.11336 (P-17-351), and 40 CFR 721.11337 (P-17-352).
PMN Number: P-17-395
Chemical name: Alkyl tri dithiocarbamate tri salt (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a water treatment
additive. Based on the physical/chemical properties of the PMN
substance and Structure Activity Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for
developmental toxicity, neurotoxicity, carcinogenicity, and skin
sensitization, and toxicity to aquatic organisms, if the chemical
substance is used in ways other than as intended by the PMN submitter.
Other conditions of use of the PMN substance that EPA intends to assess
before they occur include the following:
1. Use of the PMN substance other than for the confidential uses
described in the PMN.
2. Any manufacture, processing or use of the PMN substance that
results in inhalation exposure.
3. Release to the PMN substance into the waters of the United
States resulting in surface water concentrations exceeding 1 ppb.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental toxicity of the
PMN substance 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 sensitization, reproductive/developmental toxicity,
specific target organ toxicity, and environmental toxicity testing
would help characterize the potential health and environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.11338.
PMN Number: P-18-35
Chemical name: Methacrylic acid heterocyclic alkyl ester (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a monomer for polymer
applications. Based on the physical/chemical properties of the PMN
substance and Structure Activity Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for skin and
eye irritation and reproductive/developmental toxicity if the chemical
substance is used in ways other than as intended by the PMN submitter.
Other conditions of use of the PMN substance that EPA intends to assess
before they occur include the following:
Uses other than the confidential uses identified in the
PMN.
The proposed SNUR would designate as a ``significant new use'' this
condition of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance 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 genetic
toxicology testing would help characterize the potential health effects
of the PMN substance.
CFR citation: 40 CFR 721.11339.
PMN Number: P-18-103
Chemical name: Alkylnitrile imidazole (generic).
CAS number: Not available.
Basis for action: The PMN states that the use of the substance will
be as an intermediate for amine manufacture. Based on the physical/
chemical properties of the PMN substance and Structure Activity
Relationships (SAR) analysis of test data on analogous substances, EPA
has identified concerns for eye irritation, reproductive/developmental
toxicity, and specific target organ toxicity if the chemical substance
is used in ways other than as intended by the PMN submitter. Other
conditions of use of the PMN substance that EPA intends to assess
before they occur include the following:
1. Use for other than an intermediate for amine manufacture.
2. Any manufacture, processing or use of the PMN substance that
results in inhalation exposure.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance 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 specific target
organ toxicity, reproductive/developmental toxicity, and eye irritation
testing would help characterize the potential health effects of the PMN
substance.
CFR citation: 40 CFR 721.113340.
PMN Numbers: P-18-155 and P-18-156
Chemical names: Crosslinked polymer of alkyl acrylamides, acrylate
esters, and alkyl acrylamide sulfonate salt (generic).
CAS number: Not available.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substance will be as a component in cement.
Based on the physical/chemical properties of the PMN substances and
Structure Activity Relationships (SAR) analysis of test data on
analogous
[[Page 40375]]
substances, EPA has identified concerns for lung effects and
carcinogenicity if the chemical substance is used in ways other than as
intended by the PMN submitter. Other conditions of use of the PMN
substances that EPA intends to assess before they occur include the
following:
1. Use of the PMN substances other than for the confidential uses
described in the PMNs.
2. Manufacture (including import) of the PMN substances with
greater than 10% of particles <10 microns.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substances 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 pulmonary effects
testing would help characterize the potential health effects of the PMN
substances.
CFR citation: 40 CFR 721.11341 (P-18-155 and P-18-156).
PMN Number: P-18-286
Chemical name: Propane, 1,1,1,3,3,3-hexafluoro-2-methoxy-.
CAS number: 13171-18-1.
Basis for action: The PMN states that the use of the substance will
be as solvent in vapor degreasing/vapor cleaning and other confidential
uses generically described as heat transfer fluid and additive
contained/sealed in low voltage electronics. Based on the physical/
chemical properties of the PMN substance and Structure Activity
Relationships (SAR) analysis of test data on analogous substances, EPA
has identified concerns for irritation and developmental neurotoxicity
effects, if the chemical substance is used in ways other than as
intended by the PMN submitter. Other conditions of use of the PMN
substance that EPA intends to assess before they occur include the
following:
1. Use of the PMN substance other than as a solvent in vapor
degreasing/vapor cleaning or additional confidential uses described in
the PMN.
2. Manufacture (including import), processing or use of the PMN
substance without the transport container loading process described in
the PMN.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance 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 skin irritation
and developmental neurotoxicity testing would help characterize the
potential health effects of the PMN substance.
CFR citation: 40 CFR 721.11342.
PMN Number: P-18-392
Chemical name: Heteromonocycle, alkenyl alkyl (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an intermediate chemical.
Based on the physical/chemical properties of and test data on the PMN
substance and Structure Activity Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for
irritation/corrosion and carcinogenicity if the chemical substance is
used in ways other than as intended by the PMN submitter. Other
conditions of use of the PMN substance that EPA intends to assess
before they occur include the following:
No use other than the confidential uses identified in the
PMN.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance 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 absorption, skin
and eye irritation/corrosion, and carcinogenicity testing would help
characterize the potential health effects of the PMN substance.
CFR citation: 40 CFR 721.11343.
PMN Number: P-19-29
Chemical name: Phosphonium, tributylethyl-, diethyl phosphate
(1:1).
CAS number: 20445-94-7.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a catalyst. Based on the
physical/chemical properties of and available data on the PMN substance
and Structure Activity Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for irritation,
corrosion, neurotoxicity, reproductive toxicity, liver toxicity, and
toxicity to aquatic organisms at surface water concentrations exceeding
51 ppb, if the chemical substance is used in ways other than as
intended by the PMN submitter. Other conditions of use of the PMN
substance that EPA intends to assess before they occur include the
following:
1. Use of the PMN substance other than for the confidential uses
described in the PMN.
2. Release to the PMN substance into the waters of the United
States resulting in surface water concentrations exceeding 51 ppb.
The proposed SNUR would designate as a ``significant new use''
these conditions of use.
Potentially useful information: EPA has determined that certain
information about the human health and environmental fate of the PMN
substance 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 irritation,
specific target organ toxicity, neurotoxicity, and reproductive
toxicity, and environmental fate testing would help characterize the
potential health and environmental effects of the PMN substance.
CFR citation: 40 CFR 721.11344.
PMN Number: P-19-62
Chemical name: Hydrochlorofluoroolefin (generic).
CAS number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as an industrial solvent.
Based on the physical/chemical properties of the PMN substance and
Structure Activity Relationships (SAR) analysis of test data on
analogous substances, EPA has identified concerns for neurotoxicity,
systemic toxicity, reproductive toxicity, and lung effects if the
chemical substance is used in ways other than as intended by the PMN
submitter. Other conditions of use of the PMN substance that EPA
intends to assess before they occur include the following:
Use other than for the confidential uses identified in the
PMN.
The proposed SNUR would designate as a ``significant new use'' this
condition of use.
Potentially useful information: EPA has determined that certain
information about the human health toxicity of the PMN substance may be
potentially useful to characterize the health effects of the PMN
substance if a manufacturer
[[Page 40376]]
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 and neurotoxicity testing
would help characterize the potential health effects of the PMN
substance.
CFR citation: 40 CFR 721.11345.
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are the subject of these proposed SNURs and as further discussed
in Unit IV, EPA identified certain other reasonably foreseen conditions
of use, in addition to those conditions of use intended by the
submitter. EPA has preliminarily determined that the chemical under the
intended conditions of use is not likely to present an unreasonable
risk. However, EPA has not assessed risks associated with the
reasonably foreseen conditions of use. EPA is proposing to designate
these conditions of use as significant new uses to ensure that they are
no longer reasonably foreseen to occur without first going through a
separate, subsequent EPA review and determination process associated
with a SNUN.
B. Objectives
EPA is proposing SNURs for 17 specific chemical substances which
are undergoing premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses that would be designated in this proposed rule:
EPA would have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA would be obligated to make a determination under TSCA
section 5(a)(3) regarding the use described in the SNUN, under the
conditions of use. The Agency will either determine under TSCA section
5(a)(3)(C) that the significant new use is not likely to present an
unreasonable risk, including an unreasonable risk to a potentially
exposed or susceptible subpopulation identified as relevant by the
Administrator under the conditions of use, or make a determination
under TSCA section 5(a)(3) (A) or (B) and take the required regulatory
action associated with the determination, before manufacture or
processing for the significant new use of the chemical substance can
occur.
EPA would be able to complete its review and determination
on each of the PMN substances, while deferring analysis on the
significant new uses proposed in these rules unless and until the
Agency receives a SNUN.
Issuance of a proposed SNUR for a chemical substance does not
signify that the chemical substance is listed on the TSCA Inventory.
Guidance on how to determine if a chemical substance is on the TSCA
Inventory is available on the internet at https://www.epa.gov/tsca-inventory.
VI. Applicability of the Proposed Rules to Uses Occurring Before the
Effective Date of the Final Rule
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
were undergoing premanufacture review at the time of signature of this
proposed rule and were not on the TSCA Inventory. 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
the chemical substances subject to these proposed SNURs, EPA concludes
that the proposed significant new uses are not ongoing.
EPA designates August 1, 2019 (date of web posting) 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 on or after
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
EPA would have to take action under section 5 allowing manufacture or
processing to proceed. In developing this proposed rule, EPA has
recognized that, given EPA's general practice of posting proposed rules
on its website a week or more in advance of Federal Register
publication, this objective could be thwarted even before Federal
Register publication of the proposed rule.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require development of
any particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: If a person is required to
submit information for a chemical substance pursuant to a rule, order
or consent agreement under TSCA section 4 (15 U.S.C. 2603), then TSCA
section 5(b)(1)(A) (15 U.S.C. 2604(b)(1)(A)) requires such information
to be submitted to EPA at the time of submission of the SNUN.
In the absence of a rule, order, or consent agreement under TSCA
section 4 covering the chemical substance, persons are required only to
submit information in their possession or control and to describe any
other information known 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 for all SNURs listed here. Descriptions are provided
for informational purposes. The potentially useful information
identified in Unit IV. will be useful to EPA's evaluation in the event
that someone submits a SNUN for the significant new use. Companies who
are considering submitting a SNUN are encouraged, but not required, to
develop the information on the substance, which may assist with EPA's
analysis of the SNUN.
EPA strongly encourages persons, before performing any testing, to
consult with the Agency pertaining to protocol selection. Furthermore,
pursuant to TSCA section 4(h), which pertains to reduction of testing
in vertebrate animals, EPA encourages consultation with the Agency on
the use of alternative test methods and strategies (also called New
Approach Methodologies, or NAMs), if available, to generate the
recommended test data. EPA encourages dialog with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h).
The potentially useful information described in Unit IV. may not be
the only means of providing information to evaluate the chemical
substance associated with the significant new uses. However, submitting
a SNUN without any test data may increase the likelihood that EPA will
take action under TSCA section 5(e) or 5(f). EPA recommends that
potential SNUN submitters contact EPA early enough so that they will be
able to conduct the appropriate tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
[[Page 40377]]
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 https://www.epa.gov/reviewing-new-chemicals-under-toxic-substances-control-act-tsca.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket under docket ID number EPA-HQ-OPPT-
2019-0263.
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 8 new chemical
substances that were the subject of PMNs. The Office of Management and
Budget (OMB) has exempted these types of actions from review under
Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR
3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to the PRA, 44 U.S.C. 3501 et seq., an Agency may not
conduct or sponsor, and a person is not required to respond to a
collection of information that requires OMB approval under PRA, unless
it has been approved by OMB and displays a currently valid OMB control
number. The OMB control numbers for EPA's regulations in title 40 of
the CFR, after appearing in the Federal Register, are listed in 40 CFR
part 9, and included on the related collection instrument or form, if
applicable.
The information collection requirements related to this action have
already been approved by OMB pursuant to 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 section 605(b) of the RFA, 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, 12 in FY2016, 13 in FY2017, and
11 in FY2018, 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 proposed
rule. As such, EPA has determined that this proposed rule does 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. 1531-1538 et seq.).
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This 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 does 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 proposed rule.
G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23,
[[Page 40378]]
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 action is not expected to affect
energy supply, distribution, or use and because this action is not a
significant regulatory action under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does 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 action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: July 31, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR part 721 is amended as
follows:
PART 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. 721.11330 through 721.11345 to subpart E to read as
follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
Sec. 721.11330 Polymer of polyethylene polyamine and alkanediol
diglycidyl ether (generic).
Sec. 721.11331 Triarylalkyl phosphonium halide salt (generic).
Sec. 721.11332 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
butyloctyl) ether.
Sec. 721.11333 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
hexyldecyl) ether.
Sec. 721.11334 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
octyldodecyl) ether.
Sec. 721.11335 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
decyltetradecyl) ether.
Sec. 721.11336 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
dodecylhexadecyl) ether.
Sec. 721.11337 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
tetradecyloctadecyl) ether.
Sec. 721.11338 Alkyl tri dithiocarbamate tri salt (generic).
Sec. 721.11339 Methacrylic acid heterocyclic alkyl ester (generic).
Sec. 721.11340 Alkylnitrile imidazole (generic).
Sec. 721.11341 Crosslinked polymer of alkyl acrylamides, acrylate
esters, and alkyl acrylamide sulfonate salt (generic).
Sec. 721.11342 Propane, 1,1,1,3,3,3-hexafluoro-2-methoxy-.
Sec. 721.11343 Heteromonocycle, alkenyl alkyl (generic).
Sec. 721.11344 Phosphonium, tributylethyl-, diethyl phosphate
(1:1).
Sec. 721.11345 Hydrochlorofluoroolefin (generic).
Subpart E--Significant New Uses for Specific Chemical Substances
Sec. 721.11330 Polymer of polyethylene polyamine and alkanediol
diglycidyl ether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as polymer
of polyethylene polyamine and alkanediol diglycidyl ether (PMN P-16-92)
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,
importers, 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. 721.11331 Triarylalkyl phosphonium halide salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
triarylalkyl phosphonium halide salt (PMN P-17-346) 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) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N = 5.
(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,
importers, 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. 721.11332 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
butyloctyl) ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with oxirane, mono(2-butyloctyl) ether. (P-17-347, CASRN
252756-20-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s) (5,000 kilograms, aggregate of
PMN substances P-17-347, P-17-348, P-17-349, P-17-350, P-17-351 and P-
17-352). It is a significant new use to manufacture, process or use the
PMN substances in a manner that results in inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, 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
[[Page 40379]]
of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.
Sec. 721.11333 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
hexyldecyl) ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with oxirane, mono(2-hexyldecyl) ether (P-17-348, CASRN 125005-
52-9) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s) (5,000 kilograms, aggregate of
PMN substances P-17-347, P-17-348, P-17-349, P-17-350, P-17-351 and P-
17-352). It is a significant new use to manufacture, process or use the
PMN substances in a manner that results in inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, 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. 721.11334 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
octyldodecyl) ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with oxirane, mono(2-octyldodecyl) ether (P-17-349, CASRN
102640-44-8) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s) (5,000 kilograms, aggregate of
PMN substances P-17-347, P-17-348, P-17-349, P-17-350, P-17-351 and P-
17-352). It is a significant new use to manufacture, process or use the
PMN substances in a manner that results in inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, 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. 721.11335 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
decyltetradecyl) ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with oxirane, mono(2-decyltetradecyl) ether (P-17-350, CASRN
72484-69-6) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s) (5,000 kilograms, aggregate of
PMN substances P-17-347, P-17-348, P-17-349, P-17-350, P-17-351 and P-
17-352). It is a significant new use to manufacture, process or use the
PMN substances in a manner that results in inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, 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. 721.11336 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
dodecylhexadecyl) ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as Oxirane, 2-methyl-,
polymer with oxirane, mono(2-dodecylhexadecyl) ether (P-17-351, CASRN
102640-42-6) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s) (5,000 kilograms, aggregate of
PMN substances P-17-347, P-17-348, P-17-349, P-17-350, P-17-351 and P-
17-352). It is a significant new use to manufacture, process or use the
PMN substances in a manner that results in inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, 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. 721.11337 Oxirane, 2-methyl-, polymer with oxirane, mono(2-
tetradecyloctadecyl) ether.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as oxirane, 2-methyl-,
polymer with oxirane, mono(2-tetradecyloctadecyl) ether (P-17-352,
CASRN 102640-46-0) is subject to reporting under this section for the
significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j) and (s) (5,000 kilograms, aggregate of
PMN substances P-17-347, P-17-348, P-17-349, P-17-350, P-17-351 and P-
17-352). It is a significant new use to manufacture, process or use the
PMN substances in a manner that results in inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, 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
[[Page 40380]]
of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of this section.
Sec. 721.11338 Alkyl tri dithiocarbamate tri salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as alkyl
tri dithiocarbamate tri salt (PMN P-17-395) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j). It is a significant new use to
manufacture, process, or use the substance in a manner that results in
inhalation exposure.
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N = 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) are applicable to manufacturers,
importers, 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. 721.11339 Methacrylic acid heterocyclic alkyl ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
methacrylic acid heterocyclic alkyl ester (PMN P-18-35) 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,
importers, 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. 721.11340 Alkylnitrile imidazole (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as alkylnitrile
imidazole (P-18-103) 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
for use other than as an intermediate for amine manufacture. It is a
significant new use to manufacture, process or use the PMN substance in
a manner that results in inhalation exposure.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11341 Crosslinked polymer of alkyl acrylamides, acrylate
esters, and alkyl acrylamide sulfonate salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances generically identified as
crosslinked polymer of alkyl acrylamides, acrylate esters, and alkyl
acrylamide sulfonate salt (PMNs P-18-155 and P-18-156) are subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j). It is a significant new use to
manufacture the PMN substances with greater than 10% of the particles
less than 10 microns.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, 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. 721.11342 Propane, 1,1,1,3,3,3-hexafluoro-2-methoxy-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as propane,
1,1,1,3,3,3-hexafluoro-2-methoxy- (PMN P-18-286, CASRN 13171-18-1) 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. Requirements
as specified in Sec. 721.80(j). It is a significant new use to
manufacture, process or use the substance without the transport
container loading process described in the PMN.
(ii) [Reserved].
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers,
importers, 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. 721.11343 Heteromonocycle, alkenyl alkyl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
heteromonocycle, alkenyl alkyl (PMN P-18-392) 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
[[Page 40381]]
applicable to manufacturers, importers, 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. 721.11344 Phosphonium, tributylethyl-, diethyl phosphate (1:1).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phosphonium,
tributylethyl-, diethyl phosphate (1:1) (PMN P-19-29, CASRN 20445-94-7)
is subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, Commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N = 51.
(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,
importers, 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. 721.11345 Hydrochlorofluoroolefin (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance generically identified as
hydrochlorofluoroolefin (P-19-62) 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), (i), (j) and (k) are applicable to
manufacturers, importers, 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.
[FR Doc. 2019-17148 Filed 8-13-19; 8:45 am]
BILLING CODE 6560-50-P
