Significant New Use Rules on Certain Chemical Substances, 26448-26460 [2015-11166]
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Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Rules and Regulations
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Parts 9 and 721
[EPA–HQ–OPPT–2014–0908; FRL–9925–42]
RIN 2070–AB27
Significant New Use Rules on Certain
Chemical Substances
Environmental Protection
Agency (EPA).
ACTION: Direct final rule.
AGENCY:
EPA is promulgating
significant new use rules (SNURs) under
the Toxic Substances Control Act
(TSCA) for 25 chemical substances
which were the subject of
premanufacture notices (PMNs). Nine of
these chemical substances are subject to
TSCA section 5(e) consent orders issued
by EPA. This action requires persons
who intend to manufacture (including
import) or process any of these 25
chemical substances for an activity that
is designated as a significant new use by
this rule to notify EPA at least 90 days
before commencing that activity. The
required notification will provide EPA
with the opportunity to evaluate the
intended use and, if necessary, to
prohibit or limit that activity before it
occurs.
SUMMARY:
This rule is effective on July 7,
2015. For purposes of judicial review,
this rule shall be promulgated at 1 p.m.
(e.s.t.) on May 22, 2015.
Written adverse or critical comments,
or notice of intent to submit adverse or
critical comments, on one or more of
these SNURs must be received on or
before June 8, 2015 (see Unit VI. of the
SUPPLEMENTARY INFORMATION). If EPA
receives written adverse or critical
comments, or notice of intent to submit
adverse or critical comments, on one or
more of these SNURs before June 8,
2015, EPA will withdraw the relevant
sections of this direct final rule before
its effective date.
For additional information on related
reporting requirement dates, see Units
I.A., VI., and VII. of the SUPPLEMENTARY
INFORMATION.
ADDRESSES: Submit your comments,
identified by docket identification (ID)
number EPA–HQ–OPPT–2014–0908, 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.
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DATES:
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• 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 (7405
M), 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 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
12.118 through 12.127 and 19 CFR
127.28. Chemical importers must certify
that the shipment of the chemical
substance complies with all applicable
rules and orders under TSCA. Importers
of chemicals subject to these 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
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intend to export a chemical substance
that is the subject of a proposed or final
rule are subject to the export
notification provisions of TSCA section
12(b) (15 U.S.C. 2611(b)) (see § 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 promulgating these SNURs
using direct final procedures. These
SNURs will require persons to notify
EPA at least 90 days before commencing
the manufacture or processing of a
chemical substance for any activity
designated by these SNURs as a
significant new use. Receipt of such
notices allows EPA to assess risks that
may be presented by the intended uses
and, if appropriate, to regulate the
proposed use before it occurs.
Additional rationale and background to
these rules are 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 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
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‘‘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.
Once EPA determines that a use of a
chemical substance is a significant new
use, TSCA section 5(a)(1)(B) requires
persons to submit a significant new use
notice (SNUN) to EPA at least 90 days
before they manufacture or process the
chemical substance for that use. Persons
who must report are described in
§ 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear
in 40 CFR part 721, subpart A. These
provisions describe persons subject to
the rule, recordkeeping requirements,
exemptions to reporting requirements,
and applicability of the rule to uses
occurring before the effective date of the
rule. Provisions relating to user fees
appear at 40 CFR part 700. According to
§ 721.1(c), persons subject to these
SNURs must comply with the same
SNUN requirements and EPA regulatory
procedures as submitters of PMNs under
TSCA section 5(a)(1)(A). In particular,
these requirements include the
information submission requirements of
TSCA section 5(b) and 5(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 may take
regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities
for which it has received the SNUN. If
EPA does not take action, EPA is
required under TSCA section 5(g) to
explain in the Federal Register its
reasons for not taking action.
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III. Significant New Use Determination
Section 5(a)(2) of TSCA 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 addition to these factors
enumerated in TSCA section 5(a)(2), the
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statute authorized EPA to consider any
other relevant factors.
To determine what would constitute a
significant new use for the 25 chemical
substances that are the subject of these
SNURs, EPA considered relevant
information about the toxicity of the
chemical substances, likely human
exposures and environmental releases
associated with possible uses, and the
four bulleted TSCA section 5(a)(2)
factors listed in this unit.
IV. Substances Subject to This Rule
EPA is establishing significant new
use and recordkeeping requirements for
25 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 (assigned for nonconfidential chemical identities).
• Basis for the TSCA section 5(e)
consent order or the basis for the TSCA
non-section 5(e) SNURs (i.e., SNURs
without TSCA section 5(e) consent
orders).
• Tests recommended by EPA to
provide sufficient information to
evaluate the chemical substance (see
Unit VIII. for more information).
• CFR citation assigned in the
regulatory text section of this rule.
The regulatory text section of this rule
specifies the activities designated as
significant new uses. Certain new uses,
including production volume limits
(i.e., limits on manufacture volume) and
other uses designated in this rule, may
be claimed as CBI. Unit IX. discusses a
procedure companies may use to
ascertain whether a proposed use
constitutes a significant new use.
This rule includes nine PMN
substances (P–12–115, P–12–116, P–13–
568, P–13–646, P–13–647, P–13–648, P–
13–649, P–13–678, and P–13–679) that
are subject to ‘‘risk-based’’ consent
orders under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined
that activities associated with the PMN
substances may present unreasonable
risk to human health or the
environment. Those consent orders
require protective measures to limit
exposures or otherwise mitigate the
potential unreasonable risk. The socalled ‘‘TSCA section 5(e) SNURs’’ on
these PMN substances are promulgated
pursuant to § 721.160, and are based on
and consistent with the provisions in
the underlying consent orders. The
TSCA section 5(e) SNURs designate as
a ‘‘significant new use’’ the absence of
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the protective measures required in the
corresponding consent orders.
This rule also includes SNURs on 16
PMN substances that are not subject to
consent orders under TSCA section 5(e).
In these cases, for a variety of reasons,
EPA did not find that the use scenario
described in the PMN triggered the
determinations set forth under TSCA
section 5(e). However, EPA does believe
that certain changes from the use
scenario described in the PMN could
result in increased exposures, thereby
constituting a ‘‘significant new use.’’
These so-called ‘‘TSCA non-section 5(e)
SNURs’’ are promulgated pursuant to
§ 721.170. EPA has determined that
every activity designated as a
‘‘significant new use’’ in all TSCA nonsection 5(e) SNURs issued under
§ 721.170 satisfies the two requirements
stipulated in § 721.170(c)(2), i.e., these
significant new use activities are
different from those described in the
premanufacture notice for the
substance, including any amendments,
deletions, and additions of activities to
the premanufacture notice, and may be
accompanied by changes in exposure or
release levels that are significant in
relation to the health or environmental
concerns identified’’ for the PMN
substance.
PMN Numbers P–12–115, P–12–116,
and P–13–568
Chemical names: (P–12–115)
Alkylbenzene sulfonic acid (generic)
and (P–12–116 and P–13–568)
Benzenesulfonic acid, dimethyl-, alkyl
derivatives, sodium salt (generic).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e)
consent orders: August 1, 2014 (P–12–
115 and P–12–116) and July 2, 2014 (P–
13–568).
Basis for TSCA section 5(e) consent
orders: The PMNs state that P–12–115
will be used as a chemical intermediate
to prepare an interfacial tension reducer
for enhanced oil recovery, P–12–116
will be used as an interfacial tension
reducer for enhanced oil recovery, and
P–13–568 will be used generically in
enhanced oil recovery applications.
Based on surfactant properties and SAR
analysis of test data on PMN substance
P–13–568 and other analogous
substances, EPA identified concerns for
corrosion to the eyes, mucous
membranes, lungs, and skin. In
addition, based on test data on the PMN
substances P–12–116 and P–13–568, as
well as test data on analogous
substances, EPA predicts toxicity to
aquatic organisms at concentrations that
exceed 4 parts per billion (ppb) of the
PMN substances in surface waters. The
consent order for PMNs P–12–115 and
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P–12–116 was issued under TSCA
sections 5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I)
based on a finding that the uncontrolled
manufacture, processing, distribution in
commerce, use and disposal of the PMN
substances may present an unreasonable
risk to the environment. The consent
order for PMN P–13–568 was issued
under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that
that the uncontrolled manufacture,
processing, distribution in commerce,
use and disposal of the PMN substance
may present an unreasonable risk to
human health and the environment. To
protect against these risks, the consent
orders require:
1. Manufacturing, processing, or use
of the PMN substance P–12–115 only as
a chemical intermediate to prepare an
interfacial tension reducer for enhanced
oil recovery.
2. Manufacturing, processing, or use
of the PMN substance identified as P–
12–116 and P–13–568 only as an
interfacial tension reducer for enhanced
oil recovery or for the specific
confidential enhanced oil recovery
applications described in the consent
order for PMN P–13–568.
3. No predictable or purposeful
release of the PMN substances from
manufacturing, processing or use into
the waters of the United States that
result in surface water concentrations
exceeding 4 ppb.
4. Individual aggregate production
volume limits for the PMN substance
identified as P–12–116 and P–13–568
shall not exceed the confidential
production limit identified in the
consent order for PMN P–13–568.
5. Establishment and use of a hazard
communication program, including
environmental hazard precautionary
statements on each label and the MSDS
for the PMN substance P–12–115.
6. Establishment and use of a hazard
communication program, including
human health and environmental
hazard precautionary statements on
each label and the MSDS for the PMN
substance identified as P–12–116 and
P–13–568.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) in clean dilution
water; and a daphnid chronic toxicity
test (OPPTS Test Guideline 850.1300)
would help characterize the
environmental effects of the PMN
substances.
CFR citations: 40 CFR 721.10812 (P–
12–115) and 40 CFR 721.10813 (P–12–
116 and P–13–568).
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PMN Number P–12–397
Chemical name: 2-Propenoic acid, 3phenyl-, zinc salt (2:1), (2E)-.
CAS number: 18957–59–0.
Basis for action: The PMN states that
the PMN substance will be used as a
reinforcing additive in polyolefins.
Based on structure activity relationship
(SAR) analysis of test data on analogous
zinc salts, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 3 ppb of the
PMN substance in surface waters for
greater than 20 days per year. This 20day criterion is derived from partial life
cycle tests (daphnid chronic and fish
early-life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if releases of the substance to
surface water, from uses other than as
described in the PMN, exceed releases
from the use described in the PMN. For
the use described in the PMN,
environmental releases did not exceed 3
ppb for more than 20 days per year.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance other than as a reinforcing
additive in polyolefins may result in
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity
test, freshwater daphnids (OPPTS Test
Guideline 850.1010); an algal toxicity
test (OCSPP Test Guideline 850.4500);
and a ready biodegradability test
(OPPTS Test Guideline 835.3110) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10814.
PMN Number P–13–139
Chemical name: Fatty acids, satd. and
unsatd alkyl-, esters with polyol
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used as an
ingredient in multipurpose additive in
gasoline to reduce friction in engines.
Based on SAR analysis of test data on
analogous nonionic surfactants, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
190 ppb of the PMN substance in
surface waters for greater than 20 days
per year. This 20-day criterion is
derived from partial life cycle tests
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(daphnid chronic and fish early-life
stage tests) that typically range from 21
to 28 days in duration. EPA predicts
toxicity to aquatic organisms may occur
if releases of the substance to surface
water, from uses other than as described
in the PMN, exceed releases from the
use described in the PMN. For the use
described in the PMN, environmental
releases did not exceed 190 ppb for
more than 20 days per year. Therefore,
EPA has not determined that the
proposed manufacturing, processing, or
use of the substance may present an
unreasonable risk. EPA has determined,
however, that any use of the substance
other than as an ingredient in
multipurpose additive in gasoline to
reduce friction in engines may result in
significant adverse environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity
test, freshwater daphnids (OPPTS Test
Guideline 850.1010); and an algal
toxicity test (OCSPP Test Guideline
850.4500) would help characterize the
environmental effects of the PMN
substance. EPA also recommends that
the guidance document on aquatic
toxicity testing of difficult substance
and mixtures (Organisation for
Economic Co-operation and
Development (OECD) Test Guideline 23)
be consulted to facilitate solubility in
the test media.
CFR citation: 40 CFR 721.10815.
PMN Numbers P–13–646, P–13–647, P–
13–648, P–13–649, P–13–678, and P–13–
679
Chemical names: (P–13–646 and P–
13–648) Fluoroalkyl acrylate copolymer
modified with polysiloxanes (generic);
(P–13–647, P–13–649, and P–13–679)
Fluoroalkyl acrylate copolymer
(generic); and (P–13–678) Fluoroalkyl
methacrylate copolymer (generic).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e)
consent order: August 4, 2014.
Basis for TSCA section 5(e) consent
order: The PMNs state that the generic
(non-confidential) use of the substances
will be as a tile treatment (P–13–646
and P–13–648), a textile treatment (P–
13–647 and P–13–649), a water and oil
repellent for plastic and inorganic
substrates (P–13–678), and a paper
treatment (P–13–679). EPA has concerns
for potential incineration or other
decomposition products of the PMN
substances. These perfluorinated
decomposition products may be
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released to the environment from
incomplete incineration of the PMN
substances at low temperatures. EPA
has preliminary evidence, including
data on some fluorinated polymers,
which suggests that, under some
conditions, the PMN substances could
degrade in the environment. EPA has
concerns that these degradation
products will persist in the
environment, could bioaccumulate or
biomagnify, and could be toxic (PBT) to
people, wild mammals, and birds. These
concerns are based on data on analogous
chemical substances, including
perfluorooctanoic acid (PFOA) and
other perfluorinated alkyls, including
the presumed environmental degradant.
The order was issued under TSCA
sections 5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I),
and 5(e)(1)(A)(ii)(II), based on a finding
that these substances may present an
unreasonable risk of injury to the
environment and human health, the
substances may be produced in
substantial quantities and may
reasonably be anticipated to enter the
environment in substantial quantities,
and there may be significant (or
substantial) human exposure to the
substances and their potential
degradation products. To protect against
these exposures and risks, the consent
order requires:
1. Risk notification. If as a result of
the test data required, the company
becomes aware that the PMN substances
may present a risk of injury to human
health or the environment, the company
must incorporate this new information,
and any information on methods for
protecting against such risk into a
Material Safety Data Sheet (MSDS),
within 90 days.
2. Submission of certain physical/
chemical property and environmental
fate testing prior to exceeding the
confidential production volume limits
of the PMN substances specified in the
consent order.
3. Recording and reporting of certain
fluorinated impurities in the starting
raw material; and manufacture of the
PMN substances not to exceed the
maximum established impurity levels of
certain fluorinated impurities.
The SNUR designates as a ‘‘significant
new use’’ the absence of these protective
measures.
Recommended testing: EPA has
determined that the results of certain
toxicity, physical/chemical property
and environmental fate testing
identified in the TSCA 5(e) consent
order would help characterize possible
effects of the substances and their
degradation products. The Order
prohibits the Company from exceeding
specified confidential production
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volumes unless the Company submits
the information described in the Testing
section of this Order in accordance with
the conditions specified in the Testing
section. Further, EPA has identified
certain toxicity and environmental fate
testing described in the Pended Testing
section of the Preamble to the Order that
would help characterize the PMN
substances. The Order does not require
submission of the pended testing at any
specified time or production volume.
However, the Order’s restrictions on
manufacture, processing, distribution in
commerce, use, and disposal of the
PMN substances will remain in effect
until the Order is modified or revoked
by EPA based on submission of that or
other relevant information.
CFR citations: 40 CFR 721.10816 (P–
13–646 and P–13–648); 40 CFR
721.10817 (P–13–647, P–13–649, and P–
13–679); and 40 CFR 721.10818 (P–13–
678).
PMN Number P–13–951
Chemical name: Zinc carboxylate
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a destructive use in
the manufacture of coating materials
and fuels. Based on SAR analysis of test
data on analogous soluble zinc
compounds, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 3 ppb of the
PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations exceeding
3 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance that results in
releases to surface waters exceeding 3
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic
toxicity test (OPPTS Test Guideline
850.1300); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would
help characterize the environmental
effects of the PMN substance. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substance and mixtures (OECD
Test Guideline 23) be consulted to
facilitate solubility in the test media.
CFR citation: 40 CFR 721.10819.
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PMN Number P–14–364
Chemical name: Phenol, styrenated,
reaction products with polyethylene
glycol and 2-[(2-propen-1yloxy)methyl]oxirane.
CAS number: 1539128–27–2.
Basis for action: The PMN states that
the substance will be used as a reactive
emulsifier for manufacturing aqueous
emulsion polymers or alkyd resins, a
dispersant for pigments in aqueous or
solvent-based coatings, and an
intermediate for production of related
anionic dispersants. Based on SAR
analysis of test data on analogous
nonionic surfactant compounds, EPA
predicts toxicity to aquatic organisms
may occur at concentrations that exceed
170 ppb of the PMN substance in
surface waters. As described in the
PMN, releases of the substance are not
expected to result in surface water
concentrations exceeding 170 ppb.
Therefore, EPA has not determined that
the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance that results in releases to
surface waters exceeding 170 ppb may
result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test (OPPTS Test Guideline
850.1010); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a ready
biodegradability test (OECD Test
Guideline 301B) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10820.
PMN Number P–14–382
Chemical name: Quaternary
ammonium compounds, tri-C8–10alkylmethyl, hydrogen sulfates
(generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a cleaning
component for fuels. Based on test data
on the PMN substance, EPA predicts
toxicity to aquatic organisms may occur
at concentrations that exceed 1 ppb of
the PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations exceeding
1 ppb. Therefore, EPA has not
determined that the proposed
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manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance that results in
releases to surface waters exceeding 1
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170(b)(4)(i).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10821.
PMN Number P–14–395
Chemical name: 1,2,3-Propanetriol,
homopolymer, dodecanoate.
CAS number: 74504–64–6.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a detergent
additive. Based on SAR analysis of test
data on analogous nonionic surfactant
compounds, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 18 ppb of the
PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations exceeding
18 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance that results in
releases to surface waters exceeding 18
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test (OPPTS Test Guideline
850.1010); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a ready
biodegradability test (OECD Test
Guideline 301B) would help
characterize the environmental effects of
the PMN substance. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substance and mixtures (OECD
Test Guideline 23) be consulted to
facilitate solubility in the test media.
CFR citation: 40 CFR 721.10822.
PMN Number P–14–564
Chemical name: 2-Propenal, 3-[4-(1methylethyl)phenyl]-.
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CAS number: 6975–24–2.
Basis for action: The PMN states that
the generic (non-confidential) use of the
substance will be as a chemical
intermediate for the synthesis of
fragrance compounds. Based on SAR
analysis of test data on analogous vinyl/
allyl aldehydes, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb of the
PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations exceeding
1 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance that results in
releases to surface waters exceeding 1
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test (OPPTS Test Guideline
850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would
help characterize the environmental
effects of the PMN substance.
CFR citation: 40 CFR 721.10823.
PMN Number P–14–594
Chemical name: Brominated filtration
residue (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used as a feed for
a bromine recovery unit. Based on the
physical/chemical properties of the
PMN substance and test data on
structurally similar substances, the PMN
substance is a potentially persistent,
bioaccumulative, and toxic (PBT)
chemical, as described in the New
Chemical Program’s PBT category (64
FR 60194; November 4, 1999)(FRL–
6097–7). EPA estimates that the PMN
substance will persist in the
environment more than 2 months and
estimates a bioaccumulation factor of
greater than or equal to 1,000. There are
also concerns for liver toxicity based on
the brominated phenyl moiety. As
described in the PMN notice, the PMN
substance is not released to surface
water. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance other than as
described in the PMN and/or any use of
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the substance resulting in surface water
releases may result in significant
adverse health and environmental
effects. Based on this information, the
PMN substance meets the concern
criteria at § 721.170 (b)(3)(ii), (b)(4)(ii),
and (b)(4)(iii).
Recommended testing: EPA has
determined that the results of a partition
coefficient (n-octanol/water) test
(OPPTS Test Guideline 830.7570/OECD
Test Guideline 117); a ready
biodegradability test (OPPTS Test
Guideline 835.3110/OECD Test
Guideline 301); a fish bioconcentration
factor (BCF) test (OPPTS Test Guideline
850.1730/(OECD Test Guideline 305);
and a water solubility test (OECD Test
Guideline 111) would help characterize
the health and environmental effects of
the PMN substance. Depending on the
results of these tests, additional testing
as identified in the PBT category may be
recommended.
CFR citation: 40 CFR 721.10824.
PMN Numbers P–14–616 and P–14–617
Chemical names: Fatty acids reaction
products with polyethylenepolyamine
and naphthenic acids (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be in hydrocarbon
processing applications. Based on SAR
analysis of test data on analogous
aliphatic amines, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 1 ppb of the
PMN substances in surface waters for
greater than 20 days per year. This 20day criterion is derived from partial life
cycle tests (daphnid chronic and fish
early-life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if releases of the PMN
substances to surface water, from uses
other than as described in the PMNs,
exceed releases from the uses described
in the PMN. For the uses described in
the PMN, environmental releases did
not exceed 1 ppb for more than 20 days
per year. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances other than as
described in the PMNs could result in
exposures which may cause significant
adverse environmental effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
early life-stage toxicity test (OPPTS Test
Guideline 850.1400); a daphnid chronic
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toxicity test (OPPTS Test Guidelines
850.1300); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would
help to characterize the environmental
effects of the PMN substances. EPA also
recommends that the guidance
document on aquatic toxicity testing of
difficult substances and mixtures (OECD
Test Guideline 23) be consulted to
facilitate solubility in the test media.
The Agency prefers that the testing be
completed on P–14–616.
CFR citation: 40 CFR 721.10825.
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PMN Number P–14–625
Chemical name: Substituted
aminoalkyl nitrile (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the use of the substance will be as a
chemical intermediate. Based on SAR
analysis of test data on analogous
aliphatic amines, EPA predicts toxicity
to aquatic organisms may occur at
concentrations that exceed 18 ppb of the
PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations exceeding
18 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance that results in
releases to surface waters exceeding 18
ppb may result in significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test (OPPTS Test Guideline
850.1010); an algal toxicity test (OCSPP
Test Guideline 850.4500); and a ready
biodegradability test (OECD Test
Guideline 301B) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10826.
PMN Number P–14–640
Chemical name: Cyclooctadiene metal
derivatives (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used as a synthetic
intermediate. Based on test data on the
analogous metal compounds, the EPA
identified human health concerns
regarding acute handling hazard from
exposure to metal compounds. As
described in the PMN, exposure is
expected to be minimal for this use.
Therefore, EPA has not determined that
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the proposed manufacturing,
processing, or use of the substance may
present an unreasonable risk. EPA has
determined, however, that any use of
the substance other than as a synthetic
intermediate or in any non-enclosed
processes may result in significant
adverse human health effects. Based on
this information, the PMN substance
meets the concern criteria at
§ 721.170(b)(3)(ii).
Recommended testing: EPA has
determined that the results of a 90-day
subchronic study (OPPTS Test
Guideline 870.3100) in rats, by
inhalation route, would help
characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10827.
PMN Numbers P–14–792, P–14–793,
and P–14–794
Chemical names: (P–14–792,
Chemical A; P–14–793; and P–14–794)
1,2,3-Propanetriol, homopolymer,
alkanoates (generic) and (P–14–792,
Chemical B) Glycerides, alkanoate,
mono-, di- and tri- (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that
the generic (non-confidential) use of the
substances will be as agricultural
additives. Based on SAR analysis of test
data on analogous non-ionic surfactants,
EPA predicts chronic toxicity to aquatic
organisms may occur at concentrations
that exceed 53 ppb of the PMN
substances in surface waters for greater
than 20 days per year. This 20-day
criterion is derived from partial life
cycle tests (daphnid chronic and fish
early life stage tests) that typically range
from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms
may occur if releases of the PMN
substances to surface water, from uses
other than as described in the PMNs,
exceed releases from the use described
in the PMNs. For the use described in
the PMNs, environmental releases did
not exceed 53 ppb for more than 20 days
per year. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substances may present an unreasonable
risk. EPA has determined, however, that
any use of the substances other than as
described in the PMNs could result in
exposures which may cause significant
adverse environmental effects. Based on
this information, the PMN substances
meet the concern criteria at
§ 721.170(b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
acute toxicity test, freshwater and
marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute
toxicity test, freshwater daphnids
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(OPPTS Test Guidelines 850.1010); and
an algal toxicity test (OCSPP Test
Guideline 850.4500) would help to
characterize the environmental effects of
the PMN substances.
CFR citations: 40 CFR 721.10828 (P–
14–792, Chemical A; P–14–792,
Chemical B; P–14–793; and P–14–794)
PMN Number P–14–800
Chemical name: Xanthylium, x-[2(alcoxycarbonyl)phenyl]bis(alkylamino)-dimethyl-, x′-[x″[hydroxy-x′″-[[[[hydroxy-x″″(phenyldiazenyl)-sulfo-2naphthalenyl]amino]carbonyl]amino]
sulfo-naphthalenyl]diazenyl]benzoate,
sodium salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that
the substance will be used in ink for ball
point pens. Based on an analog of the
PMN substance, EPA predicts toxicity to
aquatic organisms may occur at
concentrations that exceed 1 ppb of the
PMN substance in surface waters. As
described in the PMN, releases of the
substance are not expected to result in
surface water concentrations that exceed
1 ppb. Therefore, EPA has not
determined that the proposed
manufacturing, processing, or use of the
substance may present an unreasonable
risk. EPA has determined, however, that
any use of the substance resulting in
surface water concentrations exceeding
1 ppb may cause significant adverse
environmental effects. Based on this
information, the PMN substance meets
the concern criteria at § 721.170 (b)(4)(i)
and (b)(4)(ii).
Recommended testing: EPA has
determined that the results of a fish
early-life stage toxicity test (OPPTS Test
Guideline 850.1400) and a daphnid
chronic toxicity test (OPPTS Test
Guideline 850.1300) would help
characterize the environmental effects of
the PMN substance.
CFR citation: 40 CFR 721.10829.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted
for the chemical substances that are
subject to these SNURs, EPA concluded
that for 9 of the 25 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) consent
orders requiring the use of appropriate
exposure controls were negotiated with
the PMN submitters. The SNUR
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provisions for these chemical
substances are consistent with the
provisions of the TSCA section 5(e)
consent orders. These SNURs are
promulgated pursuant to § 721.160 (see
Unit VI.).
In the other 16 cases, where the uses
are not regulated under a TSCA section
5(e) consent order, EPA determined that
one or more of the criteria of concern
established at § 721.170 were met, as
discussed in Unit IV.
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B. Objectives
EPA is issuing these SNURs for
specific chemical substances which
have undergone premanufacture review
because the Agency wants to achieve
the following objectives with regard to
the significant new uses designated in
this rule:
• EPA will 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.
• EPA will have an opportunity to
review and evaluate data submitted in a
SNUN before the notice submitter
begins manufacturing or processing a
listed chemical substance for the
described significant new use.
• EPA will be able to regulate
prospective manufacturers or processors
of a listed chemical substance before the
described significant new use of that
chemical substance occurs, provided
that regulation is warranted pursuant to
TSCA sections 5(e), 5(f), 6, or 7.
• EPA will ensure that all
manufacturers and processors of the
same chemical substance that is subject
to a TSCA section 5(e) consent order are
subject to similar requirements.
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.
VI. Direct Final Procedures
EPA is issuing these SNURs as a
direct final rule, as described in
§ 721.160(c)(3) and § 721.170(d)(4). In
accordance with § 721.160(c)(3)(ii) and
§ 721.170(d)(4)(i)(B), the effective date
of this rule is July 7, 2015 without
further notice, unless EPA receives
written adverse or critical comments, or
notice of intent to submit adverse or
critical comments before June 8, 2015.
If EPA receives written adverse or
critical comments, or notice of intent to
submit adverse or critical comments, on
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one or more of these SNURs before June
8, 2015, EPA will withdraw the relevant
sections of this direct final rule before
its effective date. EPA will then issue a
proposed SNUR for the chemical
substance(s) on which adverse or
critical comments were received,
providing a 30-day period for public
comment.
This rule establishes SNURs for a
number of chemical substances. Any
person who submits adverse or critical
comments, or notice of intent to submit
adverse or critical comments, must
identify the chemical substance and the
new use to which it applies. EPA will
not withdraw a SNUR for a chemical
substance not identified in the
comment.
VII. Applicability of the 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 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 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) consent orders have
been issued for 9 of the 25 chemical
substances, and the PMN submitters are
prohibited by the TSCA section 5(e)
consent orders from undertaking
activities which would be designated as
significant new uses. The identities of
21 of the 25 chemical substances subject
to this rule have been claimed as
confidential and EPA has received no
post-PMN bona fide submissions (per
§§ 720.25 and 721.11). 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 rule are ongoing.
Therefore, EPA designates May 8,
2015 as the cutoff date for determining
whether the new use is ongoing. 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
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comply with all applicable SNUR
notification requirements and wait until
the notice review period, including any
extensions, expires. If such a person met
the conditions of advance compliance
under § 721.45(h), the person would be
considered exempt from the
requirements of the SNUR. Consult the
Federal Register document of April 24,
1990 for a more detailed discussion of
the cutoff date for ongoing uses.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5
does not require developing any
particular test data before submission of
a SNUN. The two exceptions are:
1. Development of test data is
required where the chemical substance
subject to the SNUR is also subject to a
test rule under TSCA section 4 (see
TSCA section 5(b)(1)).
2. Development of test data may be
necessary where the chemical substance
has been listed under TSCA section
5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a TSCA section 4
test rule or a TSCA section 5(b)(4)
listing covering the chemical substance,
persons are required only to submit test
data in their possession or control and
to describe any other data 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.
In cases where EPA issued a TSCA
section 5(e) consent order that requires
or recommends certain testing, Unit IV.
lists those tests. Unit IV. also lists
recommended testing for TSCA nonsection 5(e) SNURs. Descriptions of tests
are provided for informational purposes.
EPA strongly encourages persons, before
performing any testing, to consult with
the Agency pertaining to protocol
selection. 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 (OECD) test
guidelines are available from the OECD
Bookshop at https://
www.oecdbookshop.org or SourceOECD
at https://www.sourceoecd.org.
In the TSCA section 5(e) consent
orders for several of the chemical
substances regulated under this rule,
EPA has established production volume
limits in view of the lack of data on the
potential health and environmental
risks that may be posed by the
significant new uses or increased
exposure to the chemical substances.
These limits cannot be exceeded unless
the PMN submitter first submits the
results of toxicity tests that would
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permit a reasoned evaluation of the
potential risks posed by these chemical
substances. Under recent TSCA section
5(e) consent orders, each PMN submitter
is required to submit each study before
reaching the specified production limit.
Listings of the tests specified in the
TSCA section 5(e) consent orders are
included in Unit IV. The SNURs contain
the same production volume limits as
the TSCA section 5(e) consent orders.
Exceeding these production limits is
defined as a significant new use.
Persons who intend to exceed the
production limit must notify the Agency
by submitting a SNUN at least 90 days
in advance of commencement of nonexempt commercial manufacture or
processing.
The recommended tests specified in
Unit IV. may not be the only means of
addressing the potential risks of the
chemical substance. However,
submitting a SNUN without any test
data may increase the likelihood that
EPA will take action under TSCA
section 5(e), particularly if satisfactory
test results have not been obtained from
a prior PMN or SNUN submitter. 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.
• Potential benefits of the chemical
substances.
• Information on risks posed by the
chemical substances compared to risks
posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing
certain significant new uses which have
been claimed as CBI subject to Agency
confidentiality regulations at 40 CFR
part 2 and 40 CFR part 720, subpart E.
Absent a final determination or other
disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is
required to keep this information
confidential. EPA promulgated a
procedure to deal with the situation
where a specific significant new use is
CBI, at 40 CFR 721.1725(b)(1).
Under these procedures a
manufacturer or processor may request
EPA to determine whether a proposed
use would be a significant new use
under the rule. The manufacturer or
processor must show that it has a bona
fide intent to manufacture or process the
chemical substance and must identify
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the specific use for which it intends to
manufacture or process the chemical
substance. If EPA concludes that the
person has shown a bona fide intent to
manufacture or process the chemical
substance, EPA will tell the person
whether the use identified in the bona
fide submission would be a significant
new use under the rule. Since most of
the chemical identities of the chemical
substances subject to these SNURs are
also CBI, manufacturers and processors
can combine the bona fide submission
under the procedure in § 721.1725(b)(1)
with that under § 721.11 into a single
step.
If EPA determines that the use
identified in the bona fide submission
would not be a significant new use, i.e.,
the use does not meet the criteria
specified in the rule for a significant
new use, that person can manufacture or
process the chemical substance so long
as the significant new use trigger is not
met. In the case of a production volume
trigger, this means that the aggregate
annual production volume does not
exceed that identified in the bona fide
submission to EPA. Because of
confidentiality concerns, EPA does not
typically disclose the actual production
volume that constitutes the use trigger.
Thus, if the person later intends to
exceed that volume, a new bona fide
submission would be necessary to
determine whether that higher volume
would be a significant new use.
X. SNUN Submissions
According to § 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.
XI. Economic Analysis
EPA has evaluated the potential costs
of establishing SNUN requirements for
potential manufacturers and processors
of the chemical substances subject to
this rule. EPA’s complete economic
analysis is available in the docket under
docket ID number EPA–HQ–OPPT–
2014–0908.
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XII. Statutory and Executive Order
Reviews
A. Executive Order 12866
This action establishes SNURs for
several new chemical substances that
were the subject of PMNs, or TSCA
section 5(e) consent orders. The Office
of Management and Budget (OMB) has
exempted these types of actions from
review under Executive Order 12866,
entitled ‘‘Regulatory Planning and
Review’’ (58 FR 51735, October 4, 1993).
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. EPA is amending the table in
40 CFR part 9 to list the OMB approval
number for the information collection
requirements contained in this action.
This listing of the OMB control numbers
and their subsequent codification in the
CFR satisfies the display requirements
of PRA and OMB’s implementing
regulations at 5 CFR part 1320. This
Information Collection Request (ICR)
was previously subject to public notice
and comment prior to OMB approval,
and given the technical nature of the
table, EPA finds that further notice and
comment to amend it is unnecessary. As
a result, EPA finds that there is ‘‘good
cause’’ under section 553(b)(3)(B) of the
Administrative Procedure Act (5 U.S.C.
553(b)(3)(B)) to amend this table
without further notice and comment.
The information collection
requirements related to this action have
already been approved by OMB
pursuant to PRA under OMB control
number 2070–0012 (EPA ICR No. 574).
This action does not impose any burden
requiring additional OMB approval. If
an entity were to submit a SNUN to the
Agency, the annual burden is estimated
to average between 30 and 170 hours
per response. This burden estimate
includes the time needed to review
instructions, search existing data
sources, gather and maintain the data
needed, and complete, review, and
submit the required SNUN.
Send any comments about the
accuracy of the burden estimate, and
any suggested methods for minimizing
respondent burden, including through
the use of automated collection
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techniques, to the Director, Collection
Strategies Division, Office of
Environmental Information (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)
On February 18, 2012, EPA certified
pursuant to RFA section 605(b) (5 U.S.C.
601 et seq.), that promulgation of a
SNUR does not have a significant
economic impact on a substantial
number of small entities where the
following are true:
1. A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small
entity would not cost significantly more
than $8,300.
A copy of that certification is
available in the docket for this action.
This action is within the scope of the
February 18, 2012 certification. Based
on the Economic Analysis discussed in
Unit XI. and EPA’s experience
promulgating SNURs (discussed in the
certification), EPA believes that the
following are true:
• A significant number of SNUNs
would not be submitted by small
entities in response to the SNUR.
• Submission of the SNUN would not
cost any small entity significantly more
than $8,300.
Therefore, the promulgation of the
SNUR would not have a significant
economic impact on a substantial
number of small entities.
asabaliauskas on DSK5VPTVN1PROD with RULES
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 action does not impose any
enforceable duty, contain any unfunded
mandate, or otherwise have any effect
on small governments subject to the
requirements of UMRA sections 202,
203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will 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
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Executive Order 13132, entitled
‘‘Federalism’’ (64 FR 43255, August 10,
1999).
F. Executive Order 13175
This action does not have Tribal
implications because it is not expected
to have substantial direct effects on
Indian Tribes. This action does not
significantly nor uniquely affect the
communities of Indian Tribal
governments, nor does it involve or
impose any requirements that affect
Indian Tribes. Accordingly, the
requirements of Executive Order 13175,
entitled ‘‘Consultation and Coordination
with Indian Tribal Governments’’ (65 FR
67249, November 9, 2000), do not apply
to this action.
G. Executive Order 13045
This action is not subject to Executive
Order 13045, entitled ‘‘Protection of
Children from Environmental Health
Risks and Safety Risks’’ (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.
General of the United States prior to
publication of the rule in the Federal
Register. This action is not a ‘‘major
rule’’ as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting
and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals,
Hazardous substances, Reporting and
recordkeeping requirements.
Dated: May 1, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office
of Pollution Prevention and Toxics.
Therefore, 40 CFR parts 9 and 721 are
amended as follows:
PART 9—[AMENDED]
1. The authority citation for part 9
continues to read as follows:
■
H. Executive Order 13211
This action is not subject to Executive
Order 13211, entitled ‘‘Actions
Concerning Regulations That
Significantly Affect Energy Supply,
Distribution, or Use’’ (66 FR 28355, May
22, 2001), because this action is not
expected to affect energy supply,
distribution, or use and because this
action is not a significant regulatory
action under Executive Order 12866.
Authority: 7 U.S.C. 135 et seq., 136–136y;
15 U.S.C. 2001, 2003, 2005, 2006, 2601–2671;
21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318,
1321, 1326, 1330, 1342, 1344, 1345 (d) and
(e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971–1975 Comp. p. 973; 42 U.S.C. 241,
242b, 243, 246, 300f, 300g, 300g-1, 300g-2,
300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j2, 300j-3, 300j-4, 300j-9, 1857 et seq., 6901–
6992k, 7401–7671q, 7542, 9601–9657, 11023,
11048.
■
I. National Technology Transfer and
Advancement Act (NTTAA)
In addition, since this action does not
involve any technical standards,
NTTAA section 12(d) (15 U.S.C. 272
note), does not apply to this action.
J. Executive Order 12898
XIII. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), EPA will
submit a report containing this rule and
other required information to the U.S.
Senate, the U.S. House of
Representatives, and the Comptroller
Frm 00020
Fmt 4700
Sfmt 4700
§ 9.1 OMB approvals under the Paperwork
Reduction Act.
*
*
*
*
*
OMB control
No.
40 CFR citation
*
This action does not entail special
considerations of environmental justice
related issues as delineated by
Executive Order 12898, entitled
‘‘Federal Actions to Address
Environmental Justice in Minority
Populations and Low-Income
Populations’’ (59 FR 7629, February 16,
1994).
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2. In § 9.1, add the following sections
in numerical order under the
undesignated center heading
‘‘Significant New Uses of Chemical
Substances’’ to read as follows:
*
*
*
*
Significant New Uses of Chemical
Substances
*
721.10812
721.10813
721.10814
721.10815
721.10816
721.10817
721.10818
721.10819
721.10820
721.10821
721.10822
721.10823
721.10824
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*
*
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
.............................
08MYR1
*
*
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
Federal Register / Vol. 80, No. 89 / Friday, May 8, 2015 / Rules and Regulations
OMB control
No.
40 CFR citation
721.10825
721.10826
721.10827
721.10828
721.10829
.............................
.............................
.............................
.............................
.............................
*
*
*
*
*
*
*
2070–0012
2070–0012
2070–0012
2070–0012
2070–0012
*
*
*
PART 721—[AMENDED]
3. The authority citation for part 721
continues to read as follows:
■
Authority: 15 U.S.C. 2604, 2607, and
2625(c).
4. Add § 721.10812 to subpart E to
read as follows:
■
asabaliauskas on DSK5VPTVN1PROD with RULES
§ 721.10812
(generic).
Alkylbenzene sulfonic acid
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as alkylbenzene sulfonic
acid (PMN P–12–115) 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 PMN
substance that have partitioned into oil
or petroleum streams following use as
an interfacial tension reducer for
enhanced oil recovery applications.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72(a)
through (f), (g)(3), (g)(4)(ii), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use is any manufacturing, processing, or
use of the PMN substance other than as
a chemical intermediate to prepare an
interfacial tension reducer for enhanced
oil recovery.
(iii) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (where N=4).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (f), (g), (h), (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.
■ 5. Add § 721.10813 to subpart E to
read as follows:
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§ 721.10813 Benzenesulfonic acid,
dimethyl-, alkyl derivatives, sodium salt
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as benzenesulfonic acid,
dimethyl-, alkyl derivatives, sodium salt
(PMNs P–12–116 and P–13–568) 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 PMN
substance that have partitioned into oil
or petroleum streams when used in
enhanced oil recovery applications.
(2) The significant new uses are:
(i) Hazard communication program.
Requirements as specified in § 721.72(a)
through (f), (g)(1) (corrosion to the eyes,
mucous membranes, skin, and lungs),
(g)(2)(i), (g)(2)(ii), (g)(2)(iii), (g)(2)(v),
(g)(3), (g)(4)(ii), and (g)(5).
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (manufacturing,
processing, or use of the PMN substance
other than as an interfacial tension
reducer for enhanced oil recovery or the
confidential use as stated in the consent
order for P–13–568) and § 721.80(q)
(production volume limit as stated in
the consent order for P–13–568).
(iii) Release to water. Requirements as
specified in § 721.90 (a)(4), (b)(4), and
(c)(4) (where N=4).
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (c), (f), (g), (h), (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.
(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.
■ 6. Add § 721.10814 to subpart E to
read as follows:
§ 721.10814 2-Propenoic acid, 3-phenyl-,
zinc salt (2:1), (2E)-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenoic acid, 3-phenyl-, zinc salt
(2:1), (2E)- (PMN P–12–397; CAS No.
18957–59–0) is subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
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Frm 00021
Fmt 4700
Sfmt 4700
26457
(i) Industrial commercial, and
consumer activities. Requirements as
specified in § 721.80. A significant new
use is any use of the PMN substance
other than as a reinforcing additive in
polyolefins.
(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), (b), (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.
■ 7. Add § 721.10815 to subpart E to
read as follows:
§ 721.10815 Fatty acids, satd. and unsatd
alkyl-, esters with polyol (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fatty acids, satd. and
unsatd alkyl-, esters with polyol (PMN
P–13–139) 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. A significant new
use is any use of the PMN substance
other than as an ingredient in a
multipurpose additive in gasoline to
reduce friction in engines.
(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), (b), (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.
■ 8. Add § 721.10816 to subpart E to
read as follows:
§ 721.10816 Fluoroalkyl acrylate
copolymer modified with polysiloxanes
(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fluoroalkyl acrylate
copolymer modified with polysiloxanes
(PMNs P–13–646 and P–13–648) are
subject to reporting under this section
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for the significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A
significant new use of the substances is
any manner or method of manufacture
or processing associated with any use of
the substances without providing risk
notification as follows:
(A) If as a result of the test data
required under the TSCA section 5(e)
consent order for the substances, the
employer becomes aware that the
substances may present a risk of injury
to human health or the environment, the
employer must incorporate this new
information, and any information on
methods for protecting against such risk,
into a MSDS as described in § 721.72(c)
within 90 days from the time the
employer becomes aware of the new
information. If the substance(s) are not
being manufactured, processed, or used
in the employer’s workplace, the
employer must add the new information
to a MSDS before the substance(s) are
reintroduced into the workplace.
(B) The employer must ensure that
persons who will receive the PMN
substance(s) from the employer, or who
have received the PMN substance(s)
from the employer within 5 years from
the date the employer becomes aware of
the new information described in
paragraph (a)(2)(i)(A) of this section, are
provided an MSDS containing the
information required under paragraph
(a)(2)(i)(A) of this section within 90 days
from the time the employer becomes
aware of the new information.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (a significant
new use is any use other than as
allowed by the section 5(e) consent
order, which includes analysis and
reporting and limitations of maximum
impurity levels of certain fluorinated
impurities), and § 721.80(q).
(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), (f), and (i) are
applicable to manufacturers and
processors of these substances.
(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.
■ 9. Add § 721.10817 to subpart E to
read as follows:
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§ 721.10817 Fluoroalkyl acrylate
copolymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fluoroalkyl acrylate
copolymer (PMNs P–13–647, P–13–649,
and P–13–679) are subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Hazard communication program. A
significant new use of the substances is
any manner or method of manufacture
or processing associated with any use of
the substances without providing risk
notification as follows:
(A) If as a result of the test data
required under the TSCA section 5(e)
consent order for the substances, the
employer becomes aware that the
substances may present a risk of injury
to human health or the environment, the
employer must incorporate this new
information, and any information on
methods for protecting against such risk,
into a MSDS as described in § 721.72(c)
within 90 days from the time the
employer becomes aware of the new
information. If the substance(s) are not
being manufactured, processed, or used
in the employer’s workplace, the
employer must add the new information
to a MSDS before the substance(s) are
reintroduced into the workplace.
(B) The employer must ensure that
persons who will receive the PMN
substance(s) from the employer, or who
have received the PMN substance(s)
from the employer within 5 years from
the date the employer becomes aware of
the new information described in
paragraph (a)(2)(i)(A) of this section, are
provided an MSDS containing the
information required under paragraph
(a)(2)(i)(A) of this section within 90 days
from the time the employer becomes
aware of the new information.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (a significant
new use is any use other than as
allowed by the section 5(e) consent
order, which includes analysis and
reporting and limitations of maximum
impurity levels of certain fluorinated
impurities), and § 721.80(q).
(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), (f), and (i) are
applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of
certain notification requirements. The
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Fmt 4700
Sfmt 4700
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.
■ 10. Add § 721.10818 to subpart E to
read as follows:
§ 721.10818 Fluoroalkyl methacrylate
copolymer (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as fluoroalkyl methacrylate
copolymer (PMN P–13–678) 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 program. A
significant new use of the substance is
any manner or method of manufacture
or processing associated with any use of
the substance without providing risk
notification as follows:
(A) If as a result of the test data
required under the TSCA section 5(e)
consent order for the substance, the
employer becomes aware that the
substance may present a risk of injury
to human health or the environment, the
employer must incorporate this new
information, and any information on
methods for protecting against such risk,
into a MSDS as described in § 721.72(c)
within 90 days from the time the
employer becomes aware of the new
information. If the substance is not
being manufactured, processed, or used
in the employer’s workplace, the
employer must add the new information
to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that
persons who will receive the PMN
substance from the employer, or who
have received the PMN substance from
the employer within 5 years from the
date the employer becomes aware of the
new information described in paragraph
(a)(2)(i)(A) of this section, are provided
an MSDS containing the information
required under paragraph (a)(2)(i)(A) of
this section within 90 days from the
time the employer becomes aware of the
new information.
(ii) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(k) (a significant
new use is any use other than as
allowed by the section 5(e) consent
order, which includes analysis and
reporting and limitations of maximum
impurity levels of certain fluorinated
impurities), and § 721.80(q).
(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), (f), 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)(ii) of this section.
■ 11. Add § 721.10819 to subpart E to
read as follows:
§ 721.10819
Zinc carboxylate (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as zinc carboxylate (PMN P–
13–951) 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) (N=3).
(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), (b), (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.
■ 12. Add § 721.10820 to subpart E to
read as follows:
asabaliauskas on DSK5VPTVN1PROD with RULES
§ 721.10820 Phenol, styrenated, reaction
products with polyethylene glycol and 2-[(2propen-1-yloxy)methyl]oxirane.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
phenol, styrenated, reaction products
with polyethylene glycol and 2-[(2propen-1-yloxy)methyl]oxirane (PMN
P–14–364; CAS No. 1539128–27–2) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=170).
(ii) [Reserved]
(b) Specific requirements. The
provisions of subpart A of this part
apply to this section except as modified
by this paragraph.
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(1) Recordkeeping. Recordkeeping
requirements as specified in
§ 721.125(a), (b), (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.
■ 13. Add § 721.10821 to subpart E to
read as follows:
§ 721.10821 Quaternary ammonium
compounds, tri-C8-10-alkylmethyl,
hydrogen sulfates (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as quaternary ammonium
compounds, tri-C8-10-alkylmethyl,
hydrogen sulfates (PMN P–14–382) 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) (N=1).
(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), (b), (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.
■ 14. Add § 721.10822 to subpart E to
read as follows:
§ 721.10822 1,2,3-Propanetriol,
homopolymer, dodecanoate.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
1,2,3-propanetriol, homopolymer,
dodecanoate (PMN P–14–395; CAS
Number 74504–64–6) is subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=18).
(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), (b), (c), and (k) are
applicable to manufacturers and
processors of this substance.
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26459
(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
■ 15. Add § 721.10823 to subpart E to
read as follows:
§ 721.10823 2-Propenal, 3-[4-(1methylethyl)phenyl]-.
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified as
2-propenal, 3-[4-(1-methylethyl)phenyl](PMN P–14–564; CAS No. 6975–24–2) 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) Release to water. Requirements as
specified in § 721.90(a)(4), (b)(4), and
(c)(4) (N=1).
(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), (b), (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.
■ 16. Add § 721.10824 to subpart E to
read as follows:
§ 721.10824
(generic).
Brominated filtration residue
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as brominated filtration
residue (PMN P–14–594) 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. A significant new
use is any use of the PMN substance
other than as a feed for bromine
recovery unit.
(ii) 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), (i), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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provisions of § 721.185 apply to this
section.
■ 17. Add § 721.10825 to subpart E to
read as follows:
provisions of § 721.185 apply to this
section.
■ 19. Add § 721.10827 to subpart E to
read as follows:
§ 721.10825 Fatty acids reaction products
with polyethylenepolyamine and naphthenic
acids (generic).
§ 721.10827 Cyclooctadiene metal
derivatives (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as fatty acids reaction
products with polyethylenepolyamine
and naphthenic acids (PMNs P–14–616
and P–14–617) are subject to reporting
under this section for the significant
new uses described in paragraph (a)(2)
of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(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), (b), (c), and (i) are
applicable to manufacturers and
processors of these substances.
(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.
■ 18. Add § 721.10826 to subpart E to
read as follows:
asabaliauskas on DSK5VPTVN1PROD with RULES
§ 721.10826
(generic).
Substituted aminoalkyl nitrile
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as substituted aminoalkyl
nitrile (PMN P–14–625) 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) (N=18).
(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), (b), (c), and (k) are
applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of
certain notification requirements. The
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(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as cyclooctadiene metal
derivatives (PMN P–14–640) 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. A significant new
use is any use in non-enclosed
processes or any use other than as a
synthetic intermediate.
(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), (b), (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.
■ 20. Add § 721.10828 to subpart E to
read as follows:
§ 721.10828 1,2,3-Propanetriol,
homopolymer, alkanoates (generic) and
Glycerides, alkanoate, mono-, di- and tri(generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substances identified
generically as 1,2,3-propanetriol,
homopolymer, alkanoates (PMNs P–14–
792, Chemical A; P–14–793; and P–14–
794) and generically as glycerides,
alkanoate, mono-, di- and tri- (PMN P–
14–792, Chemical B) are subject to
reporting under this section for the
significant new uses described in
paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial, commercial, and
consumer activities. Requirements as
specified in § 721.80(j).
(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), (b), (c), and (i) are
applicable to manufacturers and
processors of these substances.
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(2) Limitations or revocation of
certain notification requirements. The
provisions of § 721.185 apply to this
section.
(3) Determining whether a specific use
is subject to this section. The provisions
of § 721.1725(b)(1) apply to paragraph
(a)(2)(i) of this section.
21. Add § 721.10829 to subpart E to
read as follows:
■
§ 721.10829 Xanthylium, x-[2(alcoxycarbonyl)phenyl]-bis(alkylamino)dimethyl-, x′-[x″ -[hydroxy-x″′-[[[[hydroxyx′′′′-(phenyldiazenyl)-sulfo-2naphthalenyl]amino]carbonyl]amino]sulfonaphthalenyl]diazenyl]benzoate, sodium
salt (generic).
(a) Chemical substance and
significant new uses subject to reporting.
(1) The chemical substance identified
generically as xanthylium, x-[2(alcoxycarbonyl)phenyl]bis(alkylamino)-dimethyl-, x′-[x″
-[hydroxy-x″′-[[[[hydroxy-x′′′′(phenyldiazenyl)-sulfo-2naphthalenyl]amino]carbonyl]amino]
sulfo-naphthalenyl]diazenyl]benzoate,
sodium salt (PMN P–14–800) 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) (N=1).
(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), (b), (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.
[FR Doc. 2015–11166 Filed 5–7–15; 8:45 am]
BILLING CODE 6560–50–P
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[Federal Register Volume 80, Number 89 (Friday, May 8, 2015)]
[Rules and Regulations]
[Pages 26448-26460]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-11166]
[[Page 26448]]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 9 and 721
[EPA-HQ-OPPT-2014-0908; FRL-9925-42]
RIN 2070-AB27
Significant New Use Rules on Certain Chemical Substances
AGENCY: Environmental Protection Agency (EPA).
ACTION: Direct final rule.
-----------------------------------------------------------------------
SUMMARY: EPA is promulgating significant new use rules (SNURs) under
the Toxic Substances Control Act (TSCA) for 25 chemical substances
which were the subject of premanufacture notices (PMNs). Nine of these
chemical substances are subject to TSCA section 5(e) consent orders
issued by EPA. This action requires persons who intend to manufacture
(including import) or process any of these 25 chemical substances for
an activity that is designated as a significant new use by this rule to
notify EPA at least 90 days before commencing that activity. The
required notification will provide EPA with the opportunity to evaluate
the intended use and, if necessary, to prohibit or limit that activity
before it occurs.
DATES: This rule is effective on July 7, 2015. For purposes of judicial
review, this rule shall be promulgated at 1 p.m. (e.s.t.) on May 22,
2015.
Written adverse or critical comments, or notice of intent to submit
adverse or critical comments, on one or more of these SNURs must be
received on or before June 8, 2015 (see Unit VI. of the SUPPLEMENTARY
INFORMATION). If EPA receives written adverse or critical comments, or
notice of intent to submit adverse or critical comments, on one or more
of these SNURs before June 8, 2015, EPA will withdraw the relevant
sections of this direct final rule before its effective date.
For additional information on related reporting requirement dates,
see Units I.A., VI., and VII. of the SUPPLEMENTARY INFORMATION.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2014-0908, 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 (7405 M), 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 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 12.118 through 12.127
and 19 CFR 127.28. Chemical importers must certify that the shipment of
the chemical substance complies with all applicable rules and orders
under TSCA. Importers of chemicals subject to these 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 a proposed or final rule are subject
to the export notification provisions of TSCA section 12(b) (15 U.S.C.
2611(b)) (see Sec. 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 promulgating these SNURs using direct final procedures.
These SNURs will require persons to notify EPA at least 90 days before
commencing the manufacture or processing of a chemical substance for
any activity designated by these SNURs as a significant new use.
Receipt of such notices allows EPA to assess risks that may be
presented by the intended uses and, if appropriate, to regulate the
proposed use before it occurs. Additional rationale and background to
these rules are 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
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
[[Page 26449]]
``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. Once EPA determines that a
use of a chemical substance is a significant new use, TSCA section
5(a)(1)(B) requires persons to submit a significant new use notice
(SNUN) to EPA at least 90 days before they manufacture or process the
chemical substance for that use. Persons who must report are described
in Sec. 721.5.
C. Applicability of General Provisions
General provisions for SNURs appear in 40 CFR part 721, subpart A.
These provisions describe persons subject to the rule, recordkeeping
requirements, exemptions to reporting requirements, and applicability
of the rule to uses occurring before the effective date of the rule.
Provisions relating to user fees appear at 40 CFR part 700. According
to Sec. 721.1(c), persons subject to these SNURs must comply with the
same SNUN requirements and EPA regulatory procedures as submitters of
PMNs under TSCA section 5(a)(1)(A). In particular, these requirements
include the information submission requirements of TSCA section 5(b)
and 5(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 may take regulatory action under TSCA section
5(e), 5(f), 6, or 7 to control the activities for which it has received
the SNUN. If EPA does not take action, EPA is required under TSCA
section 5(g) to explain in the Federal Register its reasons for not
taking action.
III. Significant New Use Determination
Section 5(a)(2) of TSCA 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 addition to these factors enumerated in TSCA section 5(a)(2),
the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the 25
chemical substances that are the subject of these SNURs, EPA considered
relevant information about the toxicity of the chemical substances,
likely human exposures and environmental releases associated with
possible uses, and the four bulleted TSCA section 5(a)(2) factors
listed in this unit.
IV. Substances Subject to This Rule
EPA is establishing significant new use and recordkeeping
requirements for 25 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 (assigned
for non-confidential chemical identities).
Basis for the TSCA section 5(e) consent order or the basis
for the TSCA non-section 5(e) SNURs (i.e., SNURs without TSCA section
5(e) consent orders).
Tests recommended by EPA to provide sufficient information
to evaluate the chemical substance (see Unit VIII. for more
information).
CFR citation assigned in the regulatory text section of
this rule.
The regulatory text section of this rule specifies the activities
designated as significant new uses. Certain new uses, including
production volume limits (i.e., limits on manufacture volume) and other
uses designated in this rule, may be claimed as CBI. Unit IX. discusses
a procedure companies may use to ascertain whether a proposed use
constitutes a significant new use.
This rule includes nine PMN substances (P-12-115, P-12-116, P-13-
568, P-13-646, P-13-647, P-13-648, P-13-649, P-13-678, and P-13-679)
that are subject to ``risk-based'' consent orders under TSCA section
5(e)(1)(A)(ii)(I) where EPA determined that activities associated with
the PMN substances may present unreasonable risk to human health or the
environment. Those consent orders require protective measures to limit
exposures or otherwise mitigate the potential unreasonable risk. The
so-called ``TSCA section 5(e) SNURs'' on these PMN substances are
promulgated pursuant to Sec. 721.160, and are based on and consistent
with the provisions in the underlying consent orders. The TSCA section
5(e) SNURs designate as a ``significant new use'' the absence of the
protective measures required in the corresponding consent orders.
This rule also includes SNURs on 16 PMN substances that are not
subject to consent orders under TSCA section 5(e). In these cases, for
a variety of reasons, EPA did not find that the use scenario described
in the PMN triggered the determinations set forth under TSCA section
5(e). However, EPA does believe that certain changes from the use
scenario described in the PMN could result in increased exposures,
thereby constituting a ``significant new use.'' These so-called ``TSCA
non-section 5(e) SNURs'' are promulgated pursuant to Sec. 721.170. EPA
has determined that every activity designated as a ``significant new
use'' in all TSCA non-section 5(e) SNURs issued under Sec. 721.170
satisfies the two requirements stipulated in Sec. 721.170(c)(2), i.e.,
these significant new use activities are different from those described
in the premanufacture notice for the substance, including any
amendments, deletions, and additions of activities to the
premanufacture notice, and may be accompanied by changes in exposure or
release levels that are significant in relation to the health or
environmental concerns identified'' for the PMN substance.
PMN Numbers P-12-115, P-12-116, and P-13-568
Chemical names: (P-12-115) Alkylbenzene sulfonic acid (generic) and
(P-12-116 and P-13-568) Benzenesulfonic acid, dimethyl-, alkyl
derivatives, sodium salt (generic).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e) consent orders: August 1, 2014
(P-12-115 and P-12-116) and July 2, 2014 (P-13-568).
Basis for TSCA section 5(e) consent orders: The PMNs state that P-
12-115 will be used as a chemical intermediate to prepare an
interfacial tension reducer for enhanced oil recovery, P-12-116 will be
used as an interfacial tension reducer for enhanced oil recovery, and
P-13-568 will be used generically in enhanced oil recovery
applications. Based on surfactant properties and SAR analysis of test
data on PMN substance P-13-568 and other analogous substances, EPA
identified concerns for corrosion to the eyes, mucous membranes, lungs,
and skin. In addition, based on test data on the PMN substances P-12-
116 and P-13-568, as well as test data on analogous substances, EPA
predicts toxicity to aquatic organisms at concentrations that exceed 4
parts per billion (ppb) of the PMN substances in surface waters. The
consent order for PMNs P-12-115 and
[[Page 26450]]
P-12-116 was issued under TSCA sections 5(e)(1)(A)(i) and
5(e)(1)(A)(ii)(I) based on a finding that the uncontrolled manufacture,
processing, distribution in commerce, use and disposal of the PMN
substances may present an unreasonable risk to the environment. The
consent order for PMN P-13-568 was issued under TSCA sections
5(e)(1)(A)(i) and 5(e)(1)(A)(ii)(I) based on a finding that that the
uncontrolled manufacture, processing, distribution in commerce, use and
disposal of the PMN substance may present an unreasonable risk to human
health and the environment. To protect against these risks, the consent
orders require:
1. Manufacturing, processing, or use of the PMN substance P-12-115
only as a chemical intermediate to prepare an interfacial tension
reducer for enhanced oil recovery.
2. Manufacturing, processing, or use of the PMN substance
identified as P-12-116 and P-13-568 only as an interfacial tension
reducer for enhanced oil recovery or for the specific confidential
enhanced oil recovery applications described in the consent order for
PMN P-13-568.
3. No predictable or purposeful release of the PMN substances from
manufacturing, processing or use into the waters of the United States
that result in surface water concentrations exceeding 4 ppb.
4. Individual aggregate production volume limits for the PMN
substance identified as P-12-116 and P-13-568 shall not exceed the
confidential production limit identified in the consent order for PMN
P-13-568.
5. Establishment and use of a hazard communication program,
including environmental hazard precautionary statements on each label
and the MSDS for the PMN substance P-12-115.
6. Establishment and use of a hazard communication program,
including human health and environmental hazard precautionary
statements on each label and the MSDS for the PMN substance identified
as P-12-116 and P-13-568.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) in clean
dilution water; and a daphnid chronic toxicity test (OPPTS Test
Guideline 850.1300) would help characterize the environmental effects
of the PMN substances.
CFR citations: 40 CFR 721.10812 (P-12-115) and 40 CFR 721.10813 (P-
12-116 and P-13-568).
PMN Number P-12-397
Chemical name: 2-Propenoic acid, 3-phenyl-, zinc salt (2:1), (2E)-.
CAS number: 18957-59-0.
Basis for action: The PMN states that the PMN substance will be
used as a reinforcing additive in polyolefins. Based on structure
activity relationship (SAR) analysis of test data on analogous zinc
salts, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 3 ppb of the PMN substance in surface waters
for greater than 20 days per year. This 20-day criterion is derived
from partial life cycle tests (daphnid chronic and fish early-life
stage tests) that typically range from 21 to 28 days in duration. EPA
predicts toxicity to aquatic organisms may occur if releases of the
substance to surface water, from uses other than as described in the
PMN, exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 3 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any use of the
substance other than as a reinforcing additive in polyolefins may
result in significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); an algal toxicity test (OCSPP Test
Guideline 850.4500); and a ready biodegradability test (OPPTS Test
Guideline 835.3110) would help characterize the environmental effects
of the PMN substance.
CFR citation: 40 CFR 721.10814.
PMN Number P-13-139
Chemical name: Fatty acids, satd. and unsatd alkyl-, esters with
polyol (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
an ingredient in multipurpose additive in gasoline to reduce friction
in engines. Based on SAR analysis of test data on analogous nonionic
surfactants, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 190 ppb of the PMN substance in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if releases of the
substance to surface water, from uses other than as described in the
PMN, exceed releases from the use described in the PMN. For the use
described in the PMN, environmental releases did not exceed 190 ppb for
more than 20 days per year. Therefore, EPA has not determined that the
proposed manufacturing, processing, or use of the substance may present
an unreasonable risk. EPA has determined, however, that any use of the
substance other than as an ingredient in multipurpose additive in
gasoline to reduce friction in engines may result in significant
adverse environmental effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an acute invertebrate toxicity test, freshwater daphnids
(OPPTS Test Guideline 850.1010); and an algal toxicity test (OCSPP Test
Guideline 850.4500) would help characterize the environmental effects
of the PMN substance. EPA also recommends that the guidance document on
aquatic toxicity testing of difficult substance and mixtures
(Organisation for Economic Co-operation and Development (OECD) Test
Guideline 23) be consulted to facilitate solubility in the test media.
CFR citation: 40 CFR 721.10815.
PMN Numbers P-13-646, P-13-647, P-13-648, P-13-649, P-13-678, and P-13-
679
Chemical names: (P-13-646 and P-13-648) Fluoroalkyl acrylate
copolymer modified with polysiloxanes (generic); (P-13-647, P-13-649,
and P-13-679) Fluoroalkyl acrylate copolymer (generic); and (P-13-678)
Fluoroalkyl methacrylate copolymer (generic).
CAS numbers: Claimed confidential.
Effective date of TSCA section 5(e) consent order: August 4, 2014.
Basis for TSCA section 5(e) consent order: The PMNs state that the
generic (non-confidential) use of the substances will be as a tile
treatment (P-13-646 and P-13-648), a textile treatment (P-13-647 and P-
13-649), a water and oil repellent for plastic and inorganic substrates
(P-13-678), and a paper treatment (P-13-679). EPA has concerns for
potential incineration or other decomposition products of the PMN
substances. These perfluorinated decomposition products may be
[[Page 26451]]
released to the environment from incomplete incineration of the PMN
substances at low temperatures. EPA has preliminary evidence, including
data on some fluorinated polymers, which suggests that, under some
conditions, the PMN substances could degrade in the environment. EPA
has concerns that these degradation products will persist in the
environment, could bioaccumulate or biomagnify, and could be toxic
(PBT) to people, wild mammals, and birds. These concerns are based on
data on analogous chemical substances, including perfluorooctanoic acid
(PFOA) and other perfluorinated alkyls, including the presumed
environmental degradant. The order was issued under TSCA sections
5(e)(1)(A)(i), 5(e)(1)(A)(ii)(I), and 5(e)(1)(A)(ii)(II), based on a
finding that these substances may present an unreasonable risk of
injury to the environment and human health, the substances may be
produced in substantial quantities and may reasonably be anticipated to
enter the environment in substantial quantities, and there may be
significant (or substantial) human exposure to the substances and their
potential degradation products. To protect against these exposures and
risks, the consent order requires:
1. Risk notification. If as a result of the test data required, the
company becomes aware that the PMN substances may present a risk of
injury to human health or the environment, the company must incorporate
this new information, and any information on methods for protecting
against such risk into a Material Safety Data Sheet (MSDS), within 90
days.
2. Submission of certain physical/chemical property and
environmental fate testing prior to exceeding the confidential
production volume limits of the PMN substances specified in the consent
order.
3. Recording and reporting of certain fluorinated impurities in the
starting raw material; and manufacture of the PMN substances not to
exceed the maximum established impurity levels of certain fluorinated
impurities.
The SNUR designates as a ``significant new use'' the absence of
these protective measures.
Recommended testing: EPA has determined that the results of certain
toxicity, physical/chemical property and environmental fate testing
identified in the TSCA 5(e) consent order would help characterize
possible effects of the substances and their degradation products. The
Order prohibits the Company from exceeding specified confidential
production volumes unless the Company submits the information described
in the Testing section of this Order in accordance with the conditions
specified in the Testing section. Further, EPA has identified certain
toxicity and environmental fate testing described in the Pended Testing
section of the Preamble to the Order that would help characterize the
PMN substances. The Order does not require submission of the pended
testing at any specified time or production volume. However, the
Order's restrictions on manufacture, processing, distribution in
commerce, use, and disposal of the PMN substances will remain in effect
until the Order is modified or revoked by EPA based on submission of
that or other relevant information.
CFR citations: 40 CFR 721.10816 (P-13-646 and P-13-648); 40 CFR
721.10817 (P-13-647, P-13-649, and P-13-679); and 40 CFR 721.10818 (P-
13-678).
PMN Number P-13-951
Chemical name: Zinc carboxylate (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a destructive use in the
manufacture of coating materials and fuels. Based on SAR analysis of
test data on analogous soluble zinc compounds, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 3 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the substance are not expected to result in surface water
concentrations exceeding 3 ppb. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any use
of the substance that results in releases to surface waters exceeding 3
ppb may result in significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300); and an
algal toxicity test (OCSPP Test Guideline 850.4500) would help
characterize the environmental effects of the PMN substance. EPA also
recommends that the guidance document on aquatic toxicity testing of
difficult substance and mixtures (OECD Test Guideline 23) be consulted
to facilitate solubility in the test media.
CFR citation: 40 CFR 721.10819.
PMN Number P-14-364
Chemical name: Phenol, styrenated, reaction products with
polyethylene glycol and 2-[(2-propen-1-yloxy)methyl]oxirane.
CAS number: 1539128-27-2.
Basis for action: The PMN states that the substance will be used as
a reactive emulsifier for manufacturing aqueous emulsion polymers or
alkyd resins, a dispersant for pigments in aqueous or solvent-based
coatings, and an intermediate for production of related anionic
dispersants. Based on SAR analysis of test data on analogous nonionic
surfactant compounds, EPA predicts toxicity to aquatic organisms may
occur at concentrations that exceed 170 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the substance are
not expected to result in surface water concentrations exceeding 170
ppb. Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance that results
in releases to surface waters exceeding 170 ppb may result in
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test (OPPTS Test
Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline
850.4500); and a ready biodegradability test (OECD Test Guideline 301B)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10820.
PMN Number P-14-382
Chemical name: Quaternary ammonium compounds, tri-C8-10-
alkylmethyl, hydrogen sulfates (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a cleaning component for
fuels. Based on test data on the PMN substance, EPA predicts toxicity
to aquatic organisms may occur at concentrations that exceed 1 ppb of
the PMN substance in surface waters. As described in the PMN, releases
of the substance are not expected to result in surface water
concentrations exceeding 1 ppb. Therefore, EPA has not determined that
the proposed
[[Page 26452]]
manufacturing, processing, or use of the substance may present an
unreasonable risk. EPA has determined, however, that any use of the
substance that results in releases to surface waters exceeding 1 ppb
may result in significant adverse environmental effects. Based on this
information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(i).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10821.
PMN Number P-14-395
Chemical name: 1,2,3-Propanetriol, homopolymer, dodecanoate.
CAS number: 74504-64-6.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a detergent additive.
Based on SAR analysis of test data on analogous nonionic surfactant
compounds, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 18 ppb of the PMN substance in surface
waters. As described in the PMN, releases of the substance are not
expected to result in surface water concentrations exceeding 18 ppb.
Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance that results
in releases to surface waters exceeding 18 ppb may result in
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test (OPPTS Test
Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline
850.4500); and a ready biodegradability test (OECD Test Guideline 301B)
would help characterize the environmental effects of the PMN substance.
EPA also recommends that the guidance document on aquatic toxicity
testing of difficult substance and mixtures (OECD Test Guideline 23) be
consulted to facilitate solubility in the test media.
CFR citation: 40 CFR 721.10822.
PMN Number P-14-564
Chemical name: 2-Propenal, 3-[4-(1-methylethyl)phenyl]-.
CAS number: 6975-24-2.
Basis for action: The PMN states that the generic (non-
confidential) use of the substance will be as a chemical intermediate
for the synthesis of fragrance compounds. Based on SAR analysis of test
data on analogous vinyl/allyl aldehydes, EPA predicts toxicity to
aquatic organisms may occur at concentrations that exceed 1 ppb of the
PMN substance in surface waters. As described in the PMN, releases of
the substance are not expected to result in surface water
concentrations exceeding 1 ppb. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substance may
present an unreasonable risk. EPA has determined, however, that any use
of the substance that results in releases to surface waters exceeding 1
ppb may result in significant adverse environmental effects. Based on
this information, the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test (OPPTS Test
Guideline 850.1010); and an algal toxicity test (OCSPP Test Guideline
850.4500) would help characterize the environmental effects of the PMN
substance.
CFR citation: 40 CFR 721.10823.
PMN Number P-14-594
Chemical name: Brominated filtration residue (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a feed for a bromine recovery unit. Based on the physical/chemical
properties of the PMN substance and test data on structurally similar
substances, the PMN substance is a potentially persistent,
bioaccumulative, and toxic (PBT) chemical, as described in the New
Chemical Program's PBT category (64 FR 60194; November 4, 1999)(FRL-
6097-7). EPA estimates that the PMN substance will persist in the
environment more than 2 months and estimates a bioaccumulation factor
of greater than or equal to 1,000. There are also concerns for liver
toxicity based on the brominated phenyl moiety. As described in the PMN
notice, the PMN substance is not released to surface water. Therefore,
EPA has not determined that the proposed manufacturing, processing, or
use of the substance may present an unreasonable risk. EPA has
determined, however, that any use of the substance other than as
described in the PMN and/or any use of the substance resulting in
surface water releases may result in significant adverse health and
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(3)(ii), (b)(4)(ii), and
(b)(4)(iii).
Recommended testing: EPA has determined that the results of a
partition coefficient (n-octanol/water) test (OPPTS Test Guideline
830.7570/OECD Test Guideline 117); a ready biodegradability test (OPPTS
Test Guideline 835.3110/OECD Test Guideline 301); a fish
bioconcentration factor (BCF) test (OPPTS Test Guideline 850.1730/(OECD
Test Guideline 305); and a water solubility test (OECD Test Guideline
111) would help characterize the health and environmental effects of
the PMN substance. Depending on the results of these tests, additional
testing as identified in the PBT category may be recommended.
CFR citation: 40 CFR 721.10824.
PMN Numbers P-14-616 and P-14-617
Chemical names: Fatty acids reaction products with
polyethylenepolyamine and naphthenic acids (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be in hydrocarbon processing
applications. Based on SAR analysis of test data on analogous aliphatic
amines, EPA predicts toxicity to aquatic organisms may occur at
concentrations that exceed 1 ppb of the PMN substances in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early-
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if releases of the
PMN substances to surface water, from uses other than as described in
the PMNs, exceed releases from the uses described in the PMN. For the
uses described in the PMN, environmental releases did not exceed 1 ppb
for more than 20 days per year. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that any use
of the substances other than as described in the PMNs could result in
exposures which may cause significant adverse environmental effects.
Based on this information, the PMN substances meet the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early life-stage toxicity test (OPPTS Test Guideline 850.1400); a
daphnid chronic
[[Page 26453]]
toxicity test (OPPTS Test Guidelines 850.1300); and an algal toxicity
test (OCSPP Test Guideline 850.4500) would help to characterize the
environmental effects of the PMN substances. EPA also recommends that
the guidance document on aquatic toxicity testing of difficult
substances and mixtures (OECD Test Guideline 23) be consulted to
facilitate solubility in the test media. The Agency prefers that the
testing be completed on P-14-616.
CFR citation: 40 CFR 721.10825.
PMN Number P-14-625
Chemical name: Substituted aminoalkyl nitrile (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the use of the substance will
be as a chemical intermediate. Based on SAR analysis of test data on
analogous aliphatic amines, EPA predicts toxicity to aquatic organisms
may occur at concentrations that exceed 18 ppb of the PMN substance in
surface waters. As described in the PMN, releases of the substance are
not expected to result in surface water concentrations exceeding 18
ppb. Therefore, EPA has not determined that the proposed manufacturing,
processing, or use of the substance may present an unreasonable risk.
EPA has determined, however, that any use of the substance that results
in releases to surface waters exceeding 18 ppb may result in
significant adverse environmental effects. Based on this information,
the PMN substance meets the concern criteria at Sec.
721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test (OPPTS Test
Guideline 850.1010); an algal toxicity test (OCSPP Test Guideline
850.4500); and a ready biodegradability test (OECD Test Guideline 301B)
would help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10826.
PMN Number P-14-640
Chemical name: Cyclooctadiene metal derivatives (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used as
a synthetic intermediate. Based on test data on the analogous metal
compounds, the EPA identified human health concerns regarding acute
handling hazard from exposure to metal compounds. As described in the
PMN, exposure is expected to be minimal for this use. Therefore, EPA
has not determined that the proposed manufacturing, processing, or use
of the substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance other than as a synthetic
intermediate or in any non-enclosed processes may result in significant
adverse human health effects. Based on this information, the PMN
substance meets the concern criteria at Sec. 721.170(b)(3)(ii).
Recommended testing: EPA has determined that the results of a 90-
day subchronic study (OPPTS Test Guideline 870.3100) in rats, by
inhalation route, would help characterize the human health effects of
the PMN substance.
CFR citation: 40 CFR 721.10827.
PMN Numbers P-14-792, P-14-793, and P-14-794
Chemical names: (P-14-792, Chemical A; P-14-793; and P-14-794)
1,2,3-Propanetriol, homopolymer, alkanoates (generic) and (P-14-792,
Chemical B) Glycerides, alkanoate, mono-, di- and tri- (generic).
CAS numbers: Claimed confidential.
Basis for action: The PMNs state that the generic (non-
confidential) use of the substances will be as agricultural additives.
Based on SAR analysis of test data on analogous non-ionic surfactants,
EPA predicts chronic toxicity to aquatic organisms may occur at
concentrations that exceed 53 ppb of the PMN substances in surface
waters for greater than 20 days per year. This 20-day criterion is
derived from partial life cycle tests (daphnid chronic and fish early
life stage tests) that typically range from 21 to 28 days in duration.
EPA predicts toxicity to aquatic organisms may occur if releases of the
PMN substances to surface water, from uses other than as described in
the PMNs, exceed releases from the use described in the PMNs. For the
use described in the PMNs, environmental releases did not exceed 53 ppb
for more than 20 days per year. Therefore, EPA has not determined that
the proposed manufacturing, processing, or use of the substances may
present an unreasonable risk. EPA has determined, however, that any use
of the substances other than as described in the PMNs could result in
exposures which may cause significant adverse environmental effects.
Based on this information, the PMN substances meet the concern criteria
at Sec. 721.170(b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
acute toxicity test, freshwater and marine (OPPTS Test Guideline
850.1075); an aquatic invertebrate acute toxicity test, freshwater
daphnids (OPPTS Test Guidelines 850.1010); and an algal toxicity test
(OCSPP Test Guideline 850.4500) would help to characterize the
environmental effects of the PMN substances.
CFR citations: 40 CFR 721.10828 (P-14-792, Chemical A; P-14-792,
Chemical B; P-14-793; and P-14-794)
PMN Number P-14-800
Chemical name: Xanthylium, x-[2-(alcoxycarbonyl)phenyl]-
bis(alkylamino)-dimethyl-, x'-[x''-[hydroxy-x'''-[[[[hydroxy-x''''-
(phenyldiazenyl)-sulfo-2-naphthalenyl]amino]carbonyl]amino]sulfo-
naphthalenyl]diazenyl]benzoate, sodium salt (generic).
CAS number: Claimed confidential.
Basis for action: The PMN states that the substance will be used in
ink for ball point pens. Based on an analog of the PMN substance, EPA
predicts toxicity to aquatic organisms may occur at concentrations that
exceed 1 ppb of the PMN substance in surface waters. As described in
the PMN, releases of the substance are not expected to result in
surface water concentrations that exceed 1 ppb. Therefore, EPA has not
determined that the proposed manufacturing, processing, or use of the
substance may present an unreasonable risk. EPA has determined,
however, that any use of the substance resulting in surface water
concentrations exceeding 1 ppb may cause significant adverse
environmental effects. Based on this information, the PMN substance
meets the concern criteria at Sec. 721.170 (b)(4)(i) and (b)(4)(ii).
Recommended testing: EPA has determined that the results of a fish
early-life stage toxicity test (OPPTS Test Guideline 850.1400) and a
daphnid chronic toxicity test (OPPTS Test Guideline 850.1300) would
help characterize the environmental effects of the PMN substance.
CFR citation: 40 CFR 721.10829.
V. Rationale and Objectives of the Rule
A. Rationale
During review of the PMNs submitted for the chemical substances
that are subject to these SNURs, EPA concluded that for 9 of the 25
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) consent orders requiring the use
of appropriate exposure controls were negotiated with the PMN
submitters. The SNUR
[[Page 26454]]
provisions for these chemical substances are consistent with the
provisions of the TSCA section 5(e) consent orders. These SNURs are
promulgated pursuant to Sec. [emsp14]721.160 (see Unit VI.).
In the other 16 cases, where the uses are not regulated under a
TSCA section 5(e) consent order, EPA determined that one or more of the
criteria of concern established at Sec. [emsp14]721.170 were met, as
discussed in Unit IV.
B. Objectives
EPA is issuing these SNURs for specific chemical substances which
have undergone premanufacture review because the Agency wants to
achieve the following objectives with regard to the significant new
uses designated in this rule:
EPA will 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.
EPA will have an opportunity to review and evaluate data
submitted in a SNUN before the notice submitter begins manufacturing or
processing a listed chemical substance for the described significant
new use.
EPA will be able to regulate prospective manufacturers or
processors of a listed chemical substance before the described
significant new use of that chemical substance occurs, provided that
regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
EPA will ensure that all manufacturers and processors of
the same chemical substance that is subject to a TSCA section 5(e)
consent order are subject to similar requirements.
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. Direct Final Procedures
EPA is issuing these SNURs as a direct final rule, as described in
Sec. [emsp14]721.160(c)(3) and Sec. [emsp14]721.170(d)(4). In
accordance with Sec. [emsp14]721.160(c)(3)(ii) and Sec.
[emsp14]721.170(d)(4)(i)(B), the effective date of this rule is July 7,
2015 without further notice, unless EPA receives written adverse or
critical comments, or notice of intent to submit adverse or critical
comments before June 8, 2015.
If EPA receives written adverse or critical comments, or notice of
intent to submit adverse or critical comments, on one or more of these
SNURs before June 8, 2015, EPA will withdraw the relevant sections of
this direct final rule before its effective date. EPA will then issue a
proposed SNUR for the chemical substance(s) on which adverse or
critical comments were received, providing a 30-day period for public
comment.
This rule establishes SNURs for a number of chemical substances.
Any person who submits adverse or critical comments, or notice of
intent to submit adverse or critical comments, must identify the
chemical substance and the new use to which it applies. EPA will not
withdraw a SNUR for a chemical substance not identified in the comment.
VII. Applicability of the 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 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 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) consent orders have
been issued for 9 of the 25 chemical substances, and the PMN submitters
are prohibited by the TSCA section 5(e) consent orders from undertaking
activities which would be designated as significant new uses. The
identities of 21 of the 25 chemical substances subject to this rule
have been claimed as confidential and EPA has received no post-PMN bona
fide submissions (per Sec. Sec. 720.25 and 721.11). 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 rule are ongoing.
Therefore, EPA designates May 8, 2015 as the cutoff date for
determining whether the new use is ongoing. 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 the notice
review period, including any extensions, expires. If such a person met
the conditions of advance compliance under Sec. 721.45(h), the person
would be considered exempt from the requirements of the SNUR. Consult
the Federal Register document of April 24, 1990 for a more detailed
discussion of the cutoff date for ongoing uses.
VIII. Test Data and Other Information
EPA recognizes that TSCA section 5 does not require developing any
particular test data before submission of a SNUN. The two exceptions
are:
1. Development of test data is required where the chemical
substance subject to the SNUR is also subject to a test rule under TSCA
section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical
substance has been listed under TSCA section 5(b)(4) (see TSCA section
5(b)(2)).
In the absence of a TSCA section 4 test rule or a TSCA section
5(b)(4) listing covering the chemical substance, persons are required
only to submit test data in their possession or control and to describe
any other data 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. In cases where EPA issued a
TSCA section 5(e) consent order that requires or recommends certain
testing, Unit IV. lists those tests. Unit IV. also lists recommended
testing for TSCA non-section 5(e) SNURs. Descriptions of tests are
provided for informational purposes. EPA strongly encourages persons,
before performing any testing, to consult with the Agency pertaining to
protocol selection. 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 (OECD) test guidelines are available from
the OECD Bookshop at https://www.oecdbookshop.org or SourceOECD at
https://www.sourceoecd.org.
In the TSCA section 5(e) consent orders for several of the chemical
substances regulated under this rule, EPA has established production
volume limits in view of the lack of data on the potential health and
environmental risks that may be posed by the significant new uses or
increased exposure to the chemical substances. These limits cannot be
exceeded unless the PMN submitter first submits the results of toxicity
tests that would
[[Page 26455]]
permit a reasoned evaluation of the potential risks posed by these
chemical substances. Under recent TSCA section 5(e) consent orders,
each PMN submitter is required to submit each study before reaching the
specified production limit. Listings of the tests specified in the TSCA
section 5(e) consent orders are included in Unit IV. The SNURs contain
the same production volume limits as the TSCA section 5(e) consent
orders. Exceeding these production limits is defined as a significant
new use. Persons who intend to exceed the production limit must notify
the Agency by submitting a SNUN at least 90 days in advance of
commencement of non-exempt commercial manufacture or processing.
The recommended tests specified in Unit IV. may not be the only
means of addressing the potential risks of the chemical substance.
However, submitting a SNUN without any test data may increase the
likelihood that EPA will take action under TSCA section 5(e),
particularly if satisfactory test results have not been obtained from a
prior PMN or SNUN submitter. 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.
Potential benefits of the chemical substances.
Information on risks posed by the chemical substances
compared to risks posed by potential substitutes.
IX. Procedural Determinations
By this rule, EPA is establishing certain significant new uses
which have been claimed as CBI subject to Agency confidentiality
regulations at 40 CFR part 2 and 40 CFR part 720, subpart E. Absent a
final determination or other disposition of the confidentiality claim
under 40 CFR part 2 procedures, EPA is required to keep this
information confidential. EPA promulgated a procedure to deal with the
situation where a specific significant new use is CBI, at 40 CFR
721.1725(b)(1).
Under these procedures a manufacturer or processor may request EPA
to determine whether a proposed use would be a significant new use
under the rule. The manufacturer or processor must show that it has a
bona fide intent to manufacture or process the chemical substance and
must identify the specific use for which it intends to manufacture or
process the chemical substance. If EPA concludes that the person has
shown a bona fide intent to manufacture or process the chemical
substance, EPA will tell the person whether the use identified in the
bona fide submission would be a significant new use under the rule.
Since most of the chemical identities of the chemical substances
subject to these SNURs are also CBI, manufacturers and processors can
combine the bona fide submission under the procedure in Sec.
[emsp14]721.1725(b)(1) with that under Sec. [emsp14]721.11 into a
single step.
If EPA determines that the use identified in the bona fide
submission would not be a significant new use, i.e., the use does not
meet the criteria specified in the rule for a significant new use, that
person can manufacture or process the chemical substance so long as the
significant new use trigger is not met. In the case of a production
volume trigger, this means that the aggregate annual production volume
does not exceed that identified in the bona fide submission to EPA.
Because of confidentiality concerns, EPA does not typically disclose
the actual production volume that constitutes the use trigger. Thus, if
the person later intends to exceed that volume, a new bona fide
submission would be necessary to determine whether that higher volume
would be a significant new use.
X. SNUN Submissions
According to Sec. [emsp14]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 Sec. 721.25. E-PMN software is
available electronically at https://www.epa.gov/opptintr/newchems.
XI. Economic Analysis
EPA has evaluated the potential costs of establishing SNUN
requirements for potential manufacturers and processors of the chemical
substances subject to this rule. EPA's complete economic analysis is
available in the docket under docket ID number EPA-HQ-OPPT-2014-0908.
XII. Statutory and Executive Order Reviews
A. Executive Order 12866
This action establishes SNURs for several new chemical substances
that were the subject of PMNs, or TSCA section 5(e) consent orders. The
Office of Management and Budget (OMB) has exempted these types of
actions from review under Executive Order 12866, entitled ``Regulatory
Planning and Review'' (58 FR 51735, October 4, 1993).
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. EPA is amending the table in 40 CFR part 9 to list the OMB
approval number for the information collection requirements contained
in this action. This listing of the OMB control numbers and their
subsequent codification in the CFR satisfies the display requirements
of PRA and OMB's implementing regulations at 5 CFR part 1320. This
Information Collection Request (ICR) was previously subject to public
notice and comment prior to OMB approval, and given the technical
nature of the table, EPA finds that further notice and comment to amend
it is unnecessary. As a result, EPA finds that there is ``good cause''
under section 553(b)(3)(B) of the Administrative Procedure Act (5
U.S.C. 553(b)(3)(B)) to amend this table without further notice and
comment.
The information collection requirements related to this action have
already been approved by OMB pursuant to PRA under OMB control number
2070-0012 (EPA ICR No. 574). This action does not impose any burden
requiring additional OMB approval. If an entity were to submit a SNUN
to the Agency, the annual burden is estimated to average between 30 and
170 hours per response. This burden estimate includes the time needed
to review instructions, search existing data sources, gather and
maintain the data needed, and complete, review, and submit the required
SNUN.
Send any comments about the accuracy of the burden estimate, and
any suggested methods for minimizing respondent burden, including
through the use of automated collection
[[Page 26456]]
techniques, to the Director, Collection Strategies Division, Office of
Environmental Information (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)
On February 18, 2012, EPA certified pursuant to RFA section 605(b)
(5 U.S.C. 601 et seq.), that promulgation of a SNUR does not have a
significant economic impact on a substantial number of small entities
where the following are true:
1. A significant number of SNUNs would not be submitted by small
entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost
significantly more than $8,300.
A copy of that certification is available in the docket for this
action.
This action is within the scope of the February 18, 2012
certification. Based on the Economic Analysis discussed in Unit XI. and
EPA's experience promulgating SNURs (discussed in the certification),
EPA believes that the following are true:
A significant number of SNUNs would not be submitted by
small entities in response to the SNUR.
Submission of the SNUN would not cost any small entity
significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a
significant economic impact on a substantial number of small entities.
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 action does not impose any
enforceable duty, contain any unfunded mandate, or otherwise have any
effect on small governments subject to the requirements of UMRA
sections 202, 203, 204, or 205 (2 U.S.C. 1501 et seq.).
E. Executive Order 13132
This action will 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, entitled
``Federalism'' (64 FR 43255, August 10, 1999).
F. Executive Order 13175
This action does not have Tribal implications because it is not
expected to have substantial direct effects on Indian Tribes. This
action does not significantly nor uniquely affect the communities of
Indian Tribal governments, nor does it involve or impose any
requirements that affect Indian Tribes. Accordingly, the requirements
of Executive Order 13175, entitled ``Consultation and Coordination with
Indian Tribal Governments'' (65 FR 67249, November 9, 2000), do not
apply to this action.
G. Executive Order 13045
This action is not subject to Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (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
This action is not subject to Executive Order 13211, entitled
``Actions Concerning Regulations That Significantly Affect Energy
Supply, Distribution, or Use'' (66 FR 28355, May 22, 2001), because
this action is not expected to affect energy supply, distribution, or
use and because this action is not a significant regulatory action
under Executive Order 12866.
I. National Technology Transfer and Advancement Act (NTTAA)
In addition, since this action does not involve any technical
standards, NTTAA section 12(d) (15 U.S.C. 272 note), does not apply to
this action.
J. Executive Order 12898
This action does not entail special considerations of environmental
justice related issues as delineated by Executive Order 12898, entitled
``Federal Actions to Address Environmental Justice in Minority
Populations and Low-Income Populations'' (59 FR 7629, February 16,
1994).
XIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects
40 CFR Part 9
Environmental protection, Reporting and recordkeeping requirements.
40 CFR Part 721
Environmental protection, Chemicals, Hazardous substances,
Reporting and recordkeeping requirements.
Dated: May 1, 2015.
Maria J. Doa,
Director, Chemical Control Division, Office of Pollution Prevention and
Toxics.
Therefore, 40 CFR parts 9 and 721 are amended as follows:
PART 9--[AMENDED]
0
1. The authority citation for part 9 continues to read as follows:
Authority: 7 U.S.C. 135 et seq., 136-136y; 15 U.S.C. 2001, 2003,
2005, 2006, 2601-2671; 21 U.S.C. 331j, 346a, 348; 31 U.S.C. 9701; 33
U.S.C. 1251 et seq., 1311, 1313d, 1314, 1318, 1321, 1326, 1330,
1342, 1344, 1345 (d) and (e), 1361; E.O. 11735, 38 FR 21243, 3 CFR,
1971-1975 Comp. p. 973; 42 U.S.C. 241, 242b, 243, 246, 300f, 300g,
300g-1, 300g-2, 300g-3, 300g-4, 300g-5, 300g-6, 300j-1, 300j-2,
300j-3, 300j-4, 300j-9, 1857 et seq., 6901-6992k, 7401-7671q, 7542,
9601-9657, 11023, 11048.
0
2. In Sec. [emsp14]9.1, add the following sections in numerical order
under the undesignated center heading ``Significant New Uses of
Chemical Substances'' to read as follows:
Sec. [emsp14]9.1 OMB approvals under the Paperwork Reduction Act.
* * * * *
------------------------------------------------------------------------
OMB control
40 CFR citation No.
------------------------------------------------------------------------
* * * * *
------------------------------------------------------------------------
Significant New Uses of Chemical Substances
------------------------------------------------------------------------
* * * * *
721.10812............................................... 2070-0012
721.10813............................................... 2070-0012
721.10814............................................... 2070-0012
721.10815............................................... 2070-0012
721.10816............................................... 2070-0012
721.10817............................................... 2070-0012
721.10818............................................... 2070-0012
721.10819............................................... 2070-0012
721.10820............................................... 2070-0012
721.10821............................................... 2070-0012
721.10822............................................... 2070-0012
721.10823............................................... 2070-0012
721.10824............................................... 2070-0012
[[Page 26457]]
721.10825............................................... 2070-0012
721.10826............................................... 2070-0012
721.10827............................................... 2070-0012
721.10828............................................... 2070-0012
721.10829............................................... 2070-0012
* * * * *
------------------------------------------------------------------------
* * * * *
PART 721--[AMENDED]
0
3. The authority citation for part 721 continues to read as follows:
Authority: 15 U.S.C. 2604, 2607, and 2625(c).
0
4. Add Sec. 721.10812 to subpart E to read as follows:
Sec. 721.10812 Alkylbenzene sulfonic acid (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
alkylbenzene sulfonic acid (PMN P-12-115) 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 PMN substance that have partitioned into oil or
petroleum streams following use as an interfacial tension reducer for
enhanced oil recovery applications.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72(a) through (f), (g)(3), (g)(4)(ii), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80. A significant new use is any
manufacturing, processing, or use of the PMN substance other than as a
chemical intermediate to prepare an interfacial tension reducer for
enhanced oil recovery.
(iii) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (where N=4).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), (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.
0
5. Add Sec. 721.10813 to subpart E to read as follows:
Sec. 721.10813 Benzenesulfonic acid, dimethyl-, alkyl derivatives,
sodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
benzenesulfonic acid, dimethyl-, alkyl derivatives, sodium salt (PMNs
P-12-116 and P-13-568) 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 PMN
substance that have partitioned into oil or petroleum streams when used
in enhanced oil recovery applications.
(2) The significant new uses are:
(i) Hazard communication program. Requirements as specified in
Sec. 721.72(a) through (f), (g)(1) (corrosion to the eyes, mucous
membranes, skin, and lungs), (g)(2)(i), (g)(2)(ii), (g)(2)(iii),
(g)(2)(v), (g)(3), (g)(4)(ii), and (g)(5).
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (manufacturing, processing, or use of
the PMN substance other than as an interfacial tension reducer for
enhanced oil recovery or the confidential use as stated in the consent
order for P-13-568) and Sec. 721.80(q) (production volume limit as
stated in the consent order for P-13-568).
(iii) Release to water. Requirements as specified in Sec. 721.90
(a)(4), (b)(4), and (c)(4) (where N=4).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), (g), (h), (i), and (k) are applicable to
manufacturers and processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to paragraph (a)(2)(ii) of
this section.
0
6. Add Sec. [emsp14]721.10814 to subpart E to read as follows:
Sec. [emsp14]721.10814 2-Propenoic acid, 3-phenyl-, zinc salt (2:1),
(2E)-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenoic acid,
3-phenyl-, zinc salt (2:1), (2E)- (PMN P-12-397; CAS No. 18957-59-0) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Industrial commercial, and consumer activities. Requirements as
specified in Sec. 721.80. A significant new use is any use of the PMN
substance other than as a reinforcing additive in polyolefins.
(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), (b), (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.
0
7. Add Sec. [emsp14]721.10815 to subpart E to read as follows:
Sec. [emsp14]721.10815 Fatty acids, satd. and unsatd alkyl-, esters
with polyol (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as fatty
acids, satd. and unsatd alkyl-, esters with polyol (PMN P-13-139) 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. A significant new use is any use of the PMN
substance other than as an ingredient in a multipurpose additive in
gasoline to reduce friction in engines.
(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), (b), (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.
0
8. Add Sec. 721.10816 to subpart E to read as follows:
Sec. 721.10816 Fluoroalkyl acrylate copolymer modified with
polysiloxanes (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
fluoroalkyl acrylate copolymer modified with polysiloxanes (PMNs P-13-
646 and P-13-648) are subject to reporting under this section
[[Page 26458]]
for the significant new uses described in paragraph (a)(2) of this
section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of the
substances is any manner or method of manufacture or processing
associated with any use of the substances without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substances, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance(s) are
not being manufactured, processed, or used in the employer's workplace,
the employer must add the new information to a MSDS before the
substance(s) are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance(s) from the employer, or who have received the PMN
substance(s) from the employer within 5 years from the date the
employer becomes aware of the new information described in paragraph
(a)(2)(i)(A) of this section, are provided an MSDS containing the
information required under paragraph (a)(2)(i)(A) of this section
within 90 days from the time the employer becomes aware of the new
information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order, which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and Sec. 721.80(q).
(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), (f), and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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.
0
9. Add Sec. 721.10817 to subpart E to read as follows:
Sec. 721.10817 Fluoroalkyl acrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as
fluoroalkyl acrylate copolymer (PMNs P-13-647, P-13-649, and P-13-679)
are subject to reporting under this section for the significant new
uses described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Hazard communication program. A significant new use of the
substances is any manner or method of manufacture or processing
associated with any use of the substances without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substances, the employer becomes aware that
the substances may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance(s) are
not being manufactured, processed, or used in the employer's workplace,
the employer must add the new information to a MSDS before the
substance(s) are reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance(s) from the employer, or who have received the PMN
substance(s) from the employer within 5 years from the date the
employer becomes aware of the new information described in paragraph
(a)(2)(i)(A) of this section, are provided an MSDS containing the
information required under paragraph (a)(2)(i)(A) of this section
within 90 days from the time the employer becomes aware of the new
information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order, which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and Sec. 721.80(q).
(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), (f), and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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.
0
10. Add Sec. 721.10818 to subpart E to read as follows:
Sec. 721.10818 Fluoroalkyl methacrylate copolymer (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
fluoroalkyl methacrylate copolymer (PMN P-13-678) 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 program. A significant new use of the
substance is any manner or method of manufacture or processing
associated with any use of the substance without providing risk
notification as follows:
(A) If as a result of the test data required under the TSCA section
5(e) consent order for the substance, the employer becomes aware that
the substance may present a risk of injury to human health or the
environment, the employer must incorporate this new information, and
any information on methods for protecting against such risk, into a
MSDS as described in Sec. 721.72(c) within 90 days from the time the
employer becomes aware of the new information. If the substance is not
being manufactured, processed, or used in the employer's workplace, the
employer must add the new information to a MSDS before the substance is
reintroduced into the workplace.
(B) The employer must ensure that persons who will receive the PMN
substance from the employer, or who have received the PMN substance
from the employer within 5 years from the date the employer becomes
aware of the new information described in paragraph (a)(2)(i)(A) of
this section, are provided an MSDS containing the information required
under paragraph (a)(2)(i)(A) of this section within 90 days from the
time the employer becomes aware of the new information.
(ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(k) (a significant new use is any use other
than as allowed by the section 5(e) consent order, which includes
analysis and reporting and limitations of maximum impurity levels of
certain fluorinated impurities), and Sec. 721.80(q).
(b) Specific requirements. The provisions of subpart A of this part
[[Page 26459]]
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (f), 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)(ii) of
this section.
0
11. Add Sec. [emsp14]721.10819 to subpart E to read as follows:
Sec. [emsp14]721.10819 Zinc carboxylate (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as zinc
carboxylate (PMN P-13-951) 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) (N=3).
(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), (b), (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.
0
12. Add Sec. [emsp14]721.10820 to subpart E to read as follows:
Sec. [emsp14]721.10820 Phenol, styrenated, reaction products with
polyethylene glycol and 2-[(2-propen-1-yloxy)methyl]oxirane.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as phenol, styrenated,
reaction products with polyethylene glycol and 2-[(2-propen-1-
yloxy)methyl]oxirane (PMN P-14-364; CAS No. 1539128-27-2) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=170).
(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), (b), (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.
0
13. Add Sec. [emsp14]721.10821 to subpart E to read as follows:
Sec. [emsp14]721.10821 Quaternary ammonium compounds, tri-C8-10-
alkylmethyl, hydrogen sulfates (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
quaternary ammonium compounds, tri-C8-10-alkylmethyl, hydrogen sulfates
(PMN P-14-382) 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) (N=1).
(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), (b), (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.
0
14. Add Sec. [emsp14]721.10822 to subpart E to read as follows:
Sec. [emsp14]721.10822 1,2,3-Propanetriol, homopolymer, dodecanoate.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 1,2,3-propanetriol,
homopolymer, dodecanoate (PMN P-14-395; CAS Number 74504-64-6) is
subject to reporting under this section for the significant new uses
described in paragraph (a)(2) of this section.
(2) The significant new uses are:
(i) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=18).
(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), (b), (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.
0
15. Add Sec. [emsp14]721.10823 to subpart E to read as follows:
Sec. [emsp14]721.10823 2-Propenal, 3-[4-(1-methylethyl)phenyl]-.
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified as 2-propenal, 3-[4-
(1-methylethyl)phenyl]- (PMN P-14-564; CAS No. 6975-24-2) 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) Release to water. Requirements as specified in Sec.
721.90(a)(4), (b)(4), and (c)(4) (N=1).
(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), (b), (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.
0
16. Add Sec. [emsp14]721.10824 to subpart E to read as follows:
Sec. [emsp14]721.10824 Brominated filtration residue (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
brominated filtration residue (PMN P-14-594) 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. A significant new use is any use of the
PMN substance other than as a feed for bromine recovery unit.
(ii) Release to water. Requirements as specified in Sec.
721.90(a)(1), (b)(1), and (c)(1).
(b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
(1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125(a), (b), (c), (i), and (k) are applicable to manufacturers and
processors of this substance.
(2) Limitations or revocation of certain notification requirements.
The
[[Page 26460]]
provisions of Sec. 721.185 apply to this section.
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17. Add Sec. [emsp14]721.10825 to subpart E to read as follows:
Sec. [emsp14]721.10825 Fatty acids reaction products with
polyethylenepolyamine and naphthenic acids (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as fatty
acids reaction products with polyethylenepolyamine and naphthenic acids
(PMNs P-14-616 and P-14-617) are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(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), (b), (c), and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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.
0
18. Add Sec. [emsp14]721.10826 to subpart E to read as follows:
Sec. [emsp14]721.10826 Substituted aminoalkyl nitrile (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
substituted aminoalkyl nitrile (PMN P-14-625) 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) (N=18).
(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), (b), (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.
0
19. Add Sec. [emsp14]721.10827 to subpart E to read as follows:
Sec. [emsp14]721.10827 Cyclooctadiene metal derivatives (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
cyclooctadiene metal derivatives (PMN P-14-640) 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. A significant new use is any use in non-
enclosed processes or any use other than as a synthetic intermediate.
(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), (b), (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.
0
20. Add Sec. [emsp14]721.10828 to subpart E to read as follows:
Sec. [emsp14]721.10828 1,2,3-Propanetriol, homopolymer, alkanoates
(generic) and Glycerides, alkanoate, mono-, di- and tri- (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substances identified generically as 1,2,3-
propanetriol, homopolymer, alkanoates (PMNs P-14-792, Chemical A; P-14-
793; and P-14-794) and generically as glycerides, alkanoate, mono-, di-
and tri- (PMN P-14-792, Chemical B) are subject to reporting under this
section for the significant new uses described in paragraph (a)(2) of
this section.
(2) The significant new uses are:
(i) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80(j).
(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), (b), (c), and (i) are applicable to manufacturers and
processors of these substances.
(2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
(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.
0
21. Add Sec. [emsp14]721.10829 to subpart E to read as follows:
Sec. [emsp14]721.10829 Xanthylium, x-[2-(alcoxycarbonyl)phenyl]-
bis(alkylamino)-dimethyl-, x'-[x'' -[hydroxy-x'''-[[[[hydroxy-x''''-
(phenyldiazenyl)-sulfo-2-naphthalenyl]amino]carbonyl]amino]sulfo-
naphthalenyl]diazenyl]benzoate, sodium salt (generic).
(a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as
xanthylium, x-[2-(alcoxycarbonyl)phenyl]-bis(alkylamino)-dimethyl-, x'-
[x'' -[hydroxy-x'''-[[[[hydroxy-x''''-(phenyldiazenyl)-sulfo-2-
naphthalenyl]amino]carbonyl]amino]sulfo-naphthalenyl]diazenyl]benzoate,
sodium salt (PMN P-14-800) 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) (N=1).
(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), (b), (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.
[FR Doc. 2015-11166 Filed 5-7-15; 8:45 am]
BILLING CODE 6560-50-P