Significant New Use Rules on Certain Chemical Substances (19-3.F), 54816-54832 [2019-21720]
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Federal Register / Vol. 84, No. 198 / Friday, October 11, 2019 / Proposed Rules
exist in the project’s service area, as
demonstrated through a job market
analysis, and have provided a letter of
support for the project.
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(c) * * *
(2) The extent to which the proposed
project has a plan for recruiting and
selecting participants, including
students who may not be of traditional
college age, that ensures that program
participants are likely to complete the
program.
(3) The extent to which the proposed
project will incorporate the needs of
potential employers, as identified by a
job market analysis, by establishing
partnerships and relationships with
LEAs that serve a high proportion of
Indian students and developing
programs that meet their employment
needs.
(d) * * *
(5) The extent to which the proposed
project has a plan for recruiting and
selecting participants, including
students who may not be of traditional
college age, that ensures that the
program participants are likely to
complete the program.
(6) The extent to which the applicant
will assist participants in meeting the
service obligation requirements.
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■ 10. Newly redesignated § 263.9 is
amended by:
■ a. In paragraph (b)(1), removing the
word ‘‘people’’ and adding, in its place,
the word ‘‘students’’ and removing the
words ‘‘school that has a significant
Indian population’’ and adding, in their
place, the words ‘‘LEA that serves a high
proportion of Indian students’’.
■ b. Adding a note at the end of this
section.
The addition reads as follows:
§ 263.9 What are the payback
requirements?
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Note to § 263.9: For grants that
provide administrator training, a
participant who has received
administrator training and subsequently
works for a Tribal educational agency
that provides administrative control or
direction of public schools (e.g., BIEfunded schools or charter schools)
satisfies the requirements of paragraph
(b)(1) of this section.
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*
§ 263.11
[Amended]
11. Newly redesignated § 263.11 is
amended by removing the word
‘‘people’’ in paragraph (b)(1) and
replacing it with the phrase ‘‘students in
an LEA that serves a high proportion of
Indian students’’.
■
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12. Newly redesignated § 263.12 is
amended by
■ a. Removing the word ‘‘and’’ at the
end of paragraph (c)(1)(ii).
■ b. Redesignating paragraph (c)(1)(iii)
as paragraph (c)(1)(iv) and adding a new
paragraph (c)(1)(iii).
■ c. Removing in paragraph (c)(2) the
word ‘‘seven’’ and adding, in its place,
the word ‘‘thirty’’.
The addition reads as follows:
■
§ 263.12 What are the grantee post-award
requirements?
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(c) * * *
(1) * * *
(iii) A statement explaining that work
must be in an ‘‘LEA that serves a high
proportion of Indian students,’’ and the
regulatory definition of that phrase; and
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[FR Doc. 2019–22075 Filed 10–10–19; 8:45 am]
BILLING CODE 4000–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 721
[EPA–HQ–OPPT–2019–0228; FRL–9998–64]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances (19–3.F)
Environmental Protection
Agency (EPA).
ACTION: Proposed rule.
AGENCY:
SUMMARY: EPA is proposing significant
new use rules (SNURs) under the Toxic
Substances Control Act (TSCA) for 31
chemical substances which were the
subject of premanufacture notices
(PMNs). Eight of these chemical
substances are subject to TSCA Orders
issued by EPA and the remaining 23 of
these chemical substances received a
‘‘not likely to present an unreasonable
risk’’ determination. This action would
require persons who intend to
manufacture (defined by statute to
include import) or process any of these
31 chemical substances for an activity
that is proposed as a significant new use
to notify EPA at least 90 days before
commencing that activity. Persons may
not commence manufacture or
processing for the significant new use
until EPA has conducted a review of the
notice, made an appropriate
determination on the notice, and has
taken such actions as are required by
that determination.
DATES: Comments must be received on
or before November 12, 2019.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
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number EPA–HQ–OPPT–2019–0228, 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, process,
or use the chemical substances
contained in this proposed rule. The
following list of North American
Industrial Classification System
(NAICS) codes is not intended to be
exhaustive, but rather provides a guide
to help readers determine whether this
document applies to them. Potentially
affected entities may include:
• Manufacturers or processors of one
or more subject chemical substances
(NAICS codes 325 and 324110), e.g.,
chemical manufacturing and petroleum
refineries.
This action may also affect certain
entities through pre-existing import
certification and export notification
rules under TSCA. Chemical importers
are subject to the TSCA section 13 (15
U.S.C. 2612) import certification
requirements promulgated at 19 CFR
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12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to final SNURs
must certify their compliance with the
SNUR requirements. The EPA policy in
support of import certification appears
at 40 CFR part 707, subpart B. In
addition, any persons who export or
intend to export a chemical substance
that is the subject of this proposed rule
on or after November 12, 2019 are
subject to the export notification
provisions of TSCA section 12(b) (15
U.S.C. 2611(b)) (see 40 CFR 721.20), and
must comply with the export
notification requirements in 40 CFR part
707, subpart D.
B. What should I consider as I prepare
my comments for EPA?
1. Submitting CBI. Do not submit this
information to EPA through
regulations.gov or email. Clearly mark
the part or all of the information that
you claim to be CBI. For CBI
information in a disk or CD–ROM that
you mail to EPA, mark the outside of the
disk or CD–ROM as CBI and then
identify electronically within the disk or
CD–ROM the specific information that
is claimed as CBI. In addition to one
complete version of the comment that
includes information claimed as CBI, a
copy of the comment that does not
contain the information claimed as CBI
must be submitted for inclusion in the
public docket. Information so marked
will not be disclosed except in
accordance with procedures set forth in
40 CFR part 2.
2. Tips for preparing your comments.
When preparing and submitting your
comments, see the commenting tips at
https://www.epa.gov/dockets/
comments.html.
II. Background
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A. What action is the Agency taking?
EPA is proposing these SNURs under
TSCA section 5(a)(2) for chemical
substances that were the subject of
PMNs. These proposed SNURs would
require persons to notify EPA at least 90
days before commencing the
manufacture or processing of a chemical
substance for any activity proposed as a
significant new use. Receipt of such
notices would allow EPA to assess risks
and, if appropriate, to regulate the
significant new use before it may occur.
Additional background regarding
SNURs is more fully set out in the
preamble to EPA’s first direct final
SNUR published in the Federal Register
issue of April 24, 1990 (55 FR 17376)
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(FRL–3658–5). Consult that preamble
for further general information on the
objectives, rationale, and procedures for
SNURs and on the basis for significant
new use designations, including
provisions for developing test data.
B. What is the Agency’s authority for
taking this action?
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 bulleted TSCA
section 5(a)(2) factors listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the proposed rule, recordkeeping
requirements, and exemptions to
reporting requirements, and
applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. Pursuant to
40 CFR 721.1(c), persons subject to
SNURs must comply with the same
SNUN requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A) (15 U.S.C.
2604(a)(1)(A)). In particular, these
requirements include the information
submission requirements of TSCA
section 5(b) and 5(d)(1) (15 U.S.C.
2604(b) and 2604(d)(1)), the exemptions
authorized by TSCA section 5(h)(1),
(h)(2), (h)(3), and (h)(5), and the
regulations at 40 CFR part 720. Once
EPA receives a SNUN, EPA must either
determine that the use is not likely to
present an unreasonable risk of injury
under the conditions of use for the
chemical substance or take such
regulatory action as is associated with
an alternative determination before the
manufacture or processing for the
significant new use can commence. In
the case of a determination other than
not likely to present unreasonable risk,
the applicable review period must also
expire before manufacturing or
processing for the new use may
commence. If EPA determines that the
use is not likely to present an
unreasonable risk, EPA is required
under TSCA section 5(g) to make public,
and submit for publication in the
Federal Register, a statement of EPA’s
findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA’s
determination that a use of a chemical
substance is a significant new use must
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be made after consideration of all
relevant factors, including:
• The projected volume of
manufacturing and processing of a
chemical substance.
• The extent to which a use changes
the type or form of exposure of human
beings or the environment to a chemical
substance.
• The extent to which a use increases
the magnitude and duration of exposure
of human beings or the environment to
a chemical substance.
• The reasonably anticipated manner
and methods of manufacturing,
processing, distribution in commerce,
and disposal of a chemical substance.
In determining significant new uses
for the 31 chemical substances that are
the subject of these SNURs, EPA
considered relevant information about
the toxicity of the chemical substances
and potential human exposures and
environmental releases that may be
associated with the substances, in
addition to the factors in TSCA section
5(a)(2). Consistent with TSCA section
5(f)(4), for the eight chemical substances
subject to an order under TSCA section
5(e), EPA is proposing to identify any
use not conforming to the restrictions of
the order as a significant new use. For
the 23 chemical substances that EPA has
determined ‘‘not likely’’ to present an
unreasonable risk under the conditions
of use, EPA is proposing to identify
other circumstances that, while not
reasonably foreseen, would warrant
further EPA review before manufacture
or processing for such a use is
commenced.
IV. Substances Subject to This Proposed
Rule
EPA is proposing significant new use
and recordkeeping requirements for 31
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 or basis for the
TSCA section 5(e) Order.
• Potentially Useful Information. This
is information identified by EPA that
would help characterize the potential
health and/or environmental effects of
the chemical substance in support of a
request by the PMN submitter to modify
the Order, or if a manufacturer or
processor is considering submitting a
SNUN for a significant new use
designated by the SNUR.
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• CFR citation assigned in the
regulatory text section of the proposed
rule. The regulatory text section of each
proposed rule specifies the activities
that would be designated as significant
new uses. Certain new uses, including
exceedance of production volume limits
(i.e., limits on manufacture volume) and
other uses designated in this proposed
rule, may be claimed as CBI.
These proposed rules include 8 PMN
substances that are subject to orders
issued under TSCA section 5(e)(1)(A), as
required by the determinations made
under TSCA section 5(a)(3)(B). Those
TSCA section 5(e) Orders require
protective measures to limit exposures
or otherwise mitigate the potential
unreasonable risk. The proposed SNURs
would identify as significant new uses
any manufacturing, processing, use,
distribution in commerce, or disposal
that does not conform to the restrictions
imposed by the underlying TSCA
section 5(e) Orders, consistent with
TSCA section 5(f)(4).
These proposed rules also include 23
PMN substances that received ‘‘not
likely to present an unreasonable risk’’
determination in TSCA section
5(a)(3)(c). However, during the course of
these reviews, EPA identified concerns
for certain health and/or environmental
risks if the chemicals were not used
following the limitations identified by
the submitters in the notices. EPA did
not deem such uses as reasonably
foreseen in the TSCA section 5(a)(3)(C)
determinations. The proposed SNURs
would identify as significant new uses
any manufacturing, processing, use,
distribution in commerce, or disposal
that does not conform to those same
limitations.
The chemicals subject to these
proposed SNURs are as follows:
PMN Numbers: P–16–151, P–16–152, P–
16–153, P–16–154, and P–16–155
Chemical names: Perfluoropolyether
halide (generic) (P–16–151),
Perfluoropolyether aryl (generic) (P–16–
152), Substituted arylperfluoropolyether (generic) (P–16–153),
Sulfonated perfluoropolyether aromatic
transition metal salt (generic) (P–16–
154), and Sulfonated perfluoropolyether
aryl alkali metal salt (generic) (P–16–
155).
CAS numbers: Not available.
Effective date of TSCA section 5(e)
Order: April 30, 2019.
Basis for TSCA section 5(e) Order:
The PMNs state that the generic (nonconfidential) use of the substances P–
16–151 and P–16–152 will be as
intermediates and P–16–153, P–16–154,
P–16–155 will be as lubricant additives.
Based on the physical/chemical
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properties of the PMN substances (as
described in the New Chemical
Program’s PBT category at 64 FR 60194;
November 4, 1999) and test data on
structurally similar substances, the PMN
substances are potentially persistent,
bioaccumulative, and toxic (PBT)
chemicals. EPA estimates that the PMN
substances will persist in the
environment more than 2 months and
estimates a bioaccumulation factor of
greater than or equal to 1,000. Based on
results of testing on analogous small
fluorinated polyether substances, EPA
has identified concerns for the possible
degradation products of the PMN
substances for liver toxicity, kidney
effects, hematology and clinical
chemistry changes, pancreatic and
testicular cell tumor formation, and
reproductive and developmental effects.
Based on estimated ecotoxicity values
for the possible degradation products,
EPA predicts toxicity to aquatic
organisms may occur at concentrations
that exceed 153 parts per billion (ppb).
The TSCA section 5(e) Order was issued
under TSCA sections 5(a)(3)(B)(i) and
5(e)(1)(A)(i), based on a finding that the
available information is insufficient to
permit a reasoned evaluation of the
human health and environmental effects
of the PMN substances. The TSCA
section 5(e) Order was also issued under
TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation, the
substances may present an unreasonable
risk of injury to human health and the
environment. To protect against these
risks, the TSCA section 5(e) Order
requires:
1. Submission to EPA of certain fate
testing within one year after the Notice
of Commencement of the PMN P–16–
155;
2. Establishment and use of a hazard
communication program, including
environmental hazard precautionary
statements on each label and in the
Safety Data Sheet (SDS);
3. Dispose of the PMN substances
only with Hazardous Waste, High
Temperature Incineration with a control
efficiency of 99.99% efficiency or
greater;
4. No release of the PMN substances
to surface waters;
5. Manufacture the PMN substances
only for the confidential uses specified
in the PMNs; and
6. No manufacture beyond the annual
production volumes specified in the
TSCA section 5(e) Order.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
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Potentially useful information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the TSCA section 5(e) Order, or
if a manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this SNUR. The submitter
has agreed not to manufacture
(including import) the P–16–155
substance beyond one year after the
Notice of Commencement without
performing an indirect photolysis
screening test (OCSPP Test Guideline
835.5270). EPA has also determined that
the results of hydrolysis testing,
photodegradation in soil, chronic
aquatic toxicity, and reproductive
toxicity testing would help EPA
determine the potential human and
environmental effects of the PMN
substances. Although the TSCA section
5(e) Order does not require these tests,
the TSCA section 5(e) Order’s
restrictions remain in effect until the
TSCA section 5(e) Order is modified or
revoked by EPA based on submission of
this or other relevant information.
CFR citations: 40 CFR 721.11346 (P–
16–151); 40 CFR 721.11347 (P–16–152);
40 CFR 721.11348 (P–16–153); 40 CFR
721.11349 (P–16–154) and 40 CFR
721.11350 (P–16–155).
PMN Number: P–16–225
Chemical names: Cyclohexanol, 4ethylidene-2-propoxy- (P–16–225,
chemical A) and Cyclohexanol, 5ethylidene-2-propoxy- (P–16–225,
chemical B).
CAS numbers: 1631145–48–6 (P–16–
225, chemical A) and 1631145–49–7 (P–
16–225, chemical B).
Basis for action: The PMN states that
the use of the substance will be as a
fragrance ingredient, being blended
(mixed) with other fragrance ingredients
to make fragrance oils that will be sold
to industrial and commercial customers
for their incorporation into soaps,
detergents, cleaners, air fresheners,
candles and other similar industrial,
household and consumer products.
Based on the physical/chemical
properties of the PMN substances, test
data on the PMN substances, and
Structure Analysis Relationships (SAR)
analysis of test data on analogous
substances, EPA has identified concerns
for systemic toxicity, and aquatic
toxicity at surface water concentrations
exceeding 300 ppb, if the chemical
substance is not used following the
limitations noted. The conditions of use
of the PMN substances as described in
the PMN include the following
protective measures:
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1. No domestic manufacture of the
PMN substances (i.e., import only);
2. No import of the PMN substances
at more than 10,000 kg annual
production volume;
3. No use of the PMN substances other
than for the fragrance use stated in the
PMN submission; and
4. No processing of the PMN
substances to greater than 10% in
compounded fragrance oil formulation.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health and environmental effects of
the PMN substances in support of a
request by the PMN submitter to modify
the TSCA section 5(e) Order, or if a
manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that the results of
absorption testing and aquatic toxicity
testing would help characterize the
potential health and environmental
effects of the PMN substances.
CFR citation: 40 CFR 721.11351 (P–
16–225, chemical A) and 40 CFR
721.11352 (P–16–225, chemical B).
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PMN Number: P–16–314
Chemical Name: Ethanone, 1-(5propyl-1,3-benzodioxol-2-yl)-.
CAS Number: 1370699–98–1.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as part of a
fragrance formula. Based on test data on
the new chemical substance, the
estimated physical/chemical properties
of the PMN, and SAR analysis on
analogous neutral organics, EPA has
identified concerns for liver toxicity for
the intact new chemical substance,
oncogenicity for the ketone/aldehyde
hydrolysis product(s) that may be
formed under the acidic conditions in
the stomach, and aquatic toxicity if the
chemical substance is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measures:
1. No domestic manufacture of the
PMN substance (i.e., import only);
2. Less than 10% of the PMN
substance in any formulation from
processing; and
3. No manufacture (including import)
beyond an annual production volume of
10,000 kilograms per year.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
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Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health and environmental effects of
the PMN substance if a manufacturer or
processor is considering submitting a
SNUN for a significant new use that
would be designated by this proposed
SNUR. EPA has determined that the
results of absorption testing and aquatic
toxicity testing would help characterize
the potential health and environmental
effects of the PMN substance.
CFR Citation: 40 CFR 721.11353.
PMN Number: P–16–429
Chemical Name: Endcapped
polysiloxane (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as a universal
tint paste resin having high solids.
Based on the estimated physical/
chemical properties of the PMN
substance, structural information, and
information on analogous alkoxysilanes,
EPA has identified lung effects and
irritation to the eye, skin, lung, and
mucous membranes if the chemical
substance is not used following the
limitation noted. The condition of use of
the PMN substance as described in the
PMN includes the following protective
measure:
• Use of the PMN substance only for
the confidential use specified in the
PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health effects of the PMN substance
if a manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that the results of
pulmonary effects and skin irritation
testing would help characterize the
potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11354.
PMN Number: P–16–470
Chemical Name: 2,7-Nonadien-4-ol,
4,8-dimethyl-.
CAS Number: 103983–77–3.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as part of a
fragrance formula. Based on the
estimated physical/chemical properties
of the PMN substance and available data
on the new chemical substance, EPA
has identified concerns for skin
irritation, eye irritation, liver and
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thyroid toxicity, and aquatic toxicity if
the chemical substance is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measure:
• No release of the PMN substance
from manufacturing or processing
resulting in surface water
concentrations that exceed 113 ppb;
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health and environmental effects of
the PMN substance if a manufacturer or
processor is considering submitting a
SNUN for a significant new use that
would be designated by this proposed
SNUR. EPA has determined that the
results of specific organ toxicity and
aquatic toxicity testing would help
characterize the potential health and
environmental effects of the PMN
substance.
CFR Citation: 40 CFR 721.11355.
PMN Number: P–17–108
Chemical Name: Carbonodithioic
acid, O-[2-[(dithiocarboxy)amino]-2methylpropyl] ester, sodium salt (1:2).
CAS Number: 1947332–67–3.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be for use in ore
processing. Based on the estimated
physical/chemical properties of the
PMN substance, available PMN data,
comparison with structurally analogous
chemical substances, and SAR analysis
of test data on analogous
dithiocarbamates, EPA has identified
concerns for irritation and corrosion to
all tissues, developmental and
neurological effects, and aquatic toxicity
if the chemical substance is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measure:
• No release of the PMN substance
resulting in surface water
concentrations exceeding 2 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health and environmental effects of
the PMN substance if a manufacturer or
processor is considering submitting a
SNUN for a significant new use that
would be designated by this proposed
SNUR. EPA has determined that the
results of reproductive/developmental
toxicity, neurotoxicity, skin irritation/
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corrosion, and toxicokinetics and
chronic aquatic ecotoxicity testing
would help characterize the potential
health and environmental effects of the
PMN substance.
CFR Citation: 40 CFR 721.11356.
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PMN Number: P–17–253
Chemical Name: Oxirane, 2-methyl-,
polymer with oxirane, methyl 2(substituted carbomonocycle
isoquinolin-2(3H)-yl) propyl ether
(generic).
CAS Number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be to enhance
formulation solubilization properties.
Based on its estimated physical/
chemical properties, data on analogous
chemicals, and other structural
information, EPA has identified
concerns for lung effects and irritation
if the chemical substance is not used
following the limitations noted. The
condition of use of the PMN substance
as described in the PMN includes the
following protective measures:
• No processing of the substance to a
concentration greater than 5% by weight
in the final formulated product, for any
use; and
• No consumer use.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health effects of the PMN substance
if a manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that pulmonary effects
testing would help characterize the
potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11357.
PMN Number: P–18–91
Chemical Name: Vegetable oil,
polymers with diethylene glycol- and
polyol- and polyethylene glycoldepolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid
anhydride (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the PMN substance will be as
a chemical intermediate (polyol) for use
in the manufacture of polyurethane
polymers. Based on the estimated
physical/chemical properties of the
PMN substance, comparison with
structurally analogous chemical
substances, test data on analogous
substances, and SAR analysis on esters,
EPA has identified concerns for lung
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effects, irritation to eye, mucous
membranes and lung, anesthetization of
the eye, developmental, renal and
bladder toxicity, kidney toxicity, and
renal cancer if the chemical substance is
not used following the limitations
noted. The condition of use of the PMN
substance as described in the PMN
includes the following protective
measure:
• No modification of manufacture,
processing or use if it results in
inhalation exposures to vapors,
particulate, mist or aerosols.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health effects of the PMN substance
if a manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that the results of in
vitro skin irritation and eye damage
testing using human derived cells
would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11358.
PMN Number: P–18–120
Chemical Name: 1H-Pyrrole-2,5dione, 1,1′-C36-alkylenebis-.
CAS Number: 1911605–95–2.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as an adhesive
component. Based on the available data
for the new chemical substance,
estimated physical/chemical properties
of the PMN substance, and comparison
with structurally analogous chemical
substances, EPA has identified concerns
for developmental toxicity and
sensitization if the chemical substance
is not used following the limitation
noted. The condition of use of the PMN
substance as described in the PMN
includes the following protective
measure:
• No manufacturing, processing, or
use of the substance that results in
inhalation exposures.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
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
developmental toxicity and
sensitization testing would help
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characterize the potential health effects
of the PMN substance.
CFR Citation: 40 CFR 721.11359.
PMN Number: P–18–129
Chemical name: Benzenepropanal,
.alpha.,.alpha.,3-trimethyl-.
CAS number: 107737–97–3.
Effective date of TSCA section 5(e)
Order: April 30, 2019.
Basis for TSCA section 5(e) Order:
The PMN states that the generic (nonconfidential) use of the substance will
be as an intermediate used for chemical
production. Based on test data on the
PMN substance and analogue data, EPA
has identified concerns for sensitization
and developmental toxicity. In addition,
based on SAR analysis of test data on
analogous neutral organics, EPA
predicts toxicity to aquatic organisms
may occur at concentrations greater than
99 ppb. The TSCA section 5(e) Order
was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health and the environment. To
protect against these risks, the TSCA
section 5(e) Order requires:
• No manufacture (including import)
of the PMN substance beyond the
confidential annual production volume
specified in the TSCA section 5(e)
Order.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
may be potentially useful in support of
a request by the PMN submitter to
modify the TSCA section 5(e) Order, or
if a manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this SNUR. EPA has
determined that the results of
biodegradability, chronic aquatic
toxicity, and reproductive toxicity
testing would help EPA determine the
potential human and environmental
effects of the PMN substance. Although
the TSCA section 5(e) Order does not
require this information, the TSCA
section 5(e) Order’s restrictions remain
in effect until the TSCA section 5(e)
Order is modified or revoked by EPA
based on submission of this or other
relevant information.
CFR citation: 40 CFR 721.11360.
PMN Number: P–18–182
Chemical name: Multiwalled carbon
nanotubes (generic).
CAS number: Not available.
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Effective date of TSCA section 5(e)
Order: May 3, 2019.
Basis for TSCA section 5(e) Order:
The PMN states that substance will be
used in heat transfer, heat storage,
thermal emission, and general
temperature management in heatgenerating systems such as electronics,
to improve mechanical properties or
electrical conductivities of other
materials or products, and for light
absorption properties. EPA has
identified concerns for pulmonary
toxicity based on carbon nanotube
analogues. EPA has also identified
concerns for aquatic toxicity when the
substance is at low concentrations and
in the presence of natural organic
matter. The TSCA section 5(e) Order
was issued under TSCA sections
5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence
of sufficient information to permit a
reasoned evaluation, the substance may
present an unreasonable risk of injury to
human health and the environment. To
protect against these risks, the TSCA
section 5(e) Order requires:
1. Use of personal protective
equipment by workers to prevent
dermal exposure where there is
potential dermal exposure;
2. Use of a National Institute of
Occupational Safety and Health
(NIOSH) certified respirators with an
Assigned Protection Factor (APF) of at
least 50 workers to prevent inhalation
exposure where there is potential
inhalation exposure;
3. Refrain from using the PMN in
applications that generates a dust,
vapor, mist, or aerosol, unless such
application method occurs in an
enclosed process;
4. Process and use of the PMN
substance only as described in the PMN;
5. No release of the PMN substance to
surface waters; and
6. Disposal only by incineration or
landfill.
The proposed SNUR designates as a
‘‘significant new use’’ the absence of
these protective measures.
Potentially useful information: EPA
has determined that certain information
about the human health and
environmental effects of the PMN
substance may be potentially useful in
support of a request by the PMN
submitter to modify the TSCA section
5(e) Order, or if a manufacturer or
processor is considering submitting a
SNUN for a significant new use that
would be designated by this SNUR. EPA
has determined that the results of
pulmonary toxicity and chronic aquatic
toxicity testing would help EPA
determine the potential human and
environmental effects of the PMN
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substance. Although the TSCA section
5(e) Order does not require this
information, the TSCA section 5(e)
Order’s restrictions remain in effect
until the TSCA section 5(e) Order is
modified or revoked by EPA based on
submission of this or other relevant
information.
CFR citation: 40 CFR 721.11361.
PMN Number: P–18–186
Chemical Name: Polyolefin ester
(generic).
CAS Number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as a fuel
additive. Based on the estimated
physical/chemical properties of the
PMN substance and comparison with
structurally analogous substances, EPA
has identified concerns for lung
surfactancy and irritation to the eye and
skin if the chemical substance is not
used following the limitations noted.
The conditions of use of the PMN
substance as described in the PMN
include the following protective
measures:
1. No use involving an application
method that generates a vapor, mist, or
aerosol; and
2. No manufacture (including import)
of the substance at less than the
confidential average molecular weight
identified in the PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health 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, distribution, metabolism,
and excretion (ADME)/toxicokinetic and
lung toxicity testing would help
characterize the potential health effects
of the PMN substance.
CFR Citation: 40 CFR 721.11362.
PMN Numbers: P–18–247, P–18–248, P–
18–249, P–18–250, P–18–251, and P–18–
252
Chemical Names: Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with 2-ethyl-2(hydroxymethyl)-1,3-propanediol,
polyetherpolyol, .alpha.,.alpha.′-[(1methylethylidene)di-4,1phenylene]bis[.omega.hydroxypoly(oxy-1,2-ethanediyl)] and
1,2-propanediol, iso-Bu alc.- and 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and Et alc.- and
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methanol- and 1-methoxy-2-propanolblocked (generic) (P–18–247); Isocyanic
acid, polymethylenepolyphenylene
ester, polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanolblocked (generic) (P–18–248); Isocyanic
acid, polymethylenepolyphenylene
ester, polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanoland 1-methoxy-2-propanol-blocked
(generic) (P–18–249); Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and 1(or 2)-(2methoxymethylethoxy)propanolblocked (generic) (P–18–250); Isocyanic
acid, polymethylenepolyphenylene
ester, 2-butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanoland 1(or 2)-(2methoxymethylethoxy)propanolblocked (generic) (P–18–251); Isocyanic
acid, polymethylenepolyphenylene
ester, 2-butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanoland 1-methoxy-2-propanol-blocked
(generic) (P–18–252).
CAS Numbers: Not available.
Basis for action: The PMNs state that
the use of the PMN substances will be
as crosslinkers for automotive
electrocoats. Based on the physical/
chemical properties, chemical structure
of the substances, submitted data on the
substances, and comparison to
structurally analogous substances, EPA
has identified concerns for lung effects,
skin sensitization, and aquatic toxicity if
the chemical substances are not used
following the limitations noted. The
conditions of use of the PMN substances
as described in the PMNs include the
following protective measures:
1. No manufacture, processing, or use
in a manner that results in inhalation
exposure; and
2. No release of the PMN substance to
surface waters exceeding 200 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health and environmental effects of
the PMN substances if a manufacturer or
processor is considering submitting a
SNUN for a significant new use that
would be designated by this proposed
SNUR. EPA has determined that the
results of chronic ecotoxicity testing and
lung effects tiered testing for surfactants
would help characterize the potential
health and environmental effects of the
PMN substances.
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CFR citations: 40 CFR 721.11363 (P–
18–247); 40 CFR 721.11364 (P–18–248);
40 CFR 721.11365 (P–18–249); 40 CFR
721.11366 (P–18–250); 40 CFR
721.11367 (P–18–251); and 40 CFR
721.11368 (P–18–252).
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PMN Number: P–18–282
Chemical Name: Fatty acid ester,
polyether, diisocyanate polymer
(generic).
CAS Number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as an adhesive.
Based on the estimated physical/
chemical properties of the PMN
substance, test data on an analogue of
the residual isocyanate, and comparison
with structurally analogous chemical
substances, EPA has identified concerns
for irritation/sensitization for the skin,
eyes, mucous membrane, and lungs, and
respiratory effects if the chemical
substance is not used following the
limitation noted. The condition of use of
the PMN substance as described in the
PMN includes the following protective
measure:
• No manufacturing, processing, or
use of the PMN substance containing
greater than the confidential percentage
of residual isocyanate identified in the
PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health 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, eye damage, skin
sensitization, and pulmonary effects
testing would help characterize the
potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11369.
PMN Number: P–18–305
Chemical Name: Alkenoic acid,
alkyl-, alkyl ester, polymer with alkyl
alkenoate, substituted heteromonocycle,
substituted carbomonocycle, substituted
alkanediol and alkenoic acid, alkali
metal salt (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as a component
of ink. Based on the estimated physical/
chemical properties of the PMN
substance and comparison with
structurally analogous chemical
substances, EPA has identified lung
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effects if the chemical substance is not
used following the limitations noted.
The condition of use of the PMN
substance as described in the PMN
includes the following protective
measure:
• No manufacturing, processing, or
use of the substance that results in
inhalation exposures.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health effects of the PMN substance
if a manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that the results of
pulmonary effects testing would help
characterize the potential health effects
of the PMN substance.
CFR Citation: 40 CFR 721.11370.
PMN Number: P–18–339
Chemical Name: Alkyl
heteromonocycle with heteroatom
substituted alkyl cycloalkane and 2hydroxyethyl heteromonocycle
methacrylate-blocked homopolymer
(generic).
CAS Number: Not available.
Basis for action: The PMN states that
the use of the PMN substance will be as
an immobilizing agent for the microbial
promoter of nitrogen decomposition.
Based on the estimated physical/
chemical properties of the PMN
substance and comparison with
structurally analogous chemical
substances, EPA has identified lung
effects if the chemical substance is not
used following the limitations noted.
The condition of use of the PMN
substance as described in the PMN
includes the following protective
measure:
• No manufacture, processing, or use
that results in inhalation exposures.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
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 including
pulmonary effects testing would help
characterize the potential health effects
of the PMN substance.
CFR Citation: 40 CFR 721.11371.
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PMN Number: P–19–5
Chemical Name: Phenolformaldehyde epoxy, polymer with an
alkyl polyether polysulfide (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e)
Order: March 29, 2019.
Basis for TSCA section 5(e) Order:
The PMN states that the use of the PMN
substance will be as an adhesive for
automotive parts. EPA identified
concerns for reproductive/
developmental toxicity, mutagenicity,
and carcinogenicity for the low
molecular weight components based on
the epoxides chemical category and
submitted test data. EPA also identified
concerns for skin and lung sensitization
and systematic toxicity based on the
epoxide moieties. In addition, based on
analysis of test data on the PMN
substance and SAR analysis on
analogous thiols/mercaptans,
polyepoxides, and monoepoxides, EPA
predicts chronic toxicity to aquatic
organisms may occur at concentrations
greater than 1 ppb. The TSCA section
5(e) Order was issued under TSCA
sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that
in the absence of sufficient information
to permit a reasoned evaluation the
substance may present an unreasonable
risk of injury to human health and the
environment. To protect against these
risks, the TSCA section 5(e) Order
requires:
1. Use of personal protective
equipment where there is a potential for
dermal exposure;
2. Refraining from manufacture,
processing or use of the PMN substance
in a manner that would result in
inhalation exposure;
3. No release of the PMN substance to
surface waters exceeding 1 ppb; and
4. Establishment and use of a hazard
communication program, including
human health precautionary statements
on each label and in the SDS.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Potentially useful information: EPA
has determined that certain information
about the health and environmental
effects of the PMN substance may be
potentially useful in support of a
request by the PMN submitter to modify
the TSCA section 5(e) Order, or if a
manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this SNUR. EPA has also
determined that specific ecological
hazard, reproductive/developmental
toxicity, sensitization, and
carcinogenicity effects testing of the
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PMN substance would be useful in
determining the health and
environmental effects of the PMN
substance. Although the TSCA section
5(e) Order does not require these tests,
the TSCA section 5(e) Order’s
restrictions remain in effect until the
TSCA section 5(e) Order is modified or
revoked by EPA based on submission of
this or other relevant information.
CFR citation: 40 CFR 721.11372.
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PMN Number: P–19–20
Chemical Name: Alkylphenol,
reaction products with carbon dioxide,
distn. residues from manuf. of
alkylphenol derivs. and calcium
alkylphenol derivs. (generic).
CAS Number: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as a lubricating
additive. Based on the estimated
physical/chemical properties of the
PMN substance and comparison to
structurally analogous chemical
substances, EPA has identified concerns
for irritation, sensitization, blood and
liver toxicity, lung toxicity, and
developmental toxicity if the chemical
substance is not used following the
limitation noted. The condition of use of
the PMN substance as described in the
PMN includes the following protective
measure:
• No use of the PMN substance
involving an application method that
generates a vapor, mist, or aerosol.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the 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, irritation, target organ
toxicity/pulmonary effects, and
reproduction/developmental effects
testing would help characterize the
potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11373.
PMN Number: P–19–35
Chemical Name: Acetamide, 2-(4methylphenoxy)-N–1H-pyrazol-3-yl-N(2-thienylmethyl)-.
CAS Number: 1374760–95–8.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substance will be as a fragrance.
Based on the estimated physical/
chemical properties of the PMN
substance, available test data on the new
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chemical substance, and SAR analysis
on analogous thiophenes, EPA has
identified concerns for severe eye
irritation, sensitization, lung effects,
histopathological effects on the nasal
passages, and aquatic toxicity if the
chemical substance is not used
following the limitations noted. The
conditions of use of the PMN substance
as described in the PMN include the
following protective measures:
1. No domestic manufacture of the
PMN substance; and
2. No release of the PMN substance to
surface waters exceeding 15 ppb.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of these protective measures.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
the health effects of the PMN substance
if a manufacturer or processor is
considering submitting a SNUN for a
significant new use that would be
designated by this proposed SNUR. EPA
has determined that the results of
pulmonary effects testing would help
characterize the potential health effects
of the PMN substance.
CFR Citation: 40 CFR 721.11374.
PMN Number: P–19–54
Chemical Names: Polyamines,
reaction products with succinic
anhydride polyalkenyl derivs., metal
salts (generic) (P–19–54, chemical A)
and Polyamines, reaction products with
succinic anhydride polyalkenyl derivs.,
metal salts (generic) (P–19–54, chemical
B).
CAS Numbers: Not available.
Basis for action: The PMN states that
the generic (non-confidential) use of the
PMN substances will be as an
automotive lubricant additive. Based on
the available data for the new chemical
substance, estimated physical/chemical
properties of the PMN substances,
comparison with structurally analogous
chemical substances and other
structural information, EPA has
identified irritation to all tissues if the
chemical substance is not used
following the limitations noted. The
conditions of use of the PMN substances
as described in the PMN include the
following protective measure:
• Exceeding the concentration of the
PMN substances in a formulated
lubricant fluid for consumer use greater
than the confidential percentage
identified in the PMN.
The proposed SNUR would designate
as a ‘‘significant new use’’ the absence
of this protective measure.
Potentially useful information: EPA
has determined that certain information
may be potentially useful to characterize
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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 skin
and eye irritation testing would help
characterize the potential health effects
of the PMN substances.
CFR Citation: 40 CFR 721.11381 (P–
19–54, chemical A) and 40 CFR
721.11382
(P–19–54, chemical B).
V. Rationale and Objectives of the
Proposed Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are
subject to these proposed SNURs, EPA
concluded that for 8 chemical
substances regulation was warranted
under TSCA section 5(e), pending the
development of information sufficient to
make reasoned evaluations of the health
or environmental effects of the chemical
substances. The basis for such findings
is outlined in Unit IV. Based on these
findings, TSCA section 5(e) Orders
requiring the use of appropriate
exposure controls were negotiated with
the PMN submitters. As a general
matter, EPA believes it is necessary to
follow TSCA section 5(e) Orders with a
SNUR that identifies the absence of
those protective measures as Significant
New Uses to ensure that all
manufacturers and processors—not just
the original submitter—are held to the
same standard.
During review of the other 23
chemical substances that are the subject
of these SNURs and as further discussed
in Unit IV, EPA identified certain
circumstances different from the
intended conditions of use that raised
potential risk concerns. EPA determined
that deviations from the protective
measures identified in the submissions
could result in changes in the type or
form of exposure to the chemical
substances and/or increased exposures
to the chemical substances and/or
changes in the reasonably anticipated
manner and methods of manufacturing,
processing, distribution in commerce,
and disposal of the chemical substances,
and therefore warranted SNURs. The
SNURs would identify as significant
new uses any manufacturing,
processing, use, distribution in
commerce, or disposal that does not
conform to the protective measures in
the submission.
B. Objectives
EPA is proposing these SNURs for
specific chemical substances which
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have undergone premanufacture review
because the Agency wants:
• To receive notice of any person’s
intent to manufacture or process a listed
chemical substance for the described
significant new use before that activity
begins.
• To review and evaluate data
submitted in a SNUN before the notice
submitter begins manufacturing or
processing a listed chemical substance
for the described significant new use.
• To either determine that the
prospective manufacture or processing
is not likely to present an unreasonable
risk, or to take necessary regulatory
action associated with any other
determination, before the described
significant new use of the chemical
substance occurs.
Issuance of a SNUR for a chemical
substance does not signify that the
chemical substance is listed on the
TSCA Chemical Substance Inventory
(TSCA Inventory). Guidance on how to
determine if a chemical substance is on
the TSCA Inventory is available on the
internet at https://www.epa.gov/opptintr/
existingchemicals/pubs/tscainventory/
index.html.
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VI. Applicability of the Proposed
Significant New Use Designation
To establish a significant new use,
EPA must determine that the use is not
ongoing. The chemical substances
subject to this proposed rule have
undergone premanufacture review. In
cases where EPA has not received a
notice of commencement (NOC) and the
chemical substance has not been added
to the TSCA Inventory, no person may
commence such activities without first
submitting a PMN. Therefore, for
chemical substances for which an NOC
has not been submitted EPA concludes
that the designated significant new uses
are not ongoing.
When chemical substances identified
in this proposed rule are added to the
TSCA Inventory, EPA recognizes that,
before the rule is effective, other persons
might engage in a use that has been
identified as a significant new use.
However, TSCA section 5(e) Orders
have been issued for 8 of the 31
chemical substances, and the PMN
submitters are prohibited by the TSCA
section 5(e) Orders from undertaking
activities which would be designated as
significant new uses. The identities of
25 of the 31 chemical substances subject
to this proposed rule have been claimed
as confidential (per 40 CFR 720.85) for
a chemical substance covered by this
action. Based on this, the Agency
believes that it is highly unlikely that
any of the significant new uses
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described in the regulatory text of this
proposed rule are ongoing.
Therefore, EPA designates October 11,
2019 as the cutoff date for determining
whether the new use is ongoing. The
objective of EPA’s approach is to ensure
that a person cannot defeat a SNUR by
initiating a significant new use before
the effective date of the final rule.
Persons who begin commercial
manufacture or processing of the
chemical substances for a significant
new use identified as of that date would
have to cease any such activity upon the
effective date of the final rule. To
resume their activities, these persons
would have to first comply with all
applicable SNUR notification
requirements and wait until EPA has
conducted a review of the notice, made
an appropriate determination on the
notice, and has taken such actions as are
required with that determination.
VII. Development and Submission of
Information
EPA recognizes that TSCA section 5
does not require developing any
particular new information (e.g.,
generating test data) before submission
of a SNUN. There is an exception:
Development of test data is required
where the chemical substance subject to
the SNUR is also subject to a rule, order
or consent agreement under TSCA
section 4 (see TSCA section 5(b)(1)).
In the absence of a TSCA section 4
test rule covering the chemical
substance, persons are required only to
submit information in their possession
or control and to describe any other
information known to or reasonably
ascertainable by them (see 40 CFR
720.50). However, upon review of PMNs
and SNUNs, the Agency has the
authority to require appropriate testing.
Unit IV. lists potentially useful
information identified by EPA that
would help characterize the potential
health and/or environmental effects of
the PMN/SNUN substance for all the
listed SNURs. EPA recognizes that the
2016 Lautenberg Amendments have led
to modifications in our approach to
testing requirements, including an
increased consideration of alternatives
to vertebrate testing. Descriptions of
tests/information needs are provided for
informational purposes only and EPA
strongly encourages persons, before
performing any testing, to consult with
the Agency pertaining to protocol
selection. Pursuant to TSCA section
4(h), which pertains to reduction of
testing in vertebrate animals, EPA
encourages consultation with the
Agency on the use of alternative test
methods and strategies (also called New
Approach Methodologies, or NAMs), if
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available, to generate the potentially
useful information. EPA encourages
dialogue with Agency representatives to
help determine how best the submitter
can meet both the data needs and the
objective of TSCA section 4(h). To
access the OCSPP test guidelines
referenced in this document
electronically, please go to https://
www.epa.gov/ocspp and select ‘‘Test
Methods and Guidelines.’’ The
Organisation for Economic Co-operation
and Development test guidelines are
available from the OECD Bookshop at
https://www.oecdbookshop.org or
SourceOECD at https://
www.sourceoecd.org.
The potentially useful information
listed in Unit IV. may not be the only
means of addressing the potential risks
of the chemical substance. EPA
recommends that potential SNUN
submitters contact EPA early enough so
that they will be able to conduct the
appropriate tests.
SNUN submitters should be aware
that EPA will be better able to evaluate
SNUNs which provide detailed
information on the following:
• Human exposure and
environmental release that may result
from the significant new use of the
chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons
submitting a SNUN must comply with
the same notification requirements and
EPA regulatory procedures as persons
submitting a PMN, including
submission of test data on health and
environmental effects as described in 40
CFR 720.50. SNUNs must be submitted
on EPA Form No. 7710–25, generated
using e-PMN software, and submitted to
the Agency in accordance with the
procedures set forth in 40 CFR 720.40
and 721.25. E–PMN software is
available electronically at https://
www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this proposed rule. EPA’s complete
economic analysis is available in the
docket identified for this rulemaking
under ADDRESSES.
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 several new chemical
substances that were the subject of
PMNs and TSCA section 5(e) Orders.
The Office of Management and Budget
(OMB) has exempted these types of
actions from review under Executive
Orders 12866 (58 FR 51735, October 4,
1993) and 13563 (76 FR 3821, January
21, 2011).
B. Paperwork Reduction Act (PRA)
According to 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 proposed
rule 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 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.
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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
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54825
applies to any person (including small
or large entities) who intends to engage
in any activity described in the final
rule as a ‘‘significant new use.’’ Because
these uses are ‘‘new,’’ based on all
information currently available to EPA,
it appears that no small or large entities
presently engage in such activities. A
SNUR requires that any person who
intends to engage in such activity in the
future must first notify EPA by
submitting a SNUN. Although some
small entities may decide to pursue a
significant new use in the future, EPA
cannot presently determine how many,
if any, there may be. However, EPA’s
experience to date is that, in response to
the promulgation of SNURs covering
over 1,000 chemicals, the Agency
receives only a small number of notices
per year. For example, the number of
SNUNs received was seven in Federal
fiscal year (FY) 2013, 13 in FY2014, six
in FY2015, 10 in FY2016, 14 in FY2017,
and 18 in FY2018 and only a fraction of
these were from small businesses. In
addition, the Agency currently offers
relief to qualifying small businesses by
reducing the SNUN submission fee from
$16,000 to $2,800. This lower fee
reduces the total reporting and
recordkeeping of cost of submitting a
SNUN to about $10,116 for qualifying
small firms. Therefore, the potential
economic impacts of complying with
this proposed SNUR are not expected to
be significant or adversely impact a
substantial number of small entities. In
a SNUR that published in the Federal
Register of June 2, 1997 (62 FR 29684)
(FRL–5597–1), the Agency presented its
general determination that final SNURs
are not expected to have a significant
economic impact on a substantial
number of small entities, which was
provided to the Chief Counsel for
Advocacy of the Small Business
Administration.
E. Executive Order 13132: Federalism
D. Unfunded Mandates Reform Act
(UMRA)
I. National Technology Transfer and
Advancement Act (NTTAA)
Based on EPA’s experience with
proposing and finalizing SNURs, State,
local, and Tribal governments have not
been impacted by these rulemakings,
and EPA does not have any reasons to
believe that any State, local, or Tribal
government will be impacted by this
action. As such, EPA has determined
that this proposed rule would not
impose any enforceable duty, contain
any unfunded mandate, or otherwise
have any effect on small governments
subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C.
1501 et seq.).
In addition, since this proposed rule
would not involve any technical
standards, NTTAA section 12(d) (15
U.S.C. 272 note), does not apply to this
action.
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This action would not have a
substantial direct effect on States, on the
relationship between the national
government and the States, or on the
distribution of power and
responsibilities among the various
levels of government, as specified in
Executive Order 13132 (64 FR 43255,
August 10, 1999).
F. Executive Order 13175: Consultation
and Coordination With Indian Tribal
Governments
This action would not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This proposed rule would
not significantly nor uniquely affect the
Indian Tribal governments, nor would it
involve or impose any requirements that
affect Indian Tribes. Accordingly, the
requirements of Executive Order 13175
(65 FR 67249, November 9, 2000), do
not apply to this action.
G. Executive Order 13045: Protection of
Children From Environmental Health
Risks and Safety Risks
This action is not subject to Executive
Order 13045 (62 FR 19885, April 23,
1997), because this is not an
economically significant regulatory
action as defined by Executive Order
12866, and this action does not address
environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use
This action is not subject to Executive
Order 13211 (66 FR 28355, May 22,
2001), because this proposed rule is not
expected to affect energy supply,
distribution, or use.
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).
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Federal Register / Vol. 84, No. 198 / Friday, October 11, 2019 / Proposed Rules
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: September 26, 2019.
Tala Henry,
Deputy Director, Office of Pollution
Prevention and Toxics.
Therefore, it is proposed that 40 CFR
chapter I be amended as follows:
PARTS 721—[AMENDED]
1. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, 2613, and
2625(c).
2. Add §§ 721.11346 through
721.11374, 721.11381 and 721.11382 to
subpart E to read as follows:
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■
Subpart E—Significant New Uses for
Specific Chemical Substances
Sec.
721.11346 Perfluoropolyether halide
(generic).
721.11347 Perfluoropolyether aryl (generic).
721.11348 Substituted arylperfluoropolyether (generic).
721.11349 Sulfonated perfluoropolyether
aromatic transition metal salt (generic).
721.11350 Sulfonated perfluoropolyether
aryl alkali metal salt (generic).
721.11351 Cyclohexanol, 4-ethylidene-2propoxy- (P–16–225, chemical A).
721.11352 Cyclohexanol, 5-ethylidene-2propoxy- (P–16–225, chemical B).
721.11353 Ethanone, 1-(5-propyl-1,3benzodioxol-2-yl)-.
721.11354 Endcapped polysiloxane
(generic).
721.11355 2,7-Nonadien-4-ol, 4,8-dimethyl.
721.11356 Carbonodithioic acid, O-[2[(dithiocarboxy)amino]-2-methylpropyl]
ester, sodium salt (1:2).
721.11357 Oxirane, 2-methyl-, polymer
with oxirane, methyl 2-(substituted
carbomonocycle isoquinolin-2(3H)-yl)
propyl ether (generic).
721.11358 Vegetable oil, polymers with
diethylene glycol- and polyol- and
polyethylene glycol-depolymd.
poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid
anhydride (generic).
721.11359 1H-Pyrrole-2,5-dione, 1,1′-C36alkylenebis-.
721.11360 Benzenepropanal,
.alpha.,.alpha.,3-trimethyl-.
721.11361 Multiwalled carbon nanotubes
(generic).
721.11362 Polyolefin ester (generic).
721.11363 Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with 2-ethyl-2-(hydroxymethyl)1,3-propanediol, polyetherpolyol,
.alpha.,.alpha.′-[(1-methylethylidene)di4,1-phenylene]bis[.omega.hydroxypoly(oxy-1,2-ethanediyl)] and
1,2-propanediol, iso-Bu alc.- and 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and Et alc.- and
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methanol- and 1-methoxy-2-propanolblocked, (generic).
721.11364 Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol,
2-butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanolblocked, (generic).
721.11365 Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol,
2-butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanoland 1-methoxy-2-propanol-blocked
(generic).
721.11366 Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol,
2-butoxyethanol- and 2-(2butoxyethoxy)ethanol- and 1(or 2)-(2methoxymethylethoxy)propanol-blocked
(generic).
721.11367 Isocyanic acid,
polymethylenepolyphenylene ester,
2-butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanoland 1(or 2)-(2methoxymethylethoxy)propanol-blocked
(generic).
721.11368 Isocyanic acid,
polymethylenepolyphenylene ester,
2-butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanoland 1-methoxy-2-propanol-blocked
(generic).
721.11369 Fatty acid ester, polyether,
diisocyanate polymer (generic).
721.11370 Alkenoic acid, alkyl-, alkyl ester,
polymer with alkyl alkenoate,
substituted heteromonocycle, substituted
carbomonocycle, substituted alkanediol
and alkenoic acid, alkali metal salt
(generic).
721.11371 Alkyl heteromonocycle with
heteroatom substituted alkyl cycloalkane
and 2-hydroxyethyl heteromonocycle
methacrylate-blocked homopolymer
(generic).
721.11372 Phenol-formaldehyde epoxy,
polymer with an alkyl polyether
polysulfide (generic).
721.11373 Alkylphenol, reaction products
with carbon dioxide, distn. residues from
manuf. of alkylphenol derivs. and
calcium alkylphenol derivs. (generic).
721.11374 Acetamide, 2-(4methylphenoxy)-N–1H-pyrazol-3-yl-N(2-thienylmethyl)-.
721.11375 [Reserved]
721.11376 [Reserved]
721.11377 [Reserved]
721.11378 [Reserved]
721.11379 [Reserved]
721.11380 [Reserved]
721.11381 Polyamines, reaction products
with succinic anhydride polyalkenyl
derivs. metal salts (generic) (P–19–54,
chemical A).
721.11382 Polyamines, reaction products
with succinic anhydride polyalkenyl
derivs., metal salts (generic) (P–19–54,
chemical B).
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Subpart E—Significant New Uses for
Specific Chemical Substances
§ 721.11346
(generic).
Perfluoropolyether halide
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as perfluoropolyether halide
(PMN P–16–151) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e) (concentration set at
1.0%), (f), (g)(3)(i), (ii), (4)(i), (iii), and
(5). Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t). It is a
significant new use to manufacture the
substance for more than one year.
(iii) Disposal. Requirements as
specified in § 721.85 (a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c) and (f) through (k)
are applicable to manufacturers 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)(ii) of this section.
§ 721.11347
(generic).
Perfluoropolyether aryl
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as perfluoropolyether aryl
(PMN P–16–152) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard Communication.
Requirements as specified in § 721.72(a)
through (d), (e) (concentration set at
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1.0%), (f), (g)(3)(i), (ii), (4)(i), (iii), and
(5). Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t).
(iii) Disposal. Requirements as
specified in § 721.85 (a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c) and (f) through (k)
are applicable to manufacturers 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)(ii) of this section.
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§ 721.11348 Substituted arylperfluoropolyether (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted arylperfluoropolyether (PMN P–16–153) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e) (concentration set at
1.0%), (f), (g)(3)(i), (ii), (4)(i), (iii), and
(5). Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t).
(iii) Disposal. Requirements as
specified in § 721.85 (a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(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.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c) and (f) through (k)
are applicable to manufacturers 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)(ii) of this section.
§ 721.11349 Sulfonated perfluoropolyether
aromatic transition metal salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonated
perfluoropolyether aromatic transition
metal salt (PMN P–16–154) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e) (concentration set at
1.0%), (f), (g)(3)(i), (ii), (4)(i), (iii), and
(5). Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t).
(iii) Disposal. Requirements as
specified in § 721.85 (a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c) and (f) through (k)
are applicable to manufacturers 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)(ii) of this section.
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§ 721.11350 Sulfonated perfluoropolyether
aryl alkali metal salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as sulfonated
perfluoropolyether aryl alkali metal salt
(PMN P–16–155) 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) Hazard communication.
Requirements as specified in § 721.72(a)
through (d), (e) (concentration set at
1.0%), (f), (g)(3)(i), (ii), (4)(i), (iii), and
(5). Alternative hazard and warning
statements that meet the criteria of the
Globally Harmonized System and OSHA
Hazard Communication Standard may
be used.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) and (t).
(iii) Disposal. Requirements as
specified in § 721.85 (a)(1), (b)(1), and
(c)(1). Incineration must be hazardous
waste high temperature incineration
where the treatment efficiency is no less
than 99.99%.
(iv) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c) and (f) through (k)
are applicable to manufacturers 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)(ii) of this section.
§ 721.11351 Cyclohexanol, 4-ethylidene-2propoxy-(P–16–225, chemical A).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cyclohexanol, 4-ethylidene-2-propoxy(PMN P–16–225, chemical A; CAS No.
1631145–48–6) 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(f) and (s)(10,000
kg). It is a significant new use to use
other than as a fragrance and process the
substance to greater than 10% in
compounded fragrance oil formulations.
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(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), (b), and (i) are applicable
to manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11352 Cyclohexanol, 5-ethylidene-2propoxy-(P–16–225, chemical B).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
cyclohexanol, 5-ethylidene-2-propoxy(PMN P–16–225, chemical B; CAS No.
1631145–49–7) 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(f) and (s)(10,000
kg). It is a significant new use to use
other than as a fragrance and process the
substance to greater than 10% in
compounded fragrance oil formulations.
(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), (b), and (i) are applicable
to manufacturers 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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§ 721.11353 Ethanone, 1-(5-propyl-1,3benzodioxol-2-yl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
ethanone, 1-(5-propyl-1,3-benzodioxol2-yl)-(PMN P–16–314, CAS No.
1370699–98–1) 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(f) and (s)(10,000
kg). It is a significant new use to exceed
10% of the PMN substance in
processing formulations.
(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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11354
(generic).
Endcapped polysiloxane
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as endcapped polysiloxane
(PMN P–16–429) 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 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.
§ 721.11355
dimethyl-.
2,7-Nonadien-4-ol, 4,8-
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2,7-nonadien-4-ol, 4,8-dimethyl-(PMN
P–16–470, CAS No. 103983–77–3) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(4) and (b)(4)
where N=113.
(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 (k) are
applicable to manufacturers 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.
§ 721.11356 Carbonodithioic acid, O-[2[(dithiocarboxy)amino]-2-methylpropyl]
ester, sodium salt (1:2).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
carbonodithioic acid, O-[2[(dithiocarboxy)amino]-2-methylpropyl]
ester, sodium salt (1:2) (PMN P–17–108;
CAS No. 1947332–67–3) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N=2.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11357 Oxirane, 2-methyl-, polymer
with oxirane, methyl 2-(substituted
carbomonocycle isoquinolin-2(3H)-yl)
propyl ether (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance is identified
generically as oxirane, 2-methyl-,
polymer with oxirane, methyl 2(substituted carbomonocycle
isoquinolin-2(3H)-yl) propyl ether (PMN
P–17–253) 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(o). It is a
significant new use to process the
substance to a concentration greater
than 5% by weight in the final
formulated product for any use.
(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 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.
§ 721.11358 Vegetable oil, polymers with
diethylene glycol- and polyol- and
polyethylene glycol-depolymd.
poly(ethylene terephthalate) waste plastics
and arylcarboxylic acid anhydride (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as vegetable oil, polymers
with diethylene glycol- and polyol- and
polyethylene glycol-depolymd.
poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid
anhydride (PMN P–18–91) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to modify the manufacture,
process, or use of the substance that
results in inhalation exposure to vapors,
particulate, mist or aerosols.
(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 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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§ 721.11359 1H-Pyrrole-2,5-dione, 1,1′-C36alkylenebis-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1H-pyrrole-2,5-dione, 1,1′-C36alkylenebis-(PMN P–18–120, CAS No.
1911605–95–2) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in any manner that results
in inhalation exposures.
(ii) [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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11360 Benzenepropanal,
.alpha.,.alpha.,3-trimethyl-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
benzenepropanal, .alpha.,.alpha.,3trimethyl-(P–18–129; CAS No. 107737–
97–3) is subject to reporting under this
section for the significant new uses
described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(t).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 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.
§ 721.11361
(generic).
Multiwalled carbon nanotubes
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as multiwalled carbon
nanotubes (PMN P–18–182) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section. The
requirements of this section do not
apply to quantities of the substance that
have been:
(i) embedded or incorporated into a
polymer matrix that itself has been
reacted (cured);
(ii) embedded in a permanent solid/
polymer form that is not intended to
undergo further processing, except
mechanical processing; or
(iii) incorporated into an article as
defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1), (3), when determining
which persons are reasonably likely to
be exposed as required for § 721.63(a)(1)
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and, (a)(4), engineering control
measures (e.g., enclosure or
confinement of the operation, general
and local ventilation) or administrative
control measures (e.g., workplace
policies and procedures) shall be
considered and implemented to prevent
exposure, where feasible, (5)(respirators
must provide a National Institute for
Occupational Safety and Health
assigned protection factor of at least 50),
(6)(particulate), and (c).
(ii) Industrial, commercial, and
consumer activities. It is a significant
new use to use an application method
that generates a dust, mist, or aerosol,
unless such application method occurs
in an enclosed process. It is a significant
new use to use the substance other than
for heat transfer, heat storage, thermal
emission, and general temperature
management in heat-generating systems
such as electronics, to improve
mechanical properties or electrical
conductivities of other materials or
products, and for light absorption
properties.
(iii) Disposal. Requirements as
specified in § 721.85 (a)(1), (2), (b)(1),
(2), (c)(1), and (2).
(iv) Release to water. Requirements as
specified in § 721.90 (a)(1), (b)(1), and
(c)(1).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (k) are applicable
to manufacturers and processors of this
substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11362
Polyolefin ester (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyolefin ester (PMN P–
18–186) 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 (y)(1). It is a
significant new use to manufacture
(including import) the substance at less
than the confidential average molecular
weight identified 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).
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(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 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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§ 721.11363 Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with 2-ethyl-2-(hydroxymethyl)-1,3propanediol, polyetherpolyol,
.alpha.,.alpha.′-[(1-methylethylidene)di-4,1phenylene]bis[.omega.-hydroxypoly(oxy1,2-ethanediyl)] and 1,2-propanediol, iso-Bu
alc.- and 2-butoxyethanol- and 2-(2butoxyethoxy)ethanol- and Et alc.- and
methanol- and 1-methoxy-2-propanolblocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as isocyanic acid,
polymethylenepolyphenylene ester,
polymer with 2-ethyl-2(hydroxymethyl)-1,3-propanediol,
polyetherpolyol, .alpha.,.alpha.′-[(1methylethylidene)di-4,1phenylene]bis[.omega.hydroxypoly(oxy-1,2-ethanediyl)] and
1,2-propanediol, iso-Bu alc.- and 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and Et alc.- and
methanol- and 1-methoxy-2-propanolblocked (PMN P–18–247) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in a manner results in
inhalation exposure.
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N = 200.
(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), and (k) are
applicable to manufacturers 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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§ 721.11364 Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanolblocked, (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanolblocked, (PMN P–18–248) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in a manner results in
inhalation exposure.
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N = 200.
(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), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11365 Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanol- and
1-methoxy-2-propanol-blocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanol
and 1-methoxy-2-propanol-blocked
(PMN P–18–249) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in a manner results in
inhalation exposure.
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N = 200.
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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), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11366 Isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and 1(or 2)-(2methoxymethylethoxy)propanol-blocked
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as isocyanic acid,
polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and 1(or 2)-(2methoxymethylethoxy)propanolblocked. (PMN P–18–250) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in 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 = 200.
(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), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11367 Isocyanic acid,
polymethylenepolyphenylene ester, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanol- and
1(or 2)-(2-methoxymethylethoxy)propanolblocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as isocyanic acid,
polymethylenepolyphenylene ester, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanol-
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and 1(or 2)-(2methoxymethylethoxy)propanolblocked (PMN P–18–251) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in 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 = 200.
(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), and (k) are
applicable to manufacturers 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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§ 721.11368 Isocyanic acid,
polymethylenepolyphenylene ester, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanol- and
1-methoxy-2-propanol-blocked (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as isocyanic acid,
polymethylenepolyphenylene ester, 2butoxyethanol- and 2-(2butoxyethoxy)ethanol- and methanoland 1-methoxy-2-propanol-blocked.
(PMN P–18–252) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance in 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 = 200.
(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), and (k) are
applicable to manufacturers 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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§ 721.11369 Fatty acid ester, polyether,
diisocyanate polymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acid ester, polyether,
diisocyanate polymer (PMN P–18–282)
is subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance containing greater than
the confidential residual isocyanate
percentage identified 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 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.
§ 721.11370 Alkenoic acid, alkyl-, alkyl
ester, polymer with alkyl alkenoate,
substituted heteromonocycle, substituted
carbomonocycle, substituted alkanediol
and alkenoic acid, alkali metal salt
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkenoic acid, alkyl-, alkyl
ester, polymer with alkyl alkenoate,
substituted heteromonocycle,
substituted carbomonocycle, substituted
alkanediol and alkenoic acid, alkali
metal salt (PMN P–18–305) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance that results in inhalation
exposures.
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c) and (i) are
applicable to manufacturers and
processors of this substance.
PO 00000
Frm 00040
Fmt 4702
Sfmt 4702
54831
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11371 Alkyl heteromonocycle with
heteroatom substituted alkyl cycloalkane
and 2-hydroxyethyl heteromonocycle
methacrylate-blocked homopolymer
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkyl heteromonocycle
with heteroatom substituted alkyl
cycloalkane and 2-hydroxyethyl
heteromonocycle methacrylate-blocked
homopolymer (PMN P–18–339) is
subject to reporting under this section
for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the substance for any use 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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11372 Phenol-formaldehyde epoxy,
polymer with an alkyl polyether polysulfide
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as phenol-formaldehyde
epoxy, polymer with an alkyl polyether
polysulfide (PMN P–19–5) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace.
Requirements as specified in
§ 721.63(a)(1) and (3).
(ii) Hazard communication.
Requirements as specified in § 721.72
(a) through (d), (f), (g)(1)(iv), (vi), (vii),
(skin and respiratory sensitization),
(germ cell mutagenicity), (2)(i), (ii), (v),
(3)(i), (ii), (4)(water release restrictions
apply), and (5). Alternative hazard and
warning statements that meet the
criteria of the Globally Harmonized
System and OSHA Hazard
Communication Standard may be used.
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Federal Register / Vol. 84, No. 198 / Friday, October 11, 2019 / Proposed Rules
(iii) Industrial, commercial, and
consumer activities. It is a significant
new use to manufacture, process, or use
the PMN substance in any manner that
results in inhalation exposure.
(iv) 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), (f) through (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11373 Alkylphenol, reaction
products with carbon dioxide, distn.
residues from manuf. of alkylphenol derivs.
and calcium alkylphenol derivs. (generic).
jbell on DSK3GLQ082PROD with PROPOSALS
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylphenol, reaction
products with carbon dioxide, distn.
residues from manuf. of alkylphenol
derivs. and calcium alkylphenol derivs.
(PMN P–19–20) 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(y)(1).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph (b).
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a) through (c), and (i) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
VerDate Sep<11>2014
17:06 Oct 10, 2019
Jkt 250001
§ 721.11374 Acetamide, 2-(4methylphenoxy)-N–1H-pyrazol-3-yl-N-(2thienylmethyl)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
acetamide, 2-(4-methylphenoxy)-N–1Hpyrazol-3-yl-N-(2-thienylmethyl)- (PMN
P–19–35, CAS No. 1374760–95–8) 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(f).
(ii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) where N=15.
(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), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11375
[Reserved]
§ 721.11376
[Reserved]
§ 721.11377
[Reserved]
§ 721.11378
[Reserved]
§ 721.11379
[Reserved]
§ 721.11380
[Reserved]
§ 721.11381 Polyamines, reaction
products with succinic anhydride
polyalkenyl derivs., metal salts (generic) (P–
19–54, chemical A).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyamines, reaction
products with succinic anhydride
polyalkenyl derivs., metal salts (PMN P–
19–54, chemical A) 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
PO 00000
Frm 00041
Fmt 4702
Sfmt 9990
new use to exceed the confidential
concentration percentage of the
substance in a formulated lubricant
fluid for consumer use identified in P–
19–54.
(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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
§ 721.11382 Polyamines, reaction
products with succinic anhydride
polyalkenyl derivs., metal salts (generic) (P–
19–54, chemical B).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as polyamines, reaction
products with succinic anhydride
polyalkenyl derivs., metal salts (PMN P–
19–54, chemical B) 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 exceed the confidential
concentration percentage of the
substance in a formulated lubricant
fluid for consumer use identified in P–
19–54.
(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 and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
[FR Doc. 2019–21720 Filed 10–10–19; 8:45 am]
BILLING CODE 6560–50–P
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]]>Agencies
[Federal Register Volume 84, Number 198 (Friday, October 11, 2019)]
[Proposed Rules]
[Pages 54816-54832]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21720]
=======================================================================
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 721
[EPA-HQ-OPPT-2019-0228; FRL-9998-64]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances (19-3.F)
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 31 chemical substances which
were the subject of premanufacture notices (PMNs). Eight of these
chemical substances are subject to TSCA Orders issued by EPA and the
remaining 23 of these chemical substances received a ``not likely to
present an unreasonable risk'' determination. This action would require
persons who intend to manufacture (defined by statute to include
import) or process any of these 31 chemical substances for an activity
that is proposed as a significant new use to notify EPA at least 90
days before commencing that activity. Persons may not commence
manufacture or processing for the significant new use until EPA has
conducted a review of the notice, made an appropriate determination on
the notice, and has taken such actions as are required by that
determination.
DATES: Comments must be received on or before November 12, 2019.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2019-0228, 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,
process, or use the chemical substances contained in this proposed
rule. The following list of North American Industrial Classification
System (NAICS) codes is not intended to be exhaustive, but rather
provides a guide to help readers determine whether this document
applies to them. Potentially affected entities may include:
Manufacturers or processors of one or more subject
chemical substances (NAICS codes 325 and 324110), e.g., chemical
manufacturing and petroleum refineries.
This action may also affect certain entities through pre-existing
import certification and export notification rules under TSCA. Chemical
importers are subject to the TSCA section 13 (15 U.S.C. 2612) import
certification requirements promulgated at 19 CFR
[[Page 54817]]
12.118 through 12.127 and 19 CFR 127.28. Chemical importers must
certify that the shipment of the chemical substance complies with all
applicable rules and orders under TSCA. Importers of chemicals subject
to final SNURs must certify their compliance with the SNUR
requirements. The EPA policy in support of import certification appears
at 40 CFR part 707, subpart B. In addition, any persons who export or
intend to export a chemical substance that is the subject of this
proposed rule on or after November 12, 2019 are subject to the export
notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see
40 CFR 721.20), and must comply with the export notification
requirements in 40 CFR part 707, subpart D.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through
regulations.gov or email. Clearly mark the part or all of the
information that you claim to be CBI. For CBI information in a disk or
CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as
CBI and then identify electronically within the disk or CD-ROM the
specific information that is claimed as CBI. In addition to one
complete version of the comment that includes information claimed as
CBI, a copy of the comment that does not contain the information
claimed as CBI must be submitted for inclusion in the public docket.
Information so marked will not be disclosed except in accordance with
procedures set forth in 40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting
your comments, see the commenting tips at 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
chemical substances that were the subject of PMNs. These proposed SNURs
would require persons to notify EPA at least 90 days before commencing
the manufacture or processing of a chemical substance for any activity
proposed as a significant new use. Receipt of such notices would allow
EPA to assess risks and, if appropriate, to regulate the significant
new use before it may occur. Additional background regarding SNURs is
more fully set out in the preamble to EPA's first direct final SNUR
published in the Federal Register issue of April 24, 1990 (55 FR 17376)
(FRL-3658-5). Consult that preamble for further general information on
the objectives, rationale, and procedures for SNURs and on the basis
for significant new use designations, including provisions for
developing test data.
B. What is the Agency's authority for taking this action?
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 bulleted TSCA section 5(a)(2)
factors listed in Unit III.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the proposed rule,
recordkeeping requirements, and exemptions to reporting requirements,
and applicability of the rule to uses occurring before the effective
date of the rule. Provisions relating to user fees appear at 40 CFR
part 700. Pursuant to 40 CFR 721.1(c), persons subject to SNURs must
comply with the same SNUN requirements and EPA regulatory procedures as
submitters of PMNs under TSCA section 5(a)(1)(A) (15 U.S.C.
2604(a)(1)(A)). In particular, these requirements include the
information submission requirements of TSCA section 5(b) and 5(d)(1)
(15 U.S.C. 2604(b) and 2604(d)(1)), the exemptions authorized by TSCA
section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40
CFR part 720. Once EPA receives a SNUN, EPA must either determine that
the use is not likely to present an unreasonable risk of injury under
the conditions of use for the chemical substance or take such
regulatory action as is associated with an alternative determination
before the manufacture or processing for the significant new use can
commence. In the case of a determination other than not likely to
present unreasonable risk, the applicable review period must also
expire before manufacturing or processing for the new use may commence.
If EPA determines that the use is not likely to present an unreasonable
risk, EPA is required under TSCA section 5(g) to make public, and
submit for publication in the Federal Register, a statement of EPA's
findings.
III. Significant New Use Determination
TSCA section 5(a)(2) states that EPA's determination that a use of
a chemical substance is a significant new use must be made after
consideration of all relevant factors, including:
The projected volume of manufacturing and processing of a
chemical substance.
The extent to which a use changes the type or form of
exposure of human beings or the environment to a chemical substance.
The extent to which a use increases the magnitude and
duration of exposure of human beings or the environment to a chemical
substance.
The reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
In determining significant new uses for the 31 chemical substances
that are the subject of these SNURs, EPA considered relevant
information about the toxicity of the chemical substances and potential
human exposures and environmental releases that may be associated with
the substances, in addition to the factors in TSCA section 5(a)(2).
Consistent with TSCA section 5(f)(4), for the eight chemical substances
subject to an order under TSCA section 5(e), EPA is proposing to
identify any use not conforming to the restrictions of the order as a
significant new use. For the 23 chemical substances that EPA has
determined ``not likely'' to present an unreasonable risk under the
conditions of use, EPA is proposing to identify other circumstances
that, while not reasonably foreseen, would warrant further EPA review
before manufacture or processing for such a use is commenced.
IV. Substances Subject to This Proposed Rule
EPA is proposing significant new use and recordkeeping requirements
for 31 chemical substances in 40 CFR part 721, subpart E. In this unit,
EPA provides the following information for each chemical substance:
PMN number.
Chemical name (generic name, if the specific name is
claimed as CBI).
Chemical Abstracts Service (CAS) Registry number (if
assigned for non-confidential chemical identities).
Basis for the SNUR or basis for the TSCA section 5(e)
Order.
Potentially Useful Information. This is information
identified by EPA that would help characterize the potential health
and/or environmental effects of the chemical substance in support of a
request by the PMN submitter to modify the Order, or if a manufacturer
or processor is considering submitting a SNUN for a significant new use
designated by the SNUR.
[[Page 54818]]
CFR citation assigned in the regulatory text section of
the proposed rule. The regulatory text section of each proposed rule
specifies the activities that would be designated as significant new
uses. Certain new uses, including exceedance of production volume
limits (i.e., limits on manufacture volume) and other uses designated
in this proposed rule, may be claimed as CBI.
These proposed rules include 8 PMN substances that are subject to
orders issued under TSCA section 5(e)(1)(A), as required by the
determinations made under TSCA section 5(a)(3)(B). Those TSCA section
5(e) Orders require protective measures to limit exposures or otherwise
mitigate the potential unreasonable risk. The proposed SNURs would
identify as significant new uses any manufacturing, processing, use,
distribution in commerce, or disposal that does not conform to the
restrictions imposed by the underlying TSCA section 5(e) Orders,
consistent with TSCA section 5(f)(4).
These proposed rules also include 23 PMN substances that received
``not likely to present an unreasonable risk'' determination in TSCA
section 5(a)(3)(c). However, during the course of these reviews, EPA
identified concerns for certain health and/or environmental risks if
the chemicals were not used following the limitations identified by the
submitters in the notices. EPA did not deem such uses as reasonably
foreseen in the TSCA section 5(a)(3)(C) determinations. The proposed
SNURs would identify as significant new uses any manufacturing,
processing, use, distribution in commerce, or disposal that does not
conform to those same limitations.
The chemicals subject to these proposed SNURs are as follows:
PMN Numbers: P-16-151, P-16-152, P-16-153, P-16-154, and P-16-155
Chemical names: Perfluoropolyether halide (generic) (P-16-151),
Perfluoropolyether aryl (generic) (P-16-152), Substituted aryl-
perfluoropolyether (generic) (P-16-153), Sulfonated perfluoropolyether
aromatic transition metal salt (generic) (P-16-154), and Sulfonated
perfluoropolyether aryl alkali metal salt (generic) (P-16-155).
CAS numbers: Not available.
Effective date of TSCA section 5(e) Order: April 30, 2019.
Basis for TSCA section 5(e) Order: The PMNs state that the generic
(non-confidential) use of the substances P-16-151 and P-16-152 will be
as intermediates and P-16-153, P-16-154, P-16-155 will be as lubricant
additives. Based on the physical/chemical properties of the PMN
substances (as described in the New Chemical Program's PBT category at
64 FR 60194; November 4, 1999) and test data on structurally similar
substances, the PMN substances are potentially persistent,
bioaccumulative, and toxic (PBT) chemicals. EPA estimates that the PMN
substances will persist in the environment more than 2 months and
estimates a bioaccumulation factor of greater than or equal to 1,000.
Based on results of testing on analogous small fluorinated polyether
substances, EPA has identified concerns for the possible degradation
products of the PMN substances for liver toxicity, kidney effects,
hematology and clinical chemistry changes, pancreatic and testicular
cell tumor formation, and reproductive and developmental effects. Based
on estimated ecotoxicity values for the possible degradation products,
EPA predicts toxicity to aquatic organisms may occur at concentrations
that exceed 153 parts per billion (ppb). The TSCA section 5(e) Order
was issued under TSCA sections 5(a)(3)(B)(i) and 5(e)(1)(A)(i), based
on a finding that the available information is insufficient to permit a
reasoned evaluation of the human health and environmental effects of
the PMN substances. The TSCA section 5(e) Order was also issued under
TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I), based on a
finding that in the absence of sufficient information to permit a
reasoned evaluation, the substances may present an unreasonable risk of
injury to human health and the environment. To protect against these
risks, the TSCA section 5(e) Order requires:
1. Submission to EPA of certain fate testing within one year after
the Notice of Commencement of the PMN P-16-155;
2. Establishment and use of a hazard communication program,
including environmental hazard precautionary statements on each label
and in the Safety Data Sheet (SDS);
3. Dispose of the PMN substances only with Hazardous Waste, High
Temperature Incineration with a control efficiency of 99.99% efficiency
or greater;
4. No release of the PMN substances to surface waters;
5. Manufacture the PMN substances only for the confidential uses
specified in the PMNs; and
6. No manufacture beyond the annual production volumes specified in
the TSCA section 5(e) Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the TSCA section 5(e) Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this SNUR. The
submitter has agreed not to manufacture (including import) the P-16-155
substance beyond one year after the Notice of Commencement without
performing an indirect photolysis screening test (OCSPP Test Guideline
835.5270). EPA has also determined that the results of hydrolysis
testing, photodegradation in soil, chronic aquatic toxicity, and
reproductive toxicity testing would help EPA determine the potential
human and environmental effects of the PMN substances. Although the
TSCA section 5(e) Order does not require these tests, the TSCA section
5(e) Order's restrictions remain in effect until the TSCA section 5(e)
Order is modified or revoked by EPA based on submission of this or
other relevant information.
CFR citations: 40 CFR 721.11346 (P-16-151); 40 CFR 721.11347 (P-16-
152); 40 CFR 721.11348 (P-16-153); 40 CFR 721.11349 (P-16-154) and 40
CFR 721.11350 (P-16-155).
PMN Number: P-16-225
Chemical names: Cyclohexanol, 4-ethylidene-2-propoxy- (P-16-225,
chemical A) and Cyclohexanol, 5-ethylidene-2-propoxy- (P-16-225,
chemical B).
CAS numbers: 1631145-48-6 (P-16-225, chemical A) and 1631145-49-7
(P-16-225, chemical B).
Basis for action: The PMN states that the use of the substance will
be as a fragrance ingredient, being blended (mixed) with other
fragrance ingredients to make fragrance oils that will be sold to
industrial and commercial customers for their incorporation into soaps,
detergents, cleaners, air fresheners, candles and other similar
industrial, household and consumer products. Based on the physical/
chemical properties of the PMN substances, test data on the PMN
substances, and Structure Analysis Relationships (SAR) analysis of test
data on analogous substances, EPA has identified concerns for systemic
toxicity, and aquatic toxicity at surface water concentrations
exceeding 300 ppb, if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substances as
described in the PMN include the following protective measures:
[[Page 54819]]
1. No domestic manufacture of the PMN substances (i.e., import
only);
2. No import of the PMN substances at more than 10,000 kg annual
production volume;
3. No use of the PMN substances other than for the fragrance use
stated in the PMN submission; and
4. No processing of the PMN substances to greater than 10% in
compounded fragrance oil formulation.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
environmental effects of the PMN substances in support of a request by
the PMN submitter to modify the TSCA section 5(e) Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this proposed SNUR. EPA
has determined that the results of absorption testing and aquatic
toxicity testing would help characterize the potential health and
environmental effects of the PMN substances.
CFR citation: 40 CFR 721.11351 (P-16-225, chemical A) and 40 CFR
721.11352 (P-16-225, chemical B).
PMN Number: P-16-314
Chemical Name: Ethanone, 1-(5-propyl-1,3-benzodioxol-2-yl)-.
CAS Number: 1370699-98-1.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as part of a fragrance
formula. Based on test data on the new chemical substance, the
estimated physical/chemical properties of the PMN, and SAR analysis on
analogous neutral organics, EPA has identified concerns for liver
toxicity for the intact new chemical substance, oncogenicity for the
ketone/aldehyde hydrolysis product(s) that may be formed under the
acidic conditions in the stomach, and aquatic toxicity if the chemical
substance is not used following the limitations noted. The conditions
of use of the PMN substance as described in the PMN include the
following protective measures:
1. No domestic manufacture of the PMN substance (i.e., import
only);
2. Less than 10% of the PMN substance in any formulation from
processing; and
3. No manufacture (including import) beyond an annual production
volume of 10,000 kilograms per year.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of absorption testing and aquatic toxicity testing would
help characterize the potential health and environmental effects of the
PMN substance.
CFR Citation: 40 CFR 721.11353.
PMN Number: P-16-429
Chemical Name: Endcapped polysiloxane (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a universal tint
paste resin having high solids. Based on the estimated physical/
chemical properties of the PMN substance, structural information, and
information on analogous alkoxysilanes, EPA has identified lung effects
and irritation to the eye, skin, lung, and mucous membranes if the
chemical substance is not used following the limitation noted. The
condition of use of the PMN substance as described in the PMN includes
the following protective measure:
Use of the PMN substance only for the confidential use
specified in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of pulmonary effects and skin irritation testing would help
characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11354.
PMN Number: P-16-470
Chemical Name: 2,7-Nonadien-4-ol, 4,8-dimethyl-.
CAS Number: 103983-77-3.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as part of a fragrance
formula. Based on the estimated physical/chemical properties of the PMN
substance and available data on the new chemical substance, EPA has
identified concerns for skin irritation, eye irritation, liver and
thyroid toxicity, and aquatic toxicity if the chemical substance is not
used following the limitations noted. The conditions of use of the PMN
substance as described in the PMN include the following protective
measure:
No release of the PMN substance from manufacturing or
processing resulting in surface water concentrations that exceed 113
ppb;
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of specific organ toxicity and aquatic toxicity testing
would help characterize the potential health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11355.
PMN Number: P-17-108
Chemical Name: Carbonodithioic acid, O-[2-[(dithiocarboxy)amino]-2-
methylpropyl] ester, sodium salt (1:2).
CAS Number: 1947332-67-3.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be for use in ore
processing. Based on the estimated physical/chemical properties of the
PMN substance, available PMN data, comparison with structurally
analogous chemical substances, and SAR analysis of test data on
analogous dithiocarbamates, EPA has identified concerns for irritation
and corrosion to all tissues, developmental and neurological effects,
and aquatic toxicity if the chemical substance is not used following
the limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measure:
No release of the PMN substance resulting in surface water
concentrations exceeding 2 ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
environmental effects of the PMN substance if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of reproductive/developmental toxicity, neurotoxicity, skin
irritation/
[[Page 54820]]
corrosion, and toxicokinetics and chronic aquatic ecotoxicity testing
would help characterize the potential health and environmental effects
of the PMN substance.
CFR Citation: 40 CFR 721.11356.
PMN Number: P-17-253
Chemical Name: Oxirane, 2-methyl-, polymer with oxirane, methyl 2-
(substituted carbomonocycle isoquinolin-2(3H)-yl) propyl ether
(generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be to enhance formulation
solubilization properties. Based on its estimated physical/chemical
properties, data on analogous chemicals, and other structural
information, EPA has identified concerns for lung effects and
irritation if the chemical substance is not used following the
limitations noted. The condition of use of the PMN substance as
described in the PMN includes the following protective measures:
No processing of the substance to a concentration greater
than 5% by weight in the final formulated product, for any use; and
No consumer use.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that pulmonary
effects testing would help characterize the potential health effects of
the PMN substance.
CFR Citation: 40 CFR 721.11357.
PMN Number: P-18-91
Chemical Name: Vegetable oil, polymers with diethylene glycol- and
polyol- and polyethylene glycol-depolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid anhydride (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as a chemical intermediate (polyol) for use in the manufacture
of polyurethane polymers. Based on the estimated physical/chemical
properties of the PMN substance, comparison with structurally analogous
chemical substances, test data on analogous substances, and SAR
analysis on esters, EPA has identified concerns for lung effects,
irritation to eye, mucous membranes and lung, anesthetization of the
eye, developmental, renal and bladder toxicity, kidney toxicity, and
renal cancer if the chemical substance is not used following the
limitations noted. The condition of use of the PMN substance as
described in the PMN includes the following protective measure:
No modification of manufacture, processing or use if it
results in inhalation exposures to vapors, particulate, mist or
aerosols.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of in vitro skin irritation and eye damage testing using human derived
cells would help characterize the potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11358.
PMN Number: P-18-120
Chemical Name: 1H-Pyrrole-2,5-dione, 1,1'-C36-alkylenebis-.
CAS Number: 1911605-95-2.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an adhesive
component. Based on the available data for the new chemical substance,
estimated physical/chemical properties of the PMN substance, and
comparison with structurally analogous chemical substances, EPA has
identified concerns for developmental toxicity and sensitization if the
chemical substance is not used following the limitation noted. The
condition of use of the PMN substance as described in the PMN includes
the following protective measure:
No manufacturing, processing, or use of the substance that
results in inhalation exposures.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information 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 developmental toxicity and sensitization testing would help
characterize the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11359.
PMN Number: P-18-129
Chemical name: Benzenepropanal, .alpha.,.alpha.,3-trimethyl-.
CAS number: 107737-97-3.
Effective date of TSCA section 5(e) Order: April 30, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the generic
(non-confidential) use of the substance will be as an intermediate used
for chemical production. Based on test data on the PMN substance and
analogue data, EPA has identified concerns for sensitization and
developmental toxicity. In addition, based on SAR analysis of test data
on analogous neutral organics, EPA predicts toxicity to aquatic
organisms may occur at concentrations greater than 99 ppb. The TSCA
section 5(e) Order was issued under TSCA sections 5(a)(3)(B)(ii)(I) and
5(e)(1)(A)(ii)(I), based on a finding that in the absence of sufficient
information to permit a reasoned evaluation, the substance may present
an unreasonable risk of injury to human health and the environment. To
protect against these risks, the TSCA section 5(e) Order requires:
No manufacture (including import) of the PMN substance
beyond the confidential annual production volume specified in the TSCA
section 5(e) Order.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful in support of a request by the
PMN submitter to modify the TSCA section 5(e) Order, or if a
manufacturer or processor is considering submitting a SNUN for a
significant new use that would be designated by this SNUR. EPA has
determined that the results of biodegradability, chronic aquatic
toxicity, and reproductive toxicity testing would help EPA determine
the potential human and environmental effects of the PMN substance.
Although the TSCA section 5(e) Order does not require this information,
the TSCA section 5(e) Order's restrictions remain in effect until the
TSCA section 5(e) Order is modified or revoked by EPA based on
submission of this or other relevant information.
CFR citation: 40 CFR 721.11360.
PMN Number: P-18-182
Chemical name: Multiwalled carbon nanotubes (generic).
CAS number: Not available.
[[Page 54821]]
Effective date of TSCA section 5(e) Order: May 3, 2019.
Basis for TSCA section 5(e) Order: The PMN states that substance
will be used in heat transfer, heat storage, thermal emission, and
general temperature management in heat-generating systems such as
electronics, to improve mechanical properties or electrical
conductivities of other materials or products, and for light absorption
properties. EPA has identified concerns for pulmonary toxicity based on
carbon nanotube analogues. EPA has also identified concerns for aquatic
toxicity when the substance is at low concentrations and in the
presence of natural organic matter. The TSCA section 5(e) Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation, the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the TSCA section 5(e) Order requires:
1. Use of personal protective equipment by workers to prevent
dermal exposure where there is potential dermal exposure;
2. Use of a National Institute of Occupational Safety and Health
(NIOSH) certified respirators with an Assigned Protection Factor (APF)
of at least 50 workers to prevent inhalation exposure where there is
potential inhalation exposure;
3. Refrain from using the PMN in applications that generates a
dust, vapor, mist, or aerosol, unless such application method occurs in
an enclosed process;
4. Process and use of the PMN substance only as described in the
PMN;
5. No release of the PMN substance to surface waters; and
6. Disposal only by incineration or landfill.
The proposed SNUR designates as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information about the human health and environmental effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the TSCA section 5(e) Order, or if a manufacturer
or processor is considering submitting a SNUN for a significant new use
that would be designated by this SNUR. EPA has determined that the
results of pulmonary toxicity and chronic aquatic toxicity testing
would help EPA determine the potential human and environmental effects
of the PMN substance. Although the TSCA section 5(e) Order does not
require this information, the TSCA section 5(e) Order's restrictions
remain in effect until the TSCA section 5(e) Order is modified or
revoked by EPA based on submission of this or other relevant
information.
CFR citation: 40 CFR 721.11361.
PMN Number: P-18-186
Chemical Name: Polyolefin ester (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a fuel additive.
Based on the estimated physical/chemical properties of the PMN
substance and comparison with structurally analogous substances, EPA
has identified concerns for lung surfactancy and irritation to the eye
and skin if the chemical substance is not used following the
limitations noted. The conditions of use of the PMN substance as
described in the PMN include the following protective measures:
1. No use involving an application method that generates a vapor,
mist, or aerosol; and
2. No manufacture (including import) of the substance at less than
the confidential average molecular weight identified in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
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, distribution, metabolism, and excretion (ADME)/
toxicokinetic and lung toxicity testing would help characterize the
potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11362.
PMN Numbers: P-18-247, P-18-248, P-18-249, P-18-250, P-18-251, and P-
18-252
Chemical Names: Isocyanic acid, polymethylenepolyphenylene ester,
polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol,
polyetherpolyol, .alpha.,.alpha.'-[(1-methylethylidene)di-4,1-
phenylene]bis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-
propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-
propanol-blocked (generic) (P-18-247); Isocyanic acid,
polymethylenepolyphenylene ester, polymer with polyetherpolyol, 2-
butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol-blocked
(generic) (P-18-248); Isocyanic acid, polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked
(generic) (P-18-249); Isocyanic acid, polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-
blocked (generic) (P-18-250); Isocyanic acid,
polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and methanol- and 1(or 2)-(2-
methoxymethylethoxy)propanol-blocked (generic) (P-18-251); Isocyanic
acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked
(generic) (P-18-252).
CAS Numbers: Not available.
Basis for action: The PMNs state that the use of the PMN substances
will be as crosslinkers for automotive electrocoats. Based on the
physical/chemical properties, chemical structure of the substances,
submitted data on the substances, and comparison to structurally
analogous substances, EPA has identified concerns for lung effects,
skin sensitization, and aquatic toxicity if the chemical substances are
not used following the limitations noted. The conditions of use of the
PMN substances as described in the PMNs include the following
protective measures:
1. No manufacture, processing, or use in a manner that results in
inhalation exposure; and
2. No release of the PMN substance to surface waters exceeding 200
ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health and
environmental effects of the PMN substances if a manufacturer or
processor is considering submitting a SNUN for a significant new use
that would be designated by this proposed SNUR. EPA has determined that
the results of chronic ecotoxicity testing and lung effects tiered
testing for surfactants would help characterize the potential health
and environmental effects of the PMN substances.
[[Page 54822]]
CFR citations: 40 CFR 721.11363 (P-18-247); 40 CFR 721.11364 (P-18-
248); 40 CFR 721.11365 (P-18-249); 40 CFR 721.11366 (P-18-250); 40 CFR
721.11367 (P-18-251); and 40 CFR 721.11368 (P-18-252).
PMN Number: P-18-282
Chemical Name: Fatty acid ester, polyether, diisocyanate polymer
(generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as an adhesive. Based on
the estimated physical/chemical properties of the PMN substance, test
data on an analogue of the residual isocyanate, and comparison with
structurally analogous chemical substances, EPA has identified concerns
for irritation/sensitization for the skin, eyes, mucous membrane, and
lungs, and respiratory effects if the chemical substance is not used
following the limitation noted. The condition of use of the PMN
substance as described in the PMN includes the following protective
measure:
No manufacturing, processing, or use of the PMN substance
containing greater than the confidential percentage of residual
isocyanate identified in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
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, eye damage, skin sensitization, and pulmonary
effects testing would help characterize the potential health effects of
the PMN substance.
CFR Citation: 40 CFR 721.11369.
PMN Number: P-18-305
Chemical Name: Alkenoic acid, alkyl-, alkyl ester, polymer with
alkyl alkenoate, substituted heteromonocycle, substituted
carbomonocycle, substituted alkanediol and alkenoic acid, alkali metal
salt (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a component of ink.
Based on the estimated physical/chemical properties of the PMN
substance and comparison with structurally analogous chemical
substances, EPA has identified lung effects if the chemical substance
is not used following the limitations noted. The condition of use of
the PMN substance as described in the PMN includes the following
protective measure:
No manufacturing, processing, or use of the substance that
results in inhalation exposures.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of pulmonary effects testing would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11370.
PMN Number: P-18-339
Chemical Name: Alkyl heteromonocycle with heteroatom substituted
alkyl cycloalkane and 2-hydroxyethyl heteromonocycle methacrylate-
blocked homopolymer (generic).
CAS Number: Not available.
Basis for action: The PMN states that the use of the PMN substance
will be as an immobilizing agent for the microbial promoter of nitrogen
decomposition. Based on the estimated physical/chemical properties of
the PMN substance and comparison with structurally analogous chemical
substances, EPA has identified lung effects if the chemical substance
is not used following the limitations noted. The condition of use of
the PMN substance as described in the PMN includes the following
protective measure:
No manufacture, processing, or use that results in
inhalation exposures.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information 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 including pulmonary effects testing
would help characterize the potential health effects of the PMN
substance.
CFR Citation: 40 CFR 721.11371.
PMN Number: P-19-5
Chemical Name: Phenol-formaldehyde epoxy, polymer with an alkyl
polyether polysulfide (generic).
CAS Number: Not available.
Effective date of TSCA section 5(e) Order: March 29, 2019.
Basis for TSCA section 5(e) Order: The PMN states that the use of
the PMN substance will be as an adhesive for automotive parts. EPA
identified concerns for reproductive/developmental toxicity,
mutagenicity, and carcinogenicity for the low molecular weight
components based on the epoxides chemical category and submitted test
data. EPA also identified concerns for skin and lung sensitization and
systematic toxicity based on the epoxide moieties. In addition, based
on analysis of test data on the PMN substance and SAR analysis on
analogous thiols/mercaptans, polyepoxides, and monoepoxides, EPA
predicts chronic toxicity to aquatic organisms may occur at
concentrations greater than 1 ppb. The TSCA section 5(e) Order was
issued under TSCA sections 5(a)(3)(B)(ii)(I) and 5(e)(1)(A)(ii)(I),
based on a finding that in the absence of sufficient information to
permit a reasoned evaluation the substance may present an unreasonable
risk of injury to human health and the environment. To protect against
these risks, the TSCA section 5(e) Order requires:
1. Use of personal protective equipment where there is a potential
for dermal exposure;
2. Refraining from manufacture, processing or use of the PMN
substance in a manner that would result in inhalation exposure;
3. No release of the PMN substance to surface waters exceeding 1
ppb; and
4. Establishment and use of a hazard communication program,
including human health precautionary statements on each label and in
the SDS.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Potentially useful information: EPA has determined that certain
information about the health and environmental effects of the PMN
substance may be potentially useful in support of a request by the PMN
submitter to modify the TSCA section 5(e) Order, or if a manufacturer
or processor is considering submitting a SNUN for a significant new use
that would be designated by this SNUR. EPA has also determined that
specific ecological hazard, reproductive/developmental toxicity,
sensitization, and carcinogenicity effects testing of the
[[Page 54823]]
PMN substance would be useful in determining the health and
environmental effects of the PMN substance. Although the TSCA section
5(e) Order does not require these tests, the TSCA section 5(e) Order's
restrictions remain in effect until the TSCA section 5(e) Order is
modified or revoked by EPA based on submission of this or other
relevant information.
CFR citation: 40 CFR 721.11372.
PMN Number: P-19-20
Chemical Name: Alkylphenol, reaction products with carbon dioxide,
distn. residues from manuf. of alkylphenol derivs. and calcium
alkylphenol derivs. (generic).
CAS Number: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a lubricating
additive. Based on the estimated physical/chemical properties of the
PMN substance and comparison to structurally analogous chemical
substances, EPA has identified concerns for irritation, sensitization,
blood and liver toxicity, lung toxicity, and developmental toxicity if
the chemical substance is not used following the limitation noted. The
condition of use of the PMN substance as described in the PMN includes
the following protective measure:
No use of the PMN substance involving an application
method that generates a vapor, mist, or aerosol.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the 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, irritation, target organ toxicity/pulmonary effects,
and reproduction/developmental effects testing would help characterize
the potential health effects of the PMN substance.
CFR Citation: 40 CFR 721.11373.
PMN Number: P-19-35
Chemical Name: Acetamide, 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-
(2-thienylmethyl)-.
CAS Number: 1374760-95-8.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substance will be as a fragrance. Based on
the estimated physical/chemical properties of the PMN substance,
available test data on the new chemical substance, and SAR analysis on
analogous thiophenes, EPA has identified concerns for severe eye
irritation, sensitization, lung effects, histopathological effects on
the nasal passages, and aquatic toxicity if the chemical substance is
not used following the limitations noted. The conditions of use of the
PMN substance as described in the PMN include the following protective
measures:
1. No domestic manufacture of the PMN substance; and
2. No release of the PMN substance to surface waters exceeding 15
ppb.
The proposed SNUR would designate as a ``significant new use'' the
absence of these protective measures.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
effects of the PMN substance if a manufacturer or processor is
considering submitting a SNUN for a significant new use that would be
designated by this proposed SNUR. EPA has determined that the results
of pulmonary effects testing would help characterize the potential
health effects of the PMN substance.
CFR Citation: 40 CFR 721.11374.
PMN Number: P-19-54
Chemical Names: Polyamines, reaction products with succinic
anhydride polyalkenyl derivs., metal salts (generic) (P-19-54, chemical
A) and Polyamines, reaction products with succinic anhydride
polyalkenyl derivs., metal salts (generic) (P-19-54, chemical B).
CAS Numbers: Not available.
Basis for action: The PMN states that the generic (non-
confidential) use of the PMN substances will be as an automotive
lubricant additive. Based on the available data for the new chemical
substance, estimated physical/chemical properties of the PMN
substances, comparison with structurally analogous chemical substances
and other structural information, EPA has identified irritation to all
tissues if the chemical substance is not used following the limitations
noted. The conditions of use of the PMN substances as described in the
PMN include the following protective measure:
Exceeding the concentration of the PMN substances in a
formulated lubricant fluid for consumer use greater than the
confidential percentage identified in the PMN.
The proposed SNUR would designate as a ``significant new use'' the
absence of this protective measure.
Potentially useful information: EPA has determined that certain
information may be potentially useful to characterize the health
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 skin and eye irritation testing would help characterize the
potential health effects of the PMN substances.
CFR Citation: 40 CFR 721.11381 (P-19-54, chemical A) and 40 CFR
721.11382 (P-19-54, chemical B).
V. Rationale and Objectives of the Proposed Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these proposed SNURs, EPA concluded that for 8
chemical substances regulation was warranted under TSCA section 5(e),
pending the development of information sufficient to make reasoned
evaluations of the health or environmental effects of the chemical
substances. The basis for such findings is outlined in Unit IV. Based
on these findings, TSCA section 5(e) Orders requiring the use of
appropriate exposure controls were negotiated with the PMN submitters.
As a general matter, EPA believes it is necessary to follow TSCA
section 5(e) Orders with a SNUR that identifies the absence of those
protective measures as Significant New Uses to ensure that all
manufacturers and processors--not just the original submitter--are held
to the same standard.
During review of the other 23 chemical substances that are the
subject of these SNURs and as further discussed in Unit IV, EPA
identified certain circumstances different from the intended conditions
of use that raised potential risk concerns. EPA determined that
deviations from the protective measures identified in the submissions
could result in changes in the type or form of exposure to the chemical
substances and/or increased exposures to the chemical substances and/or
changes in the reasonably anticipated manner and methods of
manufacturing, processing, distribution in commerce, and disposal of
the chemical substances, and therefore warranted SNURs. The SNURs would
identify as significant new uses any manufacturing, processing, use,
distribution in commerce, or disposal that does not conform to the
protective measures in the submission.
B. Objectives
EPA is proposing these SNURs for specific chemical substances which
[[Page 54824]]
have undergone premanufacture review because the Agency wants:
To receive notice of any person's intent to manufacture or
process a listed chemical substance for the described significant new
use before that activity begins.
To review and evaluate data submitted in a SNUN before the
notice submitter begins manufacturing or processing a listed chemical
substance for the described significant new use.
To either determine that the prospective manufacture or
processing is not likely to present an unreasonable risk, or to take
necessary regulatory action associated with any other determination,
before the described significant new use of the chemical substance
occurs.
Issuance of a SNUR for a chemical substance does not signify that
the chemical substance is listed on the TSCA Chemical Substance
Inventory (TSCA Inventory). Guidance on how to determine if a chemical
substance is on the TSCA Inventory is available on the internet at
https://www.epa.gov/opptintr/existingchemicals/pubs/tscainventory/.
VI. Applicability of the Proposed Significant New Use Designation
To establish a significant new use, EPA must determine that the use
is not ongoing. The chemical substances subject to this proposed rule
have undergone premanufacture review. In cases where EPA has not
received a notice of commencement (NOC) and the chemical substance has
not been added to the TSCA Inventory, no person may commence such
activities without first submitting a PMN. Therefore, for chemical
substances for which an NOC has not been submitted EPA concludes that
the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added
to the TSCA Inventory, EPA recognizes that, before the rule is
effective, other persons might engage in a use that has been identified
as a significant new use. However, TSCA section 5(e) Orders have been
issued for 8 of the 31 chemical substances, and the PMN submitters are
prohibited by the TSCA section 5(e) Orders from undertaking activities
which would be designated as significant new uses. The identities of 25
of the 31 chemical substances subject to this proposed rule have been
claimed as confidential (per 40 CFR 720.85) for a chemical substance
covered by this action. Based on this, the Agency believes that it is
highly unlikely that any of the significant new uses described in the
regulatory text of this proposed rule are ongoing.
Therefore, EPA designates October 11, 2019 as the cutoff date for
determining whether the new use is ongoing. The objective of EPA's
approach is to ensure that a person cannot defeat a SNUR by initiating
a significant new use before the effective date of the final rule.
Persons who begin commercial manufacture or processing of the
chemical substances for a significant new use identified as of that
date would have to cease any such activity upon the effective date of
the final rule. To resume their activities, these persons would have to
first comply with all applicable SNUR notification requirements and
wait until EPA has conducted a review of the notice, made an
appropriate determination on the notice, and has taken such actions as
are required with that determination.
VII. Development and Submission of Information
EPA recognizes that TSCA section 5 does not require developing any
particular new information (e.g., generating test data) before
submission of a SNUN. There is an exception: Development of test data
is required where the chemical substance subject to the SNUR is also
subject to a rule, order or consent agreement under TSCA section 4 (see
TSCA section 5(b)(1)).
In the absence of a TSCA section 4 test rule covering the chemical
substance, persons are required only to submit information in their
possession or control and to describe any other information known to or
reasonably ascertainable by them (see 40 CFR 720.50). However, upon
review of PMNs and SNUNs, the Agency has the authority to require
appropriate testing. Unit IV. lists potentially useful information
identified by EPA that would help characterize the potential health
and/or environmental effects of the PMN/SNUN substance for all the
listed SNURs. EPA recognizes that the 2016 Lautenberg Amendments have
led to modifications in our approach to testing requirements, including
an increased consideration of alternatives to vertebrate testing.
Descriptions of tests/information needs are provided for informational
purposes only and EPA strongly encourages persons, before performing
any testing, to consult with the Agency pertaining to protocol
selection. Pursuant to TSCA section 4(h), which pertains to reduction
of testing in vertebrate animals, EPA encourages consultation with the
Agency on the use of alternative test methods and strategies (also
called New Approach Methodologies, or NAMs), if available, to generate
the potentially useful information. EPA encourages dialogue with Agency
representatives to help determine how best the submitter can meet both
the data needs and the objective of TSCA section 4(h). To access the
OCSPP test guidelines referenced in this document electronically,
please go to https://www.epa.gov/ocspp and select ``Test Methods and
Guidelines.'' The Organisation for Economic Co-operation and
Development test guidelines are available from the OECD Bookshop at
https://www.oecdbookshop.org or SourceOECD at https://www.sourceoecd.org.
The potentially useful information listed in Unit IV. may not be
the only means of addressing the potential risks of the chemical
substance. EPA recommends that potential SNUN submitters contact EPA
early enough so that they will be able to conduct the appropriate
tests.
SNUN submitters should be aware that EPA will be better able to
evaluate SNUNs which provide detailed information on the following:
Human exposure and environmental release that may result
from the significant new use of the chemical substances.
VIII. SNUN Submissions
According to 40 CFR 721.1(c), persons submitting a SNUN must comply
with the same notification requirements and EPA regulatory procedures
as persons submitting a PMN, including submission of test data on
health and environmental effects as described in 40 CFR 720.50. SNUNs
must be submitted on EPA Form No. 7710-25, generated using e-PMN
software, and submitted to the Agency in accordance with the procedures
set forth in 40 CFR 720.40 and 721.25. E-PMN software is available
electronically at https://www.epa.gov/opptintr/newchems.
IX. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this proposed rule. EPA's complete economic
analysis is available in the docket identified for this rulemaking
under ADDRESSES.
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.
[[Page 54825]]
A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulations and Regulatory Review
This proposed rule would establish SNURs for several new chemical
substances that were the subject of PMNs and TSCA section 5(e) Orders.
The Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Orders 12866 (58 FR 51735, October
4, 1993) and 13563 (76 FR 3821, January 21, 2011).
B. Paperwork Reduction Act (PRA)
According to 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 proposed
rule 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 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, 10 in FY2016, 14 in FY2017, and
18 in FY2018 and only a fraction of these were from small businesses.
In addition, the Agency currently offers relief to qualifying small
businesses by reducing the SNUN submission fee from $16,000 to $2,800.
This lower fee reduces the total reporting and recordkeeping of cost of
submitting a SNUN to about $10,116 for qualifying small firms.
Therefore, the potential economic impacts of complying with this
proposed SNUR are not expected to be significant or adversely impact a
substantial number of small entities. In a SNUR that published in the
Federal Register of June 2, 1997 (62 FR 29684) (FRL-5597-1), the Agency
presented its general determination that final SNURs are not expected
to have a significant economic impact on a substantial number of small
entities, which was provided to the Chief Counsel for Advocacy of the
Small Business Administration.
D. Unfunded Mandates Reform Act (UMRA)
Based on EPA's experience with proposing and finalizing SNURs,
State, local, and Tribal governments have not been impacted by these
rulemakings, and EPA does not have any reasons to believe that any
State, local, or Tribal government will be impacted by this action. As
such, EPA has determined that this proposed rule would not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132: Federalism
This action would not have a substantial direct effect on States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government, as specified in Executive Order 13132 (64 FR
43255, August 10, 1999).
F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments
This action would not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
proposed rule would not significantly nor uniquely affect the Indian
Tribal governments, nor would it involve or impose any requirements
that affect Indian Tribes. Accordingly, the requirements of Executive
Order 13175 (65 FR 67249, November 9, 2000), do not apply to this
action.
G. Executive Order 13045: Protection of Children From Environmental
Health Risks and Safety Risks
This action is not subject to Executive Order 13045 (62 FR 19885,
April 23, 1997), because this is not an economically significant
regulatory action as defined by Executive Order 12866, and this action
does not address environmental health or safety risks
disproportionately affecting children.
H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution, or Use
This action is not subject to Executive Order 13211 (66 FR 28355,
May 22, 2001), because this proposed rule is not expected to affect
energy supply, distribution, or use.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this proposed rule would not involve any
technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not
apply to this action.
J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898 (59 FR
7629, February 16, 1994).
[[Page 54826]]
List of Subjects in 40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: September 26, 2019.
Tala Henry,
Deputy Director, Office of Pollution Prevention and Toxics.
Therefore, it is proposed that 40 CFR chapter I be amended as
follows:
PARTS 721--[AMENDED]
0
1. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, 2613, and 2625(c).
0
2. Add Sec. Sec. 721.11346 through 721.11374, 721.11381 and 721.11382
to subpart E to read as follows:
Subpart E--Significant New Uses for Specific Chemical Substances
Sec.
721.11346 Perfluoropolyether halide (generic).
721.11347 Perfluoropolyether aryl (generic).
721.11348 Substituted aryl-perfluoropolyether (generic).
721.11349 Sulfonated perfluoropolyether aromatic transition metal
salt (generic).
721.11350 Sulfonated perfluoropolyether aryl alkali metal salt
(generic).
721.11351 Cyclohexanol, 4-ethylidene-2-propoxy- (P-16-225, chemical
A).
721.11352 Cyclohexanol, 5-ethylidene-2-propoxy- (P-16-225, chemical
B).
721.11353 Ethanone, 1-(5-propyl-1,3-benzodioxol-2-yl)-.
721.11354 Endcapped polysiloxane (generic).
721.11355 2,7-Nonadien-4-ol, 4,8-dimethyl-.
721.11356 Carbonodithioic acid, O-[2-[(dithiocarboxy)amino]-2-
methylpropyl] ester, sodium salt (1:2).
721.11357 Oxirane, 2-methyl-, polymer with oxirane, methyl 2-
(substituted carbomonocycle isoquinolin-2(3H)-yl) propyl ether
(generic).
721.11358 Vegetable oil, polymers with diethylene glycol- and
polyol- and polyethylene glycol-depolymd. poly(ethylene
terephthalate) waste plastics and arylcarboxylic acid anhydride
(generic).
721.11359 1H-Pyrrole-2,5-dione, 1,1'-C36-alkylenebis-.
721.11360 Benzenepropanal, .alpha.,.alpha.,3-trimethyl-.
721.11361 Multiwalled carbon nanotubes (generic).
721.11362 Polyolefin ester (generic).
721.11363 Isocyanic acid, polymethylenepolyphenylene ester, polymer
with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol,
.alpha.,.alpha.'-[(1-methylethylidene)di-4,1-phenylene]bis[.omega.-
hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-propanediol, iso-Bu alc.-
and 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and Et alc.- and
methanol- and 1-methoxy-2-propanol-blocked, (generic).
721.11364 Isocyanic acid, polymethylenepolyphenylene ester, polymer
with polyetherpolyol, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and methanol-blocked, (generic).
721.11365 Isocyanic acid, polymethylenepolyphenylene ester, polymer
with polyetherpolyol, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked
(generic).
721.11366 Isocyanic acid, polymethylenepolyphenylene ester, polymer
with polyetherpolyol, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-
blocked (generic).
721.11367 Isocyanic acid, polymethylenepolyphenylene ester, 2-
butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1(or
2)-(2-methoxymethylethoxy)propanol-blocked (generic).
721.11368 Isocyanic acid, polymethylenepolyphenylene ester, 2-
butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-
methoxy-2-propanol-blocked (generic).
721.11369 Fatty acid ester, polyether, diisocyanate polymer
(generic).
721.11370 Alkenoic acid, alkyl-, alkyl ester, polymer with alkyl
alkenoate, substituted heteromonocycle, substituted carbomonocycle,
substituted alkanediol and alkenoic acid, alkali metal salt
(generic).
721.11371 Alkyl heteromonocycle with heteroatom substituted alkyl
cycloalkane and 2-hydroxyethyl heteromonocycle methacrylate-blocked
homopolymer (generic).
721.11372 Phenol-formaldehyde epoxy, polymer with an alkyl polyether
polysulfide (generic).
721.11373 Alkylphenol, reaction products with carbon dioxide, distn.
residues from manuf. of alkylphenol derivs. and calcium alkylphenol
derivs. (generic).
721.11374 Acetamide, 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-
thienylmethyl)-.
721.11375 [Reserved]
721.11376 [Reserved]
721.11377 [Reserved]
721.11378 [Reserved]
721.11379 [Reserved]
721.11380 [Reserved]
721.11381 Polyamines, reaction products with succinic anhydride
polyalkenyl derivs. metal salts (generic) (P-19-54, chemical A).
721.11382 Polyamines, reaction products with succinic anhydride
polyalkenyl derivs., metal salts (generic) (P-19-54, chemical B).
Subpart E--Significant New Uses for Specific Chemical Substances
Sec. 721.11346 Perfluoropolyether halide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoropolyether halide (PMN P-16-151) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(3)(i),
(ii), (4)(i), (iii), and (5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t). It is a significant new use to
manufacture the substance for more than one year.
(iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11347 Perfluoropolyether aryl (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
perfluoropolyether aryl (PMN P-16-152) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard Communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at
[[Page 54827]]
1.0%), (f), (g)(3)(i), (ii), (4)(i), (iii), and (5). Alternative hazard
and warning statements that meet the criteria of the Globally
Harmonized System and OSHA Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11348 Substituted aryl-perfluoropolyether (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted aryl-perfluoropolyether (PMN P-16-153) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(3)(i),
(ii), (4)(i), (iii), and (5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11349 Sulfonated perfluoropolyether aromatic transition
metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated perfluoropolyether aromatic transition metal salt (PMN P-16-
154) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(3)(i),
(ii), (4)(i), (iii), and (5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11350 Sulfonated perfluoropolyether aryl alkali metal salt
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
sulfonated perfluoropolyether aryl alkali metal salt (PMN P-16-155) 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) Hazard communication. Requirements as specified in Sec.
721.72(a) through (d), (e) (concentration set at 1.0%), (f), (g)(3)(i),
(ii), (4)(i), (iii), and (5). Alternative hazard and warning statements
that meet the criteria of the Globally Harmonized System and OSHA
Hazard Communication Standard may be used.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) and (t).
(iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(b)(1), and (c)(1). Incineration must be hazardous waste high
temperature incineration where the treatment efficiency is no less than
99.99%.
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c) and (f) through (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
Sec. 721.11351 Cyclohexanol, 4-ethylidene-2-propoxy-(P-16-225,
chemical A).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclohexanol, 4-
ethylidene-2-propoxy-(PMN P-16-225, chemical A; CAS No. 1631145-48-6)
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(f) and (s)(10,000 kg). It is a significant
new use to use other than as a fragrance and process the substance to
greater than 10% in compounded fragrance oil formulations.
[[Page 54828]]
(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), (b), and (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11352 Cyclohexanol, 5-ethylidene-2-propoxy-(P-16-225,
chemical B).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as cyclohexanol, 5-
ethylidene-2-propoxy-(PMN P-16-225, chemical B; CAS No. 1631145-49-7)
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(f) and (s)(10,000 kg). It is a significant
new use to use other than as a fragrance and process the substance to
greater than 10% in compounded fragrance oil formulations.
(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), (b), and (i) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11353 Ethanone, 1-(5-propyl-1,3-benzodioxol-2-yl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as ethanone, 1-(5-
propyl-1,3-benzodioxol-2-yl)-(PMN P-16-314, CAS No. 1370699-98-1) 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(f) and (s)(10,000 kg). It is a significant
new use to exceed 10% of the PMN substance in processing formulations.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11354 Endcapped polysiloxane (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
endcapped polysiloxane (PMN P-16-429) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11355 2,7-Nonadien-4-ol, 4,8-dimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2,7-nonadien-4-ol,
4,8-dimethyl-(PMN P-16-470, CAS No. 103983-77-3) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4) and (b)(4) where N=113.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11356 Carbonodithioic acid, O-[2-[(dithiocarboxy)amino]-2-
methylpropyl] ester, sodium salt (1:2).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as carbonodithioic
acid, O-[2-[(dithiocarboxy)amino]-2-methylpropyl] ester, sodium salt
(1:2) (PMN P-17-108; CAS No. 1947332-67-3) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N=2.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11357 Oxirane, 2-methyl-, polymer with oxirane, methyl 2-
(substituted carbomonocycle isoquinolin-2(3H)-yl) propyl ether
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance is identified generically as
oxirane, 2-methyl-, polymer with oxirane, methyl 2-(substituted
carbomonocycle isoquinolin-2(3H)-yl) propyl ether (PMN P-17-253) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(o). It is a significant new use to process
the substance to a concentration greater than 5% by weight in the final
formulated product for any use.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
[[Page 54829]]
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11358 Vegetable oil, polymers with diethylene glycol- and
polyol- and polyethylene glycol-depolymd. poly(ethylene terephthalate)
waste plastics and arylcarboxylic acid anhydride (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
vegetable oil, polymers with diethylene glycol- and polyol- and
polyethylene glycol-depolymd. poly(ethylene terephthalate) waste
plastics and arylcarboxylic acid anhydride (PMN P-18-91) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to modify the manufacture, process, or use of the
substance that results in inhalation exposure to vapors, particulate,
mist or aerosols.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11359 1H-Pyrrole-2,5-dione, 1,1'-C36-alkylenebis-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1H-pyrrole-2,5-
dione, 1,1'-C36-alkylenebis-(PMN P-18-120, CAS No. 1911605-95-2) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in
any manner that results in inhalation exposures.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11360 Benzenepropanal, .alpha.,.alpha.,3-trimethyl-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as benzenepropanal,
.alpha.,.alpha.,3-trimethyl-(P-18-129; CAS No. 107737-97-3) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(t).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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. 721.11361 Multiwalled carbon nanotubes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
multiwalled carbon nanotubes (PMN P-18-182) is subject to reporting
under this section for the significant new uses described in paragraph
(a)(2) of this section. The requirements of this section do not apply
to quantities of the substance that have been:
(i) embedded or incorporated into a polymer matrix that itself has
been reacted (cured);
(ii) embedded in a permanent solid/polymer form that is not
intended to undergo further processing, except mechanical processing;
or
(iii) incorporated into an article as defined at 40 CFR 720.3(c).
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1), (3), when determining which persons are reasonably likely
to be exposed as required for Sec. 721.63(a)(1) and, (a)(4),
engineering control measures (e.g., enclosure or confinement of the
operation, general and local ventilation) or administrative control
measures (e.g., workplace policies and procedures) shall be considered
and implemented to prevent exposure, where feasible, (5)(respirators
must provide a National Institute for Occupational Safety and Health
assigned protection factor of at least 50), (6)(particulate), and (c).
(ii) Industrial, commercial, and consumer activities. It is a
significant new use to use an application method that generates a dust,
mist, or aerosol, unless such application method occurs in an enclosed
process. It is a significant new use to use the substance other than
for heat transfer, heat storage, thermal emission, and general
temperature management in heat-generating systems such as electronics,
to improve mechanical properties or electrical conductivities of other
materials or products, and for light absorption properties.
(iii) Disposal. Requirements as specified in Sec. 721.85 (a)(1),
(2), (b)(1), (2), (c)(1), and (2).
(iv) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (k) are applicable to manufacturers and processors
of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11362 Polyolefin ester (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyolefin ester (PMN P-18-186) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (y)(1). It is a significant new use to
manufacture (including import) the substance at less than the
confidential average molecular weight identified 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).
[[Page 54830]]
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11363 Isocyanic acid, polymethylenepolyphenylene ester,
polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol,
polyetherpolyol, .alpha.,.alpha.'-[(1-methylethylidene)di-4,1-
phenylene]bis[.omega.-hydroxypoly(oxy-1,2-ethanediyl)] and 1,2-
propanediol, iso-Bu alc.- and 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-
propanol-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polymethylenepolyphenylene ester, polymer with 2-ethyl-
2-(hydroxymethyl)-1,3-propanediol, polyetherpolyol, .alpha.,.alpha.'-
[(1- methylethylidene)di-4,1-phenylene]bis[.omega.-hydroxypoly(oxy-1,2-
ethanediyl)] and 1,2-propanediol, iso-Bu alc.- and 2-butoxyethanol- and
2-(2-butoxyethoxy)ethanol- and Et alc.- and methanol- and 1-methoxy-2-
propanol-blocked (PMN P-18-247) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in a
manner results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N = 200.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11364 Isocyanic acid, polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and methanol-blocked, (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polymethylenepolyphenylene ester, polymer with
polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and
methanol-blocked, (PMN P-18-248) is subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in a
manner results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N = 200.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11365 Isocyanic acid, polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-blocked
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polymethylenepolyphenylene ester, polymer with
polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and
methanol and 1-methoxy-2-propanol-blocked (PMN P-18-249) is subject to
reporting under this section for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in a
manner results in inhalation exposure.
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N = 200.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11366 Isocyanic acid, polymethylenepolyphenylene ester,
polymer with polyetherpolyol, 2-butoxyethanol- and 2-(2-
butoxyethoxy)ethanol- and 1(or 2)-(2-methoxymethylethoxy)propanol-
blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polymethylenepolyphenylene ester, polymer with
polyetherpolyol, 2-butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and
1(or 2)-(2-methoxymethylethoxy)propanol-blocked. (PMN P-18-250) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in 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 = 200.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c). (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11367 Isocyanic acid, polymethylenepolyphenylene ester, 2-
butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1(or
2)-(2-methoxymethylethoxy)propanol-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and
2-(2-butoxyethoxy)ethanol- and methanol-
[[Page 54831]]
and 1(or 2)-(2-methoxymethylethoxy)propanol-blocked (PMN P-18-251) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in 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 = 200.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11368 Isocyanic acid, polymethylenepolyphenylene ester, 2-
butoxyethanol- and 2-(2-butoxyethoxy)ethanol- and methanol- and 1-
methoxy-2-propanol-blocked (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
isocyanic acid, polymethylenepolyphenylene ester, 2-butoxyethanol- and
2-(2-butoxyethoxy)ethanol- and methanol- and 1-methoxy-2-propanol-
blocked. (PMN P-18-252) is subject to reporting under this section for
the significant new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance in 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 = 200.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11369 Fatty acid ester, polyether, diisocyanate polymer
(generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acid ester, polyether, diisocyanate polymer (PMN P-18-282) is subject
to reporting under this section for the significant new uses described
in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance
containing greater than the confidential residual isocyanate percentage
identified in the PMN.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(i) of
this section.
Sec. 721.11370 Alkenoic acid, alkyl-, alkyl ester, polymer with alkyl
alkenoate, substituted heteromonocycle, substituted carbomonocycle,
substituted alkanediol and alkenoic acid, alkali metal salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkenoic acid, alkyl-, alkyl ester, polymer with alkyl alkenoate,
substituted heteromonocycle, substituted carbomonocycle, substituted
alkanediol and alkenoic acid, alkali metal salt (PMN P-18-305) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance that
results in inhalation exposures.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11371 Alkyl heteromonocycle with heteroatom substituted
alkyl cycloalkane and 2-hydroxyethyl heteromonocycle methacrylate-
blocked homopolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as alkyl
heteromonocycle with heteroatom substituted alkyl cycloalkane and 2-
hydroxyethyl heteromonocycle methacrylate-blocked homopolymer (PMN P-
18-339) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the substance for
any use that results in inhalation exposure.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11372 Phenol-formaldehyde epoxy, polymer with an alkyl
polyether polysulfide (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as phenol-
formaldehyde epoxy, polymer with an alkyl polyether polysulfide (PMN P-
19-5) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Protection in the workplace. Requirements as specified in Sec.
721.63(a)(1) and (3).
(ii) Hazard communication. Requirements as specified in Sec.
721.72 (a) through (d), (f), (g)(1)(iv), (vi), (vii), (skin and
respiratory sensitization), (germ cell mutagenicity), (2)(i), (ii),
(v), (3)(i), (ii), (4)(water release restrictions apply), and (5).
Alternative hazard and warning statements that meet the criteria of the
Globally Harmonized System and OSHA Hazard Communication Standard may
be used.
[[Page 54832]]
(iii) Industrial, commercial, and consumer activities. It is a
significant new use to manufacture, process, or use the PMN substance
in any manner that results in inhalation exposure.
(iv) 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), (f) through (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11373 Alkylphenol, reaction products with carbon dioxide,
distn. residues from manuf. of alkylphenol derivs. and calcium
alkylphenol derivs. (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylphenol, reaction products with carbon dioxide, distn. residues
from manuf. of alkylphenol derivs. and calcium alkylphenol derivs. (PMN
P-19-20) is subject to reporting under this section for the significant
new uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(y)(1).
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11374 Acetamide, 2-(4-methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-
thienylmethyl)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as acetamide, 2-(4-
methylphenoxy)-N-1H-pyrazol-3-yl-N-(2-thienylmethyl)- (PMN P-19-35, CAS
No. 1374760-95-8) 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(f).
(ii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) where N=15.
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c), (i), and (k) are applicable to manufacturers
and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11375 [Reserved]
Sec. 721.11376 [Reserved]
Sec. 721.11377 [Reserved]
Sec. 721.11378 [Reserved]
Sec. 721.11379 [Reserved]
Sec. 721.11380 [Reserved]
Sec. 721.11381 Polyamines, reaction products with succinic anhydride
polyalkenyl derivs., metal salts (generic) (P-19-54, chemical A).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyamines, reaction products with succinic anhydride polyalkenyl
derivs., metal salts (PMN P-19-54, chemical A) 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 exceed the confidential concentration percentage
of the substance in a formulated lubricant fluid for consumer use
identified in P-19-54.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
Sec. 721.11382 Polyamines, reaction products with succinic anhydride
polyalkenyl derivs., metal salts (generic) (P-19-54, chemical B).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
polyamines, reaction products with succinic anhydride polyalkenyl
derivs., metal salts (PMN P-19-54, chemical B) 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 exceed the confidential concentration percentage
of the substance in a formulated lubricant fluid for consumer use
identified in P-19-54.
(ii) [Reserved]
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph (b).
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a) through (c) and (i) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
[FR Doc. 2019-21720 Filed 10-10-19; 8:45 am]
BILLING CODE 6560-50-P
